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

Poudre Valley Health System

Status: Terminated

Conditions: Surgery; Surgery--Complications

Treatments: Behavioral: Morbidity and mortality conference toolkit

Study type: Interventional

Funder types: Other

Identifiers

NCT05286580

22-0261

Details and patient eligibility

About

• 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.

Full 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)

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Details and patient eligibility

About

• 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.

Full 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)

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Morbidity and mortality conference toolkit