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

Sponsor

University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT06073041

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), Temple University (Other), University of Utah (Other), University of Nebraska (Other)

Enrollment

Location

Arms

11.1

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease Exercise Physical Activity	Other: Invitation to adopt	N/A

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. 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. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Adopting and non Adopting clinics will be followed in a parallel fashion over the course of the study. Number of participants listed below is equivalent to clinics being invited to adopt.Adopting and non Adopting clinics will be followed in a parallel fashion over the course of the study. Number of participants listed below is equivalent to clinics being invited to adopt.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Implementing and Evaluating the Comprehensive Integration of Physical Activity Into a Major Health System and Connecting Patients to Community-based Physical Activity Programs

Anticipated Study Start Date :

Oct 2, 2023

Anticipated Primary Completion Date :

Sep 4, 2024

Anticipated Study Completion Date :

Sep 4, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adopter Clinics that decide to adopt the EIMG Program	Other: Invitation to adopt All eligible Prisma Health clinics will be invited to adopt EIMG. Adopting clinics will first be sent an instructional video as a part of a low touch initial onboarding. After 4 months, clinics will then recieve an in-depth standardized onboard training.
No Intervention: Non Adopter Clinics that decide not to adopt the EIMG Program

Arm

Intervention/Treatment

Experimental: Adopter

Clinics that decide to adopt the EIMG Program

Other: Invitation to adopt

All eligible Prisma Health clinics will be invited to adopt EIMG. Adopting clinics will first be sent an instructional video as a part of a low touch initial onboarding. After 4 months, clinics will then recieve an in-depth standardized onboard training.

No Intervention: Non Adopter

Clinics that decide not to adopt the EIMG Program

Outcome Measures

Primary Outcome Measures

Referral Rate [Months 1-9]
Number of referrals given to EIMG-eligible patients by providers in referring clinics

Secondary Outcome Measures

Patient physical activity levels (minutes of moderate-to-vigorous activity/week) [Conducted at months 0, 1.5, 3, 9, 15]
Assessing changes in patient physical activity levels via the Physical Activity Vital Sign. Assessments will occur prior to enrollment in the 12-week physical activity program (week 0), midway through the program (week 6), at the completion of the program (week 12), as well as long-term maintenance (conducted via phone call 6- and 12-months post-program)
Patient blood pressure levels (mmHg) [Months 1-16]
Assessing changes in patient blood pressure using a digital blood pressure monitor. Assessments will occur prior to enrollment in the 12-week physical activity program (week 0), midway through the program (week 6), at the completion of the program (week 12). Additional blood pressure measurements may also be extracted from the Prisma Health electronic health records for the time period six months before and twelve months after the 12-week physical activity program.
Patient bodyweight (kg) [months 1-16]
Assessing changes in patient bodyweight using a minimum of a class III category weighing scale. Assessments will occur prior to enrollment in the 12-week physical activity program (week 0), midway through the program (week 6), and at the completion of the program (week 12). Additional bodyweight measurements may also be extracted from the Prisma Health electronic health records for the time period six months before and twelve months after the 12-week physical activity program.
Health economics of EIMG implementation [months 1-16]
Using data from the Prisma Epic electronic health record (EHR), we will extract primary health outcomes (e.g., blood pressure, body weight, hemoglobin A1c, lipid profiles) from the index (first) visit and again at the end of a care episode for all patients who received an EIMG referral at participating clinics during the study period. We will use the EHR record to assess changes in outcomes across the care episode and all healthcare utilization for each patient during the care episode to estimate costs. This approach will yield estimates of: 1) the impact of EIMG on changes in health outcomes across the care episode, and 2) the impact of EIMG healthcare costs during the care episode. We will use these estimates for a short-term cost-effectiveness analysis of the EIMG program, as well as the foundation for long term evaluation for modeling approaches changes in longer-term secondary health outcomes (e.g., stroke, acute myocardial infarction) on healthcare costs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Prisma Health primary care clinics (i.e., family or internal medicine) located in the Upstate of South Carolina;
Have not received EIMG onboarding or activation in the past;
Consist of at least two attending providers;
Be located 15 miles or less from a participating community PA facility.

All potentially eligible Prisma Health primary care clinics were geographically coded to determine the distance to the nearest participating community PA facility. Clinics >15 miles will be ineligible for study participation as previous research consistently demonstrates that engagement in leisure time PA and enrollment in fitness centers is negatively correlated with distance to PA destinations.