Chronic DiseaseNCT06073041
Implementing and Evaluating the Integration of Physical Activity Into a Major Health System and Connecting Patients to Physical Activity Programs.
A study testing Invitation to adopt and Onboarding strategies in people with Chronic Disease and Exercise, run by University of South Carolina at 1 site in United States.
Trial summary
Multiple case study trial examining the adoption, implementation, and reach of eligible patients visiting participating Prisma Health primary care clinics and receiving a referral to a 12-week evidence-informed physical activity (PA) program hosted at local community PA facilities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Exercise, Physical Activity
- What is being tested?
- Invitation to adopt and Onboarding strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2023to 26 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Clinic Inclusion Criteria:
- Prisma Health primary care clinic (i.e., family or internal medicine) located in the Upstate of South Carolina
- At least two attending providers
Clinic Exclusion Criteria:
- Clinics greater than 15 miles from a participating community physical activity facility
- Have received EIMG onboarding or activation in the past
Clinical Staff Inclusion Criteria:
- Prisma Health employed
- Actively seeing patients at an activated EIMG clinic by the beginning of the phase in which they will be enrolled in the study (providers)
- Staff member at an activated EIMG clinic by the beginning of the phase in which they will be enrolled in the study (managers/clinic staff)
Clinical Staff Exclusion Criteria:
- Less than 18 years old
Patient Inclusion Criteria:
- Have received an EIMG referral from their primary care provider beginning September 5, 2023
Patient Exclusion Criteria:
- Less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing and Evaluating the Comprehensive Integration of Physical Activity Into a Major Health System and Connecting Patients to Community-based Physical Activity Programs
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.
Read the detailed description
This study will employ a single arm, multiple case study design using a mixed methods approach to examine the adoption, implementation, and reach of EIMG across Prisma Health primary care clinics (i.e., clinic workflow, referral process), leading to patient enrollment in a community-based, evidence-informed PA program. Eligible Prisma Health primary care clinics that have not yet received EIMG onboard training and activation will be provided with the opportunity to adopt EIMG as a part of their clinic practice and patient workflow process. A mixed methods approach will examine contextual factors influencing decisions to adopt/not adopt EIMG.
Clinic champions at clinics adopting EIMG will be provided with a brief pre-recorded training video to disseminate to their clinic staff on how to provide their patients with an EIMG referral (phase 1). 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 (phase 2). The onboard training, which consists of an overall presentation of the EIMG program and specific information on placing the referral order and patient workflow, has been adapted for virtual environments due to its notable added benefits, including its recording to serve as an ongoing reference tool for those who cannot attend initial training and incoming staff. Implementation and reach of EIMG will be tracked for an additional four months after the onboard training.
Referred patients will have the opportunity to enroll in an evidence-informed, 12-week PA program at local community PA facilities (e.g., YMCAs) that partner with EIMG. Upon enrollment and at the completion of the 12-week PA program, patients will undergo an assessment battery that includes the completion of a patient health questionnaire, anthropometric assessments (i.e., height, weight, waist circumference) and an evaluation of their mental and emotional health (i.e., PROMIS tool, PHQ-9). The RE-AIM framework will inform the assessment of implementation outcomes (i.e., adoption, implementation, and reach), while the i-PARIHS framework will be used to examine contextual factors (i.e., determinants) influencing clinic level outcomes. Patient demographics, health outcomes, healthcare utilization and costs of eligible patients at participating primary care clinics, both before and after EIMG onboarding, will be extracted from the Prisma Health electronic health record (EHR) system. Data will be compared between patients that receive EIMG referrals and matched controls at clinics that do not adopt EIMG: 1) the impact of EIMG on changes in health outcomes, and 2) the impact of EIMG on healthcare costs. These estimates will be used as the basis for cost-effectiveness analyses of EIMG and serve as the foundation for long-term evaluation modeling approaches to incorporate changes in longer-term secondary health outcomes (e.g., stroke, acute myocardial infarction) on healthcare costs.
