View the titles and descriptions of the posters presented at the meeting below.
Concordance of Quantitative and Qualitative Findings in Research on People with Bipolar Disorder and Behavioral Health Care
Our mixed-method project used claims data to estimate impacts on individuals with bipolar disorder after their employers switched them from traditional insurance plans to high-deductible plans, which impose substantially higher patient costs. Separately, we conducted in-depth interviews with comparable individuals to understand their experiences navigating diverse employer-sponsored health plans and coping with the costs of treatment. In the claims analyses, plan members appeared to respond to increased costs by reducing psychotherapy visits, but they did not reduce psychiatrist visits or use of bipolar medications. Interviews provided rich illustration and explanation for our quantitative findings. Respondents varied widely in their perceived current need for psychotherapy. In contrast, respondents consistently prioritized having a psychiatrist prescriber and psychiatric medications that enabled their daily functioning. Respondents also more often reported that they were underutilizing needed psychotherapy care due to costs than skipping psychiatrist care or medication use due to costs.
A Transitional Care Intervention to Improve Outcomes after Stroke or TIA: The COMprehensive Post-Acute Stroke Services (COMPASS) Study
Mild stroke and transient ischemic attack (TIA) patients have multiple comorbidities, poor risk factor knowledge and management, residual disability, and high readmissions. Effective transitional care may optimize recovery and secondary prevention. The COMprehensive Post-Acute Stroke Services (COMPASS) Study sought to determine if implementation of comprehensive transitional care for stroke and TIA patients discharged home improves functional status compared to usual care. Outcomes measured post discharge included mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, and falls. There was no significant effect on patients’ functional outcomes compared to usual care, but treated patients may experience clinically meaningful improvements compared to non-treated patients, suggesting COMPASS could improve outcomes if implementation barriers were addressed. The identification of factors which contributed to implementation of transitional care may help other hospitals prepare for transitional care models in real-world clinical practice.
Hearing Norton Sound: A Mixed Methods Community Randomized Trial to Address Childhood Hearing Loss in Rural Alaska
Ear infection is one of the top diagnoses in communities served by Norton Sound Health Corporation. It often results in hearing loss and can impact Alaska Native traditional oral culture, school performance, and vocational opportunities. School hearing screening is state-mandated, but accuracy of the current screening process is unknown, and a referral system is not yet in place to prevent children being lost to follow-up. While Alaska has a well-established telemedicine network to provide health care to remote regions, this has never been applied to school hearing screenings. The Hearing Norton Sound project is a mixed methods evaluation of a cluster-randomized trial led by a diverse team of stakeholders to evaluate a new mHealth school hearing screening and telemedicine referral process. Outcomes include evaluation of referral processes, accuracy of screening solutions, prevalence of hearing loss, hearing-related quality of life, and academic performance. We are currently in preliminary analysis.
Examining Latino Men’s Preferences for and Engagement in Diabetes Prevention in Primary Care
Obesity is a major contributor to the leading causes of death among all men, and Latino men have the highest rate of obesity among US men. Behavioral lifestyle interventions that promote sustained, modest weight loss are recommended. However, evidence for how best to deliver these interventions is based on research conducted primarily in non-Hispanic white women. To address this gap, Latino men were randomized in the HOMBRE intervention or a minimal intensity intervention. In the HOMBRE intervention, a trained lifestyle coach met with participants to facilitate an informed choice of delivery modalities for a behavioral lifestyle intervention: (1) individual approach via videos, (2) online coach-facilitated groups, or (3) in-person coach-facilitated groups. We will examine participants’ intervention preferences according to their demographic, clinical, and psychosocial characteristics. We will also examine men’s engagement in the intensive phase of the intervention according to their demographic, clinical, and psychosocial characteristics.
Comparative Effectiveness and Maintenance of Diabetes Self-Management Education Interventions for Marshallese Patients with Type 2 Diabetes
Previous diabetes self-management education (DSME) interventions among Marshallese patients have shown mixed results. A randomized controlled trial compared standard-model DSME with culturally adapted family-model DSME (adapted DSME). Marshallese adults with type 2 diabetes received either standard DSME in a community setting or adapted DSME in a home setting. The primary outcome measure was improved glycemic control, evaluated as change in glycated hemoglobin. Participants in the adapted DSME arm showed significantly greater declines in mean glycated hemoglobin immediately and 12 months after the intervention than those in the standard DSME arm.
The Language Access Systems Improvement (LASI) Study
This study evaluated the impact of Language Access Systems Improvement (certification of clinicians’ non-English language skills, along with easy access to professional interpreters through videoconferencing) on communication and clinical outcomes for patients with limited English proficiency. We will be presenting results related to the following: new methodology to define language concordance, changes in interpreter utilization for primary care visits, patient report of interpretation quality by modality, patient ratings of physician non-English language skills, development of a physician language assessment tool, and comparison of communication elements by language concordance/discordance-interpretation during primary care visits.
Descriptive Characteristics of Participants in a CER Study of Two Models of Culturally Competent Diabetes Self-Management for Latinos from Low-Income Households
This poster presents baseline data gathered in our study, A Patient-Centered Framework to Identify Culturally and Contextually Appropriate Options for Latinos with Diabetes from Low-Income Households. Data were gathered from 226 Latino diabetes or prediabetes patients from low-income households and their corresponding 226 social supports. Patients and social supports were enrolled as dyads. Characteristics described for all participants include gender, age, level of education, and diabetes knowledge. Characteristics described for patients also includes A1c, BMI, and patient activation.
Which Patients are Likely to Refuse to Participate in a Clinical Trial? A Latent Class Analysis
This study used a latent class analysis to identify patient factors predictive of trial participation at a single clinical site.
Reducing Disparities in Knowledge and Use of Effective Contraception among Latina Adolescents Using a Patient-Centered, Mobile Health Application: Health-E You/Salud iTu
Health-E You/Salud iTu is a mobile health application that provides patient-centered contraceptive decision-making support to reduce disparities in knowledge and use of effective contraception among Latina adolescents. App recommendations are tailored to an individual’s responses to questions that are important when choosing contraception. User selections and app recommendations are printed for the clinician before the face-to face visit. Study participants completed a baseline previsit survey and follow-up surveys within 48 hours, 3 and 6 months postvisit. A cluster randomized controlled trial of 18 school-based health centers with 1,360 Latina adolescents showed significant increases in knowledge and contraception use self-efficacy among app users at immediate follow-up. Compared to controls, app users also reported significantly larger increases in prevalence of non-barrier contraceptive method use from baseline to 3 months and 6 months. Clinicians and adolescents reported that the app improved the quality and efficiency of the visit.
Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression
Mothers and Babies (MB) is a perinatal depression-preventive intervention that has proven effective in reducing depressive symptoms and the onset of postpartum depression when delivered in a group setting by clinicians. Our PCORI-funded cluster-randomized trial is comparing the effectiveness of MB delivered by paraprofessional home visitors vs. clinicians. We recruited 45 home-visiting programs in seven states and randomized them into one of three study arms: MB delivered by a mental health clinician, MB delivered by a paraprofessional, or usual care (control). Eight hundred seventy-four pregnant women were enrolled in the study. Mixed methods were used to collect data from intervention facilitators and intervention recipients on implementation outcomes related to intervention fidelity, dosage, acceptability, and appropriateness. Analyses of these data indicated that paraprofessional home visitors were able to deliver MB with similar adherence, competency, and acceptability as mental health clinicians.
Home Away from Home: Medical and Patient Outcomes in Children Treated Outpatient or Inpatient after Chemotherapy for Acute Myeloid Leukemia
Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy treatments resulting in profound neutropenia during which patients are highly susceptible to severe infections. Approximately three-quarters of centers hospitalize pediatric AML patients until neutrophil recovery but one-quarter of centers discharge patients to outpatient care. There are no studies in children comparing medical or patient outcomes of these two management strategies. We sought to evaluate the comparative effectiveness of outpatient and inpatient strategies to neutropenia management. In aim 1, we compared important clinical outcomes, including the incidence of bacteremia and time to subsequent chemotherapy course, for outpatient relative to inpatient management. In aim 2, we interviewed patients and caregivers to identify the outcomes related to the management of neutropenia that are most important to children with AML and their caregivers. In aim 3, we compared quality of life and other patient-centered outcomes identified in aim 2 across neutropenia management strategies.
