Hernia, AbdominalNCT07106541
Population Based Strategies for Standardized Surgical Care
A study testing Replicating Effective Programs (REP) and REP with facilitation (REP-PLUS) in people with Hernia, Abdominal, run by University of Michigan at 1 site in United States.
Trial summary
Evidence-based guidelines to improve clinical care for abdominal wall hernia repair are common, but adherence is low. This proposal aims to evaluate a stakeholder informed Replicating Effective Programs (REP) using a randomized controlled Sequential Multiple Assignment Randomized Trial (SMART). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Abdominal
- What is being tested?
- Replicating Effective Programs (REP) and REP with facilitation (REP-PLUS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All hospitals that participate in MSQC-COHR will be eligible to participate in the trial
Who cannot join
- Institutes that are not in the MSQC-COHR
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Michigan and other Michigan Surgical Quality Collaborative sites
Ann Arbor, Michigan, 48109
Alexander Hallway, 734-998-2400, ahallway@umich.edu
Anne Ehlers, MD, MPH
About this study
Evidence-based guidelines to improve clinical care for abdominal wall hernia repair are common, but adherence is low. This proposal aims to evaluate a stakeholder informed Replicating Effective Programs (REP) using a randomized controlled Sequential Multiple Assignment Randomized Trial (SMART).
The study team will leverage the 68-hospital Michigan Surgical Quality Collaborative Core Optimization Hernia Registry (MSQCCOHR), a statewide collaborative focused on quality improvement in hernia care. The study team will explore optimal remediation strategies for underperforming sites as well as opportunities to de-intensify interventions for responder sites.
- Conditions
- Hernia, Abdominal
- Being tested
- Replicating Effective Programs (REP), REP with facilitation (REP-PLUS)
- Keywords
- Abdominal wall hernia repair, Surgical approach, Quality improvement in hernia care, Evidence-based guidelines, Replicating Effective Programs
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replicating Effective Programs (REP)Behavioural
The study team will deploy this stakeholder informed REP package across the 68 sites in the MSQC-COHR collaborative. The REP program uses a blend of formats including didactics, flipped classroom design, and narrative storytelling, the REP will address key barriers to adherence previously identified by surgeons.
REP with facilitation (REP-PLUS)Behavioural
This intervention is a stepped-up REP plus virtual facilitation. The facilitator will: 1) Initiate implementation and benchmark goals: The facilitator will partner with the identified site champions but be masked to primary and secondary outcomes. Together, the facilitator and site champions will review processes to organizationally embed clinical practice guidelines into practice, assess potential barriers and facilitators to these processes, and set measurable goals for adherence to recommendations; 2) Track adherence and provide feedback: Facilitators will use abstracted MSQC-COHR and site-specific operative data to track adherence to clinical practice guidelines, identify barriers to adherence, provide solutions to identified barriers, re-engage stakeholder groups responsible for unsatisfactory measurements, and continuously promote awareness of the guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Replicating Effective Programs (REP) - baseline program non-randomized | Experimental | All sites participating will be given this REP. This will be evaluated over 12 months. Receives: Behavioral: Replicating Effective Programs (REP) |
| REP with facilitation (REP-PLUS) - stage 1 randomized group | Experimental | Non-responders to the initial baseline program of REP MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) randomized to this arm. This randomized arm will be evaluated over 12 months. Receives: Behavioral: REP with facilitation (REP-PLUS) |
| Replicating Effective Programs (REP) - stage 1 randomized group | Experimental | Non-responder to the initial baseline program of MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) randomized to this arm. This randomized arm will be evaluated over 12 months. Receives: Behavioral: Replicating Effective Programs (REP) |
| Replicating Effective Programs (REP) (non-responders) - stage 2 randomized group | Experimental | Twelve months after the stage 1, non-responder MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) that were assigned to the REP arm will be re-randomized to this arm or REP-PLUS. This randomized arm will be evaluated over 12 months. Receives: Behavioral: Replicating Effective Programs (REP) |
| REP with facilitation (REP-PLUS) (non-responders) - stage 2 randomized group | Experimental | Twelve months after the stage 1, non-responder MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) that were assigned to the REP arm will be re- randomized to this arm REP-PLUS or REP alone. This randomized arm will be evaluated over 12 months. Receives: Behavioral: REP with facilitation (REP-PLUS) |
| REP-PLUS (responders) - stage 2 randomized group | Experimental | This group will include the REP-PLUS responders from stage 1. The responding hospitals will that are re-randomized to this group will continue to receive REP-PLUS. Receives: Behavioral: REP with facilitation (REP-PLUS) |
| Replicating Effective Programs (REP) (responders)- stage 2 randomized group | Experimental | This group will include the REP-PLUS responders from stage 1. The responding hospitals will that are re-randomized to this group will receive REP alone. Receives: Behavioral: Replicating Effective Programs (REP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to clinical practice guidelines
Data will be reviewed from the MSQC-COHR. This is defined as the proportion of persons undergoing abdominal wall hernia that receive guideline concordant hernia care. The study team will define a "responder" as a site that has demonstrated ≥85% adherence to all three clinical practice guidelines.
Measured: 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startJun 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, AbdominalStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Sequential
- Model description
- Sites will get the REP package first. After this first stage of the SMART trial, non-responder MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) will be randomized to continue REP versus REP with facilitation (REP-PLUS). The unit of randomization is the hospital. Stratified randomization on baseline site adherence will ensure comparability of comparators. In stage 2 non-responders in REP group will be re-randomized as well as the responders from the REP-PLUS group to REP vs REP-PLUS. The number of anticipated sites is listed as the anticipated enrollment numbers.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Ehlers, University of Michigan
- Investigators
- Anne Ehlers, MD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106541
- Sponsor's protocol ID
- HUM00278185
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Based Strategies for Standardized Surgical Care
- ClinicalTrials.gov ID
- NCT07106541
- Acronym / sponsor ID
- HUM00278185
- Conditions
- Hernia, Abdominal
- Keywords
- Abdominal wall hernia repair, Surgical approach, Quality improvement in hernia care, Evidence-based guidelines, Replicating Effective Programs
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 6 Aug 2025 (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.
