- The PCORI Strategic Plan
- Our Programs
- Our Vision & Mission
- Financial Statements and Reports
- The PCORI Strategic Plan
- Board of Governors
- Methodology Committee
- Authorizing Law
- Evaluating Our Work
- PCORI's Advisory Panels
- Procurement Opportunities
Past Opportunities to Provide Input
- Patient-Centered Economic Outcomes Landscape (2023-2024)
- Systematic Review of Audio Care for the Management of Mental Health and Chronic Conditions (2023) -- Draft Key Questions
- Proposed New Methodology Standards for Usual Care as a Comparator (2023)
- Stakeholder Views on Components of 'Patient-Centered Value' in Health and Health Care (2023)
- PCORI's Proposed Research Agenda (2021-2022)
- Proposed National Priorities for Health (2021)
- Proposed Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research (2020)
- Proposed New PCORI Methodology Standards (2018)
- Data Access and Data Sharing Policy: Public Comment (2017)
- Proposed New PCORI Methodology Standards (2017)
Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
- 12. Standards on Research Designs Using Clusters
- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
- 3: Standards for Data Integrity and Rigorous Analysis
- 4: Standards for Preventing and Handling Missing Data
- 5: Standards for Heterogeneity of Treatment Effects
- 6: Standards for Data Registries
- 7: Standards for Data Networks as Research-Facilitating Structures
- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
- Past Opportunities to Provide Input
Telehealth—the use of digital information and communication technologies, such as computers and mobile devices, to access health care services remotely and manage health care—has grown in promise as technology has rapidly evolved over time. It enables patients to manage their care without traveling to a clinic, and it can be especially valuable in easing disparities among patients who live in areas where health resources are sparse.
During the coronavirus pandemic, there has been a rapid growth in the use of telehealth services. A Centers for Medicare and Medicaid Services analysis shows that before the pandemic, 14,000 beneficiaries received a telehealth service in a week. But from mid-March to early July, more than 10 million beneficiaries received a telehealth service.
Somewhat dependent on whether temporary changes in reimbursement and statutory requirements under the pandemic become permanent or not, telehealth is likely to remain a fixture of health care. However, it’s not as simple as handing a patient a smartphone or sending them a videoconference link. Questions remain about how to best harness its capabilities, including how to reach populations with limited access to technology or who need culturally tailored interventions. PCORI-funded studies are working to answer these important questions.
What PCORI Has Learned about Telehealth
COVID-19 Targeted PCORI Funding Announcement Awards
In addition to offering funding for COVID-19 enhancements to existing research projects, PCORI recently funded nine new projects to answer COVID-19-related questions. These studies seek to answer questions about adaptations to healthcare delivery during the pandemic, the impact of COVID-19 on vulnerable populations, and the impact of COVID-19 on the healthcare workforce’s well-being, management, and training.
Six of the nine awards have a telehealth component. They include a project examining the comparative effectiveness of different approaches to providing primary care during the widespread transition from in-person to remote visits during the pandemic. It is using data from PCORnet®, the National Patient-Centered Clinical Research Network, to examine the impact of telemedicine on patient-centered outcomes and disparities in outcomes for patients with chronic disease at many clinics.
A second study is comparing a mindfulness-based stress reduction (MBSR) group intervention via teleconference with an MBSR mobile app in reducing worry and improving other mental health outcomes among adults living in low-income racial and ethnic minority neighborhoods who lack access to mental health care.
For more information on these awards, visit the list of funded projects. These projects are operating on an accelerated timeline, aiming to produce results within the next 12 months.
Over the past decade, PCORI has committed some $400 million to fund nearly 100 studies that include telehealth interventions. In a review of our telehealth portfolio and discussions with our funded researchers, common challenges and facilitators emerged: inadequate insurance coverage; challenges using technology; challenges due to location, specifically in rural areas with poor internet connections; and concerns about personal data potentially being exposed over the Internet. While these barriers exist in the general population, they are greatly exacerbated when applied to populations at risk for health and health care disparities.
These challenges are real, but evidence from our funded researchers shows they can be addressed. Telehealth interventions can be more successful when patients and stakeholders are involved in designing the intervention, ensuring appropriate cultural tailoring and preferences and usability of technology, and attention is paid to adequate training and technical support.
Telehealth also seems to be more successful when human connection is maintained, whether through a peer, nurse, technology specialist, or another person to interact with patients so that they do not feel isolated and solely interact with technology. Interventions also should include adequate protocols for clinician involvement in their design and deployment.
Telehealth Research during the Pandemic
As part of PCORI’s multifaceted response to the pandemic, we offered supplemental funding for enhancements to existing projects to address questions related to the COVID-19 pandemic. Under this funding initiative ese initiatives, we funded 27 telehealth-related enhancements and two are highlighted below.
Rural American communities were facing a mental health crisis prior to the pandemic, with 80 percent of rural counties lacking access to a psychiatrist and 60 percent lacking access to a psychologist. A West Virginia-based study in progress is comparing two types of remote cognitive behavioral therapy (CBT) with usual primary care—which is often antidepressant medication alone—for treating depression. If effective, remote CBT could help alleviate disparities among populations without ready access to mental health professionals.
When the pandemic hit, its stressors caused dramatic increases in new mental health and substance use disorders. The research team saw a new opportunity to test remote CBT among patients without a history of mental health or substance abuse who are now experiencing mental health problems.
The research team is recruiting a new set of patients for its enhancement aim and randomizing them to either receive remote CBT immediately or to a wait list where they will receive remote CBT in the future. Through self-assessments, researchers will compare patients’ outcomes in the two groups at baseline, and at three and six months after randomization.
“We think this is very pertinent and important at this particular time given the lack of availability or shift in availability of clinical services, the expansion of symptoms of mental health disorders, and the opportunity to deliver these effectively in regions where there is a shortage of providers to begin with,” Robert Bossarte, PhD, the study’s principal investigator, said during a breakout session at last month’s PCORI Virtual Annual Meeting.
This enhancement will provide immediate guidance on the use of mental telehealth treatment options as frontline treatment for patients without history of mental health disorders, especially among underserved populations.
An implementation project in process prior to the pandemic is working to extend the use of a decision aid, shown effective in previous PCORI-funded research, at 15 diverse hospital and health system sites across the United States. The decision aid helps patients with lupus nephritis work with their clinicians during clinical visits, to weigh treatment options for this severe health condition.
But Jasvinder Singh, MD, the lead on this project, reports that once the pandemic began, more than 95 percent of lupus appointments in his health system at the University of Alabama Birmingham switched to a virtual format. Patients with lupus are immunocompromised and have an increased risk of serious complications from COVID-19.
This is very pertinent and important at this particular time given the lack of availability or shift in availability of clinical services, the expansion of symptoms of mental health disorders, and the opportunity to deliver these effectively in regions where there is a shortage of providers to begin with.Robert Bossarte, PhD West Virginia University, Principal Investigator
The enhancement funding is expanding the decision aid from a version to use during in-person office visits, to smartphone and web-based versions that patients can access in advance of a virtual appointment. The funding will also support development of educational materials for clinicians and staff on how best to use the decision aids during the virtual appointments.
The team will work with sites to develop ways identify patients with upcoming appointments and deliver the decision aid to them a week before their telehealth visit. Patients will also receive a phone call before their appointment, reminding them to view the decision aid, generate questions for their clinicians, and also complete evaluation surveys.
The enhancement will add a year to the project, extending its reach to 500 telehealth patients.
For more information on COVID-19-related project enhancements, see a list of the projects that received funding.
Tailoring a Telehealth Intervention for Latino Men with Obesity
Of course, PCORI-funded research completed before the coronavirus pandemic also provides evidence for implementing telehealth strategies among underserved populations.
Latino men more are more likely to be obese than their non-Latino peers, and they are also traditionally underrepresented in research. The HOMBRE Trial recruited more than 400 Latino men with obesity and one or more other cardiovascular disease risk factors to enroll in a culturally tailored version of the Diabetes Prevention Program (DPP), an evidence-based behavioral modification program that has shown promise in reducing obesity, but hasn’t been studied thoroughly among disadvantaged populations.
The HOMBRE Trial offered three delivery methods of culturally tailored DPP to participants: traditional in-person group sessions, group sessions via videoconference, and individual, online-only classes. The research team was interested in the pluses and minuses of each delivery method, in hopes that the results could boost participation in DPP.
Participants who chose the in-person group tended to be older and were more likely to only speak Spanish compared to participants who chose one of the online modalities. Those who chose the online options were more likely to be married and employed full-time, citing the convenience of the online options with their schedules. The research team also found that the in-person sessions thrived with a larger group and a longer session duration, while the online group-therapy modality participants preferred smaller groups. Both online options were best suited for shorter sessions than the in-person group. All this evidence can inform the design of future telehealth interventions.
More to Come
Telehealth holds great promise in increasing access to quality health care for populations that are typically underserved, but these interventions must be thoughtfully developed, implemented, and tailored appropriately to be successful. PCORI is pleased to be funding projects that can answer timely questions for patients and those who care for them.