Letters of Intent for this PCORI funding announcement were due Tuesday, February 14, 2017. Those selected to submit a full application were notified by Wednesday, March 15, 2017. Full applications were due Wednesday, May 17, 2017, by 5:00 p.m. (ET)

Summary

Table of Contents Summary Introduction Background Research of Interest Sample Research Questions Evidence to Action Networks

PCORI is seeking applications to study the comparative clinical effectiveness of alternative features of healthcare systems (e.g., innovative technologies, incentive structures, and service designs) that are intended to optimize the quality, outcomes, and efficiency of care for patients and that have the most potential for sustained impact and replication within and across healthcare systems. Healthcare systems encompass multiple levels (e.g., national, state, and local health environments; organization or practice settings; family and social supports; and the individual patient) and include entities organized to deliver, arrange, purchase, or coordinate healthcare services. PCORI seeks to fund studies that will provide information of value to patients, their caregivers, clinicians, and healthcare leaders concerning which features of delivery systems lead to better patient-centered outcomes (PCOs), so that those features proven to make a difference ultimately affect healthcare delivery.

Funds Available Up To: $16 million

Maximum Project Budget (Total Direct Costs): $5 million for large studies; $1.5 million for small studies

Maximum Research Project Period: Five years for large studies; Three years for small studies

Return to the Broad PCORI Funding Announcements page for key dates.

Introduction

The Improving Healthcare Systems (IHS) Program invites applications for research that studies the comparative effectiveness of alternative features of healthcare systems (e.g., innovative technologies, incentive structures, or healthcare service delivery designs) that are intended to optimize the quality, outcomes, and efficiency of patient care and that have the greatest potential for sustained impact and replication within and across healthcare systems. Healthcare systems encompass multiple levels (e.g., individual patients, family and social supports, providers and care teams, organizations or practice settings, local community resources, and the state- and national-level policy environments) and include entities organized to deliver, arrange, purchase, or coordinate health services. Healthcare delivery models (e.g., integrated health system, patient-centered medical home) and care settings (e.g., hospital, physician practice, nursing home, community health clinic, or patient’s home) also define healthcare system operations. PCORI seeks studies that will affect healthcare delivery by determining which system features lead to improved patient-centered outcomes (PCOs) and which provide valuable knowledge to patients, their caregivers and clinicians, as well as other key stakeholders, including payers and employers. The diagram below is intended to illustrate this summary. Please note that two levels—National Health Environment and State Health Environment—are shaded to indicate that although they clearly influence and shape the broader health policy environment, PCORI does not include them as specific targets for research interventions.

The Healthcare System

Figure adapted from: Taplin, S. H., Clauser, S., et al. (2012) Introduction: Understanding and Influencing Multilevel Factors Across the Cancer Care Continuum. Journal of the National Cancer Institute, 44, 2–10.

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Background

Healthcare organizations are under constant pressure from competing sources to improve aspects of care, but they often lack the critical information needed to guide decisions related to system-level change. Research could help develop a body of evidence supporting effective interventions that would enable organizations to provide –high-quality care that is more accessible, coordinated, effective and efficient, and that would ultimately improve PCOs.

The public entrusts PCORI with funding research that will matter to patients, their caregivers, and other stakeholders (defined as clinicians and their professional societies; hospitals; health systems administrators; payers [insurance]; purchasers [business]; industry [pharmaceutical and medical device companies]; researchers; policy makers; and training institutions). PCORI seeks to change the way in which research is conducted by emphasizing the role of diverse research teams that reflect the varying perspectives of such key stakeholders. PCORI distinguishes itself by supporting research in which patients, caregivers, and other stakeholders are actively engaged in all phases of the research process—from its inception to its conclusion—including generating research questions, reviewing research applications, conducting research, disseminating research findings, promoting the implementation of research findings, and using the results to understand and address patient and other stakeholder needs.

