Implementing and Evaluating the Comprehensive Integration of Physical Activity Into a Major Health System and Connecting Patients to Community-based Physical Activity Programs
Phase: NA
Conditions: Chronic Disease, Exercise, Physical Activity
Sponsor: University of South Carolina

  
 
 
Implementing and Evaluating the 
Comprehensive Integration of Physical 
Activity into a Major Health System and 
Connecting Patients to Community-Based 
Physical Activity Programs  
 
- Study Protocol - 
 
 
 
 
Lead Investigators: Jennifer Trilk, PhD 
 
Professor, Department of Biomedical Sciences 
 
USC School of Medicine Greenville 
 
 
Mark Stoutenberg, PhD, MSPH 
 
Associate Professor, Department of Kinesiology 
 
Temple University 
 
 
 
 
 
 
September 18, 2023 
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Principal Investigators (PIs):  
Jennifer Trilk, PhD 
Mark Stoutenberg, PhD, MSPH 
Scientific Collaborators:  
John Brooks, PhD 
Paul Estabrooks, PhD 
Meenu Jindal, MD 
Leah Schumacher, PhD 
Biostatisticians: 
Alex Ewing, PhD 
Todd Hanson 
Chris Wichman, PhD 
Research Team: 
Frankie Bennett, MS 
Stephanie Eskuri, RN 
Lia McNulty, MS 
James Rosemeyer, MS ATC 
Funding Agency: 
National Heart, Lung, and Blood Institute (NHLBI) 
Award #: 1R56HL157218-01A1 
 
NHLBI Liaisons: 
Eric J. Shiroma, PhD 
Program Director, Clinical Applications and Prevention Branch (CAPB) 
Division of Cardiovascular Sciences (DCVS) 
National Heart Lung and Blood Institute (NHLBI) 
 
Julie Delgado 
Grants Management Specialist, Office of Grants Management 
National Heart Lung and Blood Institute (NHLBI) 

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TABLE OF CONTENTS 
 
1.0 
LIST OF ABBREVIATIONS ................................................................................. 6 
2.0 
STUDY SYNOPSIS .............................................................................................. 7 
3.0 
BACKGROUND ................................................................................................. 10 
3.1 
Health Benefits of Physical Activity ........................................................................ 10 
3.2 
Physical Activity in the Health Sector ..................................................................... 10 
3.3 
Integrating Physical Activity Pathways into Health Systems ................................ 10 
3.3.1 
Assessing Patient Physical Activity Levels ................................................ 11 
3.3.2 
Providing Physical Activity Prescriptions ................................................... 11 
3.3.3 
Referring Patients to Physical Activity Resources ..................................... 11 
3.4 
Cost-Effectiveness of Physical Activity Promotion in Health Systems. ............... 11 
4.0 
EXERCISE IS MEDICINE GREENVILLE (EIMG) .............................................. 12 
4.1 
Implementing EIMG into the Prisma Health System .............................................. 12 
4.2 
Patient Eligibility ...................................................................................................... 12 
4.3 
EIMG Clinic Workflow .............................................................................................. 12 
4.4 
The EIMG Referral Team .......................................................................................... 12 
4.5 
Interface Between Prisma Health and Community PA Facilities ........................... 13 
4.6 
EIMG Community PA Facilities ................................................................................ 13 
4.7 
EIMG Community PA Facility Site Coordinators .................................................... 13 
4.8 
Evidence-Informed PA Programming at Community PA Facilities ....................... 13 
4.9 
EIMG Exercise Professionals (EIMG Pros) Selection and Training ...................... 13 
4.10 Patient Onboarding .................................................................................................. 13 
4.11 The Evidence-Informed PA Program ....................................................................... 13 
4.12 Closing the Loop: Interfacing Back to Prisma Health-Upstate .............................. 14 
4.13 Program Cost and Financial Assistance ................................................................ 14 
4.14 Initial Results from EIMG Implementation .............................................................. 14 
5.0 
STUDY OBJECTIVES ........................................................................................ 15 
5.1 
Primary Objectives ................................................................................................... 15 
5.2 
Secondary Objectives .............................................................................................. 15 
5.3 
Significance to the Field .......................................................................................... 15 
6.0 
STUDY DESIGN ................................................................................................. 16 
6.1 
Overview of Study Design ....................................................................................... 16 
6.2 
Rationale for Study Design ...................................................................................... 17 
6.2.1 
Choice of Primary Outcome ......................................................................... 17 
6.2.2 
Study Population .......................................................................................... 17 
6.2.3 
Inclusion of Women ...................................................................................... 17 
6.2.4 
Inclusion of Minorities .................................................................................. 17 
6.2.5 
Selection of Eligible Prisma Health Primary Care Clinics .......................... 17 
6.2.6 
Selection of Primary Care Settings .............................................................. 18 
6.2.7 
Rationale for Control Condition ................................................................... 18 
7.0 
STUDY POPULATION ....................................................................................... 19 
7.1 
Prisma Health - Clinic Eligibility .............................................................................. 19 

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7.2 
Prisma Health – Patient Eligibility ........................................................................... 19 
7.3 
Patient Eligibility – Participating in the PA Program ............................................. 19 
7.4 
Determining Patients Eligible for EIMG Referral .................................................... 20 
8.0 
STUDY PROCEDURES ..................................................................................... 21 
8.1 
Waves of Enrollment ................................................................................................ 21 
8.2 
Phase I – EIMG Adoption ......................................................................................... 21 
8.2.1 
Step One – Department Chair Email ............................................................ 21 
8.2.2 
Step Two – Communication with Practice Manager ................................... 21 
8.2.3 
Step Three – Brief Introductory Meeting with Practice Managers ............. 21 
8.3 
Phase II – EIMG Instructional Video ........................................................................ 21 
8.4 
Phase III – EIMG Onboard Training ......................................................................... 22 
9.0 
STUDY EVALUATION AND ASSESSMENTS .................................................. 23 
9.1 
Evaluating EIMG Adoption ....................................................................................... 23 
9.2 
Evaluating EIMG Implementation ............................................................................ 23 
9.3 
Evaluating the Effectiveness of the 12-week, Community-Based PA Program ... 24 
9.3.1 
Changes in Patient PA Levels ...................................................................... 24 
9.3.2 
Changes in Patient Health Outcomes .......................................................... 24 
9.3.3 
Individual Interviews with Patients .............................................................. 24 
10.0 
STUDY TIMELINE .............................................................................................. 25 
10.1 Timetable - Clinic Assessment of EIMG Referral Pathway .................................... 25 
10.2 Timetable - Evaluating the Effectiveness of the Community-Based PA Program 25 
10.3 Overall Study Timetable ........................................................................................... 26 
11.0 
ATTENTION TO HEALTH EQUITY ................................................................... 27 
12.0 
STATISTICAL ANALYSES ................................................................................ 28 
12.1 Primary Outcome...................................................................................................... 28 
12.2 Statistical Methods for Primary Analysis ............................................................... 28 
12.3 Rationale for Sample Size and Statistical Power ................................................... 28 
12.4 Secondary Aim 1 ...................................................................................................... 29 
12.5 Secondary Aim 2 ...................................................................................................... 30 
12.5.1 
Study Observations. ..................................................................................... 30 
12.5.2 
Episode of Care ............................................................................................. 31 
12.5.3 
Data Sources ................................................................................................. 31 
12.5.4 
EIMG Training Costs Per Eligible Patient .................................................... 31 
12.5.5 
Assessing the Effects of EIMG ..................................................................... 31 
12.6 Poolability of Data .................................................................................................... 33 
13.0 
PARTICIPANT SAFETY MEASURES ............................................................... 34 
13.1 Patient Safety Screening .......................................................................................... 34 
13.2 Healthcare Provider Screening of Patient............................................................... 34 
13.3 EIMG Care Coordinator Screening of Patients ....................................................... 34 
13.4 Safety Assessment at the Community PA Facility ................................................. 34 
13.5 Patient Exhibiting Contraindications to Exercise .................................................. 34 
13.6 Emergent Events ...................................................................................................... 35 

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13.7 Non-Emergent Events .............................................................................................. 35 
13.8 Exercise Session Absences .................................................................................... 35 
14.0 
HUMAN SUBJECTS PROTECTION .................................................................. 36 
14.1 Defining EIMG Research Participants ..................................................................... 36 
14.2 The Informed Consent Process ............................................................................... 36 
14.3 Documenting Informed Consent ............................................................................. 36 
14.3.1 
Written Informed Consent ............................................................................ 36 
14.3.2 
Verbal Informed Consent.............................................................................. 37 
14.4 Obtaining Participant Consent ................................................................................ 37 
14.4.1 
Individual (Adoption) Interviews with Practice Managers .......................... 37 
14.4.2 
Online ORCA Questionnaire with Clinic Staff ............................................. 37 
14.4.3 
Individual (Implementation) Interviews with Clinic Staff ............................ 37 
14.4.4 
Individual Interviews with Patients .............................................................. 37 
14.5 Participant Discontinuation ..................................................................................... 37 
14.6 Participant Remuneration ........................................................................................ 38 
15.0 
REPORTING AND MONITORING ..................................................................... 39 
15.1 Statement of Compliance ......................................................................................... 39 
15.2 Regulatory Files ....................................................................................................... 39 
15.3 Financial Disclosure ................................................................................................. 39 
15.4 EIMG Exercise Session Monitoring ......................................................................... 39 
15.5 Study Documentation .............................................................................................. 39 
15.6 Records Retention and Requirements .................................................................... 39 
15.7 Participant Confidentiality/Privacy .......................................................................... 39 
15.8 Confidentiality Breach ............................................................................................. 40 
15.9 Data and Safety Monitoring Board (DSMB) ............................................................ 40 
15.10 
Protocol Deviations & Violations - Reporting and Management ....................... 40 
15.11 
Adverse Events (AEs) .......................................................................................... 40 
15.11.1 Definitions of AEs ......................................................................................... 40 
15.11.2 Classification of AEs .................................................................................... 40 
15.11.3 Reporting of AEs ........................................................................................... 41 
15.11.4 Expectedness of AEs .................................................................................... 41 
15.12 
Serious Adverse Events (SAEs) .......................................................................... 41 
15.12.1 Definition of Serious Adverse Events (SAEs)..................................................... 41 
15.12.2 Reporting of SAEs ........................................................................................ 41 
15.13 
Unanticipated Problems ....................................................................................... 41 
15.13.1 Definition of Unanticipated Problems .......................................................... 41 
15.13.2 Relatedness to Study .................................................................................... 41 
15.13.3 Reporting of Unanticipated Problems ......................................................... 41 
16.0 
DATA MANAGEMENT AND PROCEDURES .................................................... 42 
16.1 Field-Based Data Collection Forms......................................................................... 42 
16.2 Field-Based Data Editing ......................................................................................... 42 
16.3 Field-Based Data Quality Assurance ...................................................................... 42 

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REFERENCES .............................................................................................................. 43 
 

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1.0 LIST OF ABBREVIATIONS 
 
ACSM 
American College of Sports Medicine 
BMI 
Body Mass Index 
CITI 
Collaborative Institutional Training Initiative 
DSMB 
Data Safety and Monitoring Board  
EHR 
Electronic Health Records 
EIMG 
Exercise is Medicine Greenville 
ERS 
Exercise Referral Scheme 
Ex Pros 
Exercise Professionals 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICD-10 
International Classification of Diseases, Tenth Revision 
i-PARIHS 
Integrated-Promoting Action of Research Implementation in Health Services 
IRB 
Institutional Review Board  
LDL 
Low Density Lipoprotein 
NCCA 
National Commission for Certifying Agencies 
NHLBI 
National Heart, Lung, and Blood Institute 
PA 
Physical Activity 
NIH 
National Institutes of Health 
PAVS 
Physical Activity Vital Sign 
PHQ-9 
Patient Health Questionnaire-9 
PROMIS 
Patient Reported Outcomes Measurement Information System 
RE-AIM 
Reach, Effectiveness, Adoption, Implementation, Maintenance 
REDCapTM 
Research Electronic Data Capture 
RPE 
Rating of Perceived Exertion 
SAE 
Serious Adverse Event  
U.S. 
United States 

