Pilot Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes (R01 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for researchers and research institutions seeking to conduct clinical trials testing post-acute care interventions and services designed to improve long-term patient outcomes. The NIH R01 mechanism supports investigator-initiated research projects with competitive peer review. Eligible applicants typically include academic medical centers, hospitals, research institutions, and healthcare organizations with institutional review board (IRB) approval capability and research infrastructure. The grant requires a mandatory clinical trial component to evaluate intervention effectiveness. There are no geographic restrictions; awards are made nationwide based on scientific merit and the quality of the proposed trial design.
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Program description
NIMH seeks applications for pilot effectiveness projects to evaluate the preliminary effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden. In this pilot phase of effectiveness research, the trial should be designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach; to address whether the intervention engages the target(s)/mechanisms(s) that is/are presumed to underlie the intervention effects; and to obtain preliminary data needed as a pre-requisite to a larger-scale effectiveness trial (e.g., comparative effectiveness study, practical trial) designed to definitely test the effectiveness of interventions to improve post-acute outcomes.
This Notice of Funding Opportunity (NOFO) supports pilot effectiveness research to evaluate the feasibility, tolerability, acceptability, safety and preliminary indications of effectiveness of post-acute phase intervention approaches and inform the design of definitive effectiveness trials. Support for fully-powered, definitive effectiveness studies focused on post-acute phase interventions is provided via the R01 currently TEMP-24813.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&R) cover page and budget forms (SF-424 R&R, SF-424 S, PHS 398 budget narrative)
- Project Narrative (typically 12-15 pages) describing research aims, clinical trial design, methodology, and expected outcomes
- Specific Aims page (one page maximum)
- Research Strategy section including significance, innovation, and approach
- Detailed Clinical Trial Protocol with study design, inclusion/exclusion criteria, enrollment projections, and patient safety monitoring plan
- IRB approval letter or evidence of IRB review exemption
- Biographical sketches (NIH Form Page) for key personnel, especially principal investigator and trial coordinator
- Letters of support from collaborating institutions and clinical sites if applicable
- Data management and statistical analysis plan including power calculations
- Other support documentation showing current and pending funding for applicants
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.242 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$78,262,050
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$75,056,208
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$74,756,329
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$64,705,159
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$63,991,707
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$54,214,022
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$48,653,752
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$38,895,082
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$38,475,557
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$35,940,675
Top States by Funding
- CA 15 awards $408.1M
- MA 9 awards $230.5M
- NY 6 awards $184.2M
- CT 4 awards $183.5M
- WA 4 awards $174.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.242). How funding has trended year over year.
| 2024 | $1,722,300,004 | |
| 2025 | $1,726,864,191 | |
| 2026 est. | $99,221,272 |
FAQ
Who can apply for this R01 Clinical Trial grant?
Eligible applicants include established research institutions, academic medical centers, teaching hospitals, and healthcare organizations with doctoral research programs and IRB oversight. Individual investigators must have appropriate research credentials and institutional affiliation. Non-domestic organizations may be eligible under specific circumstances.
Is a clinical trial required for all applications?
Yes, this solicitation specifically requires a clinical trial component. The research must test an intervention or service with a rigorous trial design and measurable outcomes related to post-acute care effectiveness.
What is the typical funding range for R01 awards?
R01 awards typically range from $250,000 to $500,000+ total costs per year, depending on scientific area and project complexity. Individual award amounts vary; consult the NIH program officer for specific expectations in your research area.
How competitive is this funding mechanism?
R01 grants are highly competitive with success rates typically between 20-25% across NIH. Clinical trial requirements add complexity, so strong preliminary data and rigorous study design are essential to competitiveness.
What is the timeline from application to award?
The typical NIH review cycle is 6-9 months from application deadline to funding notification, though this can vary. Plan for 12+ months total from submission to grant start date.
💡 Tips for applicants
- Establish strong preliminary data demonstrating feasibility and promise of your post-acute intervention before application. Pilot studies or published evidence of similar interventions significantly strengthen competitiveness.
- Work closely with your NIH program officer during application development. They can clarify expectations for clinical trial design, outcome measures, and alignment with current NIH research priorities in post-acute care.
- Design a rigorous, clearly-powered clinical trial with realistic enrollment projections. Include detailed statistical analysis plans, appropriate control/comparison conditions, and validated outcome measures that directly address post-acute effectiveness.
- Budget adequately for clinical trial infrastructure including patient recruitment, informed consent, data collection, and quality assurance. R01s often underestimate trial costs; transparent budgeting builds reviewer confidence.
- Address health equity and diverse populations in your trial design. NIH increasingly expects applicants to explain how their research will include underrepresented groups and reduce healthcare disparities in post-acute care.
⚠️ Common mistakes
Applications often fail because they propose underpowered trials with insufficient patient enrollment plans or weak preliminary data that doesn't convincingly support the intervention's promise. Another frequent issue is vague or misaligned outcome measures—reviewers reject applications where primary endpoints don't directly measure meaningful improvements in post-acute care trajectories or long-term functional outcomes. Finally, many applicants underestimate the budget and timeline required for rigorous clinical trial conduct, signaling to reviewers that the study design is not feasible.
Similar grants
- OPEN Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes (R01 Clinical Trial Required) — National Institutes of Health
- OPEN Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 Clinical Trial Required) — National Institutes of Health
- OPEN Effectiveness Trials to Test Mental Health System Interventions (R61/R33 Clinical Trial Required) — National Institutes of Health
- CLOSED Advancing Research on Empirically-Supported Interventions for Older Adults Living with Serious Mental Illness (SMI) — National Institutes of Health
- OPEN Pilot Health Services and Economic Research on the Treatment of Drug, Alcohol, and Tobacco Use Disorders (R34 Clinical Trial Optional) — National Institutes of Health