- Conditions
- Chronic Disease, Exercise, Physical Activity
- Being tested
- Invitation to adopt, Onboarding strategies
- Keywords
- Physical activity, Evidence-based, Exercise, RE-AIM, Implementation, Adoption, Referral pathway
- Medical subject headings
- Chronic Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation to adoptOther
All eligible Prisma Health clinics will be invited to adopt EIMG.
Onboarding strategiesBehavioural
Providers at adopting clinics will first be sent an instructional video as a part of a low touch initial onboarding (phase 1). After 4 months, clinics will then receive an in-depth standardized onboard training (phase 2).
| Study group | Role | What they receive |
|---|---|---|
| Adopter | Experimental | Clinics that decide to adopt the EIMG Program Receives: Other: Invitation to adopt; Behavioral: Onboarding strategies |
| Non Adopter | Other | Clinics that decide not to adopt the EIMG Program Receives: Other: Invitation to adopt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of EIMG at eligible primary care clinics
Rate of EIMG adoption at eligible primary care clinics
Measured: Months 0-1
Secondary outcomes (8)
Factors in decision to adopt/not adopt EIMG
Interviews with clinic managers at adopting and non-adopting clinics
Measured: Months 1-2
Referral of eligible patients to EIMG in adopting clinics (phase 1)
Number of referrals given to EIMG-eligible patients by providers in adopting clinics
Measured: Months 1-4
Referral of eligible patients to EIMG in adopting clinics (phase 2)
Number of referrals given to EIMG-eligible patients by providers in adopting clinics
Measured: Months 5-8
Feedback on EIMG referrals and onboarding strategies from clinic staff
Interviews with clinic staff members at adopting clinics
Measured: Months 9-12
Patient physical activity levels (minutes of moderate-to-vigorous activity/week)
Assessing changes in patient physical activity levels via the Physical Activity Vital Sign. Assessments will occur prior to enrollment in the 12-week physical activity program (week 0), midway through the program (week 6), at the completion of the program (week 12), as well as long-term maintenance (conducted via phone call 6- and 12-months post-program)
Measured: Conducted at months 0, 1.5, 3, 9, 15
Patient blood pressure levels (mmHg)
Assessing changes in patient blood pressure using a digital blood pressure monitor. Assessments will occur prior to enrollment in the 12-week physical activity program (week 0), midway through the program (week 6), at the completion of the program (week 12). Additional blood pressure measurements may also be extracted from the Prisma Health electronic health records for the time period six months before and twelve months after the 12-week physical activity program.
Measured: Months 1-16
Patient bodyweight (kg)
Assessing changes in patient bodyweight using a minimum of a class III category weighing scale. Assessments will occur prior to enrollment in the 12-week physical activity program (week 0), midway through the program (week 6), and at the completion of the program (week 12). Additional bodyweight measurements may also be extracted from the Prisma Health electronic health records for the time period six months before and twelve months after the 12-week physical activity program.
Measured: Months 1-16
Impact of EIMG on healthcare costs
Using data from the Prisma Epic electronic health record (EHR), we will extract primary health outcomes (e.g., blood pressure, body weight, hemoglobin A1c, lipid profiles) from the index (first) visit and again at the end of a care episode for all patients who received an EIMG referral at participating clinics during the study period. We will use the EHR record to assess changes in outcomes across the care episode and all healthcare utilization for each patient during the care episode to estimate costs. This approach will yield estimates of: 1) the impact of EIMG on changes in health outcomes across the care episode, and 2) the impact of EIMG healthcare costs during the care episode. We will use these estimates for a short-term cost-effectiveness analysis of the EIMG program, as well as the foundation for long term evaluation for modeling approaches changes in longer-term secondary health outcomes (e.g., stroke, acute myocardial infarction) on healthcare costs.