Evidence-based guidelines to improve clinical care for abdominal wall hernia repair are common, but adherence is low. This proposal aims to evaluate a stakeholder informed Replicating Effective Programs (REP) using a randomized controlled Sequential Multiple Assignment Randomized Trial (SMART).
The study team will leverage the 68-hospital Michigan Surgical Quality Collaborative Core Optimization Hernia Registry (MSQCCOHR), a statewide collaborative focused on quality improvement in hernia care. The study team will explore optimal remediation strategies for underperforming sites as well as opportunities to de-intensify interventions for responder sites.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Sites will get the REP package first. After this first stage of the SMART trial, non-responder MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) will be randomized to continue REP versus REP with facilitation (REP-PLUS). The unit of randomization is the hospital. Stratified randomization on baseline site adherence will ensure comparability of comparators. In stage 2 non-responders in REP group will be re-randomized as well as the responders from the REP-PLUS group to REP vs REP-PLUS. The number of anticipated sites is listed as the anticipated enrollment numbers.
| Arm | Type | Receives |
|---|---|---|
| Replicating Effective Programs (REP) - baseline program non-randomized | Experimental | Behavioral: Replicating Effective Programs (REP)All sites participating will be given this REP. This will be evaluated over 12 months. |
| REP with facilitation (REP-PLUS) - stage 1 randomized group | Experimental | Behavioral: REP with facilitation (REP-PLUS)Non-responders to the initial baseline program of REP MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) randomized to this arm. This randomized arm will be evaluated over 12 months. |
| Replicating Effective Programs (REP) - stage 1 randomized group | Experimental | Behavioral: Replicating Effective Programs (REP)Non-responder to the initial baseline program of MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) randomized to this arm. This randomized arm will be evaluated over 12 months. |
| Replicating Effective Programs (REP) (non-responders) - stage 2 randomized group | Experimental | Behavioral: Replicating Effective Programs (REP)Twelve months after the stage 1, non-responder MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) that were assigned to the REP arm will be re-randomized to this arm or REP-PLUS. This randomized arm will be evaluated over 12 months. |
| REP with facilitation (REP-PLUS) (non-responders) - stage 2 randomized group | Experimental | Behavioral: REP with facilitation (REP-PLUS)Twelve months after the stage 1, non-responder MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) that were assigned to the REP arm will be re- randomized to this arm REP-PLUS or REP alone. This randomized arm will be evaluated over 12 months. |
| REP-PLUS (responders) - stage 2 randomized group | Experimental | Behavioral: REP with facilitation (REP-PLUS)This group will include the REP-PLUS responders from stage 1. The responding hospitals will that are re-randomized to this group will continue to receive REP-PLUS. |
| Replicating Effective Programs (REP) (responders)- stage 2 randomized group | Experimental | Behavioral: Replicating Effective Programs (REP)This group will include the REP-PLUS responders from stage 1. The responding hospitals will that are re-randomized to this group will receive REP alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All hospitals that participate in MSQC-COHR will be eligible to participate in the trial
Key exclusion criteria (1 listed)
- Institutes that are not in the MSQC-COHR
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 |
|---|---|---|
| Replicating Effective Programs (REP)The study team will deploy this stakeholder informed REP package across the 68 sites in the MSQC-COHR collaborative. The REP program uses a blend of formats including didactics, flipped classroom design, and narrative storytelling, the REP will address key barriers to adherence previously identified by surgeons. | Behavioural | Replicating Effective Programs (REP) (non-responders) - stage 2 randomized group, Replicating Effective Programs (REP) (responders)- stage 2 randomized group, Replicating Effective Programs (REP) - baseline program non-randomized, Replicating Effective Programs (REP) - stage 1 randomized group |
| REP with facilitation (REP-PLUS)This intervention is a stepped-up REP plus virtual facilitation. The facilitator will: 1) Initiate implementation and benchmark goals: The facilitator will partner with the identified site champions but be masked to primary and secondary outcomes. Together, the facilitator and site champions will review processes to organizationally embed clinical practice guidelines into practice, assess potential barriers and facilitators to these processes, and set measurable goals for adherence to recommendations; 2) Track adherence and provide feedback: Facilitators will use abstracted MSQC-COHR and site-specific operative data to track adherence to clinical practice guidelines, identify barriers to adherence, provide solutions to identified barriers, re-engage stakeholder groups responsible for unsatisfactory measurements, and continuously promote awareness of the guidelines. | Behavioural | REP with facilitation (REP-PLUS) (non-responders) - stage 2 randomized group, REP with facilitation (REP-PLUS) - stage 1 randomized group, REP-PLUS (responders) - stage 2 randomized group |
Primary outcome
Adherence to clinical practice guidelines
Time frame: 12, 24, 36 months
Data will be reviewed from the MSQC-COHR. This is defined as the proportion of persons undergoing abdominal wall hernia that receive guideline concordant hernia care. The study team will define a "responder" as a site that has demonstrated ≥85% adherence to all three clinical practice guidelines.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Anne Ehlers, MD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Replicating Effective Programs (REP) and REP with facilitation (REP-PLUS) in people with Hernia, Abdominal, run by University of Michigan 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: opening soon, as of the sponsor's last update on 6 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Hallway (734-998-2400, ahallway@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to clinical practice guidelines (time frame: 12, 24, 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2025.