Comparing the Efficacy of Cognitive Behavioral Therapy versus Sertraline Treatment of Depression for Patients Undergoing Maintenance Hemodialysis
Depression is prevalent in patients receiving maintenance hemodialysis, but there is limited data on the utility of standard depression treatments in this population. The primary interventional aim of the study was to compare the efficacy of cognitive behavioral therapy (CBT) versus sertraline for treating depression in patients receiving hemodialysis. The intervention was conducted with patients who had been receiving hemodialysis for at least three months and had a Beck Depression Inventory-II score of 15 or greater. Patients were randomized to either 12 weeks of CBT delivered in the dialysis facility versus sertraline treatment with the primary outcome measured by the Quick Inventory of Depressive Symptoms–Clinician-Rated (QIDS-C). After 12 weeks, depression scores were modestly better with sertraline treatment than with CBT, but the medication group had significantly more adverse events than the CBT group. This study demonstrates the relative efficacy of depression treatments in the dialysis center.
REGAIN Trial: Regional vs. General Anesthesia for Promoting Independence after Hip Fracture
The REGAIN Trial is a multicenter randomized trial comparing the outcomes of individuals aged 50 years and older receiving either spinal or general anesthesia during hip fracture surgery. Study participants are followed up to one year after surgery to determine the effects of the assigned anesthesia technique on mortality and recovery of ambulation along with other patient-centered outcomes, including overall health and disability, pain, cognition, and post-operative delirium. There are currently 45 sites in the United States and Canada actively enrolling study participants, with the target enrollment of 1,600 expected to be reached by the summer of 2020. Although no interim analyses are planned, data on overall patient characteristics and follow-up rates will be presented.
Does Providing Immediate Normative Feedback to Patient-Reported Post-Operative Symptoms Impact Patient-Centered Outcomes and Emergency Room Visits?
As increasingly complex cancer surgeries are performed in the ambulatory setting, providing patients and their caregivers with meaningful support after discharge is imperative to delivering high-quality postoperative care. This prospective randomized trial evaluates two approaches to the use of electronic patient-reported post-operative symptom data: (1) team monitoring—by the clinical team, with nursing outreach if symptoms exceed normal limits, and (2) enhanced feedback—real-time feedback to patients about expected symptom severity, with patient-activated care as needed. We hypothesize that enhanced feedback will be more effective in mitigating emergency department visits and improving the patient/caregiver experience (i.e., patient engagement, anxiety, and caregiver burden). Importantly, our patient and stakeholder partners have been closely involved in study design, implementation, and problem solving. Recruitment began in August 2017 and will conclude September 2019. Study findings will be relevant in designing scalable care models targeting improved healthcare quality and patient experience.
CombatMS–A Multipurpose Research Vehicle where Patients and Neurologists Join Forces to Address Benefits and Risks with Multiple Sclerosis Treatments
Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system that requires continuous therapy to limit permanent neurological deficits. Today, a number of disease modulatory treatments (DMTs) are available. However, traditional clinical trials conducted during the approval process do not provide information on comparative long-term benefits and risks across different DMTs, making informed therapy decisions difficult for patients and neurologists. With close to 3,500 participating individuals, the CombatMS study is the world´s largest observational drug trial in a large population-based sample. The coprimary outcomes reflect the DMT aspects ranked highest by patients and neurologists: quality of life and protection from long-term disability, respectively. Additional safety outcomes are generated from healthcare registry data nationwide in Sweden and Kaiser Permanente Southern California. Given the unblinded design of the study, we will here summarize results generated so far as well as planned future studies.
Test Performance and Acceptability of Self- versus Provider-Collected Swabs for hrHPV DNA Testing in Female-to-Male Trans Masculine Patients
Screening for cervical cancer via Pap tests and pelvic exams can be particularly difficult for trans masculine (TM) individuals—people who were assigned a female sex at birth and identify as male or on the masculine spectrum. Drawing from the voices of TM community members, The Trans Masculine Sexual Health Collaborative at The Fenway Institute at Fenway Health in Boston, Massachusetts, conducted a study to examine alternative ways of screening for cervical cancer, namely a self-swab to test for high-risk HPV (hrHPV). The main aim of this study was to determine the acceptability, feasibility, and effectiveness of a self-collected swab for hrHPV testing compared to provider-collected swabs for hrHPV testing. Between April 2015 and September 2016, 150 TM individuals enrolled in a one-time study visit and completed both testing methods (a provider-conducted and a self-collected frontal swab). The concordance of the test results was assessed, as well as patient satisfaction.
With a Trace: Lessons Learned in Implementing an Order Entry System Intervention in a Stakeholder-Informed Pragmatic Cluster-Randomized Trial (TrACER)
Our poster will aim to share lessons learned from the TrACER study through three phases of the trial: pre-intervention, intervention implementation, and patient accrual. Topics will include recommendations for communication and engagement with stakeholders such as clinics and patient partners, strategies used to apply the intervention across a variety of ordering systems, and methods for maximizing individual site accrual. The information presented in our abstract will help inform future pragmatic trials seeking to implement an order entry system intervention across cluster-randomized clinics.
Setting Priorities among Autistic Adults to Develop a Research Agenda to Address Health Outcomes
The purpose of this poster is to share results of a two-year priority-setting engagement award conducted in collaboration with the autistic adult community. Products shared include an Engagement & Compensation Guide and the Top 10 Research Priorities.
Sages in Every Setting: Enhancing an Innovative Model to Incorporate Older Adult Voice into Research
The experiential voice of older adults living with frailty is largely absent from health research. In 2016, under a Eugene Washington Engagement Award, we created the Bureau of Sages, which is an ongoing research advisory board made up of nursing home residents receiving long-term services and supports. Following that innovative model, Sages In Every Setting worked to expand and diversify the voice of older adults living with frailty in patient-centered outcomes research/comparative effectiveness research by working with diverse stakeholders to translate the Bureau of Sages engagement model into one that could be easily disseminated and implemented in more communities. This presentation will present data on the influence and impact of this work, share lessons learned from our experiences, and provide samples of resources that could be used to help others create and engage with similar advisory boards.
Providers Guide to Promising Practices, Including Family Caregivers in Patient Care Teams
This project has used conference settings involving family caregiver/patient dyads, providers, researchers, and support services to explore learning to date about the needs of family caregivers, as well as mini-conferences at the clinic level to include more staff and family caregivers for in-depth dialogue about the implementation of practices to engage these dyads. Our focus is building and strengthening the relationship between the dyad and the professional care team, to be disseminated in detailed guides. This poster will include the history and evolution of one guide and the key recommendations.
Patient Engagement: Enhancing Culturally Appropriate Research
With an increasingly diverse society and persistent health disparities, a pressing question is: How can we reimagine research to better account for culturally diverse populations? In 2017, our team received a PCORI Engagement Award to answer this question by engaging four diverse communities to develop an understanding of what culturally responsive research is and how to implement it. Our team consisted of Ahahui Malama I Ka Lokahi, Community-Campus Partnerships for Health, SoLaHmo Partnership for Health and Wellness, and University of New England. The project objectives were:
• Gain an understanding of patients’ visions of culturally responsive research and their experiences with research
• Develop guidelines for diverse community engagement in research
• Disseminate guidelines for culturally responsive research to diverse stakeholders
Operation PCOR: Training Veterans as Partners in PTSD-Related PCOR and CER
The Veteran-Driven Research Participation Training Program (RPTP) created, piloted, evaluated, and implemented a nationally accessible, online research participation training program for veterans. Guided by the National Advisory Board, the Veteran-Driven RPTP curriculum trains veterans in research participation by providing them with the skills necessary to meaningfully act as participants in patient-centered outcomes research (PCOR) and comparative effectiveness research (CER). The second important component of Operation PCOR is the VetResearchHub, a platform and “electronic gathering place” in which veterans and key stakeholders (e.g., researchers) can connect as full partners in PTSD-related PCOR and CER.
