Clinical Strategies for Managing and Reducing Long-Term Opioid Use for Chronic Pain - Cycle 3 2015
Research Initiative Highlights
This Notice encourages research institutions or consortiums of institutions with expertise in clinical comparative effectiveness research (CER)/patient-centered outcomes research (PCOR), and in clinical and epidemiological research related to chronic opioid treatment, to consider applying for this new PFA.
The Patient-Centered Outcomes Research Institute (PCORI) seeks to fund randomized clinical trials (RCTs) that compare two or more alternative clinical strategies for reducing/eliminating opioid use while managing pain or strategies used to limit dose escalation. There is a shortage of high-quality evidence demonstrating the safety and effectiveness of long-term opioid therapy for the management of chronic pain, and to date no large-scale studies have assessed strategies for managing and reducing chronic opioid use in a real-world setting. The upcoming research initiative is expected to examine direct comparisons of different treatment strategies and modalities in patients with chronic non-cancer pain. PCORI is interested in studies that include important comorbidities such as mental health disorders, and past or current substance use disorders. Other key subgroup analyses that examine various pain sources or important disparities in the management of long-term opioid therapy are welcome.
PCORI’s mission is to improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make informed health decisions. Specifically, we fund CER and work that will improve the methods used to conduct such studies.
PCORI relies on input from multiple stakeholders to set its research priorities. Members of its advisory panels include patients, clinicians, researchers, purchasers, payers, industry, and other healthcare stakeholders. Stakeholders identified the use of long-term opioids for chronic pain as an important topic, which PCORI’s Advisory Panel on Assessment of Prevention, Diagnosis, and Treatment Options then ranked as a high-priority. PCORI then convened a large multi-stakeholder workshop to provide input on whether specific opioid CER questions could be addressed by PCORI-funded research. Through stakeholder engagement efforts and discussions with PCORI’s Science Oversight Committee (stakeholder workshop and topic brief), the topic was narrowed to focus on strategies for managing and reducing opioid use.
PCORI’s Board of Governors approved this topic on September 28, 2015, for a targeted funding initiative.
This Notice of a PCORI Funding Announcement is provided to allow potential applicants additional time to identify collaborators, obtain stakeholder input on the research question, and develop responsive, high-quality proposals.
Applications may be submitted by any private-sector research organization, including any non-profit or for-profit organization, and any public-sector research organization, including any university or college hospital or healthcare system, laboratory or manufacturer, or unit of local, state, or federal government. The Internal Revenue Service must recognize all US applicant organizations. Nondomestic components of organizations based in the United States and foreign organizations may apply, as long as there is demonstrable benefit to the US healthcare system and U.S. efforts in the area of patient-centered research can be clearly shown. Organizations may submit multiple applications for funding. Individuals are not permitted to apply.
- Potential for the study to fill critical gaps and generate actionable evidence
- Potential for the study findings to be adopted into clinical practice and improve delivery of care
- Scientific Merit (Research design, analysis, and outcomes)
- Patient and stakeholder engagement
Deadlines are at 5:00 p.m. (ET). If deadlines fall on a weekend or a federal holiday, the deadline will be the following Monday or the next day after the federal holiday.