Hybrid Effectiveness-Implementation Trials for Heart, Lung, Blood, and Sleep Diseases in the Inpatient Setting (U01 - Clinical Trials Required)

Released Date
Expiration Date
Activity Code
U01
Full Announcement
RFA-HL-21-001

Frequently Asked Questions for Hybrid Effectiveness-Implementation Trials for Heart, Lung, Blood, and Sleep Diseases in the Inpatient Setting (U01 - Clinical Trials Required)

Q1: Is RFA-HL-21-001 the FOA referenced in NOT-HL-17-493?

A1: Yes, RFA-HL-21-001 is the published FOA referenced in NOT-HL-17-493.

Q2: Can investigators apply to RFA-HL-21-001 if they were not awarded a grant in response to RFA-HL-18-018?

A2: Yes.

Q3: Can the implementation strategy(ies) tested during this U01 target evidence-based practice(s) for hospitalized patients transitioning from the inpatient to outpatient setting?

A3: This FOA will support the testing of an implementation strategy(ies) targeting evidence-based practice(s) for hospitalized patients. It is not intended to support the testing of implementation strategies targeting evidence-based practice(s) for patients recently transitioned from the inpatient to the outpatient setting. Focusing on a hospitalized patient population for the primary purpose of implementing evidence-based practice(s) once the patients are discharged from the hospital would not be responsive to this FOA. Developing an implementation strategy(ies) that targets both inpatient and outpatient evidence-based practices is allowed only if the main focus is on the evidence-based practice(s) for inpatients.

Q4: Can the implementation strategy(ies) tested during this U01 target evidence-based practice(s) for patients in a long-term acute care hospital?

A4: Yes. This FOA will support testing of an implementation strategy(ies) targeting evidence-based practice(s) for hospitalized patients. This can include patients in the emergency department, acute care hospital ward, intensive care unit, and/or long-term acute care hospital setting.

Q5: Can the clinical outcomes for the proposed hybrid effectiveness-implementation trial include outcomes after hospital discharge?

A5: Yes. This FOA will support the testing of an implementation strategy(ies) targeting evidence-based practice(s) for hospitalized patients in a hybrid effectiveness-implementation trial. Clinical outcomes that could be affected by the implementation strategy(ies) being tested may be collected, including clinical outcomes that are collected after hospital discharge.

Q6: Is testing a de-implementation strategy(ies) responsive to this FOA?

A6: Yes. Testing a de-implementation or implementation strategy(ies) targeting an evidence-based practice(s) for hospitalized patients is responsive to this FOA.

Q7: Who qualifies as an implementation research expert?

A7: There is no strict definition of an implementation research expert. However, it is expected that this investigator (or investigators) will have the appropriate knowledge, skills, and experience in implementation research to carry out the proposed project in collaboration with a multi-disciplinary team of investigators that also includes experts in inpatient clinical research and analytic methods.

Q8: Is the Data and Safety Monitoring Board (DSMB) for a trial funded by RFA-HL-20-001 anticipated to be an institutional DSMB (convened by the RFA-HL-20-001 awardee) or a DSMB convened by NHLBI?

A8: Investigators applying to RFA-HL-20-001 should anticipate that the DSMB will be an institutional DSMB (convened by the awardee). Costs associated with DSMB activities should be included in the proposed budget. If NHLBI determines that an NHLBI DSMB is appropriate, the investigators will be notified of this prior to award.

Q9: Should the application consider effects from the COVID-19 pandemic?

A9: As described in NOT-OD-20-122, NIH grant applications should not include contingency plans that would outline steps needed to recover from temporary, emergency situations, or institutional return-to-the-workplace plans, resulting from the COVID-19 pandemic. Contingency plans will not be considered in peer review but, if needed, COVID-19 contingency plans will be requested and carefully considered by NIH staff before funding.

Q10: Are there resources available to investigators working on their applications?

A10: Applicants are encouraged to contact the scientific contacts listed in RFA-HL-21-001 with any questions. Additionally, the NIH Research Methods Resources website may be helpful to investigators: https://researchmethodsresources.nih.gov/.

Q11: If I am an Early Stage Investigator (ESI)/New Investigator (NI) and I am awarded a U01 in response to this FOA, will I lose my ESI/NI status?

A11: Yes. An investigator who is awarded a U01 is no longer considered a NI and therefore is not eligible for the ESI/NI funding advantage.

Q12: If I qualify as an Early Stage Investigator (ESI), will I be given special funding consideration?

A12: There is no specific special funding advantage for ESI investigators who apply to RFA-HL-20-001, however this may be one of the factors considered by NHLBI in its funding decisions.

Q13: Where will my U01 application be reviewed?

A13: The U01 applications will be evaluated for both scientific impact and operational feasibility by a Special Emphasis Panel (or an appropriate Scientific Review Group) convened by the NHLBI Office of Scientific Review, using the FOA peer-review criteria. The review process is similar to CSR with the standard scoring system.