Implementation Facilitation of Exercise is Medicine Greenville

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-01

Study Completion Date

2030-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06073041

Chronic Disease Exercise Physical Activity

COMPLETED NA

Remote Exercise Program for Rural Men

NCT07224217

Rural Health

RECRUITING NA

Physical Activity and Sedentary Behavior Change; Impact on Lifestyle

NCT02467881

Sedentary Lifestyle Physical Activity

COMPLETED NA

Evaluating Mechanisms of Action of Adaptive Goal-Setting for Physical Activity

NCT04505241

Motivation Physical Activity Promotion Behavior Change +1 more

COMPLETED NA

Barriers to Physical Activity in People With Type 2 Diabetes

NCT01701570

Type 2 Diabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There is great potential for promoting physical activity (PA) for chronic disease prevention and treatment through the health care sector. Research has demonstrated effectiveness in assessing patient PA levels, providing 'exercise prescriptions', and referring patients to evidence-based PA programs in community settings. However, implementation barriers exist, ranging from practice integration to information flow, resulting in no major health systems integrating PA as part of a comprehensive approach to patient care. In 2016, a multi-organizational partnership between a large academic healthcare system, an academic institution, and a national PA organization launched Exercise is Medicine Greenville (EIMG), a comprehensive clinic-to-community approach that involves PA assessment, prescription, and referral of patients with chronic diseases to a tailored, community-based PA program. Since 2016, EIMG has expanded to 35 Prisma Health primary care clinics and 7 community PA facilities covering \>400 square miles. Despite referring \>1900 patients to date, great variability exists across participating clinics in correctly identifying eligible patients and providing EIMG referrals, reducing the overall reach and efficiency of engaging patients in the community-based PA programs. Using a pragmatic, stepped wedge, cluster randomized design, this research will examine the impact of implementation facilitation (IF) on improving the implementation and reach of EIMG with patients visiting participating Prisma Health primary care clinics. At six-month intervals, 35 randomly selected clinics (6 clinics in wave 1, 8 clinics in wave 2, 10 clinics in wave 3, and 11 clinics in wave 4) will receive IF planning (3 months), active IF (6 months), and post-IF maintenance (min 12 months). The specific aims of this project are to: 1) determine differences in the level of implementation (i.e., delivery fidelity) and reach (i.e., number, proportion, representativeness of patients) at Prisma primary care health clinics before and after IF, 2) assess levels of patient engagement in and the effectiveness of the 12-week, community-based PA programs, and 3) evaluate the costs of IF and the effects of increased EIMG referrals to the community-based PA program on patients costs and clinical outcomes. The mixed methods evaluation approach is guided by the RE-AIM framework to inform the assessment of implementation outcomes, and the i-PARIHS framework to describe contextual factors (i.e., determinants) influencing patient and clinic level outcomes. Through this work, the research will identify successful IF strategies across heterogeneous health settings, helping to identify and address potential inequities in the types of patients that receive EIMG referrals, are engaged in the EIMG referral pathway, and enroll and complete the community-based PA program. Study findings will provide important information on improving future implementation and scalability of PA integration in large health systems, optimizing clinic-community linkages, and the cost savings related to primary and secondary prevention of cardiovascular disease-related health outcomes in the general patient population.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 inequities 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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clinic Implementation Facilitation

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

Group Type EXPERIMENTAL

Clinic Implementation Facilitation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clinic Implementation Facilitation

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

* At least 18 years of age
* Worked at the Prisma Health-Upstate clinic a minimum of three months
* Able to understand and communicate in English

* Age \>= 18 and \<= 80 years
* Clinically eligible (diagnosis of hypertension, dyslipidemia, obesity, diabetes, or physical inactivity) to receive an EIMG referral
* A healthcare visit with an eligible encounter type (evaluation, telemedicine, consult, office visit, e-visit, follow-up, appointment, education, multidisciplinary visit, nutrition, occupational medicine-office visit)
* A healthcare visit at a participating clinic

Exclusion Criteria

* Not EIMG-activated
* Adopted EIMG \< 6 months prior to the beginning of this study
* Greater than 15 miles from the nearest YMCA

* Less than 18 years of age
* Worked at the Prisma Health-Upstate clinic less than three months
* Unable to speak or understand English
* Adults unable to provide consent

* Age \< 18 or \> 80 years
* Current referral to Physical therapy or occupational therapy
* Current referral to cardiac, pulmonary, or oncology rehab
* One of the following visit diagnoses listed below:

* Alzheimer's disease
* Amyotrophic lateral sclerosis
* angina or chest pain
* congenital stenosis of aortic valve
* congenital insufficiency of aortic valve
* moderate or severe persistent asthma
* typical or atypical atrial flutter
* autonomic dysreflexia
* acute bronchitis
* cerebral infarction
* encounter for chemotherapy
* chronic kidney disease (stage 3-5)
* end stage renal disease
* coma
* acute chronic obstructive pulmonary disease
* unspecified dementia
* dependence on renal dialysis
* trisomy 21
* pulmonary embolism
* venous embolism and thrombosis
* history of falling
* acute fracture
* left ventricular failure
* congestive heart failure
* hypertensive urgency, emergency or crisis
* diabetes with ketoacidosis
* chronic respiratory failure
* dependence on supplemental oxygen
* myocardial infarction
* osteoporosis with current fracture
* encounter for palliative care
* paraplegia or quadriplegia
* Parkinson disease
* pneumonia
* encounter for supervision of pregnancy
* encounter for radiation therapy
* serious mental illness (schizophrenia, psychotic disorder)
* homicidal or suicidal ideations
* sepsis
* injury of spinal cord
* presence of coronary stent
* dependence on wheelchair or ambulatory aid

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes