The NIA IMPACT Collaboratory is dedicated to transforming the delivery, quality, and outcomes of care provided to people living with dementia and their caregivers by accelerating the testing and adoption of evidence-based interventions within healthcare systems. However, the lack of research demonstrating how to effectively implement best practices in dementia care in real-world settings hinders the ability of health care systems to provide optimal care. The IMPACT Collaboratory funds one-year pilot studies of pragmatic clinical trials of non-pharmacological interventions embedded within healthcare systems.
The IMPACT Collaboratory funds one-year pilot studies for embedded pragmatic clinical trials (ePCT) annually. In the NIH Stage Model, this aligns with a pilot study for a Stage IV effectiveness trial. The goal of the pilot study is to generate preliminary data necessary to design and conduct a future full-scale ePCT for which funding would be sought from the National Institutes of Health (R01 or equivalent) or other sources. The IMPACT Collaboratory prioritizes applications that address dementia care for people of all backgrounds.
Pilot study grant awards are for one year, up to $165,000 (Cycle 1) in total costs (including direct and indirect costs), and are non-renewable. No-cost extensions will be permitted with strong rationale. Only a single Principal Investigator (PI) is allowed, and only one application is allowed from an individual PI is permitted per funding cycle.
Pilot studies must:
- Pilot test a non-pharmacological intervention targeting people living with Alzheimer’s disease or Alzheimer’s Disease-related dementias (AD/ADRD) and/or their caregivers using a pragmatic trial design.
- Implement the intervention in two or more health care systems or sites within health care systems (e.g., ≥ 2 nursing homes, hospitals, healthcare provider practices).
- Be feasible within the one-year time frame
To be considered for an award, applicants and all applicable collaborators must agree to cede IRB oversight to Advarra, the independent IRB chosen by the IMPACT Collaboratory.
- Eligible institutions include colleges, universities, medical or nursing schools, or other fiscally responsible organizations within the United States.
- No research may be performed outside of the United States.
- Applicants must hold a doctorate degree (MD, PhD, or equivalent)
- Applicants must hold a full-time faculty or research scientist position at an eligible institution by the start date of the award. Applicants from eligible institutions without these titles are eligible to apply if they hold an earned doctorate and are of sufficient stature to be considered a principal investigator within their organization. Individuals who are trainees, such as post-doctoral fellows, are not eligible to apply for this mechanism.
- Applicants must be citizens or permanent residents of the United States.
- Applicants from under-represented racial and ethnic groups as well as individuals with disabilities are strongly encouraged to apply for funding.
The Pilot Studies Program has a competitive two-step application process:
STEP 1: Letter of Intent (LOI)
The LOI application includes the following main elements:
- Pilot study description not exceeding 2-pages (single spaced, 11 Arial font, 0.5” margins) including:
- Specific Aims specifying primary and secondary outcomes;
- The primary outcome of the pilot study must be the scientific outcome anticipated for the full scale ePCT (e.g., antipsychotic use, hospital transfer rates). We recognize the pilot study may have a single arm or be multi-armed with the later not be powered to detect differences in the primary outcome. Rather, the intent is to ascertain feasibility of collecting the primary outcome under the rubric of an ePCT.
- Secondary outcomes should also be specified and should include additional scientific outcomes and implementation outcomes (e.g., feasibility, applicability, usability, fidelity).
- Background and Rationale;
- Overview of Research Design (e.g., study population, setting (types and/or names of health care systems)); and
- Intervention Structure and Implementation Strategy.
- Specific Aims specifying primary and secondary outcomes;
- Anticipated total budget (maximum of $165,000 in total costs) and whether any subawards are anticipated.
- Up to 3 Subawards are allowed. Each subaward must have at least one Key Personnel. Whenever feasible, purchase of services and consulting agreements are strongly preferred to subawards, and these should be listed within the PI’s main budget.
- Each application must have biostatistician named as Key Personnel.