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2.0 STUDY SYNOPSIS 
 
 
Protocol Title 
Implementing and Evaluating the Comprehensive Integration of 
Physical Activity into a Major Health System and Connecting Patients 
to Community-Based Physical Activity Programs 
Principal Investigators 
Jennifer Trilk, PhD; Mark Stoutenberg, PhD, MSPH 
Study Sponsor 
National Heart Lung and Blood Institute (NHLBI) 
Study Design 
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. 
Duration of  
Study Participation 
• Prisma Health primary care clinics will have the opportunity to adopt 
Exercise is Medicine Greenville (EIMG) 
• Adopting clinics will be provided with an introductory video and have 
EIMG activated upon study entry (baseline) 
• After approximately three months, clinics will receive a more in-
depth EIMG onboard training (months 0-3) 
• Clinic referral rates will be tracked for an additional six months after 
receiving the EIMG onboard training (months 4-9) 
• During the 9-month study period, eligible patients referred to 
participating community PA centers will have the option of enrolling 
in a 12-week, evidence-informed PA program 
Summary of 
Investigational 
Intervention 
• Implementation: our sequential design will test provider referral 
rates with eligible patients after: 1) an initial instructional video, and 
2) more in-depth EIMG onboard training 
• Effectiveness: we will examine the effectiveness of a 12-week 
evidence-informed physical activity (PA) on patient PA levels and 
health outcomes 
Summary of Key 
Eligibility Criteria 
• Prisma Health primary care clinics not yet onboarded to EIMG 
• Clinic managers at all Prisma Health primary care clinics eligible for 
the study (adoption) 
• Healthcare providers at the Prisma Health primary care clinics that 
chose to adopt EIMG (implementation) 
• Patients, age 18 or older, attending participating Prisma Health 
primary care clinics for whom exercise is not contraindicated 
(effectiveness) 
Primary  
Outcome Measure 
• Referral rates of eligible patients to the evidence-informed PA 
program 
Secondary  
Outcome Measure 
• Variables impacting adoption of EIMG at Prisma Health primary 
care clinics 
• Effectiveness of the 12-week evidence-informed PA program on 
patient PA levels and health outcomes 
• Cost of implementing EIMG in a Prisma Health primary care clinic 
• Cost effectiveness of EIMG on patient healthcare expenditures 

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NARRATIVE: The U.S. healthcare sector has great potential for promoting physical activity (PA) 
for chronic disease prevention and treatment; however, implementation barriers exist, ranging 
from practice integration to information flow. In 2016, the first multi-organizational partnership 
between a large academic healthcare system 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 tailored, community-
based PA programs. EIMG strategically leverages resources across a medical school 
(University of South Carolina School of Medicine Greenville), healthcare system (Prisma Health-
Upstate), and community organization (YMCA of Greenville) to connect patients, who are 
physically inactive and have chronic diseases, to partnering community PA centers. Clinics 
adopting EIMG typically receive standardized training to: 1) assess patient PA levels, 2) provide 
brief PA counseling, and 3) initiate a referral process connecting patients to the community PA 
centers. Referred patients are then guided by credentialed EIMG professionals in a 12-week 
evidence-informed PA program. Since launching in 2016, EIMG has grown to include 27 
provider clinics and 7 community PA facilities covering >400 urban/rural miles2. Even though 
EIMG onboard training is standardized across clinics, a high degree of variability exists in its 
implementation, impacting patient reach, referral rates, and engagement in the community-
based PA programs. As EIMG expands across Prisma Health, additional strategies are needed 
to enhance EIMG adoption, dissemination, and scale up. 
 
This multiple case study design will examine the adoption, implementation, and reach of EIMG 
(i.e., clinic workflow, referral process) across Prisma Health primary care clinics. Twenty Prisma 
Health primary care clinics will have the opportunity to adopt EIMG beginning in August 2023. 
Adopting clinics will receive a standardized instructional video and have the EIMG referral 
process activated, allowing providers to refer eligible patients to the 12-week evidence-informed 
PA program. In January 2024, adopting clinics will receive an in-depth, tailored EIMG onboard 
training. At EIMG adopting clinics, we will track referral rates of eligible patients over two phases 
lasting a total of eight months (months 1-4 after instructional video, months 5-8 after tailored 
onboard training).  
 
We will use a mixed methods approach to explore factors related to the adoption of EIMG (i.e., 
characteristics of adopting versus non-adopting clinics), achieving optimal implementation (i.e., 
clinic workflow, referral process), reach (i.e., proportion of eligible patients receiving a referral, 
characteristics of referred versus non-referred patients), and patient enrollment in evidence-
informed PA programs at participating community PA facilities. The RE-AIM framework will 
inform the assessment of implementation outcomes, while the i-PARIHS framework will be used 
to understand contextual factors (i.e., determinants) influencing patient- and clinic-level 
outcomes. Careful attention will be paid to issues of health equity across all RE-AIM dimensions 
over the course of the study. Finally, this work will examine the impacts of EIMG implementation 
on healthcare costs and patient outcomes to assess the cost-effectiveness associated with 
implementing EIMG in a major health system. 
 
Integrating the EIM model in health systems to connect patients with available community 
resources has the potential to significantly alter clinical practice and improve population health 
outcomes. Information gained from this study will lead to the development of a generalizable 
approach and materials that will inform future implementation strategies on optimizing and 
scaling up the integration of comprehensive PA models in U.S. health systems. Study findings 
will also provide cost estimates of potential savings to health systems integrating PA as a 
population health management tool through clinic-community linkages. 
 
 
 
 

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Figure 1. Overall study schematic. 
 
 
 
 

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3.0 BACKGROUND 
In 2016, Prisma Health1 began the process of integrating a physical activity (PA) pathway as a 
primary prevention strategy, connecting patients to six community partners who offer an 
evidence-informed PA program tailored for patients with chronic diseases. Prisma Health (with 
eight inpatient hospitals and more than 100 outpatient facilities and affiliated doctor offices) is 
the first large health system committed to a multi-level process of promoting PA with patients 
through a model called Exercise is Medicine Greenville (EIMG).2 This study will generate vital 
information on optimizing this pathway and developing clinic-community linkages that engage 
patients in a community-based, evidence-informed PA program. Our work will also provide data 
on cost savings related to integrating PA in a health system as a key prevention strategy.     
 
3.1 Health Benefits of Physical Activity 
The evidence around the benefits of PA are irrefutable; PA is unquestionably a “best buy” for 
overall health and is effective in reducing a broad array of health conditions.3 Exercise training is 
equally (or more) effective as drug therapy on mortality outcomes, secondary prevention of 
coronary heart disease, treatment of heart failure, and diabetes prevention.4 Globally, physical 
inactivity causes 6-10% of all major non-communicable diseases and is responsible for 9% of 
premature deaths, rates similar to other established cardiovascular disease risk factors, such as 
smoking and obesity.5 Conversely, PA acutely improves blood pressure,6 glycemic control,7 and 
inflammation.8 Regular PA reduces the risk of developing chronic conditions, such as stroke, 
hypertension, heart disease, type 2 diabetes, and several types of cancer.9,10 Given the benefits 
of PA, it is remarkable that only 54.2% of U.S. adults meet aerobic activity recommendations, 
while only 22.9% meet both aerobic and strength training recommendations.11 
 
3.2 Physical Activity in the Health Sector 
Engagement of the health sector is essential in increasing population PA levels with strategies 
well-described in the U.S. National PA Plan.12,13 Healthcare providers see a large portion of the 
general population, often several times a year. These ongoing, multiple contacts offer the ideal 
opportunity to provide brief, impactful PA counseling. The Toronto Charter,14 a global call to 
action for population-based approaches, outlines several strategies for increasing PA in health 
settings including: reorienting health services and funding systems, screening of patient PA 
levels at primary care consultations, and referral to community programs for insufficiently active 
patients. These overarching guidelines have been supported by calls to action by medical 
societies15 and leading health professionals.16,17 Yet, integration lags because health systems 
are not properly equipped/designed to promote PA. 
 
3.3 Integrating Physical Activity Pathways into Health Systems 
Similar to the SBIRT model18 (Screening, Brief Intervention, and 
Referral to  Treatment), an evidence-based, clinical strategy for 
addressing substance use disorders, Exercise is Medicine (EIM)19 is a 
comprehensive model for integrating PA in the clinic workflow. EIM is not a PA 
intervention, but a framework to improve the reach of evidence-based PA 
interventions by identifying and engaging patients that would benefit from 
increased PA. The individual components of the EIM model include: 1) 
assessing PA levels of patients, 2) providing brief PA counseling 
and/or a PA prescription, and 3) referring patients to PA resources 
for further guidance. In some instances, a ‘navigator’ or referral team 
is involved to increase referred patient engagement levels (Figure 2). As 
described below, the individual components of the “EIM model” have moderate-
to-strong evidence bases. Prisma Health-Upstate is the first and only large health 
system in the world to attempt to integrate all EIM components into their clinic workflow, 
connecting patients with chronic diseases to community-based PA programs. 
 

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3.3.1 
Assessing Patient Physical Activity Levels 
The assessment of PA in clinic settings has been noted as a catalyst to subsequent prescription 
and referral.20 The PA ‘Vital Sign’ (PAVS) is used by multiple U.S. health systems,21,22 
demonstrating strong face and discriminant validity in identifying inactive individuals across 
gender, age groups, and disease conditions.23 Significant associations exist between PA levels 
and cardiometabolic risk factors, body mass index (BMI), and patient disease burden.23,24 PAVS 
integration into the electronic health records (EHR) leads to greater PA progress note 
documentation, PA counseling, and referral compared to patient visits without PAVS 
administration.25 Despite PAVS integration in a limited number of U.S. health systems, none 
have adopted any of the following steps (4.3.2 and 4.3.3) to address low patient PA levels. 
 
3.3.2 
Providing Physical Activity Prescriptions 
The New Zealand Green Prescription is the best-known program involving health professionals 
giving patients a written/electronic PA prescription, leading to increased PA levels compared to 
verbal advice alone.26 Patients receiving a prescription, compared to usual care, were more likely 
to meet PA guidelines and achieve higher energy expenditure27 with benefits extending out 2-3 
years.28 Outside of a few small trials, PA prescriptions have not been systematically integrated 
into U.S. health systems. 
 
3.3.3 
Referring Patients to Physical Activity Resources 
The largest exercise referral schemes (ERS) exist in the United Kingdom, involving health 
professionals referring patients to community-based PA programs.29 ERS increase patient PA 
levels, lower levels of depression and anxiety, and is moderately cost effective, particularly in 
older patients and those with greater cardiovascular disease risk factors.30,31 However, ERS do 
not often involve a standardized PA assessment. In the U.S., no system-wide PA referral efforts 
have been established to date. 
 
3.4 Cost-Effectiveness of Physical Activity Promotion in Health Systems. 
Physical inactivity costs healthcare systems $53.8 billion worldwide and contributes to $13.7 
billion in productivity losses.32 In the U.S., inadequate PA, independent of BMI levels, is 
associated with 11.1% of aggregated, direct healthcare expenditures.33 Conversely, PA 
interventions are cost-effective in improving population health outcomes.34,35 Cost savings have 
been noted when examining PA interventions introduced in healthcare settings. A review found 
that linking primary care patients to community PA resources was likely to be cost-effective, but 
that evidence was sparse.36 To date, no studies have examined costs associated with 
integrating a PA referral pathway into a U.S. health system and associated cost effectiveness of 
the PA referral pathway. 

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4.0 EXERCISE IS MEDICINE GREENVILLE (EIMG) 
The EIMG model is a joint effort involving the University of South Carolina School of Medicine 
Greenville (UofSC SOM Greenville), Prisma Health, and the YMCA of Greenville. An EIMG 
Advisory Board, led by Jennifer L. Trilk, PhD, FACSM, provides oversight and direction for 
EIMG implementation and ensures compliance with program rules and regulations.2 
 
4.1 Implementing EIMG into the Prisma Health System 
EIMG implementation started in 2016 with the testing of EHR functionality, onboarding of two 
clinics, PAVS integration into the EHR, best practice alerts, risk assessment, EIMG order sets 
and electronic referrals to community PA facilities. By April 2023, 27 Prisma Health practices, 
including family and internal medicine, as well as 
specialty clinics (i.e., bariatrics, cancer), had 
adopted EIMG (Figure 3) covering, >400 miles2  
in Greenville and Oconee counties. 
 
4.2 Patient Eligibility 
Patients are eligible to participate in EIMG if they are between the ages of 18-80, physically 
inactive (<150 minutes per week of moderate intensity aerobic activity) and with or without a 
chronic condition (i.e., overweight/obese, hypertension, type 2 diabetes) that is positively 
impacted by PA. Patients with uncontrolled hypertension or diabetes, and those at increased fall 
risk are ineligible to participate in EIMG until symptoms are controlled and physician approval is 
provided. 
 
4.3 EIMG Clinic Workflow 
The EIMG Clinician Decision Modules are incorporated into the EHR as part of clinical workflow. 
The three Decision Modules include: 1) PA assessment, 2) PA prescription (through patient 
order sets), and 3) referral to a community PA facility. 
Module 1: PA Assessment. Front office or nursing staff capture the patient's current PA 
behavior via the PAVS programmed into the EHR. The PAVS consists of two questions 
(“how many minutes per day do you exercise?” and “how many days per week?”) to 
determine if the patient is meeting national PA guidelines of 150 minutes of moderate 
intensity aerobic activity a week. The PAVS identifies ‘eligible’ patients, provides a best 
practice alert (BPA) through the EHR stating that the patient may qualify for EIMG, and 
prompts providers to discuss lifestyle behavior change. 
Module 2: PA Prescription. The healthcare provider informs eligible patients about the EIMG 
program, reviews risks, and provides basic PA and health education by providing them with 
EIM Rx for Health handouts for exercising with chronic disease (e.g., obesity, diabetes, 
hypertension, peripheral artery disease), developed by experts in the field.37 The healthcare 
provider then electronically starts an ‘EIMG Order Set’ leading to the patient referral. 
Module 3: Patient Referral. Through a series of EHR prompts confirming patient eligibility, 
the healthcare provider sends a referral to the EIMG Referral Team. All aspects of the EHR 
referral process are electronic, except a paper version of the EIMG Consent to Treat and the 
Release of Information that the patient must sign (either while in the clinic room or at the 
checkout counter) in order to continue. 
 
