Implementation Facilitation of Exercise is Medicine Greenville

University of South Carolina

Status: Begins enrollment in 2 months

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

Treatments: Behavioral: Clinic Implementation Facilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT07340580

1R01HL173601-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 35 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

The primary aim of this study is implementation facilitation at the clinic level. The secondary aim of this study is at the patient level. Therefore we have divided our inclusion/exclusion eligibility criteria by primary and secondary aim.

1. Clinic (primary aim) 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

  1. Clinic (primary aim) Exclusion criteria

• Not EIMG-activated

• Adopted EIMG < 6 months prior to the beginning of this study

• Greater than 15 miles from the nearest YMCA

  1. Primary care clinic staff (primary aim) Inclusion criteria

• 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

  1. Primary care clinic staff (primary aim) Exclusion criteria

• 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

  2. Patient (secondary aim) Inclusion criteria (must meet all of below)

• 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

  2. Patient (secondary aim) Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

35 participants in 1 patient group

Clinic Implementation Facilitation

Experimental group

Description:

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

Treatment:

Behavioral: Clinic Implementation Facilitation