NCT06073041

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2024

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

September 18, 2023

Last Update Submit

December 22, 2025

Conditions

Keywords

Physical activityEvidence-basedExerciseRE-AIMImplementationAdoptionReferral pathway

Outcome Measures

Primary Outcomes (1)

  • Adoption of EIMG at eligible primary care clinics

    Rate of EIMG adoption at eligible primary care clinics

    Months 0-1

Secondary Outcomes (8)

  • Factors in decision to adopt/not adopt EIMG

    Months 1-2

  • Referral of eligible patients to EIMG in adopting clinics (phase 1)

    Months 1-4

  • Referral of eligible patients to EIMG in adopting clinics (phase 2)

    Months 5-8

  • Feedback on EIMG referrals and onboarding strategies from clinic staff

    Months 9-12

  • Patient physical activity levels (minutes of moderate-to-vigorous activity/week)

    Conducted at months 0, 1.5, 3, 9, 15

  • +3 more secondary outcomes

Study Arms (2)

Adopter

EXPERIMENTAL

Clinics that decide to adopt the EIMG Program

Other: Invitation to adoptBehavioral: Onboarding strategies

Non Adopter

OTHER

Clinics that decide not to adopt the EIMG Program

Other: Invitation to adopt

Interventions

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

AdopterNon Adopter

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).

Adopter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Clinics greater than 15 miles from a participating community physical activity facility
  • Have received EIMG onboarding or activation in the past
  • 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)
  • Less than 18 years old
  • Have received an EIMG referral from their primary care provider beginning September 5, 2023
  • Less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Chronic DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jennifer L Trilk, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR
  • Mark Stoutenberg, PhD

    Durham University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: All eligible clinics were invited to adopt the EIMG model (primary aim). Those that adopted the EIMG model received a sequential intervention involving onboarding and implementation (secondary aim).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 18, 2023

First Posted

October 10, 2023

Study Start

August 3, 2023

Primary Completion

September 5, 2023

Study Completion

November 26, 2024

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Scientific data that will be preserved and shared: individual interviews, online surveys, electronic health record data. The raw data collected for the individual interviews, online surveys, and clinical data will be electronically stored in a secured, cloud-based storage. Identifiers will be removed and maintained in a separate secure file for future reference. Patient information extracted from the Prisma Health EHR will be de-identified by the honest broker/data analyst before secure transfer to the research team. Sharing of this data will follow guidelines established by the Prisma Health Office of Research and Innovation.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
All data will be made available at the completion of the project, no later than the time of publication. The duration of preservation and sharing of the data will be in perpetuity.
Access Criteria
All data (online survey data, interview data, program participant data, and EHR data) will be de-identified and stored in data sharing repository, such as the Open Science Framework (OSF) or the Biologic Specimen and Data Repository Information Coordinating Center (BIOLINCC) managed by NHLBI. We will use unique persistent identifiers to improve data findability. The data sharing repository will provide metadata and assign our dataset a digital object identifier for ease of access.

Locations