Implementing and Evaluating the Integration of Physical Activity Into a Major Health System and Connecting Patients to Physical Activity Programs.

NCT ID: NCT06073041

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-03
• Study Completion Date: 2024-11-26

Brief Summary

Multiple case study trial examining the adoption, implementation, and reach of eligible patients visiting participating Prisma Health primary care clinics and receiving a referral to a 12-week evidence-informed physical activity (PA) program hosted at local community PA facilities.

Detailed Description

This study will employ a single arm, multiple case study design using a mixed methods approach to examine the adoption, implementation, and reach of EIMG across Prisma Health primary care clinics (i.e., clinic workflow, referral process), leading to patient enrollment in a community-based, evidence-informed PA program. Eligible Prisma Health primary care clinics that have not yet received EIMG onboard training and activation will be provided with the opportunity to adopt EIMG as a part of their clinic practice and patient workflow process. A mixed methods approach will examine contextual factors influencing decisions to adopt/not adopt EIMG.

Clinic champions at clinics adopting EIMG will be provided with a brief pre-recorded training video to disseminate to their clinic staff on how to provide their patients with an EIMG referral (phase 1). All providers at the clinic will have the ability to screen and identify physically inactive patients and provide them with an EIMG referral. Initial implementation and reach of EIMG at adopting clinics will be tracked for approximately four months following the dissemination of the pre-recorded training video. After four months, the EIMG team will provide a more in-depth, standardized clinic onboard training following established protocols iteratively developed and refined through the initial addition of EIMG clinics between 2016-19 (phase 2). The onboard training, which consists of an overall presentation of the EIMG program and specific information on placing the referral order and patient workflow, has been adapted for virtual environments due to its notable added benefits, including its recording to serve as an ongoing reference tool for those who cannot attend initial training and incoming staff. Implementation and reach of EIMG will be tracked for an additional four months after the onboard training.

Referred patients will have the opportunity to enroll in an evidence-informed, 12-week PA program at local community PA facilities (e.g., YMCAs) that partner with EIMG. Upon enrollment and at the completion of the 12-week PA program, patients will undergo an assessment battery that includes the completion of a patient health questionnaire, anthropometric assessments (i.e., height, weight, waist circumference) and an evaluation of their mental and emotional health (i.e., PROMIS tool, PHQ-9). The RE-AIM framework will inform the assessment of implementation outcomes (i.e., adoption, implementation, and reach), while the i-PARIHS framework will be used to examine contextual factors (i.e., determinants) influencing clinic level outcomes. Patient demographics, health outcomes, healthcare utilization and costs of eligible patients at participating primary care clinics, both before and after EIMG onboarding, will be extracted from the Prisma Health electronic health record (EHR) system. Data will be compared between patients that receive EIMG referrals and matched controls at clinics that do not adopt EIMG: 1) the impact of EIMG on changes in health outcomes, and 2) the impact of EIMG on healthcare costs. These estimates will be used as the basis for cost-effectiveness analyses of EIMG and serve as the foundation for long-term evaluation modeling approaches to incorporate changes in longer-term secondary health outcomes (e.g., stroke, acute myocardial infarction) on healthcare costs.

Conditions

Chronic Disease; Exercise; Physical Activity

Keywords

Physical activity; Evidence-based; Exercise; RE-AIM; Implementation; Adoption; Referral pathway

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Adopter

Clinics that decide to adopt the EIMG Program

Group Type: EXPERIMENTAL

Invitation to adopt

Intervention Type: OTHER

All eligible Prisma Health clinics will be invited to adopt EIMG.

Onboarding strategies

Intervention Type: BEHAVIORAL

Providers at adopting clinics will first be sent an instructional video as a part of a low touch initial onboarding (phase 1). After 4 months, clinics will then receive an in-depth standardized onboard training (phase 2).

Non Adopter

Clinics that decide not to adopt the EIMG Program

Group Type: OTHER

Invitation to adopt

Intervention Type: OTHER

All eligible Prisma Health clinics will be invited to adopt EIMG.

Interventions

Invitation to adopt

All eligible Prisma Health clinics will be invited to adopt EIMG.

Intervention Type: OTHER

Onboarding strategies

Providers at adopting clinics will first be sent an instructional video as a part of a low touch initial onboarding (phase 1). After 4 months, clinics will then receive an in-depth standardized onboard training (phase 2).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Prisma Health primary care clinic (i.e., family or internal medicine) located in the Upstate of South Carolina
• At least two attending providers

• Prisma Health employed
• Actively seeing patients at an activated EIMG clinic by the beginning of the phase in which they will be enrolled in the study (providers)
• Staff member at an activated EIMG clinic by the beginning of the phase in which they will be enrolled in the study (managers/clinic staff)

• Have received an EIMG referral from their primary care provider beginning September 5, 2023

Exclusion Criteria

• Clinics greater than 15 miles from a participating community physical activity facility
• Have received EIMG onboarding or activation in the past

• Less than 18 years old

• Less than 18 years old

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: collaborator

Durham University

OTHER

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Trilk

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer L Trilk, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Mark Stoutenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Durham University

Locations

Prisma Health

Greenville, South Carolina, United States

Countries

United States

References

Stoutenberg M, Estabrooks PA, Brooks JM, Jindal M, Wichman C, Rosemeyer J, Schumacher LM, McNulty LK, Ewing A, Eskuri S, Bennett F, Trilk JL. Implementing and evaluating the comprehensive integration of physical activity into a major health system: study design and protocol. BMJ Open. 2025 Jan 6;15(1):e091556. doi: 10.1136/bmjopen-2024-091556.

Reference Type: DERIVED

PMID: 39762113 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R56HL157218-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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