Implementation Lab Pilot Award (ILPA)

Background

The University of Pittsburgh’s Clinical and Translational Science Institute (CTSI)’s Implementation Lab aims to connect researchers with health care leaders and policymakers to implement partner-defined priority evidence-based practices.

We are currently accepting applications for Implementation Lab Pilot Awards. These unique pilots are designed to support investigators interested in partnering with either the UPMC CHP Primary Care Center, UPMC Children’s Community Pediatrics Group (CCP) or Wolff Center to improve the implementation of evidence-based practices and programs.

UPMC’s pediatric primary care presence includes both the UPMC CHP Primary Care Center (PCC) and the Children’s Community Pediatrics (CCP), which together have 53 practices across the region and is interested in partnering with a Pitt researcher to implement the following evidence-based practices:

1. Dental fluoride varnish application to enhance oral health. Fluoride varnish application during primary care encounters is an evidence-based practice shown to reduce dental caries, however, adoption of this practice is low.
2. Improving completion of human papilloma virus (HPV) vaccination before 13 years of age. This is a HEDIS metric (coupled with tdap and meningococcal vaccines) and earlier administration of HPV is associated with higher completion rates prior to initiation of sexual activity.
3. Evidence-based asthma care delivered to achieve high quality, cost-effective treatments with increased family engagement to achieve improved asthma control and decreased unplanned care
4. Lipid screening for pediatric patients. Routine and at-risk screening allows for early identification of hyperlipemia and intervention aimed at reducing development or progression of CVD in adulthood
5. Increase use of interpretation services (an evidenced-based and standard of care service) for non-English speaking families during all interactions with their pediatric medical home with language discordant providers including improving our patients’/offices’ ability to use standardized/evidence-based screening processes (SDOH, DEV, SBIRT) and access to services (such as video visits, communications with office or after hours)
6. Family Check-up. The Family Check-up is a strengths-based, family-centered parenting intervention that addresses child behavior problems through promoting positive parenting practices and improving parent-child relationships. This brief intervention (3 sessions/appointments) has decades of empirical support demonstrating its effectiveness in preventing child behavior problems and promoting positive child and caregiver outcomes from birth through adolescence.

The UPMC Wolff Center focuses on improving access to and quality of healthcare across the region. They are interested in partnering with a Pitt researcher to develop plans to:

1. Expand access to outpatient care across Western PA;
2. Improve the timeliness of hospital discharge;
3. Regionalize capacity management across a network of acute care hospitals.

These awards can be used to support University of Pittsburgh personnel and costs associated with helping the health operation entity with implementation and dissemination.

Purpose

These pilot awards will support new or ongoing research that uses D&I methods to support the adoption, implementation or maintenance of an evidence-based practice or program in the setting of an existing health operation and focused on a specific need as defined by the PCC/CCP or the Wolf Center (See above).

Investigators are also encouraged to consider their work in the context of health equity (e.g., including equity as an implementation outcome or metric; or focusing on expanding healthcare access for vulnerable populations).

Implementation Lab Pilot Process

Interested individuals should contact Lisa Lederer, Implementation Facilitator, at lisa.lederer@pitt.edu with questions. The Letter of Intent should include (more detail below) an introduction of the investigator and team along with an area of interest from the list above provided by our selected health operations partners.

Submission and Review Information

There are two phases in the application process. The first round requires the submission of a letter of intent, which will be reviewed to determine which applicants will be invited to submit a full proposal (Round 2).

Funding Information

Award funding of up to $100,000 is available to cover direct costs of projects with a budget of up to $25,000 each. No indirect support will be provided. The award period is 12 months. The ILPA pilots do not provide for no-cost extensions; any funds that are not spent during the award period will be forfeited.

Before the start of the award period, awardees must provide documentation of all necessary regulatory approvals (IRB, QI documentation, etc.)^[1]. Once regulatory documentation is provided, awarded projects will undergo an administrative review from the National Center for Advancing Translation Science (NCATS) which is the NIH Institute that funds Pitt’s CTSI. Funding cannot begin until projects have been approved by NCATS. Because the NCATS review may take up to 30 days, applicants are strongly encouraged to have the necessary regulatory documents ready for submission.

Eligibility

The Principal Investigator must be a University of Pittsburgh faculty member; postdoctoral trainees and trainees in clinical training programs are not eligible to serve as PI. Faculty members on early-career training awards or clinical research scholars (i.e., recipients of K-series or similar career development grants) are eligible. New PIs are strongly encouraged to apply, but submissions from established investigators will be accepted if there is clear evidence that the pilot project represents a distinctly new direction from their previously funded work.

Study teams that involve cross-disciplinary collaborations, including with community organizations, are strongly encouraged. However, because CTSI’s primary mission is to promote research at the University of Pittsburgh, so applicants should provide a strong rationale for collaborations with other academic institutions.

Round 1: Letter of Intent (LOI)

The LOI should be in the form of a single PDF document; please use Arial size 11 font with margins of 0.5 inches. All materials must be submitted before 11:59 p.m. on Wednesday, September 28. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

The LOI is meant for Pitt investigators to introduce themselves and their team and state the area of interest they would like to pursue. Applicants selected for round 2 will work with CTSI facilitation team to connect with the health operations partner in the area of interest and develop a proposal for a pilot project for submission in round 2 of this program.

