Clinical trial NCT06073041: Implementing and Evaluating the Integration of Physical Activity Into a Major Health System and Connecting Patients to Physical Activity Programs.
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Disease
Exercise
Physical Activity
Keywords: Physical activity
Evidence-based
Exercise
RE-AIM
Implementation
Adoption
Referral pathway
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Temple University
name: University of Utah
name: University of Nebraska
name: Durham University
First posted: 2023-10-10
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Clinic Inclusion Criteria:

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

Clinic Exclusion Criteria:

* Clinics greater than 15 miles from a participating community physical activity facility
* Have received EIMG onboarding or activation in the past

Clinical Staff Inclusion Criteria:

* 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)

Clinical Staff Exclusion Criteria:

* Less than 18 years old

Patient Inclusion Criteria:

* Have received an EIMG referral from their primary care provider beginning September 5, 2023

Patient Exclusion Criteria:

* Less than 18 years old

Primary outcomes:
measure: Referral Rate
timeFrame: Months 1-9
Secondary outcomes:
measure: Patient physical activity levels (minutes of moderate-to-vigorous activity/week)
timeFrame: Conducted at months 0, 1.5, 3, 9, 15
measure: Patient blood pressure levels (mmHg)
timeFrame: Months 1-16
measure: Patient bodyweight (kg)
timeFrame: months 1-16
measure: Health economics of EIMG implementation
timeFrame: months 1-16
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Jennifer L Trilk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham University
name: Mark Stoutenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: