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