The LOI should include the following sections:

• Investigator and team information:
  • Title and Department of Pitt Faculty Lead
  • Background of Faculty lead with an emphasis on Implementation and Dissemination related work.
• Areas of interest and rationale for that interest:
  • Given the brief list of areas of work indicated by health operations partners, tell us what area you are interested in.
  • provide some background or rationale for that interest.
• Study Team: Please provide the names and affiliations of all members of the study team reporting to the Faculty Lead. Note that in the Letter of interest it is not expected that an investigator will have developed a pilot project with a health operations partner so there is no need to speculate about health operations partners in the letter of interest. In the second round of this pilot application process faculty will be paired with health operations partners for the development of a project proposal.
• Suggested Reviewers: To facilitate the final round of review if you are invited, please suggest two to three Pitt faculty members, not from your department, who may be qualified to serve as scientific reviewers. Include the person’s name, title, department, and email addresses for each suggested reviewer.

SUBMISSION PORTAL

 

Round 1: Review Criteria

The review of letters of intent will be conducted by CTSI faculty and staff. Proposals will be evaluated based on:

1. Responsiveness to RFA, including alignment of proposed project with priorities as per operations partners
2. Responsiveness to addressing diversity, equity, and inclusion
3. Strength of the study team

The results of this evaluation will determine which investigators will be invited to submit a full application for Round 2.

Round 2: Full Application

Applications selected for Round 2 will have the opportunity to meet with the operations partner to collaborate around proposed methods. Applications should be in the form of a single PDF document; please use Arial size 11 font, with margins of 0.5 inches. All materials must be submitted before 11:59:59 p.m. EST on Friday, December 2. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

Include the following sections, beginning each section on a new page:

• Project Overview (one page): The first page should include the following:
  • Scientific Abstract (250-word limit): Briefly summarize the proposed work.
  • Partnership summary (250-word limit): how you will work with the partner to address the priority listed above
• Research Plan (no more than four pages, including tables and figures): This section should include the following elements from a traditional NIH proposal to best allow reviewers to address the review criteria:
  • Specific Aims (1 page)
  • Significance (~1/2 page)
  • Innovation (~1/2 page)
  • Approach (~2 pages)
    • Stakeholders and plan for integration
  • Path to Impact Plan (~1/2 page)
    • How will our research contribute to improving the health of individuals, communities, and populations?
      • How will our research contribute to increasing access and reducing disparities?

• Description of partnership plan (1 page)
• References (no page limit): Literature cited does not count toward the Research Plan's three-page limit.
• Budget with Budget Justification (no page limit): Use PHS 398 Form Page 4 and Page 5. The budget justification should include sufficient detail for reviewers to assess whether appropriate resources have been requested.
  • Grant funds may NOT be budgeted for:
    • Salary support for the PI or faculty collaborators^*
    • Effort for post-doctoral trainees or fellows
    • Routine office supplies or communication costs, including printing
    • Meals or travel, including to conferences, except as required to collect data
    • Professional education or training
    • Computers or audiovisual equipment (exceptions require clear justification)
    • Manuscript preparation and submission
    • Indirect costs
      • Effort is required of the principal investigator and must be reflected on the budget page. This effort should be cost shared by the department or other entity that will support such effort. Reviewers understand that this may be a small proportion of effort given the size of this award but will be cautious if investigators do not appear to have sufficient time to complete a project.
      • Any salary support requested in a submitted budget should reflect federal fringe benefit rates. If an award is made, a budget meeting will be held between principal investigators, their respective research administrators, and financial administrators from the CTSI. If necessary, adjustments to the requested budget will be made at that meeting.
    • Proposal Timeline (up to half a page): Describe milestones and timeline for completion of the project. These milestones are critical for the pilot program because all awards must be expended during the one-year award. The CTSI Pilot program does not have mechanisms to allow no-cost extensions. In the event an award is made, investigators should immediately confer with CTSI staff if any delay in initiation or completion of the project is anticipated.
    • Human Subjects (no page limit): NIH supported pilot awards must address Protection of Human Subjects, Adequacy of Protection Against Risks, Data and Safety Monitoring Plans, Inclusion of Women and Minorities, and Inclusion of Children.
      • Human Research Protection Office (HRPO) approval is not required prior to submission. However, HRPO approval is required for all projects involving human subjects before NCATS will approve project funding.
      • Applicants must describe any human subject issues, as well as the sources of materials that will be obtained from human subjects. If human subjects are involved, provide a description of their involvement and characteristics, specific risks to subjects who participate, and protection against those risks. Reviewers may consider whether significant delays in approval are an anticipated barrier for project completion when selecting projects. Evidence of prior or ongoing review is encouraged.
    • NIH Bio sketches (no page limit): Include bio sketches for the Principal Investigator and key members of the research team.
    • Letters of Support (optional): Letters of support are not required, but are encouraged (e.g., advisory committee members and health system partners/organization collaborators).

Round 2: Review Criteria

It is a requirement that review of CTSI pilot proposals should address the NIH review criteria^[2]. Reviewers will score final applications on an NIH scale (1-9) in the domains of Significance, Investigators, Innovation, Approach, and Environment. Special emphasis will be given to a rating of the overall impact of the proposed project. Note that the review (based on the criteria below) will be adjusted to the pilot nature of the award.

NIH Review Criteria:

• Overall Impact: The likelihood for the project to exert a sustained, powerful influence on the research field
• Significance: Does the project address an important problem or a critical barrier to progress in the field?
• Investigators: Are the PD/PIs, collaborators, and other researchers well suited, sufficient, and able to conduct the project?
• Innovation: Does the project shift current research or clinical practice paradigms use novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
• Approach: Are the strategies, methods, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
• Environment: Are the personnel, equipment, and other physical resources available to the investigators to perform the proposed research within the period allotted?

 Program-Specific Criteria:

• IMPACT: Does the project indicate a clear path to impact?
• Does the project reflect true collaboration with partners?
• Does the project have potential for sustainment?

 

^[1] Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), Human Stem Cell Research Oversight (hSCRO)

^[2] https://grants.nih.gov/grants/peer/guidelines_general/Review_Criteria_at_a_glance.pdf