- NIH Biosketch must be submitted for the Principal Investigator and study biostatistician
STEP 2: Full Proposals by Invitation Only
Applications selected for further consideration will be invited to submit a full proposal.
LOI applicants who are invited to submit a full proposal will be immediately connected to the IMPACT Collaboratory Investigator Navigation Team who will play an active role in linking applicants to the appropriate Core Groups and Teams for assistance generating a high-quality application.
Applicants are strongly encouraged to consider the following components in their research plan: evidence base for the intervention, risks, feasibility, acceptability to the health care system partners, costs, alignment with external stakeholders’ priorities, and impact. Applicants may find the Readiness Assessment for Pragmatic Trials (RAPT) model a useful tool to assess an intervention’s readiness for ePCTs. A useful guideline for consideration of key issues pertaining to the evaluation of complex interventions in ePCTs can be found at .https://www.pcori.org/ research-results/about-our-research/research-methodology/pcori- methodology-standards#Complex.
Proposals are expected to adhere to NIH policy and guidelines regarding inclusion of women and minorities in the design and conduct of their study as mandated by Public Health Service Act sec. 492B, 42 U.S.C. sec. 289a-2. The goal is to ensure that individuals are included in clinical research in a manner that is appropriate to the scientific question under study.
Moreover, a description of how the pilot project considers issues related to diversity and inclusion must be integrated into each section of the Research Plan. Rationale should be provided about how aspects of the design (for example, selection of health care system location, target study population demographics, and/or tailoring of the intervention to different cultures) are and are not relevant to people from diverse backgrounds. While it may not be possible to address all issues within the limited scope of a pilot study, at minimum, a description should be provided about how the pilot project experience will inform the design of future larger ePCT in terms of its relevance to people from diverse backgrounds who are living with dementia and/or their caregivers.
Those invited to apply for full proposals will be sent a detailed Application Guide. Full proposals will include applicable PHS 398 Forms. Full proposals will follow the general format of an NIH R21 with IMPACT Collaboratory-specific additions, including:
- Abstract (max 300 words)
- Specific Aims (1 page)
- Research Plan (6 pages)
- Background and Significance
- Preliminary Studies (if applicable)
- Research Design and Methods: Include the following: 1) Study population, 2) Setting (sites/heath care systems), 3) Randomization scheme and masking when appropriate (randomization is not expected for all pilot studies), 4) Intervention structure, implementation protocol, and fidelity/adherence monitoring plan, 5) Data sources, elements, and collection protocol, and 6) Analytic plan.
- Milestones: Specify quarterly milestones. Quarterly milestones are required to ensure that pilot ePCTs are progressing in a timely fashion given the 1-year grant period.
- Future Directions and Next Steps: Specify how the pilot study will directly inform the development of a full-scale ePCT application to the NIH or other funding sources and the anticipated timeline to apply for such funding.
- Bibliography and References Cited
- NIH Biosketch for PI, biostatistician and each additional Key Personnel (must not exceed 3 additional Key Personnel)
- sIRB Pre-Checklist (entered within online application)
- Acknowledgement letter is required from Institutional Review Board at PI’s home institution. This letter acknowledges the institution’s willingness to rely on Advarra, the single IRB for the IMPACT Collaboratory if the pilot study is funded (template is available upon request).
- Letters of Support (required from participating health care systems).
- Appendices are NOT permitted
A budget detailing research-related expenses and salary support is required along with an accompanying budget justification. All NIH rules and regulations regarding budgets for R-series grants will be enforced. The project period is for one year, and the budget may not exceed $165,000 in total costs (direct and indirect costs).
Subawards are allowed (cannot exceed 3). Each subaward must have a separate budget and budget justification and include at least one Key Personnel.
Whenever feasible, purchase of services/consulting agreements are strongly preferred to subawards.
Human subjects research cannot commence without approval by the IMPACT Collaboratory’s overseeing single Institutional Review Board (sIRB) and Data and Safety Monitoring Board (DSMB). Within 2 weeks of notification of funding recommendation, applicants must submit:
- Human Subjects and Clinical Trial Information
- sIRB Application: The IMPACT Collaboratory adheres to the NIH sIRB Policy for Multi-Site Research. Thus, all awarded grants must be approved by the IMPACT Collaboratory’s sIRB; PIs do not need to budget funds for the sIRB. The PI’s home institution must agree to cede to the IMPACT Collaboratory’s sIRB.
- Data and Safety Monitoring (DSM): Pilot Studies will strictly follow NIA DSM policies. The IMPACT Collaboratory DSMB will oversee all pilot studies. A common template for the Data and Safety Monitoring Plan (DSMP) and Charter will be provided. PIs of pilot study awards recommended for funding will be required to submit a full study-specific DSMP and Charter.
- Financial Conflict of Interest Forms and Human Subjects Certificates of Completed coursework for Principal Investigator and Other Key Personnel
The IMPACT Collaboratory Administration Core will assist the PI with the sIRB application and DSM materials
Full proposals are reviewed by three non-conflicted reviewers external to the IMPACT Collaboratory and are rated based on scientific merit following NIH scoring criteria: Significance, Innovation, Investigators, Approach, and Environment. In addition, reviewers evaluate the pilot study’s fit with the IMPACT Collaboratory’s mission and the likelihood that the pilot study will lead to successful future extramural grant funding for a full ePCT. The application’s approach to integrating diversity and inclusion into each aspect of the Research Plan is considered throughout the review process. Appropriateness of the budget, human subjects protections, and data and resource sharing plans is also considered.
Award recipients of the IMPACT Collaboratory Pilot Grants Program are expected to adhere to the following requirements:
- Pilot studies must adhere to sIRB, Data and Safety Monitoring, and Data and Resource Sharing policies.
- Complete Financial Conflict of Interest assurance and training as detailed under their respective organization’s policy.
- Register with gov in accordance with NIA guidelines. Maintain system record and complete all reporting requirements, including uploading results.
- The PI will meet with an assigned Pilot Study Core Executive Committee member for one hour every month throughout the lifecycle of the pilot. The assigned Executive Committee member will be available to help strategize and navigate challenges. To help ensure successful progress, the IMPACT Collaboratory’s Investigator Navigation Team will link PIs and their research team members with the IMPACT Collaboratory Cores and Teams, according to their pilot study’s needs.
- Engage in the IMPACT Collaboratory’s scientific community, including:
- Participating in the academic activities of the Core Groups and Teams (e.g., writing methods articles, developing guidance documents)
- Attending and presenting at the first in-person IMPACT Collaboratory Scientific Meeting in Bethesda, MD (travel and accommodations will be supported by the IMPACT Collaboratory; PIs do not need to budget for these funds)
- Attending webinar-based IMPACT Collaboratory grand rounds.
- Submit required reports for study tracking and standardized data elements on a quarterly basis, as well as final report at the end of the pilot study year.
- Follow IMPACT Collaboratory invoicing guidelines.
- Provide budget reports upon request and at the end of the pilot study year.
- Adhere to the IMPACT Collaboratory publication policy and acknowledge sponsorship in all presentations, publications, and subsequent grants stemming from this pilot project. This information is required for reporting to the National Institute on Aging.
- Respond to IMPACT Collaboratory queries for information after project ends.
Full Proposals Due (by invitation only), 5PM ET December 6, 2019
Notification of Awards January 2020
Earliest Project Start Date March 2020
Award Cycle March 2020-February 2021
The next call for applications is anticipated in Spring 2020.
For eligibility and research-related questions, please contact Ab Brody, PhD, RN, FAAN, Pilot Core Leader at IMPACTcollaboratory@hsl.harvard.edu.
For questions related to access or use of the UFunds system please contact Faye Dvorchak at Faye_Dvorchak@brown.edu