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Notice of Upcoming PCORI Funding Announcement

Key Dates

  • PFA Opens
    May 7, 2024
  • Applicant Town Hall
    May 16, 2024; 12 pm (ET)
  • Letter of Intent (LOI) Deadline
    June 4, 2024; 5 pm (ET)
  • LOI Status Notification
    July 2, 2024
  • Application Deadline
    Sept. 4, 2024; 5 pm (ET)

The Patient-Centered Outcomes Research Institute (PCORI) intends to issue a Topical PCORI Funding Announcement (PFA) on May 7, 2024, seeking to fund high-quality, patient-centered comparative clinical effectiveness research (CER) projects that focus on addressing substance use/misuse and substance use disorders. This preannouncement provides potential applicants additional time to identify collaborators; obtain patient and stakeholder input on potential studies; and develop responsive, high-quality proposals.

Research Initiative Highlights

Among those aged 12 or older in the United States, around 60 percent reported current use of tobacco products, nicotine, alcohol or an illicit drug in 2022. Nationally, over 48 million people aged 12 or older were diagnosed with a substance use disorder in 2022, of which an estimated 76 percent received no treatment. Rates of both diagnosed substance use disorders and of overdose have escalated in recent years. This Topical PFA will solicit applications focused on substance use/misuse and substance use disorders.

PCORI is particularly interested in applications focusing on substance use/misuse and substance use disorders in high-need and/or underserved populations, including but not limited to rural populations, low-income populations, sexual/gender minorities, racial/ethnic minorities, pregnant persons, those involved with the justice system, youth, older adults and individuals with co-occurring mental and physical health conditions. Applications may propose CER studies of prevention, screening, harm reduction, treatment and recovery approaches for substance use/misuse and substance use disorders at the individual, community or systems level to improve patient-centered substance-use-related outcomes. At least one primary outcome must be focused on substance use.

Substances of interest include but are not limited to alcohol, opioids, nicotine and polysubstance use.

Applications proposing novel interventions and/or aiming to develop new technologies (such as mobile apps) or decision support tools/aids will be considered nonresponsive. Adaptations of efficacious interventions used in the general population may be responsive, but the level of adaptation must be clearly described and justified a priori.

PCORI is particularly interested in submissions that address the following Special Areas of Emphasis (SAEs). The purpose of identifying these SAEs is to encourage submissions to these areas, not to limit submissions to these topics. Applicants addressing an SAE should identify the area that is best associated with their research approach.

  1. Evidence-Based Strategies to Advance Equity in the Prevention and Treatment of Substance Use Disorders: Historically underserved and underresourced populations experience significant disparities in outcomes and inequities in access to the continuum of care for substance use/misuse and substance use disorders. PCORI is interested in evidence-based approaches that advance health equity, with a strong recommendation to include individuals with lived experience contributing to the design of the study. Studies could include community-centered recovery models, trauma-informed care, and peer support interventions.
  2. Evidence-Based Interventions for Overdose Prevention: Overdose remains a deadly issue in the United States, with over 75 percent of overdose deaths involving opioids and nearly half involving multiple drugs. PCORI is interested in patient-centered CER of system-, community- and individual-level interventions to reduce overdose-related negative health outcomes and deaths, particularly for historically marginalized and underresourced populations. Examples of studies may include harm reduction strategies, multi-level interventions and approaches that increase linkage to Medications for Opioid Use Disorder (MOUD).
  3. Strategies to Reduce Nicotine and Tobacco Use in Disproportionally Affected Populations: Despite quit attempts and longer-term cessation increasing over the past two decades, considerable disparities remain in the prevalence of nicotine and tobacco use across races and ethnicities, as well as the prevalence of key indicators of smoking cessation. PCORI is interested in funding patient-centered CER assessing different forms, doses, durations and delivery of treatments, particularly when focused on disparities and health equity. Studies may include school-based initiatives, digital therapeutics and pharmacotherapy approaches.

Applicants are strongly encouraged to propose individual- or cluster-randomized controlled trials; however, well specified natural experiments and well-designed observational studies will also be considered. Proposed studies should examine large and diverse populations with an overall sample size that will allow precision in the estimation of hypothesized effect sizes and, as appropriate, analysis of population subgroups that may include heterogeneity of treatment effects. Applicants are encouraged to pay special attention to intervention implementation, with an aim of facilitating widespread uptake of findings after completion of the study. However, strict implementation or dissemination studies will not be considered responsive, nor will studies focused on the development of research methods. Applicants should propose well justified substance-use-related outcomes that are clinically meaningful, considered important by those with lived experience and can be impacted by the proposed intervention within the study duration. Objective outcome measures are encouraged where appropriate and self-report outcomes should be sufficiently justified.

Applicants should consider, as appropriate, the full range of substance-use-related clinical and patient-centered outcomes data relevant to patients and other stakeholders. PCORI’s Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research inform the expectations for applicants and the corresponding evaluation of applications submitted in response to this PFA.

This funding announcement will accept applications with direct costs up to $12 million dollars and up to five years in duration. For this funding announcement, applicants may request coverage of patient care costs (including medical products, procedures and care services) for potential funding by PCORI. These costs are included as part of the overall direct costs. For additional information, please see the full announcement upon posting.

PCORI encourages all investigators interested in applying to use this inquiry form to submit questions and request to speak with a PCORI Program Officer.

Key Dates

Online System Opens
May 7, 2024
Applicant Town Hall
-
View Event
Letter of Intent Deadline
June 4, 2024, 5 pm (ET)
Letter of Intent Status Notification
July 2, 2024
Application Deadline
Sept. 4, 2024, 5 pm (ET)
Merit Review
November 2024
Awards Announced
April 2025
Earliest Start Date
August 2025

Funds and Project Period

Funds Available Up To
$100 million
Total Direct Costs
Up to $12 million
Maximum Project Period
Up to five years

Tags

Year
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Award Types
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Status