The INSPIRE Clinical Outcomes Strategically Focused Award – Letter of Intent and Full Proposal Instructions

Overview and Eligibility:
The INSPIRE Scientific Review Committee is providing funding for one project of 2-3 years duration with a total budget of $180,000.  These projects must be simulation-based and include clinical outcome measures. For the purposes of this award, clinical outcome measures are defined as measurements of real patient outcomes in the clinical environment.  These include both process of care measures (adherence to clinical guidelines, time to administration of drug, time to critical intervention, etc.) and patient outcomes (ROSC after cardiac arrest, mortality, etc).  An example of an eligible project would be a prospective study examining the effect of just-in time ECMO simulations on time to cannulation and neurologic outcomes in single-ventricle congenital heart patients’ status post initial palliative surgery. Quantitative, qualitative or mixed methods research approaches are equally welcome.

This award is open to all investigators in INSPIRE, but priority will be to research teams with prior experience in simulation-based research that are able to demonstrate adequate pre-existing infrastructure to complete the project. We are seeking studies that are both novel and have strong potential for a positive impact on healthcare delivery processes and outcomes.  Preference will be given to those proposals addressing INSPIRE’s areas of primary focus (technology, human factors, acute care/resuscitation, patient safety, debriefing, IPE/teamwork/communication, procedural and psychomotor skills).

Only one project submission will be accepted from each Principal Investigator.

Please note as well that all INSPIRE members involved with the selection process for this award 1) cannot apply as a principle investigator and 2) must recuse themselves from any discussions involving proposals on which they are named as co-investigators.

Timeline:
Call for proposals was announced at the January 2018 INSPIRE meeting at IMSH.

Letters of Intent (LOI) will be due March 30, 2018 at midnight EST. These will be reviewed by the award committee and those applicants with highly ranked LOI’s will be invited to submit a full proposal.  Instructions for preparing this proposal will be provided at that time.

Investigators will be notified about request for full proposals on or before May 15, 2018, and completed applications will be due on November 1, 2018.

Award Notification and Funding:
Awardees will be notified in January of 2019 and formally announced at the January 2019 INSPIRE at IMSH meeting. Funds will be disbursed within one month of this formal announcement.

LOI Submission Instructions:
Please submit all required documents in one PDF format and in ONE email to inspiresimulationnetwork@gmail.com, with “INSPIRE Clinical Outcomes Award” in the subject line and the principal investigator name in the body of the email. You will receive a confirmation email when your documents have been received.

Project Duration:
The project’s stated aims must be completed within three years. Extensions will be considered on a case by case basis, and must be requested in writing no later than two months prior to the expiration of the award.

LOI Requirements and Format:
The LOI must be no more than 3 pages (including a 1 page budget). Please use single-spaced, 12 point Arial font and 1 inch margins on all sides in a regular 8.5” by 11” or A4 paper. Supporting documents as listed below will not count against the 5-page limit.

The letter should address the following questions:

  1. What do you want to do (central hypothesis/specific objectives)?
  2. Why this is a reasonable thing to do (review of previous work done on the subject matter, rationale)?
  3. Why this is important (new knowledge to be obtained, improvements to health which will result)?
  4. How you are going to do it (work plan, timelines, brief descriptions of methods, analysis, and a clear description of clinical outcomes)?
  5. Why you/your group should do it (relevant prior experience and skills, collaborators for technical gaps, preliminary data showing feasibility)?

Budget:
2 pages
. Please use the 1-page NIH PHS398 Budget form downloadable at:
http://grants.nih.gov/grants/funding/phs398/fp4.doc

A 1-page budget justification should also be included to explain how the award will be spent to ensure that adequate support and time is dedicated towards the completion of the stated goals. Also indicate any funds or in-kind resources that will be provided by the institution or other entities.

The investigator may apply the award funds toward any research-based salary and stipends for faculty/staff, postdoctoral trainees/fellows, technical support staff (including statistician, data analyst) required. Travel, membership fees, and conference registration fees can be included. Please note, however, that this award cannot be used to cover any indirect costs. A sample budget can be downloaded at the following link: INSPIRE Sample Budget

Full Application Submission Instructions:
Please submit all required documents in one PDF format and in ONE email to inspiresimulationnetwork@gmail.com, with “INSPIRE Clinical Outcomes Strategically Focused Award Application” in the subject line and the principal investigator name in the body of the email. You will receive a confirmation email when your documents have been received.

Project Duration:
The project’s stated aims must be completed within three years.  Extensions will be considered on a case by case basis, and must be requested in writing no later than two months prior to the expiration of the award.

Proposal IRB Requirement and Human Subject Protection:
All proposals submitted must include evidence of submission to the Institutional Review Board (IRB) or Ethics Board from all institutions where the proposed work will take place, regardless of whether human subjects are used. Approval from IRB or Ethics Board is not required at the time of application, but will be required before funds are given. For human subjects usage definitions guidelines, please refer to the following NIH regulatory documents:
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.102

The following online questionnaire may also be of assistance in determining whether a given proposal qualifies as human subjects’ research:
https://humansubjects.nih.gov/questionnaire

Proposal Content Instructions:
Note: Please submit only requested documents within page limits and follow instruction carefully.
Nonconforming applications will not be forwarded to reviewers.

Download the Clinical Outcomes Strategically Focused Award Proposal Format Requirements and Description of Components