Notice of Upcoming Reopened PCORI Funding Announcement (PFA)
Research Initiative Highlights
Due to the continued concern about addressing the opioid epidemic, PCORI is reopening this funding initiative to support patient-centered comparative clinical effectiveness research (CER) that addresses important questions regarding strategies to prevent unsafe opioid prescribing in primary care among patients with acute or chronic noncancer pain.
As noted in the original funding announcement, issued on August 15, 2016, the two priority research questions are:
- 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 shared decision making about the relative harms and benefits of opioids and alternative treatments on prevention of unsafe prescribing and improved patient outcomes?
Competitive applications must address at least one of the two priority research questions listed above. Studies should have a sufficient sample size and generate information that is readily generalizable to the broader population.
As in the original funding announcement, this current funding announcement excludes patients on chronic opioid therapy. For this solicitation, PCORI is particularly interested in receiving applications that target settings of high need, such as dentist offices, emergency departments, rural areas, and states with high rates of opioid prescribing. PCORI is also particularly interested in receiving applications that compare specific strategies of interest to payers (e.g., pharmacy benefit management strategies such as prior authorization, step therapy, and quantity limits). Applicants are advised to review the awards that PCORI has funded through the original announcement, which will be announced on August 15, 2017, to ensure that their proposed research complements those projects.
Applicants should also:
- Focus on patients who are potentially new users of opioids or patients who have used opioids for less than three months, with either acute or chronic pain or both. All chronic pain disorders outside of pain caused by advanced cancer are considered chronic noncancer pain.
- Have strong endorsement and study participation by relevant patient organizations, professional organizations, and payer or purchaser organizations.
- Propose projects that take place within typical clinical care and community settings.
- 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. Examples of patient subgroups include those with comorbid mental health disorders or past/present substance abuse; vulnerable populations such as racial and ethnic minorities, children, older adults, people with limited access to health care, or those with limited communication skills; and those with specific types of pain, acute or chronic.
- Compare the effectiveness of two or more alternatives for improving patient-centered outcomes.
 Effectiveness is the extent to which an intervention does more good than harm in a broad mix of patients when provided under the usual circumstances of healthcare practice (modified from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1116525/).