4.4 The EIMG Referral Team 
The EIMG Referral Team consists of an EIMG Care Coordinator employed by Prisma Health, 
who reviews the patient’s EHR, contacts them via telephone, confirms their eligibility and 
interest, identifies their preferred location and ability to pay (e.g., scholarship eligibility), and 
electronically sends all HIPAA-compliant patient information to the EIMG Site Coordinator at the 
selected community PA facilities for a warm “hand off”. 
 

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4.5 Interface Between Prisma Health and Community PA Facilities 
The EIMG Community Interface consists of: 1) EIMG Community PA Facilities, and 2) EIMG 
Community PA Facility Site Coordinators. 
 
4.6 EIMG Community PA Facilities 
The EIMG community PA facilities include one Prisma Health medical fitness facility and seven 
YMCA sites across Greenville and Oconee Counties, with a reach of >400 miles2. The PA 
facilities have a like-minded mission to serve as an extension of health care to improve 
community health and decrease geographical barriers to participation. Upon joining the EIMG 
network, each facility is educated on program operations and all associated administration and 
staff undergo standardized EIMG training. 
 
4.7 EIMG Community PA Facility Site Coordinators 
Upon receiving a patient referral from the EIMG Referral Team, the EIMG Site Coordinator at the 
patient’s preferred community PA facility contacts the patient, reviews logistic and financial 
needs, and schedules the patient for onboarding with an EIMG Professional (EIMG Pro) at their 
facility. The EIMG Site Coordinator informs the EIMG Pro about the incoming patient. The EIMG 
Site Coordinator also is responsible for HIPAA protocols, implementing EIMG protocols, 
oversight of EIMG Pros responsibilities, communicating timelines, and audit reporting. 
 
4.8 Evidence-Informed PA Programming at Community PA Facilities 
The final step involves patient enrollment in the PA program at a community PA facility. Three 
key activities take place at each community PA facility: 1) EIMG Pro selection and training, 2) 
patient onboarding, and 3) conducting the 12-week evidence-informed PA program. 
 
4.9 EIMG Professionals (EIMG Pros) Selection and Training 
EIMG Pros are community PA facility employees selected based on their experience and desire 
to work with clinical populations. All EIMG Pros have a B.S. in exercise science or health-related 
field, possess a NCCA-accredited personal training certification, obtain the EIM Credential,38 
complete HIPAA and CITI training for the protection of human subjects, and receive training on 
using REDCapTM (Research Electronic Data Capture) database. Continuing education is 
provided to all EIMG Pros twice per year and all training materials are archived on an EIMG Pro 
site. EIMG Pros are responsible for leading the 12-week PA program over one-hour sessions, 
two times per week, in the community PA facilities. 
 
4.10 Patient Onboarding 
Patient onboarding with EIMG Pros takes approximately one hour and includes completing: 1) 
appropriate paperwork (i.e., health history forms), 2) pre-participation surveys (i.e., PHQ-9, 
PROMIS Scale), and 3) measurement of height, body weight (in duplicate), blood pressure 
(after 10 minutes seated in triplicate), and heart rate (in triplicate). The assessments are also 
completed at the end of the 12-week program. A rolling enrolment feature allows patients to 
onboard in <10 business days to maximize readiness for behavior change, with new patients 
learning from current program participants. 
 
4.11 The Evidence-Informed PA Program 
The evidence-informed PA program used by EIMG was created based on evidence-based 
research and ACSM Position Stands around meeting national PA guidelines of 150 min/week of 
moderate intensity aerobic activity. Patients are referred to either the: 1) Cardiometabolic or 2) 
Musculoskeletal/ Pain modules based on their primary diagnosis and referral. Training sessions 
are guided by the following social-cognitive theory principles that: 1) all training is progressive, 
2) training should include full body movements, and 3) active education is incorporated into 
training. In lieu of a fixed curriculum, program “essential” and “recommended” building blocks 
provide a foundation and allows for flexible and adaptive delivery by EIMG Pros based on their 

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individual strengths, their unique participants, and limitations of their specific facility (i.e., 
equipment, space, scheduling). This program model is consistent with key concepts for adaptive 
and flexible health promotion interventions.39,40 Patients also are provided with EIMG Patient 
Education Handouts to increase their understanding about adopting a healthy lifestyle (i.e., PA, 
nutrition, stress management, goal setting, social support). Data from PA program sessions 
(i.e., patient attendance and progress, pre-post metrics) are tracked using REDCap that is 
accessible to the EIMG Site Coordinators, EIMG Pros, and the research team. 
 
4.12 Closing the Loop: Interfacing Back to Prisma Health 
All pertinent patient activity (e.g., contraindications to exercise notifications, Patient Consult 
Summary Form when a patient graduates or drops out from the program) is documented by 
EIMG Pros and sent by secure email to the EIMG Referral Team. The EIMG Referral Team then 
provides the patient’s summary to the healthcare provider through the EHR.  
 
4.13 Program Cost and Financial Assistance 
Understanding that EIMG only succeeds as a population health tool if it is affordable and 
delivered equitably, the YMCAs of Greenville developed a program in which a percentage of 
their annual giving campaign goes to EIMG so that no patient is turned away due to their 
inability to pay. To date, >$350,000 has been set aside for patient scholarships, a model that 
can be replicated by other YMCAs and community PA facilities outside of Greenville, SC. 
Patients receive scholarships covering 5-100% of program costs with as many as 75% of 
patients receiving some sort of financial assistance to participate in the EIMG. 
 
4.14 Initial Results from EIMG Implementation 
From launch in 2016, EIMG expanded to 18 Prisma Health practices and six community PA 
facilities across Greenville County by 2019. Over time, referral numbers have been consistent 
within a clinic, demonstrating initial sustainability of the EIMG model. Yet, large variations exist 
in referral patterns between participating clinics.  
 
As of the end of 2022, a total of 1471 patients had been correctly referred to the EIMG Referral 
Team (Figure 4) with 520 enrolling in the PA programs. Variation in referral patterns between 
clinics, as well as system level gaps in connecting patients to the PA programs, provides 
substantial rationale for investigating 
strategies to optimize the clinical 
implementation of the EIMG model.  
 
Patients enrolled in the PA program 
graduated at rates of 48%, 63%, and 
68% in 2016 through 2018, with a 
projected 72% in 2019/2020 (prior to shut 
down during coronavirus pandemic).41 
Analysis of a subgroup of patients (n=173) demonstrated a significant decrease in bodyweight 
(1.5±4.1 kg, p<0.001). Patients referred for hypertension (n=106), lost an average of 1.2±3.8 kg 
(p=0.002) and decreased their systolic (n=100) and diastolic blood pressure by 7±15 (p<0.001) 
and 3±8 mmHg (p=0.001), respectively. In an exit survey (n=153 graduates), all program 
components received high satisfaction scores (5-point Likert scale, 5 = “highly satisfied”). All 
provider ratings were above 4.75 and all satisfaction scores were above 4.9.  
 
Despite the existence of a standardized framework for integrating EIM in Prisma Health clinics, 
variability in implementation fidelity has emerged over the initial years of the EIMG program. 
This underscores the need to understand the contextual factors and processes at both clinic- 
and provider-levels to enhance implementation of the EIMG model. 

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5.0 STUDY OBJECTIVES 
 
5.1 Primary Objectives 
 
Primary Aim. To determine differences in clinic- and provider-level adoption (i.e., proportion and 
characteristics of clinics that adopt and initiate use of EIMG), implementation (i.e., delivery 
fidelity), and reach (i.e., number, proportion, and representativeness of patients) before and 
after EIMG integration at newly adopting Prisma Health primary care clinics. 
 
5.2 Secondary Objectives 
 
Secondary Aim 1. To assess the effectiveness of participating in the evidence-informed, 12-
week PA program at the community PA facilities on patient health outcomes (i.e., body weight, 
blood pressure, hemoglobin A1c, lipid profiles) captured in their electronic health records. 
 
Secondary Aim 2. To evaluate, from a health system perspective, the cost of implementing 
EIMG to estimate the effort of EIMG vs. standard care on costs and outcomes (effectiveness). 
We will use these estimates to obtain the incremental cost-effectiveness of EIMG vs. standard 
of care. 
 
5.3 Significance to the Field 
The completion of this study and achievement of our study aims has the potential to significantly 
advance understanding of how to optimally integrate a PA referral pathway into clinical settings 
that involves the prescription, referral, and engagement of patients in community-based PA 
programs. This study will enhance the operationalization of future large-scale, PA models in 
health systems that have diverse policies, practices, and patients. Study findings and resources 
will be made available to health systems for broad scale up with the goal of increasing patient 
engagement in community-based PA programs as an extension of healthcare systems. Finally, 
the achievement of our study aims will provide an economic evaluation that has the potential to 
impact coverage decisions made by insurance companies and adoption/implementation 
decisions made by health systems when determining the design and uptake of clinical/ 
community health promotion programs. 
 

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6.0 STUDY DESIGN 
 
6.1 Overview of Study Design 
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 (e.g., physicians, nurses, medical assistants, 
administrative assistants) 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 EHR. 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. 
 
 
 
 
 
 
 
 
 
 

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6.2 Rationale for Study Design 
 
6.2.1 
Choice of Primary Outcome 
Referral rates of eligible patients was chosen as our primary outcome because we wish to: 1) 
specifically examine clinic-community linkages for which the referral is the linchpin, and 2) on 
evaluating the implementation of a PA referral pathway integrated within a health system. The 
ultimate indicator of provider-patient ‘engagement’ in the clinic setting is the delivery of a 
complete and accurate EIMG referral to eligible patients. We considered examining patient 
engagement in the evidence-informed PA program, but this occurs further downstream, 
involving several additional steps on the periphery and outside of the healthcare setting. 
However, as part of a secondary aim (effectiveness of the evidence-informed PA program), we 
will examine patient enrollment rates and factors influencing their decisions (i.e., barriers and 
facilitators). 
 
6.2.2 
Study Population 
Our study population will consist of: 1) clinic staff at participating Prisma Health primary care 
clinics, and 2) all patients eligible to receive an EIMG referral to participate in the evidence-
informed PA program at local community PA facilities. 
 
6.2.3 
Inclusion of Women  
We expect that approximately equal numbers of men and women will be eligible to receive an 
EIMG referral and have the opportunity to participate in the study. We therefore might expect to 
enroll women at a similar (or greater) proportion as they appear in the underlying population of 
ambulatory care. However, in our previous work involving EIMG, women received a greater 
proportion of referrals (75%) and participated in the PA program at a greater rate (81% to 19%) 
than men. Therefore, we expect to see levels of participation in the study that reflect these past 
trends. 
 
Patients that are pregnant are not eligible for participation in EIMG and, therefore, will not be 
eligible to participate in the study. The PA program is designed for patients with chronic 
diseases and are not tailored for the specific needs and considerations of pregnant women. A 
future goal of EIMG, beyond the scope of this study, is to develop, offer, and test an EIMG 
model specifically tailored for pregnant women and other higher risk populations. 
 
6.2.4 
Inclusion of Minorities 
This study focuses on the identification of physically inactive patients with chronic disease 
and their referral to the PA program. The study will include patients regardless of their race, 
ethnicity, or any other underrepresented status. Conducting the study in Prisma Health 
primary care clinics, a major health system serving a large and diverse population in 
Greenville, South Carolina, ensures that we will have a high representation of minority patients. 
Based on the current patient population served by Prisma Health, we anticipate that 
approximately 25% of the study participants will be African American, 62% will be White, and 
approximately 8% will be Hispanic/Latino. It is our intention to pay particular attention to issues 
of health equity across all dimensions of the study, examining determinants and contextual 
factors that may potentially impact the participation of vulnerable populations at any point in 
the EIMG model. 
 
6.2.5 
Selection of Eligible Prisma Health Primary Care Clinics 
We elected to use the clinic as the unit of observation, rather than individual providers or 
patients within a clinic. Clustering is preferred when the target of an intervention is a collective 
or system rather than a particular person or patient, allowing us to evaluate a new standard of 
care or practice-wide change that may affect patient outcomes. Further, the use of clusters (at 
the clinic level) reduces potential contamination between groups as patients within a clinic are 
more likely to be treated similarly and exhibit similar outcomes. Our unit of analysis will be a 

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compilation of provider-level metrics, aggregated across all providers within a clinic. The 
negative to clustering at the clinic level includes requiring more participants to obtain equivalent 
statistical power, more complex analyses, and not being able to blind groups. 
 