Research Ready: Resources to Support the Engagement of Clinic Staff in Pragmatic Patient-Centered Outcomes Research
This poster will describe the creation and dissemination of resources that can be used to improve clinic staff engagement in patient-centered outcomes research.
The National Alliance Executes Collaboration Model w/PCORI and Expands Employer Dissemination Strategy
Our poster summarizes the end-to-end process of the current dissemination award under way through the National Alliance including the methods used to distribute the PCORI-funded findings to its employer network, how it is influencing the upstream selection of PCORI research to better respond to employer’s healthcare interests, the challenges that have been addressed, and how this effort is meant to positively impact patient-centered outcomes.
Addressing Unmet Needs and Research and Care Priorities for Women with Parkinson's
The Parkinson’s Foundation launched the Women and Parkinson's Teams to Advance Learning and Knowledge (Women and PD TALK) project to identify the unmet health and care needs of women living with Parkinson’s disease (PD). A multistakeholder team was formed to guide the design, implementation, and dissemination of the project. This team selected 10 sites, each led by a team of female community leaders, to host a forum and gather personal experiences from women with Parkinson’s, care partners, and health professionals. This feedback was compiled and presented at a national forum of Parkinson’s experts to identify priority action items. These outcomes further led to the creation of the first patient-centered research agenda promoting care practices that directly impact the health of women with PD.
Promoting High-Impact Dissemination to Accelerate Practice and Policy Change
This poster will show how the Patient-Centered Primary Care Collaborative engaged various stakeholders to test different dissemination methods tailored to reach specific audiences effectively. We also enhanced our infrastructure to more efficiently reach our diverse audiences.
Partnership Sustainability: Engagement Strategies to Determine Facilitators and Barriers in Research
As patient-centered outcomes research (PCOR) is rooted in collaborative partnerships, understanding the factors behind partnership sustainability is increasingly important in the PCOR field. There is extensive development of PCOR methodological standards, but a consensus does not exist regarding best practices specific to achieving partnership sustainability. Our poster presentation focuses on efforts to address this gap through the Conference on PCOR Sustainability, funded through a PCORI Engagement Award from 2017 to 2019.
Advancing Turner Syndrome Research: A Patient-Driven Model for Collaborative Research in Rare Disease
Turner Syndrome Global Alliance received a PCORI Engagement Award in the amount of $47,480 to help fund a scientific meeting to address the problem of inadequate Turner syndrome research. This patient-driven model was successful and could be replicated by other rare disease communities.
Faith-Academic Initiatives for Transforming Health (FAITH) Network Research Advocate Training Program
The FAITH Network Research Advocate training program was developed to increase the capacity of faith leaders to engage in health research.
Engaging Migrant and Seasonal Farmworkers in Healthcare Research
The purpose of the poster is to share information from the University of Kansas, Migrant Farmworkers Assistance Fund and their project partners on a recently completed PCORI Engagement Award focusing on engaging migrant and seasonal farmworkers and those who serve them. The content will include highlights of the partners involved, activities conducted, key results and resources produced, and lessons learned.
Training for Cardiologists and their Patients about Patient-Centered Outcomes Research
Heart conditions kill more Americans than any other disease, with higher risk for African Americans. Research to better understand heart disease in diverse people with heart conditions is needed. To increase capacity for Association of Black Cardiologists members and their patients to participate in patient-centered outcomes research (PCOR), training programs were developed. Delivering training about PCOR has resulted in more cardiologists and patients within the community who can engage as research team members.
Lessons Learned: National Partnership to Train Community Health Workers/Promotores in Patient-Centered Outcomes Research
The University of Miami along with the Florida Community Health Worker Coalition successfully developed the structured research training curriculum PCOR for CHWs, a seven-module specialized toolkit on patient-centered research (PCOR) for community health workers (CHWs) by mobilizing and engaging CHWs/promotores as stakeholders to promote the capacity for CHWs participating in PCOR. The pilot-tested toolkit includes a slide deck, Facilitator’s Guide and Student Workbook that can be used to train local CHWs/promotores as PCOR CHW Champions and is available in both English and Spanish. We have to date trained 14 PCOR Champions and 409 CHWs (goal was 360) in Florida, California, Texas, and Tennessee. In states with CHW certification programs like Florida and Texas, these seven credit hours are counted toward state certification requirements.
Fostering Stakeholder Engagement through Storytelling
This poster describes a stakeholder-engaged project that uses patient stories to amplify patient perspectives and bring together researchers and patients with shared interests to form engaged research teams.
Beyond Universal Design: Lessons Learned about Communication Accessibility for Patient Partners
People with communication disabilities, such as aphasia, and communication differences, like low English proficiency, are often excluded from research participation. For example, people with aphasia were excluded in over 70% of trials addressing information and education after stroke, and 20% of all clinical trials in Australia in 2015 excluded individuals with low English proficiency. An estimated 14% of the US population experiences some type of communication disability, and roughly 8% of the US population was considered limited English proficient in 2013. Therefore, insights, processes, and approaches to including individuals with communication disabilities and/or differences in research planning can be relevant to at least one-fifth of the US population.
Engaging Individuals with Intellectual and Developmental Disabilities, Families, and Community Members Together as Research Stakeholders: Lessons Learned from Community Conversations
We describe insights from a two-year process of engaging a stakeholder community of individuals with intellectual and developmental disabilities, family members, health professionals, and community organization members to build research capacity focused on health, well-being and quality of life in relation to community inclusion and participation equity.
A Model for Improving Patient Engagement and Data Integration with PCORnet Patient-Powered Research Networks and Payer Stakeholders: Patient Structured Interviews
The potential role of payer stakeholders, such as Anthem, in providing support to patient-centered outcomes research initiatives is poorly understood. This research explored patients’ roles and experiences in the Patient-Powered Research Networks (PPRNs) and involvement with the Health Plan Research Networks (HPRNs) and evaluated their points of view in terms of the need for longitudinal data follow-up to address research of mutual interest between PPRNs and HPRNs. We conducted nine structured interviews with PPRN members regarding the topic of healthplan outreach and data linkage. This qualitative approach identified the value of HPRN collaboration, HPRN outreach, data linkage and patient privacy, and opportunities for HPRNs to engage patients. The value of collaboration with health plans was seen as providing a broader view of the patient and that health plans could add value to PCORnet by helping with the recruitment of patients and acting as a resource for clinical trials.
The PCORnet Front Door: A Pathway to Innovative Research
The PCORnet Front Door is a website connection to an array of services which serve as a conduit to PCORnet’s members and resources. The PCORnet Coordinating Center has established and refined a process for engaging and supporting researchers who seek to access the network. This poster will describe the development, operations, and evolution of the Front Door and will highlight innovative components using real examples.
Roadmap for Collaborative Query Development in PCORnet
Query development is an essential part of any study using PCORnet data. It requires thorough knowledge of Common Data Model specifications, population of data at each DataMart, and distributed querying best practices. Together, the PCORnet Cardiovascular Health Collaborative Research Group and the PCORnet Coordinating Center established a query development process roadmap, informed from real-world query development experience. This roadmap provides a holistic view of the query development process as well as step-by-step guidance to researchers and the stakeholder community so that they may manage the query development process more efficiently and develop successful queries in collaboration with the PCORnet Coordinating Center.
Emerging Practices for Engaging Patient and Caregiver Stakeholders in a Data-Driven System for Health Equity Research
Research networks develop engagement models based on stakeholder input. Engagement in ADVANCE (Accelerating Data Value Across a National Community Health Center Network) Clinical Research Network builds on models from the OCHIN collaborative, which leads provider engagement through a practice-based research network. Research utility of our electronic health record data has increased and we’ve developed the nation’s largest research data warehouse for safety-net populations. To further integrate stakeholder involvement, OCHIN established a Patient Engagement Panel (PEP). PEP membership has broadened to reflect OCHIN’s growth and the engagement methods shifted to account for increasingly diverse stakeholders. The poster will highlight how our applied engagement model rendered rapid outcomes in facilitation improvements and garnered improved PEP inputs to projects and proposals.
Clinical and Social Complexity on Emergency Department Utilization and Diabetes Control in a Diverse Cohort of Patients
We previously found that increasing social complexity—measured through geocoded community-level social determinants of health—was significantly associated with both higher rates of emergency department utilization and rates of poor HbA1c control among safety-net patients. In the current study, we combined data from OCHIN’s ADVANCE (Accelerating Data Value Across a National Community Health Center Network) and Kaiser Permanente’s PORTAL (Patient Outcomes Research to Advance Learning) clinical research networks to conduct expanded analyses with a patient cohort more representative of the general population. Similar to our previous findings, we found that increasing social complexity was significantly associated with poorer diabetes control and increased emergency department utilization. Evidence supporting the impact of social complexity on healthcare utilization and quality of care could be used to enhance medical decision making at the point of care. These findings also highlight the need for risk adjustment to sufficiently equip providers and clinics serving more socially complex groups.
Characteristics of Persistently High-Need, High-Cost Medicare Patients with Persistent Preventable Utilization
Health systems are increasingly focusing on high-need, high-cost (HNHC) patients—a small group of individuals who account for more than half of total healthcare utilization. Previous studies have identified and characterized patients who are persistently HNHC overtime. However, it is unclear if preventable utilization persists among these patients. This study focuses on patients who are persistently HNHC with persistent preventable utilization over two years by examining a comprehensive set of medical, behavioral, and social characteristics. These findings will help health systems better target interventions to reduce unnecessary utilization and improve healthcare quality. This project was an early demonstration of PCORnet’s ability to support rapid, applied health services research. By sharing data and insights across health systems and research teams, this study facilitated the development of Learning Health Care Systems to improve health and healthcare for HNHC patients.
Use of PCORnet Reusable Tools to Inform the Analytic Approach of the PCORnet Opioid Surveillance Rapid-Cycle Research Project
The PCORnet Opioid Surveillance Rapid-Cycle Research study team and PCORnet Coordinating Center Query Fulfillment and Analytics team worked together to develop a cohort identification and description query, operationalized using Coordinating Center reusable tools, to rapidly query data from 19 PCORnet DataMarts (DMs). Use of PCORnet’s reusable Cohort Quality Assessment tool allowed for rapid querying of DM data (within four weeks) to characterize data completeness and population across DMs to help the study team define more complex, study-specific queries. Data characterization identified variability in prescribing data population RxNorm drug vocabulary identifier specificity, and medication data capture in inpatient versus outpatient settings. The results of this study will showcase the analytic resources available at the Coordinating Center that support rapid research within PCORnet and allow study teams to better understand the complexities of the data and conduct successful research within the network.
Ensuring Patient Centeredness through Parent/Patient Leadership in the LIMIT-JIA Randomized Clinical Trial
Limit-JIA includes three parent coinvestigators (members of PARTNERS Patient-Powered Research Network) who have been central to all phases of this study, beginning with concept development. The primary parent investigator also leads a 20-member Stakeholder Advisory Council, including eight parents of children with juvenile idiopathic arthritis (JIA) and two young adult JIA patients, to work with the clinical trial research team. This active partnership with diverse stakeholders has been instrumental in the development of recruitment and retention materials. By engaging diverse patients, parents, and care team members we have created recruitment/retention materials that are attractive, relatable, and engaging and that will enhance recruitment to the LIMIT-JIA trial. The mobile app will improve data completeness and allow the patient family to have an active role in the success of the project. The engagement framework of LIMIT-JIA provides a roadmap for parent/patient leadership and conduct and for the design of patient centered clinical trials in other diseases.
The PCORnet Blood Pressure Control Laboratory: A Platform for Surveillance and Efficient Trials
The PCORnet Blood Pressure Control Laboratory brings together a set of resources that can be leveraged to support efficient research. These modular resources can be configured to support blood pressure control surveillance and large, simple pragmatic randomized control trials. This includes leveraging PCORnet for electronic health record data and access to network clinical research infrastructure and the Eureka Research Platform for direct patient engagement and collection of patient-generated health data for direct-to-participant randomized controlled trials. The Blood Pressure Control Lab will support three projects, each designed to answer scientific research questions and demonstrate different aspects of blood pressure control and showcased in this poster. These projects are called BP Track (BP control registry), BP MAP (cluster randomized trial) and BP Home (direct-to-participant randomized control trial).
Building Capacity for Public Health Surveillance in PCORnet
With support from PCORI, we are developing the capacity for PCORnet to contribute to disease surveillance. Working in collaboration with the Centers for Disease Control and Prevention and other governmental partners, the program includes: coordination of surveillance activities across PCORnet; support for three pilot surveillance projects on cirrhosis (CAPriCORN, REACHnet, STAR), atrial fibrillation (CAPriCORN, STAR, ADVANCE), and uncontrolled hypertension (GPC); and development of a standardized approach for incorporating patient-level geographic information into the Common Data Model. These activities will help define how PCORnet can meaningfully contribute to surveillance at the national and state and local levels. This poster will showcase the initial lessons learned from setting up this program, including governance and human subject issues addressed, processes for restructuring PCORnet analytic tools to facilitate surveillance queries, and plans for sustainability of surveillance work in PCORnet. We also will present any preliminary pilot project results that are available.
Using PCORnet to Understand Use of Molecular Tests and Treatments for Cancerous Tumors
The objective of this project was to use PCORnet to document the patterns of use of molecular tests and molecular targeted cancer therapies for patients with solid tumors and to test the capacity of PCORnet to describe cancer pathology, test results, cancer treatment, and outcomes. The project included tumor registry and electronic health record data from 86,154 patients linked using the PCORnet Common Data Model (CDM). The patients had single solid tumors and received care from 1 of 11 research sites in 10 states between 2013 and 2016. Molecular-guided therapies that were prescribed or administered in the system were well-captured across four distinct CDM tables. The project team linked CDM with both tumor registry and electronic health record data from many sites in multiple data networks and used these combined data to describe use of molecular tumor tests and molecular targeted therapy.
Health Plan Research Network Participation in ADAPTABLE from Patient Engagement to Recruitment to Longitudinal Outcome Data
Health Plan Research Networks (HPRN) have a unique ability to support PCORnet’s longitudinal demonstration projects. Pragmatic clinical trial designs have been proposed to utilize administrative claims data to identify eligible populations and ascertain clinical events, as a cost-efficient alternative to traditional dedicated trial-specific follow-up. HPRNs have an ability to identify eligible study subjects and directly engage members in recruitment. Additionally, HPRNs can provide longitudinal follow-up for clinical events across health systems of consented and authorized members. Three health plans are engaged in PCORnet’s ADAPTABLE study: The HealthCore Anthem Research Network (HCARN), Practice Research Network (PRACnet) Humana, and Aetna, a CVS Health company. Health plan stakeholder engagement to close data gaps, evidence gaps, and, ultimately, care gaps is of vital importance to the sustainability of PCORnet. Health plan data provides valuable insight into study participant identification and where inclusion and exclusion criteria may be contained across health systems.
PCORnet Learning Healthcare Systems Network Collaborative
The PCORnet Learning Healthcare Systems (LHS) Network community is intended to help four Patient-Powered Research Networks achieve the vision of the LHS by accelerating their ability to generate new knowledge and ensure its application. Participating networks are developing systems to: 1) align stakeholders around a purpose of measurably better health for populations, 2) engage all stakeholders to improve health care and research, 3) create synergy across organizations 4) use technology to capture and reuse data from clinical care and people, 5) prioritize research, and 6) create a sustainable business model. The central hypothesis of the project is that by eliminating the boundaries between clinical care, research and improvement, and engaging everyone as part of one system, it is possible to produce better outcomes and experiences for patients and families, faster research, and lower costs. This poster will describe the progress, timeline, challenges, and successes related to systems to create and apply information to inform the decisions of patients, families and clinicians.
