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Not Yet RecruitingNCT07106541

Population Based Strategies for Standardized Surgical Care

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
68 (estimated)
Sponsor
University of Michigan · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALReplicating 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.
BEHAVIORALREP 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.

Timeline

Start date
2026-06-01
Primary completion
2029-06-01
Completion
2029-06-01
First posted
2025-08-06
Last updated
2025-08-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07106541. Inclusion in this directory is not an endorsement.

Population Based Strategies for Standardized Surgical Care (NCT07106541) · Clinical Trials Directory