6.2.6 
Selection of Primary Care Settings 
The primary care setting, as opposed to acute and urgent care centers or specialty clinics, was 
selected for this study as most patient contacts originate and end in primary care. In many 
cases, primary care is the only place that individuals have access to care. The primary care 
setting is the cornerstone of health systems in meeting the broader needs of patients, families, 
and communities. Primary care practices are tasked with providing high quality care for patients 
on a long-term basis, many of them with co-morbid conditions that are all positively impacted by 
greater PA levels. The primary care setting is the first point of contact for patient populations 
(inactive, with diabetes, hypertension, obesity, and dyslipidemia) requiring primary and/or 
secondary disease prevention, such as PA promotion and counseling. Further, the primary care 
setting allows for the ongoing observation of the trajectory of chronic diseases through multiple 
visits over time.42 Lastly, the patients seen in primary care settings are representative of the 
surrounding population, allowing for a greater examination of interventions that reduce health 
disparities and improve health equity. 
 
6.2.7 
Rationale for Control Condition 
The selection of our control group was influenced by several factors. There are currently only 20 
Prisma Health primary care clinics that have not received EIMG onboarding and activation and 
that are within 15 miles or less of a participating community PA facility. There are no other 
equivalent Prisma Health primary care clinics to serve as matched controls (i.e., via a stepped 
wedge design). We are then left with two groups of clinics to serve as controls. The first of these 
is using a within-clinic design and comparing patient health outcomes before and after the 
dissemination of the initial EIMG Instructional Video. Secondly, from past experiences, we 
anticipate that several of the 20 clinics will choose not to adopt EIMG and/or will be non-
responsive to our invitation. As one of our study aims, we will evaluate contextual factors and 
differences between adopting and non-adopting clinics. Clinics that do not adopt EIMG will not 
be ‘activated’ and can therefore serve as control clinics, particularly when evaluating patient-
level outcomes, as none of their patients will have had the opportunity to participate in EIMG. 

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7.0 STUDY POPULATION 
 
7.1 Prisma Health - Clinic Eligibility 
As the unit of randomization, we will offer the opportunity to adopt EIMG to 20 Prisma Health 
primary care clinics that have not yet implemented EIMG. The department chairs for Internal 
and Family Medicine (Drs. Peter Tilkemeier and Peter Carek) have provided their support for 
EIMG expansion across these primary care clinics.  
 
Eligibility criteria for clinics to participate in this study include the following: 
• 
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.43,44 
 
7.2 Prisma Health – Patient Eligibility 
Adult patients (≥18 years of age) will be deemed eligible for the study through two different 
approaches. First, patient eligibility to receive an EIMG referral is determined in real time 
through a series of steps that are integrated within the patient workflow process in the Prisma 
Health primary care clinics. Patients that receive an EIMG referral will have the opportunity to 
enroll in the community-based PA programs and will be considered as the numerator in our 
‘reach’ calculations. Second, all patients that were eligible for an EIMG referral (whether they 
received one or not) at participating clinics will be identified through a retrospective data 
extraction process from the Prisma Health EHR that will occur at the end of the study period 
(end of month 8). These broader sample of patients that were eligible for an EIMG referral will 
be considered as the denominator in our ‘reach’ calculations. 
 
7.3 Patient Eligibility – Participating in the PA Program 
Healthcare providers at participating Prisma Health primary care clinics that adopt EIMG will 
have the ability to identify eligible patients and provide them with an EIMG referral during the 
patient visit through a process embedded in the patient care workflow at each clinic.  
 
The first step in determining patient eligibility to receive an EIMG referral will involve identifying 
potentially eligible patients that would benefit the most from participating in an exercise training 
program. As part of EIMG adoption (both with the EIMG Instructional Video [phase I] and the 
EIMG Onboard Training [phase II]), clinicians will be guided to identify and refer patients with 
low physical activity levels with or without any of the following: overweight/obesity, high blood 
sugar, high blood pressure, or dyslipidemia. Although the provision of referrals is left to the 
judgement of each clinician, general guidelines for referring patients will be as follows: 
o >150 minutes per week of moderate intensity PA (as determined by the PAVS) 
o BMI ≥30kg/m2 
o Impaired fasting glucose 
o Prediabetes 
o Types 2 diabetes mellitus 
o Essential hypertension 
o Dyslipidemia (including hyperlipidemia, hypertriglyceridemia, hypercholesteremia) 
 

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Once a clinician has deemed that a patient would benefit from participating in EIMG, to 
complete the referral process they will be asked to:  
i. Complete a Risk Severity Assessment to ensure that participating in an exercise training 
program will be safe and that it is appropriate for their patients; 
ii. Upload the consent and release of information forms signed by the patient (these forms 
allow the transfer of a limited amount of HIPAA-protected patient health information to 
the site coordinator at the community PA facility).  
 
This information is electronically sent to a member of the EIMG Referral Team, who checks for 
completeness and ensures patient eligibility to participate in the PA program. EIMG Referral 
Team members will contact referring clinicians if any required information is missing or to clarify 
any safety concerns. 
 
The final number of patients referred to the EIMG Referral Team will serve as the ‘numerator’ in 
our Reach calculations (see 13.2 and 13.3). 
 
7.4 Determining Patients Eligible for EIMG Referral 
During the data extraction process, a list of patients that were eligible for an EIMG referral 
(regardless of whether they received a referral or not) will be extracted from the Prisma Health 
EHR. The research study team will retrospectively identify patients that could have received an 
EIMG referral based on a list of pre-determined ICD-10 codes.  
 
Inclusion Criteria. The study team will develop a list of ICD-10 codes (based off the criteria 
presented in section 7.2.1.) to identify all potentially eligible patients that could have received an 
EIMG referral. The ICD-10 codes were selected a-priori by the study team based on the priority 
health conditions identified by Prisma Health leadership in partnership with the EIMG Advisory 
Board. These conditions include patients that are physically inactive and/or who have obesity, 
diabetes, hypertension, or dyslipidemia. The list of ICD-10 codes was selected by the research 
team and verified by: a) the EIMG Advisory Board, and b) Prisma Health primary care clinicians. 
 
Exclusion Criteria. During phase I and II of the study (prior to any extraction of patient data from 
the Prisma Health EHR), the research team will engage in a process to develop a list of 
exclusionary criteria. Patients seeking medical assistance with any of these criteria would be 
deemed ineligible to receive an EIMG referral and will be removed from the denominator of our 
implementation, reach, and effectiveness analyses. To develop the list of exclusionary criteria, 
we will engage in a three-step process. First, we will identify published guidelines and existing 
tools (e.g., PAR-Q+) that list health conditions that are contraindications for physical activity. 
Second, we will seek the opinions of 8-12 primary care physicians to identify conditions for 
which they would not refer their patients to a physical activity program. Combining these 
findings, we will develop a list of ICD-10 codes that will serve as exclusionary criteria for which 
exercise training is either inappropriate or contraindicated.  
 
The final list of patients deemed eligible for a referral (inclusion criteria – exclusion criteria) will 
serve as the ‘denominator’ in our Reach calculations (see 14.1 and 14.2). 
 
 
Definition 
Description 
Numerator 
# of eligible patients that 
receive an EIMG referral 
• Determined through a real time patient workflow 
process in Prisma Health primary care clinics 
participating in the study 
Denominator 
# of patients that were 
eligible to have received 
an EIMG referral 
• Retrospectively pulled from the Prisma Health EHR 
• Determine number of eligible patients based in ICD-10 
inclusion criteria (Appendix A) 
• Remove ineligible patients based off ICD-10 
exclusionary criteria 

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8.0 STUDY PROCEDURES 
 
8.1 Waves of Enrollment 
All eligible Prisma Health primary care clinics will be invited to adopt EIMG at the same time. 
Prisma Health primary care clinics will not enter clinics into the study via stepped approach. 
Within this one wave, three distinct study phases will be conducted. 
 
8.2 Phase I – EIMG Adoption 
The first phase of this study will involve inviting all eligible Prisma Health primary care clinics to 
adopt EIMG through a three-step approach, as described below. 
 
8.2.1 Step One – Department Chair Email 
The department chairs for family and internal medicine at Prisma Health will, on behalf of the 
research team, send a brief email to all physicians and practice managers at eligible Prisma 
Health primary care clinics. The email will briefly introduce EIMG, discuss its compatibility, 
complexity, relative advantage, observability, trialability and how adopting it will benefit their 
clinic, and provide a link to the EIMG website. If a practice manager responds to this email, they 
will be invited to schedule a brief introductory meeting (section 8.2.3.) to discuss the process of 
adopting EIMG. If a physician responds to this email, they will be encouraged to reach out to 
their practice manager so that they can both be jointly involved in the EIMG adoption process. 
We decided that the practice manager must be included in the adoption process as they are 
most likely to disseminate information and materials to the clinic staff and serve as the best 
point of contact for the research team. 
 
8.2.2 Step Two – Communication with Practice Manager 
Approximately one-week after the department chair email, a study coordinator will send a follow 
up email to each practice manager to gauge their interest in adopting EIMG. Practice managers 
that express interest in adopting EIMG will be asked to schedule a brief introductory email 
(section 8.2.3.). If a practice manager expresses that their clinic is not interested in adopting 
EIMG, the clinic will be considered as a ‘non-adopter’. If the practice manager does not respond 
to the email within one week, the study coordinator will attempt to call the practice manager up 
to three times over the following ten days. If the study coordinator is unable to get in touch with 
the practice manager, they will be considered unresponsive and their clinic will be classified as 
a ‘non-adopter’. 
 
8.2.3 Step Three – Brief Introductory Meeting with Practice Managers 
A study coordinator will conduct a brief, 15-minute meeting with practice managers at clinics 
interested in adopting EIMG. The meeting will be held in-person or virtually at the request and 
convenience of the practice manager. During the meeting, the study coordinator will provide an 
overview of the adoption process (phase II and phase III), discuss the EIMG Introductory Video 
and the timeline for its dissemination and EIMG activation at the clinic, explain the optional 
research components accompanying EIMG adoption (adoption interview, section 9.1.1; online 
ORCA questionnaire, section 9.1.2; individual interviews with clinic staff, section 9.1.3), and 
answer any questions from the practice manager. 
 
8.3 Phase II – EIMG Instructional Video 
Phase II will start with disseminating the EIMG Instructional Video to adopting clinics, followed 
by EIMG activation. The EIMG Instructional Video is intended to be a low-intensity strategy for 
disseminating information and guidance on EIMG and the PA referral pathway connecting 
Prisma Health primary care clinics and the community PA facilities. The EIMG Instructional 
Video is a brief (11-minute), voice-over PowerPoint presentation that provides information on: a) 
the origins of EIMG, b) the 12-week, community-based PA program, c) initial patient 
effectiveness results, and d) process for placing an EIMG referral. The EIMG Instructional Video 
will be sent to the practice managers at EIMG-adopting clinics for broader dissemination to all 

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clinic staff. After delivery of the EIMG Instructional Video to the practice managers, access to 
the EIMG referral process in the EHR is ‘turned on’ (aka – EIMG activation) allowing clinic staff 
to electronically identify and engage with eligible patients. 
 
8.4 Phase III – EIMG Onboard Training 
Phase III will consist of a more in-depth standardized EIMG onboard training that will take place 
with EIMG-adopting Prisma Health primary clinics (section 8.2). The EIMG onboard training will 
be scheduled in collaboration with the clinic practice manager on a day and time most 
convenient for the clinic staff. The scheduling of the EIMG onboard training will occur during the 
second half of month 4, with the trainings taking place during the first half of month 5. The 
onboarding process will follow an established protocol that has been iteratively developed and 
refined from lessons learned through the addition of EIMG clinics between 2016-21. Due to the 
coronavirus pandemic, the onboard training process was adapted for virtual environments and 
will be used moving forward due to its notable benefits, including recording the training to serve 
as an ongoing reference tool for clinic staff who cannot attend initial training, as well as new and 
incoming staff. The standardized, yet flexible and adaptable training is targeted to practice 
managers, healthcare providers, nurses, and front-office staff at clinics. The training includes a 
detailed explanation of the EIMG Clinical Education Workflow, a breakdown of responsibilities 
for each part of the EIMG process (i.e., conducting the PAVS, obtaining the consent and release 
of information forms), and completing the risk severity assessment. Strategies used in the 
onboard training will be mapped to implementation strategies compiled as a part of the Expert 
Recommendations for Implementing Change (ERIC). 
 
 
 
 
 

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9.0 STUDY EVALUATION AND ASSESSMENTS 
This study is evaluating the adoption and implementation of an existing program (EIMG), which 
has previously been adopted and is in use by >27 Prisma Health clinics, at Prisma Health 
primary care clinics that have not yet had the chance to adopt this program. Our study will 
conduct research activities examining adoption, implementation, and effectiveness across three 
different groups of individuals: 
• 
Practice managers at Prisma Health primary care clinics that are eligible to adopt EIMG; 
• 
Clinic staff at Prisma Health primary care clinics that adopt EIMG; 
• 
Patients at primary care clinics that adopt EIMG and receive an EIMG referral. 
 
All individuals that agree to participate in research activities will go through an informed consent 
process as described in section 14.3. A timeline for the following research activities is 
summarized in section 10. 
 
9.1 Evaluating EIMG Adoption 
The adoption of EIMG at eligible Prisma Health primary care clinics will be examined through 
two strategies. First, we will compare key characteristics (e.g., proximity to the PA facilities, 
number of patients seen, patient insurance distribution, number and type of providers) between 
clinics that adopt versus those that do not adopt EIMG. Second, during the first month of Phase 
II, we will seek to conduct semi-structured interviews with practice managers from each Prisma 
Health primary care clinic that was offered the chance to adopt EIMG, regardless of whether 
their clinic adopted EIMG or not. The semi-structured interview will be guided by an interview 
script mapped to the i-PAHRIS framework,45 exploring decisions to adopt (or not) EIMG at their 
clinic. 
 
