Population Based Strategies for Standardized Surgical Care

NCT07106541 | Not Yet Recruiting DMC

• 1 other identifier: HUM00278185
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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). 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

Keywords

Abdominal wall hernia repair; Surgical approach; Quality improvement in hernia care; Evidence-based guidelines; Replicating Effective Programs

Outcome Measures

Primary Outcomes (1)

• 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.

  12, 24, 36 months

Study Arms (7)

Replicating Effective Programs (REP) - baseline program non-randomized

EXPERIMENTAL

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

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.

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.

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.

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.

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.

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.

Behavioral: Replicating Effective Programs (REP)

Interventions

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.

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) 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All hospitals that participate in MSQC-COHR will be eligible to participate in the trial

You may not qualify if:

• \- Institutes that are not in the MSQC-COHR

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan and other Michigan Surgical Quality Collaborative sites

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Ehlers, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Hallway

CONTACT

734-998-2400; ahallway@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)