The Patient-Centered Outcomes Research Institute (PCORI) seeks to fund up to eight pragmatic randomized controlled trials (RCTs) or well-designed, prospective observational studies that will compare two or more alternatives to prevent unsafe opioid prescribing in primary care among patients with acute and chronic non-cancer pain, while ensuring adequate or improved pain management. Note that this funding program does not support applications to conduct cost-effectiveness analysis, systematic reviews, or development and evaluation of shared decision making or decision-support tools. Interventions that have evidence to support their use in similar situations but have not been used for reducing unsafe opioid prescribing may be used with adaptation with sufficient rationale, and if the majority of time and budget is aimed at establishing comparative effectiveness rather than developing and validating the intervention.

The following types of research institutions are encouraged to consider applying for this new PCORI Funding Announcement (PFA): 1) institutions with expertise in clinical comparative effectiveness research (CER)/patient-centered outcomes research (PCOR) on strategies to promote safe opioid prescribing or 2) consortiums of research institutions collaborating with health systems and/or payers that are implementing strategies to address the opioid epidemic and improve pain management.

Background

PCORI relies on input from multiple stakeholders to set its research priorities. On March 7, 2016, PCORI convened a large multi-stakeholder workshop to provide input on whether specific CER questions on strategies to prevent unsafe opioid use could be addressed by PCORI-funded research. The aim was to complement an earlier funding announcement that targeted clinical management of people on chronic opioid therapy. Summary information from that meeting can be found here.

Research Initiative Highlights

Based on the key gaps, input from our large multi-stakeholder workshop, and the PCORI Board of Governors Scientific Oversight Committee, PCORI is interested in applications that respond to the following two priority comparative effectiveness research questions:

  • What is the comparative effectiveness of different payer or health system strategies that aim to prevent unsafe opioid prescribing while ensuring access to non-opioid methods for pain management with the goal of reducing pain and improving patient function and quality of life outcomes, while reducing patient harm? 
  • What is the comparative effectiveness of different patient- and provider-facing interventions that facilitate improved knowledge, communication, and/or shared decision making about the relative harms and benefits of opioids and alternative treatments on prevention of unsafe prescribing and improved patient outcomes?

Additionally, applications should:

  • Focus on patient populations who are potentially new users of opioids or patients who have used opioids for less than three months, with either acute or chronic pain. All chronic pain disorders outside of cancer pain at end of life are considered chronic non-cancer pain. Studies focusing on chronic opioid users will be non-responsive.
  • Include interventions intended to prevent unsafe prescribing while ensuring adequate or improved pain management.
  • Target primary care, broadly defined to include primary care practices, emergency departments, dentist offices, or urgent care centers. Applicants will need to further delineate and justify the setting for the proposed research within this broad area of primary care.
  • Have a sufficiently large study population to enable precise estimates of effect sizes and to support evaluations of potential differences in intervention effectiveness in patient subgroups. The research may focus on either acute or chronic pain or both, if there is adequate attention to subgroups.
  • Address clinical and healthcare delivery choices faced by patients, caregivers, clinicians, and delivery systems.

Helpful Resource

PCORI's Board of Governors approved this topic at its meeting on May 23, 2016. Additional information regarding the specifics of this upcoming targeted PFA can be found in the meeting's presentation slides.

Download Full Announcement

Key Dates

Online System Opens
August 15, 2016, 12:00 AM
Letter of Intent Deadline
September 14, 2016, 12:00 AM
Awards Announced
<p><a href="/events/2017/board-governors-meeting-6">August 15, 2017; 12:00 p.m. (ET)</a></p>

Funds and Project Period

Funds Available Up To

$30 Million

Total Costs

$5 Million

Maximum Project Period

3 Years

Applicant Resources

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