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

Primary Purpose

Chronic Disease, Exercise, Physical Activity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Invitation to adopt
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Disease focused on measuring Physical activity, Evidence-based, Exercise, RE-AIM, Implementation, Adoption, Referral pathway

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Prisma HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adopter

Non Adopter

Arm Description

Clinics that decide to adopt the EIMG Program

Clinics that decide not to adopt the EIMG Program

Outcomes

Primary Outcome Measures

Referral Rate
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)
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)
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)
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
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.

Full Information

First Posted
September 18, 2023
Last Updated
October 16, 2023
Sponsor
University of South Carolina
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Temple University, University of Utah, University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT06073041
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
September 4, 2024 (Anticipated)
Study Completion Date
September 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Temple University, University of Utah, University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Exercise, Physical Activity
Keywords
Physical activity, Evidence-based, Exercise, RE-AIM, Implementation, Adoption, Referral pathway

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adopter
Arm Type
Experimental
Arm Description
Clinics that decide to adopt the EIMG Program
Arm Title
Non Adopter
Arm Type
No Intervention
Arm Description
Clinics that decide not to adopt the EIMG Program
Intervention Type
Other
Intervention Name(s)
Invitation to adopt
Intervention Description
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.
Primary Outcome Measure Information:
Title
Referral Rate
Description
Number of referrals given to EIMG-eligible patients by providers in referring clinics
Time Frame
Months 1-9
Secondary Outcome Measure Information:
Title
Patient physical activity levels (minutes of moderate-to-vigorous activity/week)
Description
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)
Time Frame
Conducted at months 0, 1.5, 3, 9, 15
Title
Patient blood pressure levels (mmHg)
Description
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.
Time Frame
Months 1-16
Title
Patient bodyweight (kg)
Description
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.
Time Frame
months 1-16
Title
Health economics of EIMG implementation
Description
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.
Time Frame
months 1-16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer L Trilk, PhD
Phone
8647662092
Email
Trilk@greenvillemed.sc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Frankie Bennett, MS
Phone
8644551410
Email
bennet24@greenvillemed.sc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Trilk, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Stoutenberg, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer L Trilk, PhD
Phone
563-581-1294
Email
Trilk@greenvillemed.sc.edu
First Name & Middle Initial & Last Name & Degree
Frankie Bennett, MS
Phone
8644551410
Ext
Trilk
Email
Trilk@greenvillemed.sc.edu
First Name & Middle Initial & Last Name & Degree
Jennifer L Trilk, PhD
First Name & Middle Initial & Last Name & Degree
Mark Stoutenberg, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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