Population Based Strategies for Standardized Surgical Care
Hernia, Abdominal
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 68 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
\- All hospitals that participate in MSQC-COHR will be eligible to participate in the trial
Exclusion:
\- Institutes that are not in the MSQC-COHR
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Replicating Effective Programs (REP) - baseline program non-randomized
All sites participating will be given this REP. This will be evaluated over 12 months.
Behavioral: Replicating Effective Programs (REP)
REP with facilitation (REP-PLUS) - stage 1 randomized group
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.
Behavioral: REP with facilitation (REP-PLUS)
Replicating Effective Programs (REP) - stage 1 randomized group
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.
Behavioral: Replicating Effective Programs (REP)
Replicating Effective Programs (REP) (non-responders) - stage 2 randomized group
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.
Behavioral: Replicating Effective Programs (REP)
REP with facilitation (REP-PLUS) (non-responders) - stage 2 randomized group
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.
Behavioral: REP with facilitation (REP-PLUS)
REP-PLUS (responders) - stage 2 randomized group
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.
Behavioral: REP with facilitation (REP-PLUS)
Replicating Effective Programs (REP) (responders)- stage 2 randomized group
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.
Behavioral: Replicating Effective Programs (REP)
Replicating Effective Programs (REP) BEHAVIORAL
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) BEHAVIORAL
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
University of Michigan and other Michigan Surgical Quality Collaborative sitesAnn Arbor, Michigan, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- University of Michigan
- Study start
- 2028-06 Estimated
- Primary completion
- 2029-06 Estimated
- Study completion
- 2029-06 Estimated
- First posted
- Aug 6, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Population Based Strategies for Standardized Surgical Care
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026