Board also approves funding to promote research partnerships between PCORnet and outside organizations
WASHINGTON, D.C. — The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved $74 million to fund nine new comparative clinical effectiveness research (CER) studies. The funds will support research on a range of conditions that impose high burdens on patients, caregivers and the healthcare system.
That total includes $10 million to fund two projects on medication-assisted treatment (MAT) for pregnant women with opioid use disorders. Opioid addiction among pregnant women is of special concern because it is associated with infant concerns such as preterm birth, low birth weight and neonatal withdrawal, as well as poor health outcomes for mothers. The newly approved awards are:
- $5.3 million for a Dartmouth College project that will compare the outcomes of women receiving prenatal care in practices that also provide MAT with those of women who receive referrals from their providers to specialty care for MAT. Researchers will study outcomes identified by the women and their care teams, such as pregnancy complications, infant treatment for neonatal withdrawal, women’s continued opioid and other substance use, and mothers’ engagement in MAT.
- $4.9 million for a University of Kentucky-based project that will compare two delivery models to rural populations for comprehensive treatment for perinatal opioid use disorder. Women will receive prenatal care and MAT through their community-based providers. In addition, they will receive an evidence-based curriculum either through in-person group sessions led by a perinatal nurse facilitator and a peer support specialist, or through telemedicine consultations with specialists in high-risk pregnancy, addiction care, substance use counseling and neonatology. Researchers will compare outcomes including the long-term success of the women’s recovery and their babies’ health.
The board also approved awards totaling $63 million to fund seven other CER studies on high-burden topics that healthcare stakeholders have identified as priorities. The newly approved awards are:
- $14 million for a study based at Washington University School of Medicine in St. Louis that will compare two guideline-based approaches to obesity treatment for children. The project will evaluate which is more effective: counseling by a primary care provider focusing on healthy eating and activity habits, or a combination of provider counseling and family-based treatment that targets both children and parents.
- $13.5 million for a Boston Medical Center project comparing two methods of delivering cognitive behavioral therapy (CBT) for anxiety in children. The project will test face-to-face therapy delivered in association with primary care and pediatric practices versus online therapy with additional therapist support via telephone. The study focuses on English- and Spanish-speaking children ages 3 to 17 with mild to moderate anxiety.
- $9.7 million for a project with the University of Utah to compare clinic- and patient-level strategies to increase opportunities for patients to engage in quitlines, phone-based smoking cessation programs. Clinic-level interventions will be delivered in 30 federally qualified health centers and focus on enhanced support at the point of care. The other interventions involve opportunities to engage in motivation and practical problem-solving strategies for addressing patient barriers to quitting and treatment engagement. The study aims to increase tobacco cessation and reduce the disproportionate burden of tobacco-related morbidity and mortality among low-socioeconomic populations.
- $9.7 million for a University of Utah study on noninvasive treatment options for chronic, nonspecific low back pain. The team will compare physical therapy with CBT as first-line treatments. Patients whose pain does not lessen will switch to either the other first-line treatment or a mindfulness-based intervention. The project will determine which treatment works best for each patient and what sequence of treatments is most beneficial for patients who do not benefit from the initial therapy.
- $7.5 million for a Dartmouth College study to compare two self-management health programs for people with serious mental illness as well as a chronic medical condition. One program is Illness Management and Recovery, an integrated physical and mental health self-management program that includes a combination of group sessions and one-on-one meetings with a provider. The other is Chronic Disease Self-Management Program, a group program delivered by peers that focuses on chronic disease self-management.
- $6.1 million for an Oregon Health and Science University study to compare different antibiotic therapies for treating the most common type of chronic, pulmonary, nontuberculous infection caused by Mycobacterium avium complex. This project will compare a two-drug and a three-drug therapy to determine which combination is more tolerable and more effective at curing the infection.
- $2.6 million for a Cedars-Sinai Health System project comparing three approaches to treating depression in people with advanced heart failure. One strategy is patient-centered psychotherapy, another focuses on antidepressant medication management, and the third is a combination of medication management and psychotherapy.
“These latest projects reflect the best ideas for urgently needed research on topics prioritized using input from patients, caregivers, clinicians, and other stakeholders,” said PCORI Executive Director Joe Selby, MD, MPH. “The new studies expand our portfolio of patient-centered comparative effectiveness research that will produce vital evidence to address difficult questions on topics that matter most to patients.”
Additionally, the Board approved more than $20 million for four projects that will use PCORnet, the National Patient-Centered Clinical Research Network, to test ways to improve care for people with arthritis, blood pressure, depression and irritable bowel disease. Each of the four projects will actively foster relationships between researchers and stakeholder partners within PCORnet and in outside organizations, such as large patient groups, to support research using PCORnet’s resources. Each of the studies also focuses on linking disparate data sources for a more-complete picture of patient care.
Details of all studies approved by the Board appear on PCORI’s website. The new awards were approved pending a business and programmatic review by PCORI staff and issuance of formal award contracts.
With these latest awards, PCORI has invested $2.1 billion to fund more than 400 patient-centered CER studies and to support other projects designed to enhance CER methods and the infrastructure necessary to conduct CER rigorously and efficiently.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information they need to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.