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

• 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.

Study Overview

• Status: Terminated
• Conditions: Surgery; Surgery--Complications
• Intervention / Treatment: Behavioral: Morbidity and mortality conference toolkit

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• M&M conference attendees at enrolled level II and III trauma centers, inclusive of trainees, administrative staff, providers.

Exclusion Criteria:

• Age < 18
• Anticipated attendance at <= one M&M conference at study site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; o Sequential deployment of standardized M&M toolkit at a regional M&M conference.	Behavioral: Morbidity and mortality conference toolkit; Standardized slide deck; Code of conduct; Conference planning checklist; Case documentation form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of effective M&M conference	Participant endorses having seen a change at their institution attributable to a discussion at an M&M conference	one year

Collaborators and Investigators

• Sponsor: Poudre Valley Health System

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Actual): February 6, 2023
• Study Completion (Actual): February 6, 2023

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Implementation Science; Quality Improvement; Morbidity and mortality conference
• Other Study ID Numbers: 22-0261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No