Measured: Months 1-16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start3 Aug 2023
- Primary completion5 Sep 2023
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- All eligible clinics were invited to adopt the EIMG model (primary aim). Those that adopted the EIMG model received a sequential intervention involving onboarding and implementation (secondary aim).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Temple University, University of Utah, University of Nebraska, Durham University
- Responsible party
- Principal investigator, Jennifer Trilk, University of South Carolina
- Investigators
- Jennifer L Trilk, PhD, Principal investigator, University of South CarolinaMark Stoutenberg, PhD, Principal investigator, Durham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073041
- Sponsor's protocol ID
- 1R56HL157218-01A1
- Status last verified
- Dec 2025
- First submitted
- 18 Sep 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Scientific data that will be preserved and shared: individual interviews, online surveys, electronic health record data. The raw data collected for the individual interviews, online surveys, and clinical data will be electronically stored in a secured, cloud-based storage. Identifiers will be removed and maintained in a separate secure file for future reference. Patient information extracted from the Prisma Health EHR will be de-identified by the honest broker/data analyst before secure transfer to the research team. Sharing of this data will follow guidelines established by the Prisma Health Office of Research and Innovation.
Publications
Stoutenberg M, Estabrooks PA, Brooks JM, Jindal M, Wichman C, Rosemeyer J, Schumacher LM, McNulty LK, Ewing A, Eskuri S, Bennett F, Trilk JL. Implementing and evaluating the comprehensive integration of physical activity into a major health system: study design and protocol. BMJ Open. 2025 Jan 6;15(1):e091556. doi: 10.1136/bmjopen-2024-091556.
PubMed 39762113
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Evaluating the Comprehensive Integration of Physical Activity Into a Major Health System and Connecting Patients to Community-based Physical Activity Programs
- ClinicalTrials.gov ID
- NCT06073041
- Acronym / sponsor ID
- 1R56HL157218-01A1
- Conditions
- Chronic Disease, Exercise, Physical Activity
- Keywords
- Physical activity, Evidence-based, Exercise, RE-AIM, Implementation, Adoption, Referral pathway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Temple University, University of Utah, University of Nebraska, Durham University
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple case study trial examining the adoption, implementation, and reach of eligible patients visiting participating Prisma Health primary care clinics and receiving a referral to a 12-week evidence-informed physical activity (PA) program hosted at local community PA facilities.
Detailed description
This study will employ a single arm, multiple case study design using a mixed methods approach to examine the adoption, implementation, and reach of EIMG across Prisma Health primary care clinics (i.e., clinic workflow, referral process), leading to patient enrollment in a community-based, evidence-informed PA program. Eligible Prisma Health primary care clinics that have not yet received EIMG onboard training and activation will be provided with the opportunity to adopt EIMG as a part of their clinic practice and patient workflow process. A mixed methods approach will examine contextual factors influencing decisions to adopt/not adopt EIMG.
Clinic champions at clinics adopting EIMG will be provided with a brief pre-recorded training video to disseminate to their clinic staff on how to provide their patients with an EIMG referral (phase 1). 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 (phase 2). The onboard training, which consists of an overall presentation of the EIMG program and specific information on placing the referral order and patient workflow, has been adapted for virtual environments due to its notable added benefits, including its recording to serve as an ongoing reference tool for those who cannot attend initial training and incoming staff. Implementation and reach of EIMG will be tracked for an additional four months after the onboard training.
