PCORI approves $258 million funding to support 26 new health care-related studies

The Patient-Centered Outcomes Research Institute (PCORI) has approved funding awards totaling $258 million to support 26 new research studies. These studies aim to fill evidence gaps and improve health care decision making for a range of high-burden conditions among adults and children, including asthma, bone fractures, migraines, intellectual and developmental disabilities, and sinus infections.

Five comparative clinical effectiveness research (CER) studies focus on improving mental health and another four CER studies focus on heart conditions, which have both continued to worsen in the U.S. amid the COVID-19 pandemic.

Additionally, PCORI today announced about $3.9 million for two projects that aim to promote wider, faster adoption of useful findings from completed PCORI-funded CER studies into typical care practices.

Reflecting priorities encapsulated in PCORI's recently adopted Strategic Plan, today's funding approvals are an important step in advancing PCORI's work to generate and disseminate information that improves the quality and relevance of evidence available to help patients and all stakeholders make better-informed decisions about their health. Facing a complex health care system and many care options, patients need reliable information to help them understand which care options will work best for them in their particular circumstances."

Nakela L. Cook, M.D., M.P.H., PCORI Executive Director

$72 million to improve mental health care and outcomes

The newly approved CER studies on mental health will expand an existing robust portfolio of PCORI-funded research examining the effectiveness of mental health care options for adults and children.

One study will assess the comparative effectiveness of first- and second-line pharmacologic treatment strategies used to help people with bipolar disorder who are experiencing a major depressive episode. Funded for nearly $25 million, this large study aims to include 2,800 adult participants at 38 academic medical centers and community sites across the U.S.

A second study will compare the benefits and potential harms of electroconvulsive therapy and intravenous ketamine for rapid treatment of acute suicidal depression. Funded at about $28.5 million, this large study aims to include 1,500 adults at 10 to 13 sites across the U.S.

A third study will assess the comparative effectiveness of two interventions, text-messaging enhanced telehealth services and financial incentives, to increase outpatient addiction treatment among adults with opioid use disorder after they are discharged from an emergency department.

Two other studies will:

• Compare the effectiveness of in-person and technology-enhanced screening and referral programs at improving screening, referral, treatment attendance, and communication and care coordination for pregnant and postpartum individuals with substance use disorders.

• Compare two interventions – one involving a safety plan with follow-up contacts and the other a brief crisis-oriented intervention targeting interpersonal functioning – to see whether either is better at reducing suicidal ideation and attempts among English- and Spanish-speaking adolescents who receive care in urban emergency departments.

$52.5 million to improve heart-related health care and outcomes  

Four newly approved CER studies will add to PCORI's portfolio of funded research determining the effectiveness of cardiac health care options for adults. The largest will compare two therapies used to restore normal heartbeat patterns in millions of patients with both heart failure and reduced ejection fraction. It aims to determine whether His or left bundle branch cardiac pacing or biventricular pacing offers any advantages over the other. Funded at more than $31 million, the study aims to enroll over 2,000 adults at 55 sites in the U.S. and Canada.

Three other studies will:

• Compare patient-centered outcomes for cardiac rehabilitation delivered via telehealth or in-person among chronic heart disease patients.
• Compare the effectiveness of two classes of antianginal medications among older adults with stable angina and multiple chronic conditions.
• Compare blood pressure outcomes among a diverse population of patients with high blood pressure who receive either telehealth-supported, team-based care with a pharmacist or enhanced usual care with telehealth-enabled home blood pressure monitoring equipment and instruction.

$3.9 million to promote the uptake of evidence from PCORI-funded research into practice

These implementation projects will focus on:

• Promoting informed decision making between antibiotics versus appendectomy among eligible patients with appendicitis at 15 hospitals across the U.S., using a program that includes a patient decision support tool.
• Incorporating an mHealth program, which includes a patient smartphone app and an online clinician dashboard, into routine care at three community mental health agencies to help people with serious mental illness manage their symptoms.

PCORI also awarded funding to compare preventive therapies for migraines and bone fractures as well as multiple studies that focus on assessing ways to promote healthy aging. Details of the newly approved studies can be found on PCORI's website.

Details of all studies and projects approved for PCORI funding to date are available on the organization'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 will have invested more than $3.7 billion to fund patient-centered CER and support other projects designed to enhance CER methods and the infrastructure necessary to conduct CER rigorously and efficiently.