Implementation Facilitation of Exercise is Medicine Greenville

NCT07340580 | Not Yet Recruiting DMC

• 1 other identifier: 1R01HL173601-01A1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

A public health priority exists for the U.S. healthcare sector to integrate physical activity (PA) as a part of the patient care model. This research will provide valuable information on facilitating optimal implementation of a clinic-to-community model that identifies, refers, and enrolls physically inactive patients to community-based PA programs for the prevention and treatment of chronic diseases. Further, this work will provide evidence on the cost-effectiveness of integrating PA in healthcare systems as a population health management strategy.

Conditions

Physical Inactivity; Dyslipidemia; Obesity and Overweight; Hypertension; Diabetes; Health Care Delivery; Patients; Chronic Disease; Exercise; Physical Activity; Implementation Science

Keywords

Implementation Facilitation; Physical activity referral scheme; Effectiveness-implementation hybrid type 3; Pragmatic design; Stepped wedge

Outcome Measures

Primary Outcomes (1)

• Clinic-level differences in implementation of EIMG and reach of patients receiving EIMG referrals pre- and post-implementation facilitation

  Reach (primary study outcome measure) will be assessed by estimating the number and proportion of eligible patient visits engaged in EIMG by providers. A patient's visit will be considered 'engaged' if they receive an EIMG referral. The proportion is estimated by dividing patient visits with an EIMG referral by all eligible patient visits. Reach will be calculated by provider and aggregated at the clinic level. Adoption will be assessed at the provider level by determining the number, proportion, and representativeness (i.e., sex, age, specialty) of providers that utilize any EIMG component in their practice compared to peers that do not use EIMG. Implementation will be assessed by determining the extent to which all three steps of EIMG (i.e., assessment, prescription, patient referral) are conducted with each eligible patient at the provider level, aggregated at the clinic level.

  From Wave 1 start in pre-implementation facilitation activities to the end of Wave 4 post-implementation facilitation. Time frame for Wave 1 = 39 months, Wave 2 = 33 months, Wave 3 = 27 months, Wave 4 = 21 months.

Secondary Outcomes (2)

• Effectiveness of participating in the community-based, 12-week evidence-informed PA program on patient PA levels and health outcomes

  From the time the patient is referred to the PA program to 12 months after the patient graduates from the program

• Cost of implementation facilitation and to estimate the effectiveness of increased EIMG referrals to the community-based PA on patient costs

  IF costs will be measured from start of the Pre-IF phase to end of the IF phase (9 months) for each wave. For episode specific cost, measurements are taken from the index visit (day 0) within each episode through the end of the episode of care (day 240)

Study Arms (1)

Clinic Implementation Facilitation

EXPERIMENTAL

Clinics will work with the facilitation team to address barriers and improve clinic workflow to increase patient referral rates to the community PA program.

Behavioral: Clinic Implementation Facilitation

Interventions

Clinic Implementation Facilitation BEHAVIORAL

This single arm intervention will be applied to 35 Prisma Health primary care clinics where the EIMG model is currently activated. At six-month intervals, six or more clinics will receive tailored implementation facilitation (IF) based on pre-implementation facilitation findings at each clinic. We will explore factors related to achieving optimal implementation and reach of EIMG. Patient referral rates and health outcomes will also be captured as a result of changes of clinical workflow due to the IF.

Clinic Implementation Facilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently EIMG-activated Prisma Health-Upstate Primary Care clinic (family or internal medicine)
• Adopted EIMG \>= 6 months prior to the beginning of this study

You may not qualify if:

• Not EIMG-activated
• Adopted EIMG \< 6 months prior to the beginning of this study
• Greater than 15 miles from the nearest YMCA
• At least 18 years of age
• Has worked at the Prisma Health-Upstate clinic since the start date of the intervention in the respective wave, i.e., Pre-IF start date for each wave
• Has clinical encounters with a minimum of 25 patients per month
• Study clinic is their primary clinic (\>50% of their working time)
• Able to understand and communicate in English
• Less than 18 years of age
• Work at the Prisma Health-Upstate clinic started after the Pre-IF phase began
• Has clinical encounters with \<25 patients per month
• Unable to speak or understand English
• Adults unable to provide consent
• Age \>= 18 and \<= 80 years
• Clinically eligible (diagnosis of hypertension, dyslipidemia, obesity, diabetes, or physical inactivity) to receive an EIMG referral

Sponsors & Collaborators

• University of South Carolina: lead
• University of South Carolina School of Medicine, Greenville: collaborator
• University of Nebraska: collaborator
• University of Utah: collaborator
• Temple University: collaborator
• Prisma Health-Upstate: collaborator
• Durham University: collaborator

Study Sites (1)

Prisma Health - Upstate

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Dyslipidemias; Obesity; Overweight; Hypertension; Diabetes Mellitus; Chronic Disease; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Jennifer L Trilk, PhD

  University of South Carolina School of Medicine, Greenville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Trilk, PhD

CONTACT

864-766-2092; trilk@greenvillemed.sc.edu

Frankie Bennett, MS

CONTACT

864-455-1410; bennet24@greenvillemed.sc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biomedical Sciences

Model Details: The study will utilize a pragmatic, stepped wedge, cluster randomized design to examine the impact of implementation facilitation (IF) on increasing the reach (eligible patients that receive an EIMG referral) at 35 Prisma Health primary care clinics where the EIMG model is currently activated. At six-month intervals, randomly selected clinics will receive IF. We will use a mixed methods approach to explore factors related to achieving optimal implementation and reach of EIMG. We also will explore patient enrollment, participation, and dose-response relationships associated with changes in PA levels, health outcomes, and cost savings to the health system. Throughout the study, we will identify successful IF strategies across clinic settings, helping us identify and address potential disparities in the types of patients who receive EIMG referrals, are engaged in the EIMG referral pathway, and enroll and complete the community-based PA program.

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 14, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2030
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (1)