Referred patients will have the opportunity to enroll in an evidence-informed, 12-week PA program at local community PA facilities (e.g., YMCAs) that partner with EIMG. Upon enrollment and at the completion of the 12-week PA program, patients will undergo an assessment battery that includes the completion of a patient health questionnaire, anthropometric assessments (i.e., height, weight, waist circumference) and an evaluation of their mental and emotional health (i.e., PROMIS tool, PHQ-9). The RE-AIM framework will inform the assessment of implementation outcomes (i.e., adoption, implementation, and reach), while the i-PARIHS framework will be used to examine contextual factors (i.e., determinants) influencing clinic level outcomes. Patient demographics, health outcomes, healthcare utilization and costs of eligible patients at participating primary care clinics, both before and after EIMG onboarding, will be extracted from the Prisma Health electronic health record (EHR) system. Data will be compared between patients that receive EIMG referrals and matched controls at clinics that do not adopt EIMG: 1) the impact of EIMG on changes in health outcomes, and 2) the impact of EIMG on healthcare costs. These estimates will be used as the basis for cost-effectiveness analyses of EIMG and serve as the foundation for long-term evaluation modeling approaches to incorporate changes in longer-term secondary health outcomes (e.g., stroke, acute myocardial infarction) on healthcare costs.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All eligible clinics were invited to adopt the EIMG model (primary aim). Those that adopted the EIMG model received a sequential intervention involving onboarding and implementation (secondary aim).
| Arm | Type | Receives |
|---|---|---|
| Adopter | Experimental | Other: Invitation to adopt, Behavioral: Onboarding strategiesClinics that decide to adopt the EIMG Program |
| Non Adopter | Other | Other: Invitation to adoptClinics that decide not to adopt the EIMG Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invitation to adoptAll eligible Prisma Health clinics will be invited to adopt EIMG. | Other | Adopter, Non Adopter |
| Onboarding strategiesProviders at adopting clinics will first be sent an instructional video as a part of a low touch initial onboarding (phase 1). After 4 months, clinics will then receive an in-depth standardized onboard training (phase 2). | Behavioural | Adopter |
Primary outcome
Adoption of EIMG at eligible primary care clinics
Time frame: Months 0-1
Rate of EIMG adoption at eligible primary care clinics
8 secondary outcomes
Factors in decision to adopt/not adopt EIMG
Time frame: Months 1-2
Referral of eligible patients to EIMG in adopting clinics (phase 1)
Time frame: Months 1-4
Referral of eligible patients to EIMG in adopting clinics (phase 2)
Time frame: Months 5-8
Feedback on EIMG referrals and onboarding strategies from clinic staff
Time frame: Months 9-12
Patient physical activity levels (minutes of moderate-to-vigorous activity/week)
Time frame: Conducted at months 0, 1.5, 3, 9, 15
Patient blood pressure levels (mmHg)
Time frame: Months 1-16
Patient bodyweight (kg)
Time frame: Months 1-16
Impact of EIMG on healthcare costs
Time frame: Months 1-16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Derived from this study: PubMed 39762113Stoutenberg M, Estabrooks PA, Brooks JM, Jindal M, Wichman C, Rosemeyer J, Schumacher LM, McNulty LK, Ewing A, Eskuri S, Bennett F, Trilk JL. Implementing and evaluating the comprehensive integration of physical activity into a major health system: study design and protocol. BMJ Open. 2025 Jan 6;15(1):e091556. doi: 10.1136/bmjopen-2024-091556.
- Individual participant dataSharing planned: Yes. Scientific data that will be preserved and shared: individual interviews, online surveys, electronic health record data. The raw data collected for the individual interviews, online surveys, and clinical data will be electronically stored in a secured, cloud-based storage. Identifiers will be removed and maintained in a separate secure file for future reference. Patient information extracted from the Prisma Health EHR will be de-identified by the honest broker/data analyst before secure transfer to the research team. Sharing of this data will follow guidelines established by the Prisma Health Office of Research and Innovation.
Related trials for Chronic Disease
Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
Recruiting
Diuretic Tuner Clinical Decision Support
Edema, Hypervolemia
Active, not recruitingPhase 1/2
Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Trilk, PhD principal investigator
University of South Carolina
Mark Stoutenberg, PhD principal investigator
Durham University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invitation to adopt and Onboarding strategies in people with Chronic Disease and Exercise, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption of EIMG at eligible primary care clinics (time frame: Months 0-1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06073041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.