The Patient-Centered Outcomes Research Institute (PCORI) board of governors has 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. PCORI also approved funding to promote research partnerships between PCORnet, the National Patient-Centered Clinical Research Network, and outside organizations.
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 needed to make better-informed healthcare decisions. PCORnet is PCORI's initiative to improve the nation's capacity to conduct patient-centered comparative clinical effectiveness research (CER) more efficiently by harnessing the power of large amounts of health data and patient partnerships.
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 include $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.
PCORI also awarded $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.
The University of Utah was awarded $9.7 million for a project to compare clinic- and patient-level strategies to increase opportunities for patients to engage in quitlines, phone-based smoking cessation programs. The study aims to increase tobacco cessation and reduce the disproportionate burden of tobacco-related morbidity and mortality among low-socioeconomic populations.
The latest round of PCORI funding includes $9.7 million for a University of Utah study on noninvasive treatment options for chronic, nonspecific low back pain, and $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.
What’s more, the latest funding grants $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. And, Cedars-Sinai Health System was granted $2.6 million for a 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,” PCORI executive director Joe Selby, M.D., said in a statement. “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.
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.