Population Based Strategies for Standardized Surgical Care

Conditions

• Hernia, Abdominal

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

Jul 2025

Primary completion

Jun 30, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

68 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Replicating Effective Programs (REP) - baseline program non-randomized
  All sites participating will be given this REP. This will be evaluated over 12 months.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.

Primary Outcome Measure

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

Central Contacts

• Alexander Hallway
  734-998-2400
  [email protected]

Locations (1)

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