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

NCT ID: NCT05286580

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2023-02-06

Brief 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.

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)

Conditions

Surgery; Surgery--Complications

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

o Sequential deployment of standardized M\&M toolkit at a regional M\&M conference.

Group Type: EXPERIMENTAL

Morbidity and mortality conference toolkit

Intervention Type: BEHAVIORAL

• Standardized slide deck
• Code of conduct
• Conference planning checklist
• Case documentation form

Interventions

Morbidity and mortality conference toolkit

• Standardized slide deck
• Code of conduct
• Conference planning checklist
• Case documentation form

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Poudre Valley Health System

OTHER

Sponsor Role: lead

Responsible Party

Lacey LaGrone

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical Center of the Rockies

Loveland, Colorado, United States

Countries

United States

Other Identifiers

22-0261

Identifier Type: -

Identifier Source: org_study_id