Over the past two decades, the Institute of Medicine (IOM) and others have sharpened the focus on ensuring that healthcare systems are designed and oriented to achieve the health outcomes most desired by individual patients—that is, to become more patient-centered. In particular, the IOM has addressed key aspects of systems improvement, including making care:

• Accessible
• Effective
• Patient-centered
• Timely
• Efficient
• Safer
• Equitable
• Coordinated

IHS seeks to fund comparative clinical effectiveness research (CER) that addresses the same areas as addressed by the IOM.

Interventions designed to achieve the IOM aims listed above may target the following:

• Technology (e.g., interoperative electronic health records, telemedicine, and patient-accessible health records)
• Patient incentives (e.g., free or subsidized preventive care and automatic enrollment in certain follow-up programs).
• Provider incentives (e.g., free continuing medical education units for certain courses, reduced paperwork, provision of key comparative quality performance information); only nonfinancial incentives are acceptable for providers
• Organizational models and policies within and across healthcare systems (e.g., patient-centered medical homes and standing orders)
• Personnel (e.g., multidisciplinary teams, peer navigators, and community health workers [CHWs])

Although a focus on personnel is a key intervention area supported by IHS, the IHS portfolio already includes many projects that evaluate interventions focused on CHWs and patient or peer navigators. IHS is currently not interested in funding additional applications whose primary aim is to compare the use of CHWs or navigators with “usual care” or care delivered by other healthcare personnel. Interventions focused on CHWs and patient or peer navigators will be considered if they are part of a larger multicomponent intervention, are integrated with multidisciplinary healthcare teams, or are compared with other non-personnel-based efficacious interventions.

In addition, applications proposing to compare the use of CHWs and patient or peer navigators with “usual care” or care delivered by other healthcare personnel may be considered if there is a strong rationale supporting the need for additional research (e.g., studies target a rare disease or an understudied population or setting).  Applicants are encouraged to discuss such proposals with the IHS Program before submitting a Letter of Intent.

Innovation and changes in healthcare systems and in the behavior of healthcare system participants are often driven by economic, political, and social needs to improve access to care or quality of care, to attract patients or enrollees, and to contain costs. The effects of all such innovations may vary considerably among subgroups of the general population, but this Heterogeneity of Treatment Effect is often inadequately measured. Studies that include adequately powered subgroup analysis and address understudied or underrepresented patient populations in research are of particular interest to PCORI and the IHS Program. See the Populations Studied section.

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Research of Interest

PCORI’s IHS Program seeks to fund investigator-initiated research on the effects of system changes on the broad outcomes listed below. We are especially interested in studies that conduct head-to-head comparisons with or without “usual care” as a comparator. (See Requirements for PCORI Research for more information on “usual care.”) Such studies may include the following:

• Patients’ access to care, high quality of care, support for self-care, and coordination of care across healthcare settings
• Professional decision making on the basis of patients’ personal values
• Experiences that are important to patients and their caregivers, such as overall health; functional ability; health-related quality of life; stress; severity of symptoms; survival; and unanticipated healthcare utilization, such as unexpected hospital stays or visits to the Emergency Department
• The efficiency of healthcare delivery, as measured by the amount of ineffective, duplicative, or wasteful care provided to patients

The IHS Program is also interested in funding studies that:

• Leverage existing research resources, such as adding patient-centered outcomes research to an existing large clinical trial; using established practice-based research networks; or analyzing large databases that contain valuable, relevant information that may be used to answer important CER questions.
• Leverage healthcare system resources in support of some or all of the intervention requirements. Especially attractive is the possibility of broader and sustained impact through potential adoption by participating or supporting healthcare organizations and stakeholders (e.g., payers), should the intervention prove effective.
• Test practices that combine evidence-based guidelines (such as Choosing Wisely, http://www.choosingwisely.org/) with patient incentives, provider incentives, or patient and provider incentives combined to elicit patient preferences and reduce harms faced by patients simultaneously.

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Sample Research Questions

The following are examples of the types of questions that patients, clinicians, or healthcare administrators might ask and that your research might help answer. This is not an exhaustive list.

