Standardization of Non-academic Center Surgical Morbidity and Mortality Conference: a Type I Hybrid Implementation Non-clinical Trial.

Surgery Clinical Trial

Official title: Standardization of Non-academic Center Surgical Morbidity and Mortality Conference: a Type I Hybrid Implementation Non-clinical Trial.

Status Terminated

Clinical Trial Summary

- Specific Aim 1: Determine impact of standardized morbidity and mortality (M&M) toolkit on provider satisfaction with, and perceived impact of, M&M conference. - Specific Aim 2: Identify barriers and facilitators to toolkit implementation.

Clinical Trial Description

Design: - Pre-, post- intervention mixed-methods trial. - Inclusion: o M&M conference attendees at enrolled level II and III trauma centers, inclusive of trainees, administrative staff, providers. - Exclusion: - Age < 18 - Anticipated attendance at <= one M&M conference at study site. - Intervention: - Brief didactic regarding evidence base for M&M conferences. - Sequential deployment of standardized M&M toolkit - Standardized slide deck - Code of conduct - Conference planning checklist - Case documentation form - Recruitment: o Pre/post survey: - M&M attendees will be invited to scan a QR code made available at the beginning of an M&M conference, and to take 5 minutes to fill the associated survey if they consent. o Semi-structured interview: - The research coordinator contact information will be emailed to M&M listserv, requesting interested parties contact them to schedule an interview. - Data collection o Specific Aim 1: - Pre/post 10 question digital, anonymous mixed-methods (one free text question) survey • Demographics collected: occupation (surgeon / app / non-surgeon physician / other), years in practice (<10, 10-20, >20) - Observation of M&M to capture: • # of attendees - # of cases presented at each conference - # of cases which include literature review - # of cases which include determination of recommended system change (just culture..?) - Specific Aim 2: - Three, six and nine months after initial toolkit deployment we will conduct semi-structured interviews regarding implementation barriers and facilitators. - Interviews will be conducted in-person and audio-recorded. - Interview guide will be modified to emphasize opportunities for improvement identified in initial quantitative data collection. - For instance, if baseline data suggests case referral is the primary problem, will triage discussion of this portion of the M&M process higher and ask additional detail regarding perceived means of improvement. - The interview guide scope will not change from that submitted, the emphasis will pivot as described. - Data analysis will be ongoing, and results of each interview set will be used to inform adaptation of implementation approach. - Consent o Would like to submit a request for waiver of written consent and inclusion of information sheet in survey with confirmation of understanding but without signature, collection of names. - Timeline o Baseline survey and observational data collection Feb - April 2022, intervention deployment March - May 2022, follow-up data collection Feb - April 2023. - Study Sites o Northern Colorado M&M (Greeley, Longs Peak, Poudre Valley, Medical Center of the Rockies) ;

Related Conditions & MeSH terms

• Surgery
• Surgery--Complications

• NCT number: NCT05286580
• Study type: Interventional
• Source: Poudre Valley Health System
• Status: Terminated
• Phase: N/A
• Start date: March 24, 2022
• Completion date: February 6, 2023