Health TrialsbyHealthPanel

Population Based Strategies for Standardized Surgical Care

ConditionHernia, Abdominal
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

68 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Replicating Effective Programs (REP) - baseline program non-randomizedExperimental treatment 1 intervention
Group B: REP with facilitation (REP-PLUS) - stage 1 randomized groupExperimental treatment 1 intervention
Group C: Replicating Effective Programs (REP) - stage 1 randomized groupExperimental treatment 1 intervention
Group D: Replicating Effective Programs (REP) (non-responders) - stage 2 randomized groupExperimental treatment 1 intervention
Group E: REP with facilitation (REP-PLUS) (non-responders) - stage 2 randomized groupExperimental treatment 1 intervention
Group F: REP-PLUS (responders) - stage 2 randomized groupExperimental treatment 1 intervention
Group G: Replicating Effective Programs (REP) (responders)- stage 2 randomized groupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
12, 24, 36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: