By Clinical Research News Staff

December 8, 2021 | Last week, the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors approved two slates of research funding awards totaling $49.5 million to support nine new comparative clinical effectiveness research (CER) studies aimed at improving care for adults and children across a range of health conditions. Three of these CER studies totaling $23.5 million focus on telehealth and mobile health strategies, the future of which is currently the subject of many clinical and policy discussions.

“With the explosion of telehealth, especially during the COVID-19 pandemic, studies assessing how well telehealth strategies work in different contexts are highly relevant for many Americans, and we look forward to the insights gleaned from these studies as well as all the other newly approved research projects,” said PCORI Executive Director Nakela L. Cook, M.D., M.P.H. in a press release. “Additionally, we are pleased that PCORI is expanding its research portfolio in two priority areas with today’s approval for a new study on reducing disparities in maternal health and a new study on improving care for people living with intellectual and developmental disabilities.”

The newly approved CER studies on telehealth will expand an existing robust portfolio of PCORI-funded research determining the effectiveness of telehealth for a wide range of conditions and situations.

One new CER study will assess how effective two new mobile health (mHealth) technologies are at helping people quit smoking. It will compare the use of an mHealth approach to cognitive behavioral therapy (CBT) called iCanQuit alone to a combination of iCanQuit and Motiv8, a technology that provides financial rewards based on evidence of smoking abstinence, and each of these telehealth options to traditional cessation approaches such as telephone counseling through “quitlines.”

A pain-coping CER study seeks to determine whether a single online class dubbed Empowered Relief that teaches pain relief skills is as or more effective than the gold standard treatment of eight sessions of CBT at helping people manage their chronic pain and whether either therapy works better for some people than for others. If the online class proves as effective, it could increase access to care by offering a less burdensome means of developing coping skills.

As evidence mounts that yoga can help people with mild to moderate depression feel better, this study will compare outcomes among people who engage in a real-time remote yoga program to those who receive a recommended form of psychotherapy called behavioral activation via video conference or telephone.

Additional CER studies approved for funding include:

• The CARES Trial, which will compare use of a low-dose opioid regimen to use of a nonsteroidal anti-inflammatory drugs (NSAIDs) regimen to see which works best at helping patients relieve their pain as they recover at home after low-risk surgery and which has the least amount of associated harm.
• A CER study that will use real-world data from nearly 400,000 medical records to determine whether detecting and treating genital herpes infection early in pregnancy reduces the chances of birth-related health problems among African Americans and racial disparities in maternal outcomes. Current guidelines call for treating genital herpes infection later in pregnancy with the aim of protecting newborns from the risk of viral transmission.
• A CER study that will help parents of youth with intellectual and developmental disabilities choose which of two peer group interventions—one focusing on support and information sharing and the other with the same focus but adding advocacy skills training--best improves health outcomes for themselves and for their children.

Details of these and all other studies approved for funding are on PCORI’s website. All funding awards were approved pending a business and programmatic review by PCORI staff and the issuance of formal award contracts. With these latest awards, PCORI has invested about $3.3 billion to fund patient-centered CER and to support other projects designed to enhance CER methods and the infrastructure necessary to conduct CER rigorously and efficiently.

Targeted Funding, Three-Year Funding Commitment Plan, Research Agenda

In addition to the approval of award slates, the Board also approved PCORI’s developing and releasing two Targeted PCORI Funding Announcements in 2022. One will offer up to $30 million to fund studies comparing the effectiveness of ways to prevent or treat alcohol use among youth ages 12 through 17. The other will provide up to $30 million for research assessing interventions to prevent, detect early or treat delirium in older adults.

They will be part of an ambitious three-year funding commitment plan totaling $1.8 billion that the Board approved today. This plan includes $1.5 billion for research studies, $180 million for dissemination and implementation projects, and $160 million for projects related to infrastructure and accelerating patient-centered outcomes research.

Relatedly, PCORI is preparing to open a public comment period on its proposed Research Agenda with the Board’s approval to seek input on this proposed framework for achieving progress on its National Priorities for Health and guiding the ongoing development of a research project agenda with patient and stakeholder input.