9.2 Evaluating EIMG Implementation 
Two assessments will be utilized to examine contextual factors influencing the implementation 
and reach of EIMG at the clinic level. First, we will conduct the Organizational Readiness to 
Change Assessment (ORCA)46 with clinic staff (administrators, providers, and staff) at EIMG-
adopting clinics. The ORCA tool operationalizes constructs defined in the original PARIHS 
framework to measure organizational readiness to change in clinic settings. The ORCA consists 
of three major scales that measure the strength of evidence for the proposed innovation, 
organizational support for change, and organizational capacity to facilitate the change. In 
previous work, we adapted and pilot-tested the ORCA as an online questionnaire with Prisma 
Health primary care clinics (not included in this study) to assess contextual factors related to 
EIMG adoption and implementation. In the current study, we will conduct the ORCA as an 
online questionnaire with a representative sample of clinic staff from each clinic after the 
dissemination of the EIMG Instructional Video (months 2-3) and again after the EIMG Onboard 
Training (months 6-7). 
 
Second, we will conduct brief (~30 minutes), semi-structured interviews with clinic staff to gain a 
more nuanced understanding of EIMG implementation across clinics. While self-administered 
questionnaires or structured interviews cost less and reduce interviewer bias, semi-structured 
interviews foster rapport and are preferred when seeking information on respondents’ attitudes 
and perceptions on a topic.47 Semi-structured interviews also allow exploration of issues through 
extensive probing.48 The interview scripts will be mapped to the i-PAHRIS framework45 and 
structured to complement the quantitative data gained through the ORCA. We will attempt to 
conduct interviews with a representative sample of staff (e.g., four staff per clinic) approximately 
1-2 months after the EIMG Onboard Training (months 6-8).  
 
 
 

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9.3 Evaluating the Effectiveness of the 12-week, Community-Based PA Program 
 
9.3.1 Changes in Patient PA Levels 
Changes in patient PA levels will be evaluated through two strategies. First, patients will be 
screened for their PA levels during clinic visits using the PAVS. Patients that enroll in the 12-
week PA program will continue to complete the PAVS (to ensure consistency of assessment) at 
baseline (week 1), midpoint (week 6), conclusion (week 12), and 12 weeks after the completion 
of the PA program by the EIMG Pros. As a secondary data source, we will extract patient PAVS 
data from the Prisma Health EHR. We will use this data to monitor patient PA levels prior to 
receiving the EIMG referral through six months after completing the PA program.  
 
9.3.2 Changes in Patient Health Outcomes 
Primary data for assessing changes in patient health outcomes (i.e., body weight, blood 
pressure, hemoglobin A1c, lipid profiles) will be extracted from the Prisma Health EHR to allow 
comparisons between eligible patients that received an EIMG referral and participated in the PA 
program and eligible patients that do not receive an EIMG referral. Disease incidence, burden, 
and complications (i.e., the Charlson Comorbidity Index) will be calculated from extracted data. 
 
9.3.3 Individual Interviews with Patients 
As part of our mixed methods approach, we will conduct semi-structured individual interviews, 
based on the COM-B (Capability, Opportunity, Motivation – Behavior) framework, with patients 
receiving an EIMG referral. Patients from each of the following three categories will be 
interviewed: 1) patients who received an EIMG referral from their provider, but chose not to 
enroll in the PA program, will be queried about their awareness and reasons for not enrolling 
(i.e., perceived challenges to participation); 2) patients who received an EIMG referral and 
enrolled, but dropped out, will be asked about their perceptions and satisfaction with the PA 
program, motivations for enrolling, and reasons for discontinuation; and 3) patients who enrolled 
and completed the PA program will be queried about their motivations for enrolling, perceptions 
of and satisfaction with the program, and challenges encountered. Where possible, responses 
from the individual interviews will be linked to our EIMG implementation strategies, such as 
clarifying places for additional support and improvements to provider-patient interactions, to add 
to our comprehensive evaluation of the EIMG referral pathway. We will contact all patients that 
received an EIMG referral during Phase II (EIMG Introductory Video) to conduct an individual 
interview. We will conduct a similar number of patient interviews, matching for gender and 
referring clinic, in Phase III (EIMG Onboard Training). 

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10.0 STUDY TIMELINE 
This study will be conducted over three phases: 1) EIMG Adoption; 2) EIMG Introductory Video; 
and 3) EIMG Onboarding Training. Phase I will occur over the first month of this project in which 
practice managers and their clinic will be offered the opportunity to adopt EIMG, No research 
activities will take place during this phase. Phase II will occur between months 2 through 5, 
beginning with the dissemination of the EIMG Introductory Video to practice managers and 
EIMG activation at adopting clinics. This phase will involve several study activities including 
conducting individual (adoption) interviews with practice managers, clinic staff completing the 
online ORCA questionnaire, and conducting individual interviews with patients receiving an 
EIMG referral. Phase III will occur from months 6 through 9, beginning with the EIMG onboard 
training. This phase will involve clinic staff completing the online ORCA questionnaire, 
conducting individual (implementation) interviews with clinic staff, and continuing the individual 
interviews with patients receiving an EIMG referral.  
 
10.1 Timetable - Clinic Assessment of EIMG Referral Pathway 
 
 
10.2 Timetable - Evaluating the Effectiveness of the Community-Based PA Program 
 
* Note: patients enroll in the 12-week PA program on a rolling basis. The above timetable is relative to their individual 
enrollment, not the overall study timeline. 
 
 
Month 
 
Estimated 
Time 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Practice Manager Assessments 
Individual Interviews (Adoption) 
20 
 
X 
 
 
 
 
 
 
 
Clinic Staff Assessments 
ORCA Questionnaire 
10 
 
 
X 
X 
 
 
X 
X 
 
Individual Interviews (Implementation) 
20 
 
 
 
 
 
 
X 
X 
X 
Patient Assessments 
Individual Interviews (Enrollment) 
30 
 
X 
X 
X 
X 
X 
X 
X 
X 
EHR Patient Information Extraction 
n/a 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Week 
 
Estimated 
Time 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 11 12 13 
Patient Assessments 
Informed Consent 
10 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Participant Intake Form (Demographics) 
20 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Anthropometric Biometrics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Patient Health Questionnaire 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Food Behavior Survey 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
PROMIS Scale 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Physical Activity Levels 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
PA Session Participation 
2 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
PA Exit (Satisfaction) Survey 
15 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 

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10.3 Overall Study Timetable 
 
Milestones and Tasks 
Month 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
Study Start Up 
 
 
 
 
 
 
 
 
 
 
 
Hire and train research staff 
 
 
 
 
 
 
 
 
 
 
 
Finalizing study protocol and study forms 
 
 
 
 
 
 
 
 
 
 
 
Obtaining approval of study documents (i.e., IRB, NIH) 
 
 
 
 
 
 
 
 
 
 
 
Register trial with ClinicalTrials.gov 
 
 
 
 
 
 
 
 
 
 
 
Establish study databases, finalize study tools 
 
 
 
 
 
 
 
 
 
 
 
Finalize the EIMG Instructional Video 
 
 
 
 
 
 
 
 
 
 
 
Determine clinics eligible for study participation 
 
 
 
 
 
 
 
 
 
 
 
Phase I – Adoption of EIMG 
 
 
 
 
 
 
 
 
 
 
 
Email from department chairs to eligible clinics 
 
 
 
 
 
 
 
 
 
 
 
Follow up email to clinic practice managers 
 
 
 
 
 
 
 
 
 
 
 
Brief, in-person meeting with practice managers 
 
 
 
 
 
 
 
 
 
 
 
Phase II – EIMG Instructional Video 
Dissemination of EIMG Instructional Video 
 
 
 
 
 
 
 
 
 
 
 
Activation of EIMG to allow EIMG referrals 
 
 
 
 
 
 
 
 
 
 
 
Conduct individual (adoption) interviews 
 
 
 
 
 
 
 
 
 
 
 
Tracking of EIMG patient referrals for phase II 
 
 
 
 
 
 
 
 
 
 
 
Tracking PA program effectiveness 
 
 
 
 
 
 
 
 
 
 
 
Begin individual interviews with patients 
 
 
 
 
 
 
 
 
 
 
 
EHR data extraction at end of phase II 
 
 
 
 
 
 
 
 
 
 
 
 
Phase III – EIMG Onboard Training 
 
 
 
 
 
 
 
 
 
 
 
Conducting standardized EIMG Onboard Training 
 
 
 
 
 
 
 
 
 
 
 
 
Tracking of eligible EIMG patients for phase III 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct individual interviews with clinic staff 
 
 
 
 
 
 
 
 
 
 
 
Tracking patient PA program effectiveness 
 
 
 
 
 
 
 
 
 
 
 
Continue individual interviews with patients 
 
 
 
 
 
 
 
 
 
 
 
EHR data extraction at end of phase II 
 
 
 
 
 
 
 
 
 
 
 
 
Study Wrap Up 
 
 
 
 
 
 
 
 
 
 
 
Package and disseminate implementation resources 
 
 
 
 
 
 
 
 
 
 
 
Distribute findings to stakeholders/health system 
 
 
 
 
 
 
 
 
 
 
 
Manuscript preparation, submission, and publication 
 
 
 
 
 
 
 
 
 
 
 
Attend national meetings to present study findings 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11.0 ATTENTION TO HEALTH EQUITY 
When examining the adoption and implementation of EIMG, we will pay particular attention to 
questions of health equity across all dimensions of RE-AIM, including: 
1. ADOPTION: We will examine the ability of lower resource clinics to adopt EIMG to the same 
extent as high resource clinics; necessary adaptations to EIMG at lower resource clinics for 
more equitable adoption of EIMG; and adapting clinic context to better support staff efforts to 
utilize EIMG with their patients. 
2. IMPLEMENTATION: We will examine characteristics of providers implementing EIMG with a 
high vs low proportion of patients; differences in clinics and staff capacity; resources to 
deliver EIMG on an ongoing basis; EIMG implementation strategies distribution among 
various clinic staff; the impact of setting characteristics on successful EIMG implementation. 
3. REACH – We will examine the representativeness of patients reached (i.e., across 
race/ethnicity, education) compared to all eligible patients; equitableness of the reach of 
EIMG; which population subgroups are not being equitably reached; barriers to participation 
in the community-based PA programs. 
4. EFFECTIVENESS – We will examine whether the health benefits of EIMG are experienced 
equitably across subgroups based on social dimensions and social determinants of health; 
certain subgroups experience higher levels of barriers, negative effects, or burden due to 
EIMG participation. 
5. COST – Participation may present considerable burden to patients, resulting in unintentional 
inequities. We will examine patient participation in the PA program, paying consideration to 
cost, time, resources, and unintended social consequences, discussing findings with the 
EIMG Advisory Board to develop more equitable and sustainable outcomes. 

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12.0 STATISTICAL ANALYSES 
 
12.1 Primary Outcome 
To determine differences in implementation (i.e., delivery fidelity) and reach (i.e., number, 
proportion, and representativeness of patients) before and after EIMG integration at Prisma 
Health clinics. 
 
12.2 Statistical Methods for Primary Analysis 
Clinic level nominal characteristics will be summarized as count and proportion; quantitative 
characteristics (e.g., patient census, provider census, etc) will be summarized as using the 
median and interquartile range. Patient level data will be summarized monthly by clinic using 
count and proportions for categorical data and mean (standard deviation) or median 
(interquartile range) as appropriate. 
 
Clinic level characteristics will be compared between adopting and non-adopting clinics to look 
for indicators that may be leveraged to improve the adoption of EIMG into the patient care 
workflow. Similarly, there may be providers within participating clinics that choose not to adopt 
EIMG (refer eligible patients to the physical activity program); characteristics of the providers will 
be compared to look for ways to adopt / improve EIMG referral.  
 
The primary endpoint will be analyzed on an intent-to-treat basis. This means that clinics will be 
analyzed according to their agreement to adopt regardless of their subsequent participation. For 
analyses at the patient level, patients within EIMG-adopting clinics that receive referrals will be 
analyzed as EIMG participants regardless of their subsequent actions / participation. Referred 
patients will be considered as part of the “EIMG group” even though they may not be perfectly 
compliant or follow the prescribed dose of exercise in the physical activity program. 
 
