Population Based Strategies for Standardized Surgical Care

University of Michigan

Status: Begins enrollment in 3 months

Conditions: Hernia, Abdominal

Treatments: Behavioral: Replicating Effective Programs (REP); Behavioral: REP with facilitation (REP-PLUS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07106541

HUM00278185

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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68 participants in 7 patient groups

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

Experimental group

Description:

All sites participating will be given this REP. This will be evaluated over 12 months.

Treatment:

Behavioral: Replicating Effective Programs (REP)

REP with facilitation (REP-PLUS) - stage 1 randomized group

Experimental group

Description:

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.

Treatment:

Behavioral: REP with facilitation (REP-PLUS)

Replicating Effective Programs (REP) - stage 1 randomized group

Experimental group

Description:

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.

Treatment:

Behavioral: Replicating Effective Programs (REP)

Replicating Effective Programs (REP) (non-responders) - stage 2 randomized group

Experimental group

Description:

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.

Treatment:

Behavioral: Replicating Effective Programs (REP)

REP with facilitation (REP-PLUS) (non-responders) - stage 2 randomized group

Experimental group

Description:

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.

Treatment:

Behavioral: REP with facilitation (REP-PLUS)

REP-PLUS (responders) - stage 2 randomized group

Experimental group

Description:

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.

Treatment:

Behavioral: REP with facilitation (REP-PLUS)

Replicating Effective Programs (REP) (responders)- stage 2 randomized group

Experimental group

Description:

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.

Treatment:

Behavioral: Replicating Effective Programs (REP)