Hernia, Abdominal
Conditions
Keywords
Abdominal wall hernia repair, Surgical approach, Quality improvement in hernia care, Evidence-based guidelines, Replicating Effective Programs
Brief 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.
Interventions
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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Sites will get the REP package first. After this first stage of the SMART trial, non-responder MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) will be randomized to continue REP versus REP with facilitation (REP-PLUS). The unit of randomization is the hospital. Stratified randomization on baseline site adherence will ensure comparability of comparators. In stage 2 non-responders in REP group will be re-randomized as well as the responders from the REP-PLUS group to REP vs REP-PLUS. The number of anticipated sites is listed as the anticipated enrollment numbers.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to clinical practice guidelines | 12, 24, 36 months | 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. |
Countries
United States
Contacts
Primary ContactAlexander Hallway
Outcome results
None listed