Implementation Facilitation of Exercise is Medicine Greenville

Official title

Facilitating Health System Implementation of Physical Activity Screening and Referral to Community-Based Programs: Exercise is Medicine Greenville

Overview

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.

Detailed 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 disparities 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.

Interventions

• Behavioral 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 t

Primary outcome measures

• Clinic-level differences in implementation of EIMG and reach of patients receiving EIMG referrals pre- and post-implementation facilitation [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 outcome measures (2)

• Effectiveness of participating in the community-based, 12-week evidence-informed PA program on patient PA levels and health outcomes [Time frame: From the time the patient is referred to the PA program to 12 months after the patient graduates from the program]
• Cost of implementation facilitation and to estimate the effectiveness of increased EIMG referrals to the community-based PA on patient costs [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)]

Eligibility 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 clinic (family or internal medicine)
• Adopted EIMG >= 6 months prior to the beginning of this study

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
• Has worked at the Prisma Health-Upstate clinic since the start date of the intervention in the respective wave, i.e., Pre-IF start date for each wave
• Has clinical encounters with a minimum of 25 patients per month
• Study clinic is their primary clinic (>50% of their working time)
• Able to understand and communicate in English

Exclusion criteria

• Less than 18 years of age
• Work at the Prisma Health-Upstate clinic started after the Pre-IF phase began
• Has clinical encounters with <25 patients per month
• 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

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

For patients completing accelerometry data collection, the additional inclusion/exclusion criteria apply:

Inclusion criteria

• Received an EIMG referral and scheduled for orientation
• Attending orientation at two pre-determined community PA facilities (these sites were selected due to each being the largest urban and rural YMCA referral sites in the study)

Exclusion criteria

• Unable to provide verbal informed consent
• Planning on travel or vacation during data collection, as patient PA behavior is anticipated to differ from 'everyday' PA behavior at home
• Unable to wear a watch during work hours due to employment restrictions e.g., food service, healthcare, operating heavy machinery/construction, laboratory-based work etc.

In addition, for patients completing interviews, the additional inclusion/exclusion criteria apply:

Inclusion criteria

\- Received an EIMG referral

Exclusion criteria

• Unable to provide verbal informed consent
• Unable to speak or understand English
• <18 years of age

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Prisma Health - Upstate — Greenville

Identifiers

NCT: NCT07340580 · 1R01HL173601-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