Healthy Heart Healthy Minds (H3M)
This study examines the effect of Fitbits alone, Fitbits plus online cognitive behavioral therapy, or Fitbits plus online mindfulness training on increasing the number of steps for people with a mood disorder plus a cardiovascular disorder or risk. The online study was able to recruit efficiently, in part because participants would receive a free Fitbit. As expected, about a third of participants received a Fitbit but did not engage in the study while the remainder engaged in most of the study activities. Technical challenges included integrating and coordinating the intervention and assessment portals as well as analyzing over 5 million lines of results from Fitbit. Online studies for virtual communities allow us to conduct studies of large numbers of people efficiently. Researchers must carefully plan how interventions and assessments will be done. The most optimal mechanism would be a single integrated platform.
Resilience Against Depression Disparities: Characteristics of Participants Screened for Study Enrollment
The Resilience Against Depression Disparities (RADD) study is testing two ways to improve depression symptoms among LGBTQ adults. The first way is depression care quality improvement training for staff at primary care, mental health, and community agencies. The second includes the same agencywide training plus classes for patients in resilience, or the ability to recover quickly from setbacks. The study is focusing in areas with large African American and Latino populations. This poster will provide a descriptive summary of characteristics of participants screened for the study in both Los Angeles and New Orleans. Participants were predominantly male, more than half identified as lesbian, gay, bisexual, or queer/questioning, three-quarters were racial/ethnic minorities, nearly half were unemployed, and over one-quarter were homeless or at risk of homelessness. Future work will describe RADD study baseline characteristics as well as compared interventions on 6- and 12-month depression and quality of life related outcomes.
The O2VERLAP Study: A PCORnet Research Demonstration Project
The poster will present on two aspects of the O2VERLAP Project: 1) the qualitative project that was done before the main study to identify outcomes that are important to patients, and (2) the preliminary results of the project’s main scientific study, including main findings, study promotional efforts, and methodological challenges. The study promotional efforts for the main study comprised a variety of electronic campaigns (e.g., email, Facebook, Twitter, etc.) targeting several different communities (e.g., COPD, sleep apnea, PCORnet members, and miscellaneous). The pros and cons of each focus group method used (telephone, in person, and synchronous and then asynchronous chat) will be provided. The focus groups revealed that the most important outcome to patients is daytime functioning. Additionally, there are three main methodological lessons learned from which the broader research and stakeholder community may benefit: 1) focus group methodology, 2) electronic study promotional efforts, and 3) medical device data sharing.
Implementing a Common Privacy-Preserving Record-Linkage Solution Across PCORnet
PCORnet consists of Clinical Research Networks and Health Plan Research Networks. Few have complete capture of all variables and outcomes of interest within their Common Data Models. One way to bridge this gap is to link records in a privacy-preserving manner across networks/data partners with overlapping patients. Previously, networks implemented their own solutions for linking within or between networks, but there was a lack of a network-wide approach in PCORnet. Relying on study-specific linkage requires separate governance and technical solutions for each one, which is inefficient and unsustainable at scale. The PCORnet community is implementing a common linkage solution to be deployed across the network. Having a common linkage approach will be a market differentiator for PCORnet. While we will demonstrate our ability to execute with an overlap analysis, we believe linkage will support several additional use cases, including linkage to registries, commercial claims partners, patient-reported sources, and more.
The importance of Health Insurance Claims Data in Creating Learning Health Systems: Evaluating Care for High-Need, High-Cost Patients Using PCORnet
PCORnet has substantial potential to support learning health systems in rapidly evaluating these programs, but access to complete patient data on healthcare utilization is limited as PCORnet is based on electronic health records, not health insurance claims data. Because matching cases to comparison patients on baseline utilization is often a critical component of high-quality observational comparative effectiveness research for high-need, high-cost patients, limited access to claims may negatively affect the quality of the matching process. We sought to determine whether the evaluation of programs for these patients required claims data to match cases to comparison patients. We determined that the rapid evaluation of programs for these patients does require the use of claims data. Observational studies of these types of programs that do not use claims-based utilization in the matching process will face challenges in identifying appropriate comparison patients and in identifying the most appropriate baseline time period for the matched comparison patient.
Engaging Patients in Primary Care Practice-Based Redesign
The “Integrated Behavioral Health and Primary Care” (IBH-PC) study examines the effectiveness of behavioral health services in primary care delivered by a behavioral health provider (BHP) co-located at the same address compared with practices fully integrating a BHP into the care team. The research team created the IBH-PC Toolkit, which combines customized online education, a well-defined quality improvement protocol, an online learning community, and coaching from remote experts in practice change management, and supports practices in engaging patients as partners in their redesign efforts. The research poster focuses on the inclusion of patients as direct partners on redesign teams, highlighting reported implementation successes, benefits, challenges, and resources from the intervention sites.
RAND/PPMD Patient-Centeredness Method: A New Online Modified-Delphi Approach for Engaging Patients and Caregivers in Developing Clinical Guidelines
New scalable methods for systematically engaging patients and caregivers in clinical practice guideline development are needed. An interdisciplinary team of researchers from RAND, clinicians from Parent Project Muscular Dystrophy (PPMD), and a caregiver to individuals with Duchenne muscular dystrophy (DMD) developed the RAND/PPMD Patient-Centeredness Method. This online approach uses a modified-Delphi technique, helps engage patients and caregivers in a way that mirrors how clinicians are engaged in guideline development, and maximizes the expertise that these stakeholders have with an outcome of patient-centeredness recommendations. The poster describes the impact and influence of this new online method for patient and caregiver engagement with clinical practice guideline development with lessons learned.
C3FIT – Engagement Design in a Pragmatic, Multicenter Comparative Effectiveness Trial
C3FIT is a pragmatic, multicenter, randomized trial to determine the effectiveness of Joint Commission-certified Comprehensive or Primary Stroke Centers with an Integrated Stroke Practice Unit design focused on improving stroke care coordination for patients and caregivers across the continuum from acute/in-hospital care to postdischarge recovery at skilled nursing or rehabilitation centers or at home for 12 months. The poster describes the comprehensive engagement elements of C3FIT, which include the vertical and horizontal structural dimensions, stakeholder partner preparation, governance, leadership, and ongoing assessment and performance improvements.
Importance of Culture, Trust, and Respect in Patient and Stakeholder Engagement
Patients with opioid use disorder on methadone have high hepatitis C virus (HCV) incidence and prevalence; conventionally, only one quarter of them adhere to off-site HCV referral. In this study, the research team is evaluating the effectiveness of telemedicine along with coadministration of HCV medications and methadone compared to off-site referral at 12 opioid treatment programs throughout New York State. Through the implementation of study procedures, the research team has learned that trust and the demonstration of appreciation toward staff, patients, and stakeholders is crucial to successful engagement.
Stakeholder Collaboration in the Development of Engagement and Recruitment Strategies for the Kids FACE FEAR RCT
Anxiety is the most prevalent mental health diagnosis for children and yet only about 10% of children with anxiety receive treatment. Kids FACE FEARS is an RCT designed to test equivalency of evidence-based cognitive behavioral therapy treatment in face-to-face and online modalities. Informed within the RE-AIM framework, stakeholders are included on several levels including youth patients and parents, from English-speaking and Spanish-speaking backgrounds. The research team conducted multiple in-person and teleconferences with stakeholders and present key themes describing engagement challenges, successes, and outcomes.
Early Engagement and Shared Decision Making with a Diverse Group of Patient Partners and Stakeholders Produces a Sustainable 93% Survey Response Rate over a Year in a Large Pragmatic Asthma Trial, Person Empowered Asthma Relief (PREPARE)
The PREPARE study is a pragmatic open-label trial testing a patient-empowered approach to use inhaled corticosteroids together with short-acting bronchodilators as rescue therapy, Patient Activated Reliever-Triggered Inhaled Corticosteroids, or PARTICS, to reduce exacerbations in highly-impacted populations of adult Hispanic/Latinos and African Americans/Blacks with asthma. Currently, 950 participants are enrolled and 5,600 monthly surveys have been completed with a consistent response rate of over 93% after 12 months of follow-up, a greater than 20% increase since the pilot study where they tested materials and logistics. Additionally, the research poster presents how building partnerships and engaging patient partners who are representative of the study population and other stakeholders from the beginning of a research project can result in a more beneficial study design as well as unique, patient-centered solutions for common research issues.
Engaging with Pennsylvania Schools and Communities to Address Adolescent Depression
The prevalence of annual major depressive disorder (MDD) episodes among US adolescents rose from 8.3% in 2008 to 12.8% in 2016. The research team actively cultivated relationships with key stakeholders in adolescent mental health as part of a randomized controlled trial in Pennsylvania public senior high schools to evaluate the effectiveness of universal school-based MDD screening. The research poster shares the broad spectrum of stakeholders and their involvement of many aspects of the research study design and conduct. Lessons learned describe the study team’s community engagement activities assessing the barriers to MDD screening and how to better tailor engagement with adolescents in school environments.
Engaging Patients in Recruitment and Data Collection: Notes from a Multisite Randomized Trial
The What Matters Most study is comparing two encounter decision aids against usual care for women making a choice for early-stage breast cancer surgery. Through patient partner input, the patient associate role was developed for four partners, who received research training at study onset, then recruited participants, administered study questionnaires, actively participated in study calls, and were regarded as key study personnel at each site throughout the whole study. The research poster presents qualitative findings on the patient associate experience, including challenges, benefits, and overall thoughts on this formalized role on the research team.
Tailoring Stakeholder Engagement for Study of Adults with Opioid-Treated Chronic Low Back Pain
Chronic low back pain is often resistant to standard-of-care treatment and can result in the need for opioid medications. Strategies to Assist with Management of Pain (STAMP) study is a five-year multisite randomized clinical trial that will compare the effectiveness of mindfulness meditation and cognitive behavioral therapy in 766 individuals with opioid-treated chronic low back pain, followed for one year. Currently, in year three of the STAMP study, the research team presents several best practices for sustaining the engagement of multiple, specialized stakeholder groups and the impact of engagement on the study conduct, recruitment, and retention.
Made for Each Other—How Practice-Based Research Networks are Engaging Clinicians in a Study of Advance Care Planning in Primary Care
The Advance Care Planning Trial uses Meta-LARC (consortium of seven practice-based research networks) to conduct a cluster randomized trial of two models of the Serious Illness Care Program (SICP). SICP helps clinicians initiate and follow up on conversations about values and goals with seriously ill patients. The research poster shares how clinician engagement has influenced and impacted the trial design, informs current activities, and will shape future efforts to understand and disseminate results. Specifically, findings from measuring and monitoring clinician activities and attitudes through SICP implementation and research activities will be shared.
Development and Implementation of a Health Equity Model for Stakeholder Engagement across a Multisite Study
Reducing Disparities in the Quality of Advance Care Planning for Older African Americans through Improved Advance Care Planning (EQUAL ACP) is a comparative effectiveness study of two advance care planning interventions to reduce racial disparities in advance care planning and palliative care outcomes among older adults with serious illness. The research poster explains EQUAL ACP, which is an example of an intentional model of stakeholder engagement which incorporates investigator and stakeholder training, systematic processes for engagement, and attention to sociocultural issues to promote diverse, authentic perspectives into a multisite study to promote health equity. The research team is currently developing measures to assess outcomes that are relevant to stakeholders and investigators.
Community Health Representative-Led Tribal Home-Based Kidney Care with American Indians of New Mexico–A Disruptive Innovation
The Home-Based Kidney Care program, based on a successful model for delivering kidney care in Zuni Indians, is a three-year PCORI-funded project to explore the effectiveness of a home-based kidney care intervention for patients identified with chronic kidney disease as a means of slowing the progression of kidney disease among affected community members in four additional tribes in New Mexico. The study objective is to extend a culturally specific, community health representative-led, evidence-based intervention model into high-risk communities of American Indians in New Mexico. Many lessons have been learned through the implementation of this study including working in sovereign tribal nations, working with a transdisciplinary research team, resolving technological issues, conducting training, engaging the community, and respecting Native American culture and customs. This innovative collaborative approach has the potential to produce dramatic improvements in clinical outcomes and health-related quality of life and to reduce health care costs.
Stakeholder Engagement and Participation in the Design, Delivery, and Dissemination of the Ostomy Telehealth for Cancer Survivors Program
The program is a three-year, multisite, randomized controlled trial of 216 cancer survivors with ostomies and their caregivers. The purpose was to test a telehealth program to promote ostomy self-management, compared to usual care with a primary aim to determine whether activation, self-efficacy, ostomy-related knowledge, and health-related quality of life will be improved and sustained over time. During the multisite trial and protocol design, as well as throughout the study, peers played an influential role in selection of efficacy and utilization outcomes, making improvements to the program curriculum, study implementation procedures, and general team chemistry. The research poster reflects on the impact and influence of engagement on the study as well as next steps for future research adaptations.
MOms in REcovery (MORE) Study: The Power of a Patient, Clinician, and State Policymaker Research Partnership
This research study investigates the impact of two models of medication-assisted treatment (MAT) for pregnant women with opioid use disorder (OUD) on maternal and infant outcomes: 1) Integrated MAT, where treatment of OUD is delivered in the context of prenatal care, and 2) Referral-Based MAT, where treatment of OUD is delivered at a site external to the prenatal care setting. The poster will describe how patients, clinicians, and policymakers are engaged in all stages (planning, conducting, disseminating) of the research study. There is bidirectional learning, shared power, and collaboration incorporated across all stages of research to ensure relevance of the study and maximize the likelihood that the study will yield translatable findings to inform practice and policy (e.g., CITI Research training, piloting of study forms, input into the study website, maintaining a FaceBook page, and Photovoice training and projects).
TEAM UP – A Family-Centered Approach to Childhood Obesity Treatment – Lessons Learned from Key Engagement Strategies
Treatment Efforts to Address Child Weight Management by Unifying Patients, Parents, and Providers (TEAM UP) is a pragmatic, multisite trial that compares the effectiveness of enhanced standard of care delivered by primary care providers vs. enhanced standard of care plus family-based behavioral treatment delivered by trained coaches to treat childhood obesity. The project includes a multipronged engagement approach with patients, providers, payers, and scientists to implement acceptable and effective treatment strategies for sustainable delivery in primary care. Stakeholder engagement is measured annually using the Engagement 360° Assessment, an assessment tool developed by the Research Action for Health Network clinical data research network to identify strengths and opportunities to improve bidirectional relationships between stakeholder groups and the project team. Results of the Engagement 360° Assessment are used to facilitate discussion among the study team and stakeholder partners about strategies to strengthen meaningful stakeholder engagement and will be reported in the research poster.
A Stakeholder-Centered Approach to Facilitating and Prioritizing Engagement
The BRITE Study, a six-site, pragmatic clinical trial, is aimed at improving the transition from inpatient rehabilitation to community following moderate to severe traumatic brain injury. The research team describes how human-centered design methods strengthened the first annual stakeholder meeting for the trial and how the dynamic process provided guidance for the course of the study, optimized stakeholder participation, and helped to develop priorities for further engagement topics. The approach included principles from human-centered design with an iterative approach to creative problem-solving and innovation to foster collaborative input from the large group of patient and family and professional stakeholders in attendance. The research poster discusses the engagement successes and lessons learned from utilizing human-centered design for diverse stakeholder meetings.
Engagement Tools and Key Process Elements from the SEED Method
In this project, the study team created a method of setting research agendas called the SEED Method (Stakeholder Engagement in quEstion Development). The SEED Method gathers input from three groups who represent differing views: a research team with community residents and academic researchers, three different groups of stakeholder participants, and stakeholder consultants who take part in interviews and group discussions. The study team tested the SEED Method at two sites in Virginia. The poster will present the SEED Method Stakeholder Identification Matrices and Participatory Modeling Training and Facilitation Guides tools that can be used by other project teams.
PaTH to Partnership in Stakeholder-Engaged Research: A Framework for Patient and Stakeholder Engagement in the PaTH to Health Diabetes Study
The research team will present their approach for patient partner and stakeholder engagement in the PCORI-funded PaTH to Health: Diabetes study at Penn State College of Medicine, which utilizes the PaTH clinical data research network. A diverse stakeholder body including patients, policy makers, clinicians, and leadership from relevant national professional organizations is engaged throughout the research process, from proposal development to dissemination of study findings. Annual qualitative and quantitative evaluations are offered to patient partners and stakeholders to provide regular monitoring of engagement activities and to ensure meaningful involvement. Findings from the evaluations as well as lessons learned from engaging diverse community stakeholders will be shared.
A Patient‐Initiated Engagement Model for Patient‐Centered Research in Rare Disease: Insights from a Multi‐Institute Collaborative Mixed‐Methods Study in Urea Cycle Disorders
The National Urea Cycle Disorders Foundation (NUCDF) engaged in a PCORI‐funded collaborative mixed-methods study with Children’s National Health System and The George Washington University to provide families with evidence‐based information about treatment alternatives for urea cycles disorders. The study utilized a patient‐initiated engagement model, where objectives are developed in direct response to patient‐reported concerns. Through their Patient-Powered Research Team, assembled by NUCDF to set priorities and guide advancements in research, NUCDF proposed the study and helped develop the patient‐centric study protocol. This is an especially effective and mutually beneficial model for patient‐centered outcomes research in ultra‐rare disorders with a small number of geographically diverse patients, enabling researchers and patients to partner on the development of new evidence to support improvements in the management of these conditions.
Engaging Stakeholders to Optimize a Telemonitoring Intervention for Heart Failure Patients from Underserved Communities: A Community-Based Participatory Research Process
The objective of this qualitative study, conducted in the New York Metropolitan Area, was to adapt a home telemonitoring program using community-based participatory research for Black and Hispanic heart failure patients from underserved communities, with the goal of optimizing program usability. Here we report results from the formative phase of a larger mixed-methods study which included a randomized control trial designed to assess whether telemonitoring is effective in improving care for this population. Three focus groups were conducted at a county hospital with stakeholders utilizing features of the ADAPT-ITT model across multiple phases: 1) a needs Assessment, 2) program choice Decision-making, 3) Adaption theater testing, 4) Producing a draft of proposed intervention, 5) including Topical experts in adaptation, 6) Integrating input into the new intervention, 7) staff Training and 8) Testing an intervention pilot. As there was no existing framework to engage community stakeholders in the process of telehealth intervention adaptation, we learned that the ADAPT-ITT framework, developed for evidence-based HIV interventions, could be used effectively for this purpose. This was the first study to describe the formative process of a community-based participatory research study aimed at optimizing telehealth utilization among Black and Hispanic patients from underserved communities.
Parent and Stakeholder Involvement in a Multicenter Study of Continued Anticonvulsants after Resolution of Neonatal Seizures
Neonatal seizures occur before 44 weeks postmenstrual age (or up to 28 days after birth for a full-term baby). Infants with hypoxic-ischemic encephalopathy, intracranial hemorrhage, or stroke are at high risk for seizures. We are taking a closer look at the short- and long-term treatment effects on the infant as well as their parents and families as there is currently no standard of care. Due to the engagement of parents, nurses, and neonatal researcher, the retention rate for study participants has never dropped below 86%. The research poster describes the successes, barriers, and findings from parent and stakeholder engagement on the design and conduct of the study.
Stakeholder engagement in Eight Comparative Effectiveness Trials in African Americans and Latinos with Asthma
The research teams describe the methods of asthma research teams in which the patients and stakeholders participated meaningfully as research partners in the development, implementation, and dissemination of comparative effectiveness trials. Eight comparative effectiveness studies were funded by PCORI under an asthma disparities program for African Americans and Latinos. All eight studies engaged their patients and other key stakeholders in developing and refining the study designs, questionnaires, outcome measures, recruitment strategies, and intervention protocols. Engagement activities led to significant changes in the study design from what the investigator originally planned and were extremely useful in developing studies that are supported and well received by patients and the community. This level of investigator-stakeholder interaction is unprecedented and is increasingly required in research studies which can lead to a level of engagement that lives on during and after the actual studies.
Engaging Patients, Family Members and Stakeholders in Kidney Research – Lessons Learned from the “Putting Patients at the Center of Kidney Care Transitions: PREPARE NOW
The PREPARE NOW study research team is helping patients with kidney disease at Geisinger Health System prepare for kidney failure and choose a treatment option that is best for them. Some examples of this engagement influence and impact include having patient and family coinvestigators and stakeholders formulate the study research questions and defining essential characteristics of study participants. In this poster presentation, we will share the resources, tools, and handouts from our study that are examples of our patient, family member, and stakeholder engagement and can be transferred to the patient-centered outcomes research community.
Shared Decision Making for Bariatric Surgery in Patients with Severe Obesity
Although 14.5% of adults in the U.S. suffer from severe obesity linked with morbidity, mortality, and reduced quality of life, only 1% of eligible patients choose to undergo bariatric surgery each year, despite data that support its safety and effectiveness. After a five-year follow-up, the PCORnet Bariatric Study, the largest multisite longitudinal study of bariatric surgery in the U.S., provides statistically significant and clinically meaningful differences in weight loss, diabetes outcomes, and rates of reoperation and rehospitalization across the three most common types of bariatric surgery. The study’s approach, offering high-quality evidence to engage surgeons and patients in shared decision making, will be implemented within two systems that provide care to more than 400,00 patients with severe obesity. Implementation will include updating an existing decision aid on weight loss treatment options and developing a process for providers to complete four core components of shared decision making.
Dissemination and Implementation of a Patient-Centered Decision Aid for Ventricular Assist Device Placement: First Quarter Findings
Left ventricular assist device (LVAD) therapy is the fastest growing treatment for heart failure, with more than 2,500 patients implanted annually. Patients, however, often have no access to unbiased information about the device, often making reflexive, rather than deliberate, treatment decisions. A newly developed, validated patient-centered decision aid (DA) to help patients understand LVAD placements has resulted in improved knowledge compared to standard education. Patients and clinicians rated it highly for promoting informed, value-based decisions and avoiding disruptions to clinical flow. While numerous studies have described the benefits of DA, other reports indicate lack of uptake due to lack of training on its use. In this project, nine hospitals will disseminate the LVAD DA, with the goal of implementing it as the standard of care for education and consent. Site-specific meetings will elicit feedback, troubleshoot, and set goals to increase reach and fidelity of the DA for site-tailored implementation.
Tailored Implementation of a Decision Support Strategy for Left Ventricular Assist Devices
The PCORI-funded DECIDE-LVAD trial assessed the implementation and effectiveness of shared decision making (SDM) for patients and their caregivers, considering destination therapy left ventricular assist devices (DT LVAD). The SDM program was successfully implemented at six geographically diverse sites and significantly improved patient knowledge and patient and caregiver values-choice concordance. Patient LVAD implantation significantly decreased in the intervention period by six months. This project aims to implement the SDM program at as many of the 177 LVAD programs in the U.S. as possible, using diffusion of innovation therapy as a guide to provide the most effective resources (decision aid packets, user’s guide, webinars, etc.) at each site. The RE-AIM framework used to help implement programs into real-world settings will guide evaluation. At this point, 27 early adopters have been identified and baseline surveys on site readiness have been sent and completed by 598 eligible individuals.
Implementation of Childbirth-Specific Patient-Reported Outcomes Measures in the Hospital Setting
An original PCORI study featured a Childbirth Experience Survey (CBEX) administered nationally, with data analyzed on 500 women who planned a vaginal delivery. The analysis identified 23 childbirth-specific patient-reported experience outcomes that were predictors of childbirth hospital satisfaction, both antepartum and postpartum. Many of these outcomes are modifiable factors hospitals can review to improve the patient care experience during childbirth and increase hospital ratings and value-based reimbursements. The original survey has been shortened and made available on any internet-connected device. The project goal is to collect data on approximately 3,000 women across 10 hospital sites. Since October 2018, 108 antepartum surveys and five postpartum surveys have been completed, with a significant increase in the number of postpartum surveys collected anticipated. To increase recruitment, a CBEX Study Toolkit in English and Spanish was distributed in March 2019 that includes items such as FAQ sheets, flyers with QR codes, and volunteer scripts.
