1. May I apply if I am not a U.S. citizen?

You may apply provided your visa immigration status is acceptable and you are employed by a U.S. institution. Individuals who are noncitizens of the U.S. or do not have a Permanent Resident Card should contact the IMPACTcollaboratory@hsl.harvard.edu prior to submitting a Letter of Intent.

2. Can research be performed outside of the U.S.?

No. Research cannot be performed in study sites outside of the U.S.
Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. organizations are not eligible to apply.

3. Can an application have multiple PDs/PIs?

No. Applications may have only one principal investigator.

4. Do I have to submit a Letter of Intent (LOI)?

 Yes. LOIs are required and will be reviewed on a rolling basis.  Applicants are strongly encouraged to submit their LOI as early as possible, but no later than the LOI deadline.

5. Can I submit more than one Letter of Intent (LOI)?

 No, only one LOI is permitted per cycle from each principal investigator.

6. How are Letters of Intent (LOI) reviewed?

 LOIs will be reviewed on a rolling basis by an interdisciplinary review committee. Applicants may receive a decision on their LOI at any time, but generally within 2 weeks of their submission. LOI decisions may include 1) invited for full proposal for the current cycle, 2) invited for full proposal for a future cycle, and 3) not invited for a full proposal.

7. What is the timeframe from submission to funding notification?

The entire process generally takes approximately 6 months from the LOI deadline. The time from submission of the full proposal application and notification is typically 2 months.

8.  When will funding commence for selected projects?

 Exact timelines will vary. Generally, the timeline from the LOI deadline to project start date is approximately six months. This timeline assumes there are no delays in receiving approvals of the single IRB (sIRB), Data Safety and Monitoring Plan and Data Sharing and Resources Plan.

9. What is an embedded pragmatic clinical trial (ePCT)?

 An embedded pragmatic clinical trial (ePCT) is a trial based on implementing an intervention that can be “embedded” within routine care provided within a healthcare system, agency or organization, or other non-healthcare based organizations. The intervention is implemented in a “real-world” environment by practicing clinicians or non-clinical staff, not interventionists. A core component is that the intervention can be maintained for real-world use and sustained beyond the scope of a trial. ePCTs use a variety of systematic research methods to test the effectiveness of the intervention. Randomization generally occurs at the level of an organization, care team or unit rather than at an individual level, though this is not a hard and fast rule. Most ePCTs utilize data available from electronic health records, administrative data, or claims data to assess effectiveness outcomes.

The NIH Health Care Systems Research Collaboratory Living Textbook of Pragmatic Trials is a helpful resource to learn more about ePCTs. Additional resources include the State of the Science for pragmatic trials for non-pharmacological interventions to improve outcomes among people living with dementia and their caregivers; lessons learned from the NIH Health Care Systems Research Collaboratory; and the process of embedding PCTs in health care systems.

10. How do I know if my intervention is ready for a pragmatic clinical trial?

 Investigators can use the Readiness Assessment for Pragmatic Trials (RAPT) model to assess an intervention’s readiness for ePCTs.

11. How pragmatic does my pilot proposal have to be?

Research methods used in your pilot proposal may fall along a continuum of less to more pragmatic. The PRECIS-2 model (original paper, model website) can help you to evaluate where your proposed pilot trial lies on this continuum. PRECIS-2 can also help to think through your pragmatic trial design and what is needed to obtain pilot data to develop a strong application to NIH or other organizations for a large-scale ePCT.

12. Can I use two or more sites within the same healthcare organization?

 Yes, you may use two or more sites within the same healthcare organization, but you must provide the rationale for site selection. You should also address how pilot data from sites within a single organization will prepare you for implementation in a future trial involving more than one organization.

 13. What types of interventions are acceptable?

 Interventions must be non-pharmacologic in nature and involve people living with dementia or their caregivers. Ideally the intervention (or components thereof) should have some level of evidence supporting its efficacy, and a high potential for implementation in “real world” settings. It may be helpful to consider PCORI Methodology Standards of Complex Interventions.

14.  What level of evidence is required to support the intervention’s efficacy before pilot testing an ePCT?

Ideally, some level of evidence demonstrating efficacy of the intervention (or its components) from a more traditional randomized trial is preferable before pilot testing an ePCT. Evidence may be based on the applicant’s work or the work of others.

15. What types of settings are permissible within this funding mechanism?

 Settings that provide care to people living with dementia and/or their caregivers are permissible within this funding mechanism. Most often this will be a health care setting, but residential (e.g., senior housing) or other units (e.g., recreational day program) are also acceptable.

16.   Why do I need to integrate Diversity and Inclusion throughout the Research Plan?

Dementia affects all Americans and disproportionately impacts African Americans. At the same time, disparities in dementia care are well-established. Ensuring the research supported by the IMPACT Collaboratory includes people from diverse backgrounds and culturally-tailored interventions is core to its mission.

17.   Is it adequate to describe minority representation using the NIH standard planned enrollment table and statement about minority representation?

No. Diversity and inclusion should be integrated throughout the Research Plan. Rationale should be provided about how aspects of the study 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. It may not be possible to address all diversity and inclusion considerations within the scope of a pilot study, however at minimum, investigators should describe how the pilot project experience will inform the design of a future large-scale ePCT in terms of its relevance to people from diverse backgrounds who are living with dementia and/or their caregivers.  These requirements are in addition to the required NIH Planned Inclusion Enrollment Table(s) and statement about minority representation.

18.   What is the purpose of providing quarterly milestones in my application?

Applicants must specify quarterly milestones as part of the full proposal application. Quarterly milestones are required to ensure that pilot ePCTs are progressing in a timely fashion given the 1-year grant period. Quarterly milestones will also be used to assess feasibility by the reviewers and Pilot Core Executive Committee as part of the application review process.

19.  What costs are allowable in my budget?

 This pilot funding mechanism follows NIH guidelines in regard to allowable costs and activities.

 20.  Does the $150,000 budget cap include indirect costs?

 Yes. Each pilot application may have total costs budget up to $150,000. This amount includes both direct and indirect costs.

21.  Do I have to build costs for the single IRB (sIRB) into my budget?

No. You do not need to include costs for the single IRB (sIRB) in your budget. These costs will be supported by the IMPACT Collaboratory.

 22.  Do I have to build travel costs into my budget to attend IMPACT Collaboratory Scientific Meeting in Bethesda meeting into my budget?

No. You do not need to include costs for travel to the in-person IMPACT Collaboratory Scientific Meeting in Bethesda, MD. Costs for travel and accommodations will be supported by the IMPACT Collaboratory.

23. Can my application include Subawards?

Yes. You may have up to 3 Subawards. Each Subaward must have a separate budget and budget justification and at least one Key Personnel. All Subawards will be issued by Brown University on behalf of the IMPACT Collaboratory.  Whenever feasible, purchase of services and/or consulting agreements are strongly preferred to Subawards.

24.  When should I use a Subaward versus a consultant or contractor?

 The table below may help to determine whether to use a Subaward or a Consultant/Contractor. Whenever feasible, purchase of services and/or consultant agreements are strongly preferred.

25. When will I gain access the IMPACT Cores and Teams for their expert support?

Applicants who are invited for a full proposal will be immediately connected to the IMPACT Collaboratory Investigator Navigation Team. The Navigator will play an active role in linking applicants to appropriate Cores and Teams for support in developing a high-quality full proposal. Applicants will be asked to complete an online needs assessment to help target their needs to the appropriate Cores and Teams.