The effect of EIMG on outcomes for overall reach will be analyzed using generalized linear 
mixed models (GLMM). The use of the GLMM accounts for the variability between clinics 
(random intercept) and the random effect of time within each clinic. The right-hand side of the 
model will have the same form. The left-hand side of the model may require the use of different 
link functions. Our experimental units are the clinics themselves with the observational units 
being the EIMG eligible patients nested within each clinic. The analytical models will have the 
following form: 
 
𝑔(𝑌𝑖𝑗𝑘) = (𝛽0 + 𝜇0𝑖) + 𝛽1𝐸𝐼𝑀𝐺𝑗+ (𝛽2 + 𝜇2𝑖)𝑋𝑖+ (𝛽3 + 𝜇3𝑘) 𝑇𝑘+ (𝛽4 + 𝜇4𝑗𝑘)𝐸𝐼𝑀𝐺𝑗𝑇𝑘+ 𝑒𝑖𝑗𝑘 
 
The subscripts i, j and k refer to clinic, EIMG status and time (monthly), respectively. 𝑌𝑖𝑗𝑘 is the 
clinic level outcome measure; 𝑔(𝑌𝑖𝑗𝑘) is the link function; 𝛽0 is the mean response across clinics; 
𝛽1is the effect of EIMG; 𝛽2 is the mean effect of clinic level covariates controlling for EIMG 
status; 𝛽3 is the effect of time; 𝛽4 is the effect of the interaction between EIMG status and time. 
The remaining terms in the model represent random variability and are assumed to have an 
expected value of 0 and associated non-zero variance. Specifically, 𝜇0𝑖 is the uncertainty term 
for the intercepts between clusters;  𝜇2𝑖 is the uncertainty term for clinic level covariate slopes 
between clusters; 𝜇3𝑘 is the uncertainty term for the effect of time; 𝜇4𝑖𝑗𝑘 is the uncertainty term 
for EIMG by time interaction between clusters; and 𝑒𝑖𝑗𝑘 is the unexplained residual. 
 
12.3 Rationale for Sample Size and Statistical Power 
Sample size was established via simulation in R version 4.2.3 (R Core Team, 2023) utilizing 
preliminary data from clinics participating in a pilot study. This analysis is based on a within 
clinics, repeated measures design with two levels of EIMG exposure: Instructional Video and 
Onboard Training. The outcomes (e.g., referral rates) will be measured 4 times (once per 
month) under each level of EIMG, for a total of 8 observations per outcome per clinic. Two 
marginal referral rate profiles were considered in determining the sample size: a step effect of 

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EIMG onboarding with parallel time effect (main effects model) and a step plus accelerated time 
effect. A generic plot showing the two marginal rate profiles considered is presented in Figure 5.  
 
Figure 5. Referral rate profiles considered in sample size analysis. 
 
 
 
Pilot data from 12 previously onboarded EIMG-clinics indicate the marginal referral rate (reach 
with eligible patients) prior to onboarding to EIMG is approximately 0.01. The following 
assumptions were made for both referral rate profiles. The standard deviation for the random 
effect of clinic, and random deviation is 0.01, the significance level for each comparison is 0.05. 
For the step with constant time effect, it was assumed that there was a linear change from 0.001 
to 0.01 over the four months following the EIMG Instructional Video, a step-jump of 0.02, 
followed by a linear and parallel time effect achieving 0.04 (4%) referral rate at 8 months. For 
the step with accelerated time effect profile, the profile for the first 4 months was assumed to be 
the same as for EIMG Instructional Video with a step-jump of 0.01 followed by a linear increase 
to 0.04. Simulations (n=100) under each profile were conducted to compute a single empirical 
power, this was repeated 100 times. The power reported corresponds to the minimum empirical 
power observed. For a step with constant time effect a total of 10 clinics are needed to achieve 
a power of 92% to detect the EIMG Onboarding effect of 0.02. For the step plus accelerated 
time effect profile, a total of 20 clinics achieves 78% power to detect the time by EIMG status 
interaction when using a significance level of 0.05. Ten clinics provide 40% power to detect the 
step plus accelerated time effect profile. 
 
12.4 Secondary Aim 1 
To assess the effectiveness of participating in the community-based, 12-week evidence-
informed PA program on EIMG-referred patient health outcomes (i.e., body weight, blood 
pressure, hemoglobin A1c, lipid profiles). 
 
Hypothesis 1: Patients participating in the 12-week evidence-informed, community-based PA 
program will experience increased PA levels that is associated with a dose-response, significant 
reduction in body weight, systolic and diastolic blood pressure, hemoglobin A1c level, as well as 
improvements in their lipid profiles. 
 
Effectiveness is the degree to which participating in the evidence-informed PA programs 
improves patient physical activity levels and health outcomes (i.e., changes in cardiometabolic 
biometric values). Primary data for assessing effectiveness will be extracted from the Prisma 

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Health EHR to allow comparisons between patients that are engaged in EIMG and participate in 
the evidence-informed PA programs and patients that do not participate (either those that are 
not engaged in EIMG by their providers or those who choose not to participate). Disease 
incidence, burden, and complications (i.e., the Charlson Comorbidity Index) may also be 
calculated from data captured in the EHR. Secondary assessment of patient-level effectiveness 
(e.g., blood pressure, blood glucose, cholesterol concentrations) will be collected by the EIMG 
Ex Pros at the community PA facilities. 
 
Qualitative Data Collection. As part of our mixed methods approach, we will conduct semi-
structured individual interviews with patients from each participating clinic. Patients will be 
randomly selected from one of three categories:  
i. Patients who received a referral from their provider, but chose not to enroll in the 
evidence-informed PA program, will be queried about their awareness of and reasons for 
not enrolling (i.e., perceived challenges to participation) 
ii. Patients who received a referral and enrolled, but dropped out of the evidence-informed 
PA program, will be asked about their perceptions of and satisfaction with the program, 
motivations for enrolling, and reasons for discontinuation, and  
iii. Patients who enroll and complete the program will be queried about their motivations for 
enrolling, perceptions of and satisfaction with the program, and challenges encountered. 
 
Analysis of Qualitative Data. Dr. Leah Schumacher will oversee the collection and analysis of 
the patient interviews. We will employ a rigorous approach to the analysis of the qualitative data. 
Open-ended responses will be uploaded to a qualitative software program (e.g., Dedoose) to 
create and apply codes to textual data, write analytic memos, and conduct analyses by question 
and respondent. Individual responses will be analyzed as follows: responses will be reviewed to 
develop an initial coding scheme for each question. Codes will be developed deductively from 
the questions posed and inductively from responses.49 As new codes emerge, they will be 
incorporated into the schemes for each question. A coding manual with definitions for each code 
will ensure high levels of intercoder reliability (>80%) are achieved throughout the coding 
process.50,51 Disagreements in the application of codes will be resolved by Drs. Schumacher 
and/or Stoutenberg. The analyses will catalogue facilitators, barriers, and challenges to EIMG® 
implementation in each phase, as well as strategies for overcoming those barriers. 
 
12.5 Secondary Aim 2 
To evaluate, from the health system perspective, the cost of implementing EIMG, employing 
variation from the step-wedge design to estimate the effect of EIMG vs. standard care on costs 
and outcomes (effectiveness). These estimates will be used to obtain the incremental cost-
effectiveness of EIMG vs. standard of care. 
 
Hypothesis 2: Patients receiving an EIMG referral and participating in the 12-week, community-
based PA program will experience improved health outcomes, decreased healthcare service 
utilization, and a reduction in health care expenditures compared to patients that do not receive 
an EIMG referral and the opportunity to participate in the PA program. 
 
12.5.1 Study Observations. 
The first observed visit for each patient with an EIMG-eligible diagnosis will be designated the 
index visit date for “candidate” care episodes within each study period. To ensure consistent 
episodes across periods, candidate episodes will be excluded if the index date is within 90 of 
the end of a previous care episode for that patient. 
 

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12.5.2 Episode of Care 
For each patient, a 90-day Run-in-Period prior to the index date will be used to calculate 
baseline patient baseline covariates. The EIMG Referral Decision Period is the 30 days after the 
index visit date. The Treatment Period is 120 days from the initial visit date, providing sufficient 
time for patient referral, entry into and completion of the 
12-
week PA program. The Outcome Period is 
the 90 days following the treatment 
period. 
 
 
 
 
12.5.3 Data Sources 
Resource Activity Logs: Prisma employment records by-labor-type (i.e., physician, nurse care 
coordinator, referral coordinator). 
 
Patient-Specific Healthcare Resources Used: For EIMG-eligible patients, we will collect from the 
Prisma Health Epic EHR during the episode of care:  
1) All healthcare utilization received by Healthcare Common Procedure Coding System 
(HCPCS), Diagnosis Related Group (DRG), and National Drug (NDC) codes; and  
2) REDCap-based provider surveys to assess the resources used by EIMG and the 12-
week PA program. 
 
Resource Unit Price Data: Medicare standard pricing files for HCPCS, DRG and NDCs, and 
Prisma average wage rates of Prisma labor resources.  
 
Patient-Specific Health Outcomes: From the Prisma Epic EHR we will collect: 1) blood pressure; 
2) body weight; 3) hemoglobin A1c; 4) full lipid profiles, and 5) PA levels for each patient at the 
index visit and across the episode of care. 
 
12.5.4 EIMG Training Costs Per Eligible Patient 
Analysis will be performed from the perspective of a healthcare system interested in the costs of 
initiating EIMG across system clinics (i.e., physician nurse care coordinator, referral coordinator) 
for implementing the EIMG model. Toward this end we will calculate: 1) Total Fixed Cost (TFC) 
to develop the EIMG implementation toolkit; 2) Total Variable Cost (TVC) of providing the EIMG 
onboard training and EIMG activation at participating clinics; and (3) number of EIMG eligible-
patients (N) over the study period. Retrospective analysis of the Prisma Employment records 
will be used to estimate the labor hours by labor type used to develop the fixed costs associated 
with developing the EIMG implementation toolkit (TFC). For the TVC, we will calculate the labor 
hours by labor type for those performing and attending the standardized EIMG training classes. 
TFC and TVC will be estimated by multiplying hours by Prisma wage rates by labor type. TFC 
and TVC will be combined with the number of eligible patients (N) to calculate: 
                                             (1) 𝐸𝐼𝑀𝐺 𝑇𝑟𝑎𝑖𝑛𝑖𝑛𝑔 𝐶𝑜𝑠𝑡𝑠 𝑃𝑒𝑟 𝑃𝑎𝑡𝑖𝑒𝑛𝑡= 
𝑇𝐹𝐶+𝑇𝑉𝐶
𝑁
  
 
12.5.5 Assessing the Effects of EIMG 
We will use episode of care level data generated using the quasi-experimental stepped wedge 
design52–56 to estimate the relationship between EIMG referral and study outcomes. Outcomes 
will include: 
 
Episode Healthcare Costs – the price-weighted sum of all healthcare resources used by 
patient “i” during the episode of care 

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Episode-Specific Health Outcomes - Change in health outcomes (blood pressure; body 
weight; hemoglobin A1c; full lipid profile and physical activity for patient “i”) between the 
index visit and the first provider visit in the episode in the Outcome Period (Figure 6) in 
which this information is collected.  
 
We will initially regress whether patients in an episode were referred to EIMG on variables 
representing whether the patient’s clinic had received standardized EIMG training, patient 
clinical and demographic characteristics, time trends, and clinic specific fixed effects 
represented by: 
 
         (2)       𝐸𝑖𝑗𝑘= 𝛽0 + 𝛽1 ∙𝑋𝑖𝑗𝑘+ 𝛽2 ∙𝐿𝑗+ 𝛽3 ∙𝑀𝑘 + 𝜷𝟒∙𝐶𝑖𝑗𝑘+ 𝜔𝑗+ 𝑢𝑘+ 𝜖𝑖𝑗𝑘 , 𝑤ℎ𝑒𝑟𝑒 
 
𝐸𝑖𝑗𝑘 equals 1 if patient “i” in the episode at clinic “j” in the “k-th” month after study initiation was 
referred to EIMG, 0 otherwise; 𝑋𝑖𝑗𝑘 represents patient-specific baseline demographic, clinical, 
and socioeconomic factors, 𝐿𝑗 are a series of binary variable for each Prisma clinic “j”,  𝑀𝑘 is a 
count variable representing the number of months since the beginning the study that contains 
patient “i’s” index date, and 𝐶𝑖𝑗𝑘 equals 1 if the episode occurred in a period in which the clinic 
“j” received or had previously received EIMG activation, 0 otherwise. The parameters 
𝜔𝑗, 𝑢𝑘, 𝑎𝑛𝑑 𝜖𝑖𝑗𝑘 represent the model random effects associated with site “j”, month “k”, and 
patient “i”, respectively.  We will estimate equation (1) using a generalized linear mixed model.57 
The estimate of parameter 𝜷𝟒 equals the effect of standardized EIMG training on the probability 
of the patient within the episode being referred to EIMG. Variables within 𝑋𝑖𝑗𝑘 will include patient 
history of EIMG use. Our stepped wedge design will enable us to directly control for 
unmeasured factors associated with site and time.58 Secondary analyses will assess differences 
in the impact of standardized EIMG training by stratifying by eligible conditions (i.e., 
overweight/obese, hypertension, type 2 diabetes). 
 