Dissemination of PCORI Results: Sharing PlanYourLifespan.org through Patient/Community Partner Train the Trainer Approach
PlanYourLifespan.org (PYL.org) is a free, publicly available website that helps seniors and their families understand future needs and plan for the fourth quarter of their lives. PCORI funded a multisite randomized controlled trial of the comparative effectiveness of PYL.org with 400 older adults, and results included improved knowledge of options and accessing services and increased communications about their future. Dissemination focused on a train-the-trainer approach, with original PCORI community partners engaging other partners to share research results and PYL.org. Over three months, the trainees targeted adults in hard-to-reach sites and diverse populations, specifically African Americans and Pacific Islanders, in rural and urban areas of Chicago, Indiana, and Hawaii. From August to December 2018, 11,361 log-in sessions were registered, and after one week, 89,068 sessions. The project team has received additional funding from an NIH/NIA grant to study how PYL.org affects decision making for patients with Alzheimer’s disease and their caregivers.
Assessing Context Factors in Pain Treatment: Using Patient and Provider Formative and Process Evaluations to Guide Implementation Strategies
The Healing Encounters and Attitudes List (HEAL) context factors, developed in a prior PCORI Methods project, measured factors that can contribute to positive treatment outcomes of chronic pain. The HEAL assessment is being implemented at seven pain medicine clinics at the University of Pittsburgh Medical Center, where measures were programmed into the existing online assessment system that patients complete on a regular basis. This implementation approach, which draws upon the Theory of Diffusion of Innovations, includes formative evaluation and process interviews with patients, physicians, and clinicians to identify barriers and effective strategies that increase impact of the intervention. The target audience incudes more than 60 staff and clinicians of the university’s seven pain medicine clinics as well as patients (over 100 per day). Widespread use of HEAL may have a positive influence on all treatment outcomes and care beyond those related to pain.
UPFRONT: Multi-Component Implementation of Shared Decision Making for Uterine Fibroids across Socioeconomic Strata
Uterine fibroids can cause severe symptoms, from pelvic pain to difficulty in becoming pregnant, and can possibly cause miscarriage and preterm birth. Currently, hysterectomy is the most common procedure for uterine fibroids, while alternatives such as endometrial ablation, myomectomy, and uterine artery embolization are used at much lower rates. Clear evidence from existing research and consultation with patient partners indicates that women with fibroids want to engage in shared decision making (SDM). However, implementing encounter patient decision aids (ePDAs) to facilitate SDM in routine care has been challenging. Five geographically diverse implementation sites will be offered a multicomponent SDM strategy that includes access to multiple formats of Option Grid ePDAs and integration of the SDM approach and new evidence (as appropriate) into existing clinical practice guidelines. A community participatory approach will assure patient-centered content targeting women of lower socioeconomic status and health literacy is available for implementation in February 2020.
Using Tailored Risk/Benefit Profiles in Shared Decision Making for Diabetes Prevention
This project implements findings of a PCORI-funded research study that reanalyzed the Diabetes Prevention Program (DPP), demonstrating that lifestyle change lowers type 2 diabetes risk by a similar magnitude across all risk quartiles, while the benefit of metformin differs between quartiles. An electronic health records-based model will be used to focus on real-world uptake of this evidence that will integrate tailored risk/benefit profiles with shared decision making (SDM). Higher-risk prediabetes patients from 39 primary practices in California will be engaged in SDM. Our strategy has three aims: 1) to create a collaboration of patients and clinicians to incorporate tailored risk/benefit profiles for lifestyle change and/or metformin in an established, effective SDM strategy for diabetes prevention; 2) to guide implementation through the use of the Consolidated Framework for Implementation Research (CFIR); and 3) to use CFIR and the RE-AIM framework to study this approach on decisional and clinical outcomes.
Refining, Implementing, and Disseminating a Patient-Centered Telehealth Model for Chronic Conditions
A PCORI-funded study, Connect.Parkinson, was the first national, randomized controlled trial of telehealth for Parkinson’s in which 200 patients received either actual (in-person) care or up to four telehealth visits with a remote specialist. The telehealth visits were rated highly by patients (97% satisfied, 55% preferring this model). Telehealth patients with chronic disease can access expert care, despite distance, disability, and socioeconomic factors. The implementation strategy 1) refines and expands their telehealth model to improve care and self-management; 2) implements this refined model into the Parkinson Disease Care New York program that offers free specialist care to any resident in the state with Parkinson’s; and 3) engages diverse stakeholders to address barriers and facilitate dissemination. The project has already launched an educational television series reaching more than 800,000 viewers worldwide and initiated a pilot program with UnitedHealthcare to assess telemedicine’s global effectiveness by tracking overall healthcare utilization through claims data.
Re-Think the Strip: Dissemination of the MONITOR TRIAL Results
The MONITOR Trial compared the effects of three approaches to self-monitoring blood glucose (SMBG) on hemoglobin A1C levels and health-related quality of life (HRQOL) among people with non-insulin-treated type 2 diabetes in primary care practice. The team observed no clinically or statistically significant differences at one year in glycemic control or HRQOL between patients who performed SMBG compared with those who did not. These results support the claim that daily SMBG adds no value to routine clinical management; several professional organizations now recommend against routine SMBG in patients with non-insulin-treated type 2 diabetes. However, an estimated two-thirds of these patients still routinely perform SMBG. Re-Think the Strip engages 20 primary care practices to implement de-adoption of SMBG through practice facilitation, audit and feedback, practice champions, and educational meetings and materials. Implementation will begin with three practices; after stakeholder input, the strategy will be refined for rollout to the remaining practices.
Early Implementation Outcomes from a Shared Decision Making Intervention for Men with Localized Prostate Cancer
Over 160,000 men were diagnosed with prostate cancer in 2017; however, many of these cancers grow slowly with no mortality risk. Some men, including many African Americans, are at risk for undergoing treatments that have side effects but confer no survival benefit. Observational data from the PCORI-funded Comparative Effectiveness Analysis of Surgery and Radiation for localized prostate cancer (CEASAR) study were used to predict sexual, urinary, and bowel function-related outcomes of treatment by age, baseline functions, comorbidities, and other factors. These data were incorporated into an existing software-based decision aid (DA) that has been shown to improve decisional quality in men with prostate cancer. Researchers deployed the DA at three locations, targeting newly diagnosed men with prostate cancer and their counseling physicians. Two months into the launch, 64 men have used the DA in usual care, with broad scalability across a variety of care settings anticipated for shared decision making.
Supporting Behavioral Health Home Plus Approaches to Improve Health and Wellness
Positive outcomes from an earlier PCORI clinical trial implemented one of two evidence-based behavioral health home models: Providers-Supported Integrated Care and Patient Self-Directed Care in 11 community mental health centers (CMHCs) across Pennsylvania. This study provided evidence on how to more effectively engage individuals with serious mental illness in their physical health care in a patient-centered, clinically meaningful way. The two models, which used a learning collaborative, were combined into Behavioral Health Home Plus (BHHP) and implemented in more than 50 CMHCs. This project targets providers, clinical leadership, and administrators at seven opioid treatment programs and five residential treatment facilities to implement BHHP in Pennsylvania. This poster describes the implementation strategy, evaluation, outcomes, and the role of stakeholders. The project has succeeded in integrating behavioral and physical health within an organizational culture change that can be applied to diverse settings to improve outcomes for vulnerable populations.
Horizon Scanning to Identify Health Care Innovations with High Potential for Disruption
The purpose of the PCORI Health Care Horizon Scanning System (HCHSS) is to inform PCORI and the public about potentially disruptive new healthcare interventions expected to be clinically available in the U.S. within three years. The HCHSS process begins with broad scanning, leads review, and topic nomination, leading to topic profile development. Topic profiles are circulated to stakeholder commenters (e.g., patients, caregivers, clinicians, researchers, and health systems experts) who provide input regarding the intervention’s potential for disruption. Stakeholder comments drive selection for topic inclusion in the High Potential Disruption Report, which details interventions that stakeholders and the horizon scanning team agree have high potential to cause disruption. We will report high-level summaries of our Status Report and High Potential Disruption Report. Finally, we will discuss future directions for the HCHSS (e.g., use of social media to bolster patient and caregiver engagement).