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Not yet recruiting NCT07106541

Population Based Strategies for Standardized Surgical Care

No phase Interventional Hernia, Abdominal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Replicating Effective Programs (REP), REP with facilitation (REP-PLUS).
Who it may be relevant to
Registry conditions: Hernia, Abdominal. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 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.
  • Behavioral 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 recommenda

Primary outcome measures

  • Adherence to clinical practice guidelines [Time frame: 12, 24, 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Michigan and other Michigan Surgical Quality Collaborative sites — Ann Arbor

Identifiers

NCT: NCT07106541 · HUM00278185

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