While EIMG activation will be randomly assigned to clinics using the stepped wedge design, 
actual EIMG referral decisions will remain at the discretion of provider and patient. As a result, 
referral decisions for some patients will be “non-compliant” at the clinical level. Providers may 
refer patients into EIMG based on factors unmeasured by the researcher that are related to 
study outcomes which can confound estimation of the effect of EIMG on study outcomes. With 
non-compliance, it is problematic to use “as treated” EIMG referral variation to assess the 
effects of EIMG referrals on study outcomes.59 Instrumental variable (IV) methods using 
randomized EIMG activation as an “instrument” will be used to avoid confounding problems. In 
this scenario IV estimation will yield consistent estimates of the effect of EIMG referral on study 
outcomes for the subset of patients whose referrals are responsive to the randomized clinical-
level EIMG activation. This is known as the Complier Average Causal Effect (CACE).60–64  The 
CACE model is specified as: 
 
 
            (3)      𝑌𝑖𝑗𝑘= 𝛼0 + 𝛼1 ∙𝑋𝑖𝑗𝑘+ 𝛼2 ∙𝐿𝑗+ 𝛼3 ∙𝑀𝑘 + 𝜶𝟒∙𝐸̂𝑖𝑗𝑘+ 𝜌𝑗+ 𝜏𝑘+ 𝜗𝑖𝑗𝑘 , where  
 
𝐸̂𝑖 equals the predicted probability of that patient “i” is referred to EIMG from equation (2); and 
the other variables defined as in equation (2). The parameters 𝜌𝑗, 𝜏𝑘, 𝑎𝑛𝑑 𝜗𝑖𝑗𝑘 represent the 
random effects associated with site “j”, month “k”, and patient “I”, respectively. The estimated 
parameter 𝜶𝟒 on 𝐸̂𝑖𝑗𝑘 is the CACE or the average treatment effect for patient subset whose 
EIMG referral was influenced by EIMG activation at the clinic. 𝐶𝑖𝑗𝑘 in equation (2) serves as the 
“instrument” and only the portion of variation in 𝐸̂𝑖𝑗𝑘 stemming from 𝐶𝑖𝑗𝑘 is used to estimate 𝜶𝟒. 
Because 𝐶𝑖𝑗𝑘 will be randomly assigned, EIMG referral variation stemming from this assignment 
will be independent of unmeasured confounding variables. Two-stage least squares (2SLS) IV 
estimators will be used to estimate the effects of EIMG referrals induced by clinical-level EIMG 
activation on study outcomes. For each study outcome, equation (2) will serve as the first stage 

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equation of 2SLS, and second stage model will be equation (3). Because our expected sample 
sizes will be greater than 500 our 2SLS estimates will be distributed normally via the central limit 
theorem regardless of the distribution of the underlying error term.58,65,66 Each 2SLS model will 
be estimated with robust standard error methods appropriate for 2SLS models using STATA to 
account for error structure in equation (3). 
 
Define 𝜶𝟒𝑪 as the 2SLS estimate when episode healthcare cost is the dependent variable in 
equation (3) and 𝜶𝟒𝑯 as the 2SLS estimate when a health outcome change is the dependent 
variable in equation (3). Combining these estimates with the estimates of average patient EIMG 
training costs from Section F3.2 yields the following cost-effectiveness ratio of EIMG relative to 
standard care: 
 
(4) 𝐸𝐼𝑀𝐺 𝐶𝑜𝑠𝑡 𝐸𝑓𝑓𝑒𝑐𝑡𝑖𝑣𝑒𝑛𝑒𝑠𝑠 𝑅𝑎𝑡𝑖𝑜= [(𝐸𝐼𝑀𝐺 𝑇𝑟𝑎𝑖𝑛𝑖𝑛𝑔 𝐶𝑜𝑠𝑡𝑠 𝑝𝑒𝑟 𝑃𝑎𝑡𝑖𝑒𝑛𝑡+ 𝛼4𝑐) 
𝛼4𝐻
] 
 
The ratio in equation (4) equals the incremental cost per patient associated with the EIMG 
referral induced by clinical-level EIMG activation per average change in health outcome 
associated with the EIMG referral induced by clinical-level EIMG activation. Separate estimates 
of equation (4) will be calculated by clinical diagnosis using the health outcome change in the 
denominator most relevant to the specific diagnosis (e.g., change in hemoglobin A1c for type 2 
diabetes). 
 
12.6 Poolability of Data 
We intend to perform the primary treatment effect analysis by pooling data from all clinics. It is 
possible that treatment effect will differ across clinics and this will be investigated. We will fit a 
model with site by treatment interaction and if significant (at 0.05 level), we will present 
treatment effects by clinic. Although the study is not powered for detection of different treatment 
effects across clinics, this analysis will provide insight into possible varied treatment effects 
across sites or reassure that data can reasonably be pooled over sites with respect to the 
treatment effect. 

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13.0 PARTICIPANT SAFETY MEASURES 
 
13.1 Patient Safety Screening 
Even though referral through EIMG and participation in the community-based physical activity 
program is not part of the research study, we will monitor and track patient safety in the physical 
activity program as we are tracking participant (effectiveness) outcomes as a part of the study. 
 
13.2 Healthcare Provider Screening of Patient 
Prior to receiving an EIMG referral, participants are screened by the ordering provider to 
determine eligibility in the program. Upon opening the referral order set, the provider is shown a 
list of conditions that excludes a patient from participating in EIMG. The list of exclusion criteria 
is as follows: 
• 
Patients <18 years 
• 
Patients >350 lbs (evaluated on a case-by-case basis) 
• 
Obstetric patients 
• 
Patients paralyzed and/or have inability to move 
• 
Patients on daily oxygen use 
• 
Using ambulatory aid (cane, walker, wheelchair, etc.) 
• 
Patients on dialysis 
• 
Patients with several High Risks and/or Comorbidities 
• 
Patients with high-risk behavior health issues: acute suicidal ideation, acute psychiatric 
or psychological disorders not resolved within 90 days prior to EIMG referral 
• 
Patients receiving chemotherapy within the past 3 months 
• 
Patients with a concurrent referral to PT or OT 
 
Prior to signing the referral, the ordering provider completes a risk severity assessment 
evaluation of asthma, chronic obstructive pulmonary disease, hypertension, and congestive 
heart failure to document if the patient has one or multiple of these diagnoses. A patient will 
become ineligible for the program if any of the listed diagnoses are uncontrolled. 
 
13.3 EIMG Care Coordinator Screening of Patients 
The EIMG Care Coordinator will complete a chart review in the electronic health record (EHR) 
of the patient upon receipt of the referral. The medical history and referral diagnosis will be 
reviewed to ensure the patient is eligible to participate.  
 
13.4 Safety Assessment at the Community PA Facility 
Prior to every physical activity session, patients complete a “Contraindications to Exercise” 
worksheet (see Appendix B). The EIMG Professional (EIMG Pro) reviews the worksheet and if 
any signs or symptoms are marked as positive, a safety protocol (Patients Exhibiting 
Contraindications to Exercise Workflow; see section 13.5) is initiated. If any signs or symptoms 
develop during the exercise session, the session ends immediately and the EIMG Pro initiates 
the safety protocol.  
 
13.5 Patient Exhibiting Contraindications to Exercise 
If there is a contraindication to exercise, the participant is ineligible to participate in the exercise 
session or, if already engaged, they will stop the activity immediately. An email will be sent to 
the Facility Coordinator and the EIMG Care Coordinator with a copy of the “Contraindications to 
Exercise” worksheet, which will be subsequently uploaded into the patient’s EHR. A message is 
sent to the referring provider via the EHR messaging system notifying them of the 
contraindication. An EIMG Release Form is required from the provider for the participant to 
resume the program. 
 

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13.6 Emergent Events 
In the event of an emergency, the EIMG Pro will follow the facility emergency action plan and 
then notify the EIMG Care Coordinator. The participant will be evaluated by the referring 
physician after the acute event. If the patient requires further work-up and is not cleared for 
exercise, the patient will be released from the program and require another referral in the future 
if they wish to continue the program. If it is determined the participant may continue, the EIMG 
Release Form will be completed by the referring provider. 
 
13.7 Non-Emergent Events 
In the case of a non-emergent event, the EIMG Pro will evaluate the participant to determine the 
severity of the event. The “Contraindications Worksheet” will be reviewed by the participant if 
appropriate and the Patients Exhibiting Contraindications to Exercise Workflow will be activated 
as needed. For mild or moderate events, the EIMG Pro will document the reported symptoms in 
REDCap. 
 
13.8 Exercise Session Absences 
Any unplanned absence from an exercise session will require an EIMG Pro to contact the patient 
by phone if they have not already notified the EIMG team of their absence. The reason for their 
absence will be documented in REDCap. 

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14.0 HUMAN SUBJECTS PROTECTION 
All requirements relating to obtaining institutional review board (IRB) review and approval and 
informed consent will be met. Written informed consent will be obtained from each study 
participant utilizing the local IRB-approved informed consent form. Appropriate research 
personnel will explain all aspects of the study to each participant, answering all questions and 
ensuring that all basic elements of the informed consent process are covered. All study 
personnel will be required to complete Human Subject Protection, Good Clinical Practice and 
HIPAA training (as required) and will be instructed to act under those guidelines at all times 
when working with participants, participants data or protected participant health information. 
 
14.1 Defining EIMG Research Participants 
The Exercise is Medicine Greenville (EIMG) program (the referral of patients to the community-
based physical activity program and their participation in the program) is part of a clinical 
workflow process that is not considered as a part of the research study. The research study 
consists of gathering data from surveys, individual interviews with clinic staff and patients that 
have been referred to EIMG and evaluating the effectiveness of the physical activity program 
(using data that is already collected as a part of the program). There will be minimal risk to the 
participants with study activities and all available measures will be taken to protect privacy of 
participant responses. 
 
14.2 The Informed Consent Process 
Prior to consenting to participate in the study, a copy of the informed consent will be mailed or 
emailed to prospective participants to review ahead of the consent process and to keep as a 
reference. At a scheduled study meeting, a member of the research staff will explain the study 
to the potential participant, reviewing all sections of the informed consent in detail and answer 
any of the participant’s questions. During the informed consent process (for all study 
participants), details of the study will be explained, including participant burden, potential risks 
and benefits, names and contact information for the study PIs, and other local individuals (i.e., 
IRB staff) that can be contacted for additional study details. All participants will be asked if they 
want a copy of the consent form (either a hard or electronic copy) for their personal records. 
There will be no coercion to participate or prejudice against those who choose not to take part in 
the study and potential participants will be encouraged to ask any questions they have regarding 
study procedures. Informed consent will be obtained prior to any participation in the study. Proxy 
consent will not be accepted as we anticipate that all individuals eligible to participate in the study 
will be able to provide their own informed consent. 
 
Study participation is voluntary and there are no benefits lost (e.g., ability to participate in the PA 
program) if an individual declines participation. Individuals who refuse to participate or who 
withdraw from the study will be treated without prejudice. 
 
The informed consent form will be updated and revised whenever important new safety 
information is available, or whenever the protocol is amended in a way that may affect a 
participants’ participation in the trial. 
 
14.3 Documenting Informed Consent 
 
14.3.1 Written Informed Consent 
Individuals involved with in-person study activities (e.g., individual interviews) will be asked to 
provide their written consent by signing and dating the consent form. The person obtaining 
consent will also sign and date the consent document. The consent must be properly executed 
and complete to be valid. Another research staff member will review the consent form after it is 
signed to ensure that the consent is properly executed and complete. The participant will be 
informed that their participation is voluntary and they may withdraw from the study at any time, 
for any reason without penalty. Participants will be given the option of having a signed copy of 

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the informed consent form. The original version will be stored in a secure location at each study 
site. Members of the research team will inspect the informed consent forms periodically to 
ensure that correct signatures and dates were obtained on valid informed consent forms. 
 
14.3.2 Verbal Informed Consent 
Individuals conducting virtual study activities (i.e., telephone or virtual interviews) will be asked 
to provide their verbal consent to participate in the study. The research team member will follow 
the same informed consent process as with the written informed consent process. However, the 
participant will not be asked to sign a consent form, only to verbally agree to participate in the 
study after the informed consent process. The final page of the informed consent form will have 
a page for documentation of verbal consent that the research team member will check off (if 
provided) and date. 
 
14.4 Obtaining Participant Consent 
A description of how informed consent will be obtained from study participants is described 
below:  
 
14.4.1 Individual (Adoption) Interviews with Practice Managers 
All practice managers at clinics eligible to adopt EIMG will receive an email inviting them to 
participate in an individual (adoption) interview. Practice managers that wish to participate in the 
individual (implementation) interviews will undergo the informed consent process to obtain either 
their written (for in-person interviews) or verbal (for virtual interviews) consent immediately prior 
to conducting the interview. 
 
14.4.2 Online ORCA Questionnaire with Clinic Staff 
All staff at participating clinics that adopted EIMG will receive an email inviting them to complete 
the online ORCA questionnaire. The email will contain an electronic link to the online 
questionnaire. The first page of the online questionnaire will be a consent form providing a 
detailed explanation of the study (both the online survey and the individual (implementation) 
interview and potential risks of participation. At the bottom of the webpage, participants will be 
asked to provide their consent to participate in the study before continuing to the online 
questionnaire. Individuals that do not agree to participate in the study will be thanked for their 
time and exited from the questionnaire. 
 
14.4.3 Individual (Implementation) Interviews with Clinic Staff 
All staff at participating clinics that adopted EIMG will receive an email inviting them to 
participate in an individual (implementation) interview. If an individual provided their consent to 
participate in the online ORCA questionnaire, they will not undergo an additional informed 
consent process prior to conducting the individual interview as verbiage in the online consent will 
also describe participation in this individual interview. Eligible clinic staff that did not complete the 
online ORCA questionnaire will undergo the informed consent process to obtain either their 
written (for in-person interviews) or verbal (for virtual interviews) consent.  
 
14.4.4 Individual Interviews with Patients 
Patients that received an EIMG referral at a participating clinic will be invited to participate in an 
individual interview. Patients that wish to participate in the individual interviews will undergo the 
informed consent process virtually (over the phone) to obtain their verbal consent immediately 
prior to conducting the phone interview.  
 
14.5 Participant Discontinuation 
Participants will have the right to discontinue study participation at any time. This includes 
stopping the individual interviews at any time or not responding to questions they do not wish to 
answer, closing out the online ORCA questionnaire, or declining to have their PA program data 
included in the research study. Females participating in the PA program who become pregnant 

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during the study will be required to discontinue participation. Additionally, participants may be 
asked to stop their participation in the PA program if any situation arises that, in the 
investigator’s judgment, poses a safety risk. Participants who must stop the PA program will not 
continue completing program assessments. 
 
14.6 Participant Remuneration 
Participants (practice managers, clinic staff, and patients) will receive monetary remuneration 
(gift cards) for participating in the individual interviews to compensate them for their time, travel, 
and burden of participation. Clinic staff will not be compensated for completing the online ORCA 
questionnaire and patients will not be compensated for participating in the 12-week, community-
based PA program or any of the program assessments. 
 
 
 
 

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15.0 REPORTING AND MONITORING 
 
15.1 Statement of Compliance 
This trial will be conducted in compliance with the appropriate protocol, appropriate ICH 
guidelines (including current Good Clinical Practice [GCP]), the principles of the Declaration of 
Helsinki, and all other applicable regulatory requirements. Written approval of the study 
protocol, consent form, other supporting documents, and any advertising for participant 
recruitment will be obtained by the Prisma Health institutional review board (IRB) prior to study 
initiation. Any amendments to the protocol or consent materials will be approved before they are 
implemented. Annual progress reports and Serious Adverse Event (SAE) reports will be 
submitted to the IRB according to its usual procedures. 
 
15.2 Regulatory Files 
The regulatory files should contain all required regulatory documents, study-specific documents, 
and all communications. Regulatory files will be reviewed for compliance prior to study initiation, 
throughout the study, as well as at the study closure. 
 
15.3 Financial Disclosure 
All investigators will comply with the requirements of 42 CFR Part 50, Subpart F to ensure that 
the design, conduct, and reporting of the research will not be biased by any conflicting financial 
interest. Everyone with decision-making responsibilities regarding the protocol will have an up-to-
date signed financial disclosure form on file with their respective institutions. 
 
15.4 EIMG Exercise Session Monitoring 
Study team members may periodically audit, at mutually agreed upon times, EIMG exercise 
sessions and source documents for each participant. Monitoring will take place as specified by 
the research team and occur as often as needed to help prevent, detect, and correct issues at 
the community PA facilities. Research staff will verify that procedures for the exercise sessions 
are properly followed and that EIMG Pros are trained and able to conduct the protocol as 
intended. If the review of exercise session documentation indicates that additional training is 
needed, research staff arrange for that training. 
 
15.5 Study Documentation 
Study documentation includes all exercise session report forms, data correction forms, 
questionnaires, monitoring logs, sponsor-investigator correspondence, signed protocol and 
amendments, Institutional Review Committee correspondence, approved consent forms, and 
signed participant consent forms. Source documents include all (audio) recordings of individual 
interviews, notations of interviews or exercise sessions, and records necessary for the 
evaluation and reconstruction of the clinical research study. Whenever possible, the original 
(audio) recording of an observation should be retained as the source document. Transcripts 
should provide a clear and exact duplication of the recordings, but are not considered source 
documentation. 
 
15.6 Records Retention and Requirements 
All research records will be stored by the PI in a secure location to be accessed only by 
authorized research personnel. Study records will be stored in accordance with local IRB, state, 
and federal regulations and will be kept for a minimum of 3 years following study completion. 
 
15.7 Participant Confidentiality/Privacy 
Participant records will be made confidential by using study codes for identifying participants, 
secure and separate storage of any documents that have participant identifiers, and secure 
computing procedures for entering and transferring electronic data. All research information 
obtained on participants is confidential, and disclosure to any third parties without specific 
authorization is strictly prohibited. To maintain subject privacy, all study forms and reports will 

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be identified by a coded study identification number only. No subject identifying information will 
be included in any presentations or publications resulting from the study. Study records may be 
inspected by the sponsor and its authorized representatives, other government agencies such 
as the U.S. Department of Health and Human Services (DHHS) Office for Human Research 
Protections (OHRP), authorized Node Staff, or the local IRB for quality assurance purposes. 
 
15.8 Confidentiality Breach 
In the event of a confidentiality breach with our survey and/or interview data, reporting to the site 
IRB will be done within 10 business days of the co-Principal Investigators (PI) becoming aware 
of the breach. 
 
15.9 Data and Safety Monitoring Board (DSMB) 
As required by the National Institutes of Health (NIH), this study will develop and maintain an 
IRB-approved data and safety monitoring plan. In discussion with the funding agency (the 
National Heart, Lung, and Blood Institute), it was determined that an independent DSMB for this 
study is not necessary for this study. NIH policy states that monitoring activities of all NIH-
sponsored or -conducted clinical studies are commensurate with their risks, nature, size, and 
complexity. Given that the nature of this research study involves conducting individual 
interviews and online surveys with participants, none of whom would be considered vulnerable 
subjects, this trial was deemed to be a low-risk behavioral study. 
 
15.10 Protocol Deviations & Violations - Reporting and Management 
A protocol departure is any departure from procedures and requirements outlined in the 
protocol. Protocol departures may occur on two levels, deviation versus violation. The difference 
between a protocol deviation and violation has to do with the seriousness of the event and the 
corrective action required. A protocol deviation is considered an action (or inaction) that by itself 
is not likely to affect the scientific soundness of the investigation or seriously affect the safety, 
rights, or welfare of a study participant. Protocol violations are departures that may compromise 
the participant safety, participant rights, inclusion/exclusion criteria or study data and could be 
cause for corrective actions if not rectified or prevented from re-occurrence. Protocol violations 
will be monitored for: 1) significance, 2) frequency, and 3) impact on the study objectives, to 
ensure that violations do not compromise the integrity of the trial. Any protocol deviations that 
are substantive and affects rights, safety, or welfare of subjects or willingness to continue in 
study or the integrity of the research data will be reported within 10 business days from the date 
either of the co-PIs becoming aware. The decision about whether a departure from the protocol 
will be designated as a protocol deviation or a protocol violation will be made by the multiple 
PIs. 
 
15.11 Adverse Events (AEs) 
 
15.11.1 Definitions of AEs  
Any unfavorable or unintended medical or psychological event experienced by a study 
participant. This can represent a new symptom or an exacerbation of an existing condition. The 
event does not necessarily have to be causally related to the research study intervention. 
 
15.11.2 Classification of AEs 
An AE will be classified as one of the following: 
i. Mild: events that do not interfere with the participants daily activities (i.e., muscle soreness, 
fatigue, anxiety). 
ii. Moderate: events that have a low level of inconvenience for the participant. This may cause 
some interference with EIMG participation but is not a contraindication. 
iii. Severe: events that interrupt the normal daily activities of a participant. Events would 
include, but are not limited to, those listed on the Contraindications to Exercise worksheet. 

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15.11.3 Reporting of AEs 
Mild and moderate AEs will be documented but need not be reported to the site IRB or sponsor 
(NHLBI) unless a trend appears. If an adverse event is classified as severe and is expected and 
related to study participation, IRB guidelines indicate this will be reported periodically (annually). 
 
15.11.4 Expectedness of AEs 
Adverse events will be reviewed weekly by the co-PIs and determined if it was expected within 
the described study procedures. 
 
15.12 Serious Adverse Events (SAEs) 
 
15.12.1 
Definition of Serious Adverse Events (SAEs) 
Any AE occurring, which results in any of the following outcomes: death, a life-threatening 
experience, inpatient hospitalization, or prolongation of existing hospitalization, a persistent or 
significant disability, incapacity, a congenital anomaly, or birth defect. 
 
15.12.2 Reporting of SAEs 
Per IRB guidelines, serious adverse events (SAE) related to study participation will be reported 
promptly. The Prisma Health IRB does not require reporting of unrelated SAEs. In the case of 
fatal or life-threatening events, reporting will take place within 7 calendar days of initial receipt of 
information by either of the co-PIs. For any other unanticipated SAE that is non-fatal, reporting 
to the site IRB and sponsor (NHLBI) will take place within 10 business days from the time that 
either of the co-PIs are aware of the event. Expected and related SAEs will be reported 
annually. 
 
15.13 Unanticipated Problems 
 
15.13.1 
Definition of Unanticipated Problems 
Any incident, experience, or outcome that meets all the following criteria: 
i. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures 
described in the protocol-related documents, and (b) the characteristics of the subject 
population. 
ii. Related or possibly related to participation in the research (possibly related means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by 
the procedures involved in the research). 
iii. Suggest the research places the subject or any others at greater risk of harm than was 
previously recognized. 
 
15.13.2 
Relatedness to Study 
Adverse events will be reviewed weekly by the co-PIs and determined whether the event was 
related or possibly related to the research study. 
 
15.13.3 
Reporting of Unanticipated Problems 
Any unanticipated problem that is not a SAE will be reported to the site IRB and sponsor 
(NHLBI) within 10 calendar days from the time either of the co-PIs are aware of the event. 
 
 

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16.0 DATA MANAGEMENT AND PROCEDURES 
 
16.1 Field-Based Data Collection Forms 
The data collection process consists of direct data entry at the community PA facilities into the 
REDCap system. In the event that the REDCap system is not available, the study team will 
provide EIM Ex Pros at the community PA facilities with a set of source documents (i.e., hard 
copies) and completion instructions. Data entry into REDCap will be completed according to the 
EIMG program instructions provided during facility onboard training and established manuals of 
operation. The EIMG Ex Pros are responsible for maintaining accurate, complete, and up-to-
date records, and for ensuring the completion of data entry for each participant at every 
exercise session. An EIMG research team member will conduct regular quality control checks 
ensuring that participant data is being regularly collected and properly entered into the REDCap 
system. 
 
16.2 Field-Based Data Editing 
Completed data will be entered into REDCap system. If incomplete or inaccurate data are 
found, a data query will be generated to resolves inconsistencies and errors, and all corrections 
and changes will be entered into and documented in REDCap system in accordance with the 
data management plan. 
 
16.3 Field-Based Data Quality Assurance 
To address the issue of data entry quality, we will follow a standard data monitoring plan. An 
acceptable quality level prior to study closeout will be established as a part of the data 
management plan. Data quality summaries will be made available during the course of the 
study. 
 

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APPENDIX A – Patient Eligibility for EIMG Referral: Inclusion Criteria 
Condition 
Data Variables (per ICD code) 
Physical Inactivity 
Z71.3 
Encounter for weight loss counseling 
Z71.82 Exercise counseling 
Z72.3 
Inactivity 
Z91.89 Sedentary lifestyle 
Obesity 
E66.01 Obesity  
E66.09 Obesity  
E66.9 
Obesity  
Z68.30 BMI 30.0-30.9, adult 
Z68.31 BMI 31.0-31.9, adult 
Z68.32 BMI 32.0-32.9, adult 
Z68.33 BMI 33.0-33.9, adult 
Z68.34 BMI 34.0-34.9, adult 
Z68.35 BMI 35.0-35.9, adult 
Z68.36 BMI 36.0-36.9, adult 
Z68.37 BMI 37.0-37.9, adult 
Z68.38 BMI 38.0-38.9, adult 
Z68.39 BMI 39.0-39.9, adult 
Z68.41 BMI 40.0-44.9, adult (HCC) 
Z68.42 BMI 45.0-49.9, adult (HCC) 
Z68.43 BMI 50.0-59.9, adult (HCC) 
Z71.3 
Encounter for weight loss counseling 
Diabetes 
E11.8 
Type 2 DM with complication, without long-term current use of insulin (HCC) 
E11.9 
Type 2 DM 
E11.65 Type 2 diabetes with hyperglycemia 
R73.01 Impaired fasting glucose (covered by prediabetes and diabetes) 
R73.03 Prediabetes 
Blood Pressure 
I10 
Essential hypertension 
Dyslipidemia 
E78.5 
Dyslipidemia 
E78.5 
Hyperlipidemia, unspecified hyperlipidemia type 
E78.2 
Mixed hyperlipidemia 
E78.2 
Combined hyperlipidemia 
E78.2 
Moderate mixed hyperlipidemia not requiring statin therapy 
E78.1 
Hypertriglyceridemia 
E78.00 Pure hypercholesterolemia 
E78.00 Hypercholesteremia 
 
 
 
 
 
 

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Appendix B. Patient Checklist for Contraindications to Exercise.