Implementation Facilitation of Exercise is Medicine Greenville

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of South Carolina

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adopted EIMG >= 6 months prior to the beginning of this study

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Clinic Implementation FacilitationExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
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

1

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

Effectiveness is the degree to which participating in the evidence-informed PA programs improves patient PA levels and health outcomes (i.e., changes in cardiometabolic biometric values). Patient PA levels will be evaluated using the PAVS and objective measurement (accelerometry) before starting the PA program, after completion of the PA program, and 12 weeks post-PA program. Patient health outcomes (i.e., body weight, blood pressure, hemoglobin A1c, lipid profiles) will be extracted from the Prisma Health electronic health record (EHR) at time of referral, after completion of the PA program, and at least 12 months after the PA program.

Time frame
From the time the patient is referred to the PA program to 12 months after the patient graduates from the program
2

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

Each ambulatory visit with an EIMG eligible diagnosis will serve as the standard unit of observation. Episodes of care will be defined after each visit through the end of follow-up and cost information will be summarized across each episode of care. For each episode of care we will extract from the EHR all healthcare utilization that occurred during the episode by type and quantity. Utilization types during the episode will be designated by Healthcare Common Procedure Coding System (HCPCS), Diagnosis Related Group (DRG), and National Drug (NDC) codes. In addition, we will use the REDCap-based data file to measure implementation costs and capture activity during the 12-week PA program. To obtain standardized costs across episodes, we will apply Prisma standard resource unit prices to all healthcare utilization. For each visit episode we will calculate Episode Healthcare Costs as the price-weighted sum of all healthcare resources used by patient "i" during the episode of care.

Time frame
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)

Other outcomes

Sponsors and contacts

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University of South Carolina

Lead sponsor

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

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