The Pilot Study Program

The Pilot Study Program

Letters of Intent Due June 1, 2023

2023 Request for Applications
CoHSTAR is pleased to announce that in 2023, we seek to fund up to two one-year pilot studies. 

CoHSTAR PILOT STUDY DEADLINES 

The purpose of the CoHSTAR Pilot Study Program is to provide funding for pilot research in areas related to physical therapy health services research. The pilot studies may be designed to provide preliminary data that will support larger subsequent funding efforts, or develop infrastructure (new instruments, data registries, etc.) needed to pursue physical therapy health services research questions. For this funding cycle, up to two pilot projects will be awarded for up to $25,000.00 total cost. Only direct costs are covered by this program. Pilot projects in this cycle are limited to one year.

Types of Studies Supported By the CoHSTAR Pilot Study Program

CoHSTAR includes four areas of specialization:  1) analysis of large data sets, 2) rehabilitation outcome measurement, and 3) implementation science and quality improvement research, and 4) cost-effectiveness. The pilot study program will accept pilot studies that address physical therapy health services research questions in these four areas. Examples of the specific types of pilot studies that would be funded include:

• Studies of Telerehabilitation.
• Studies addressing inclusion, and access in rehabilitation.
• Studies examining electronic healthcare records, insurance claims databases, or federal and state healthcare claims databases to examine variability of healthcare utilization, healthcare costs, and/or clinical practice patterns related to physical therapy practice.
• Studies examining the psychometric properties (reliability, validity, responsiveness) of newly developed or revised rehabilitation outcome instruments or systems, or new applications of existing systems.
• Studies to develop and provide feasibility testing of monitoring systems for physical activity outcomes.
• Studies that examine the effectiveness of integrating rehabilitation outcomes databases with shared-savings payment models between payers and physical therapy practices.
• Studies to develop and test feasibility of clinical pathways for physical therapy evaluation and interventions. Feasibility testing may include the compliance and accuracy of reporting and utilization of the clinical pathway elements.
• Studies that develop and examine the implementation of strategies to promote adherence to established clinical practice guidelines. Examples might include use of minimum data sets, decision-aids, and shared decision-making models.
• Studies that examine the effectiveness of payment models in physical therapy practice.
• Studies that examine non-traditional roles for physical therapists (in primary care, interprofessional healthcare team management systems, patient-centered medical homes, accountable care organizations, or community health and wellness systems.)

Types of Studies Not Likely to Be Competitive

Studies on development of outcome instruments, activity monitors, etc. that are at the prototype phase of development would likely not be competitive. The development of such instruments should be beyond the prototype phase and ready for pilot testing at the clinical application phase in order to be competitive for this request for proposals.

Priorities for Funding

Priority for funding will be given to applications that best meet the overall goals of the CoHSTAR Pilot Study Program.  These priorities include studies that:

1. Address physical therapy health service topics in one of the four CoHSTAR specialty track areas (large data sets, rehabilitation outcome measurement, implementation science and quality improvement research, cost-effectiveness).
2. Have a strong likelihood of leading directly to broader research with major external funding.
3. Have good potential to result in future research with high societal and/or policy impact for physical therapy.

Eligibility Requirements of the Principal Investigator

The eligibility requirement for the Principal Investigator (PI) of a pilot study will be satisfied under either of the following scenarios:

1. The PI is a Physical Therapist that is a United States citizen or certified permanent resident of the United States.
2. The study consists of Co-PIs in which at least one of the PIs is a Physical Therapist and one of the PIs is a United States citizen or certified permanent resident of the United States.

CoHSTAR PILOT STUDY APPLICATION PROCESS

General Overview

We will utilize a 2-tiered application and review process. In the first tier, potential applicants will be asked to submit a 1-2 page structured letter of intent (LOI) which will describe the aims of the project, a brief overview of the study design, how the study is relevant to the funding priorities stated in the RFA, and the direct impact the results of the study will have for subsequent funding of research projects and the significance for physical therapy policy and/or practice. The CoHSTAR scientific review committee will identify LOIs that show the most promise and will be invited to submit a full application.