• An 84-year-old woman in a rural community with multiple chronic diseases is having increasing difficulty managing at home alone but does not want to leave her home or neighborhood to live in a nursing home. What are the benefits and drawbacks of a new care management program designed to help her stay at home and remain safe and independent, compared with a program that links her to comprehensive community services?
• A 27-year-old Hispanic man with diabetes, chronic back pain, and depression has been invited by his public hospital-based clinic to participate in a group visit program for patients with chronic conditions. The program is led by a behavioral care specialist and a health educator. How likely is it that he will benefit from this program compared with the “usual care” he has been receiving (defined by quarterly visits with his primary care practitioner punctuated by referrals to specialists as needed)? What is the nature of the benefit? Are there any risks? What should his physician recommend?
• A 50-year-old African-American man has frequent exacerbations of his chronic obstructive pulmonary disease that trigger recurrent Emergency Department visits and acute-care hospitalizations. Does regularly scheduled home-based respiratory care reduce his Emergency Department utilization and hospital readmissions, compared to physician office visits that he or his caregiver must schedule? Does it improve functional status, health-related quality of life, or other PCOs?

Below is one research question of interest that the IHS Program seeks to support through this announcement. The IHS advisory panel identified this topic as an evidence gap in need of further research.

Care Coordination for High-Cost, High-Need Patients

High-Cost, High-Need (HCHN) patients make up 5 percent of the patient population in the United States, yet consume 50 percent of all healthcare resources. HCHN patients include children with complex needs; adults less than 65 years old with disabilities; frail older adults; and patients with multiple or complex chronic conditions, which may be complicated by functional limitations, behavioral and substance abuse challenges, and social needs. HCHN patients require regular primary care consultation and at least one additional specialty consultation multiple times a year. Despite frequent contact with various healthcare providers, their physical, social, and behavioral needs often remain unmet due to low-quality and uncoordinated care. The traditional primary care model is not designed to meet this population’s unique needs because these patients require constant and effective communication among healthcare providers. Studies suggest that this group could benefit from a more holistic approach to care delivery achieved through effective care coordination (https://nam.edu/wp-content/uploads/2016/09/Tailoring-Complex-Care-Management-Coordination-and-Integration-for-High-Need-High-Cost-Patients.pdf). Comparative clinical effectiveness research (CER) on care coordination for HCHN patients is of interest to all stakeholders, including payers who need evidence of effective and scalable care coordination strategies for these high healthcare utilizers. Thus, the IHS Program seeks to fund CER that addresses an adapted version of a first quartile Institute of Medicine (IOM) CER topic: Compare the effectiveness of comprehensive care coordination programs—such as the medical home—and “usual care” in managing children and adults with severe chronic disease, especially in populations with known health disparities. The adapted IOM comparative clinical effectiveness question of interest in this funding announcement is: What is the comparative clinical effectiveness of different comprehensive care coordination models on improving patient-centered outcomes for HCHN patients? HCHN population of interest: patients with multiple chronic conditions Care coordination models may include, but are not limited to: Expanded primary care teams Home-based primary care Patient-centered medical homes Outcomes should be measured at more than one level of the healthcare system, such as the patient, caregiver, clinician, or healthcare organization.

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Evidence to Action Networks

PCORI is interested in connecting PCORI-funded investigators who are studying similar research topics and populations to help strengthen the body of research and to facilitate collaborative learning and dissemination of research findings. To meet this goal, PCORI has set up Evidence to Action Networks (E2AN), whereby we facilitate engagement among awardees and cross-learning between projects and teams composed of researchers, patients, caregivers, and other stakeholders. In addition, PCORI facilitates exchanges between awardees and end-users (e.g., patients; caregivers; and other stakeholders, such as payers, employers and purchasers, clinicians, professional societies, policy makers, and training institutions) for disseminating and implementing important research findings.

Awardees are encouraged to participate in such E2AN as they become available.

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