Guidelines for the LOI

The letter should be no more than 2 pages (reference page not included in this page limit). The page layout should use 0.5” margins. Acceptable fonts include Arial, Helvetica, Palatino Linotype or Georgia typeface, a black font color, and a font size of 11 points or larger. Documents not in this format will be returned to the applicant without review.

LOI content should be formatted as follows:

• Title of the study
• Name and credentials of the investigators
• Eligibility status of the PI or co-PIs (i.e., physical therapist, U.S. citizen or permanent resident)
• Aims of the study
• Significance and/or innovation
• Brief overview of the study design (should include methodological elements such as sample characteristics, relevant comparisons, data sources, sample size estimates, data analysis plan if applicable)
• Relevance of the study to the funding priorities of this announcement
• References

A biosketch (no more than 5 pages) of the investigators listed on the LOI should accompany the LOI. NIH biosketch format is recommended.

The LOI and biosketches should be submitted together in a single PDF file to Brianna Higginbottom, Bjh105@pitt.edu, no later than June 1, 2023. Please note that applications not submitted in a single pdf file will not be reviewed.

Notification of invitation to submit a full application will be sent by July 1, 2023. The deadline for the full application will be August 15, 2023.

Guidelines for Submitting a Full Application

Applicants who have received an invitation to submit a full application should prepare their application using the following format:

• Cover page that includes the following:
  • • Title of the study
    • Name, credentials, and contact information of the PI or co-PIs
    • Eligibility status of the PI or co-PIs (i.e., physical therapist, U.S. citizen or permanent resident)
    • Name, credentials of key personnel
    • Specialty track that best represents the pilot study topic (large data sets, rehabilitation outcome measurement, implementation science and quality improvement research, cost-effectiveness)
    • Abstract (Limit to 300 words)
    • Name, contact information, and signature of institution’s authorized person (grants management office, department chair, etc.)
• Research Plan
  • The research plan should be no more than 5 pages in length (reference page not included in this page limit) using 0.5” margins, and acceptable fonts which include Arial, Helvetica, Palatino Linotype or Georgia typeface, a black font color, and a font size of 11 points or larger. The research plan should use the following format:
    • Aims
    • Background and Significance
    • Methods
    • Timeline
    • Plans for future funding
    • References
  • Budget
  • Budget Justification
  • Biosketches of all key personnel

The full application should be submitted together in a single PDF file to Brianna Higginbottom, Bjh105@pitt.edu, no later than August 15, 2023. Please note that applications not submitted in a single pdf file will not be reviewed.

PILOT STUDY PROPOSAL REVIEW CRITERIA

The elements of the pilot study that will be taken into consideration are as follows:

• Relevance to HSR CoHSTAR Pilot Core Mission
  • Addresses health service in physical therapy research topics in one of the four CoHSTAR specialty tracks
  • Addresses health services/health policy research questions of high priority and significance for the field of physical therapy
  • High likelihood to lead to future research with potential for significant societal and/or policy impact.
• Technical Quality of Proposed Approach
• Innovation
• Likelihood of Successful Completion of Project
• Likelihood to Progress to Future Funded Work

Ongoing Obligations of Funded Investigators

• All pilot studies selected for funding will be required to provide official certification of their respective Institutional Review Board for Human Subjects Research approval prior to receiving any funding. The certification of IRB renewal will also be required each year while the study is active.
• During the period when the study is active, investigators will be required to submit progress reports every 6 months that will include information concerning study conduct such as progress with subject recruitment and adverse events, breaches of participant confidentiality, or other difficulties or barriers to study progress. Details on required content for progress reports will be specific to each pilot study and will be negotiated with the Pilot Study Core administrative team prior to funding.
• Once the study has been completed, progress reports will be reported annually for up to 5 years from the initial date of funding and include an overview of the study results, plans for submissions of funding for broader research efforts, publications and scientific presentations related to the study results, and any subsequent health service programs implemented that emanate from the funded pilot study.
• Investigators will acknowledge funding from CoHSTAR in any scientific presentations and publications related to the funded pilot study.

For more information about the CoHSTAR Pilot Study program, please email Christine McDonough: CMM295@pitt.edu.