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

Sponsor
Poudre Valley Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT05286580
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
20.3
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Morbidity and mortality conference toolkit
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Standardization of Non-academic Center Surgical Morbidity and Mortality Conference: a Type I Hybrid Implementation Non-clinical Trial.
Actual Study Start Date :
Mar 24, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Perception of effective M&M conference [one year]

    Participant endorses having seen a change at their institution attributable to a discussion at an M&M conference

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical Center of the Rockies Loveland Colorado United States 80538

Sponsors and Collaborators

  • Poudre Valley Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lacey LaGrone, Investigator, Poudre Valley Health System
ClinicalTrials.gov Identifier:
NCT05286580
Other Study ID Numbers:
  • 22-0261
First Posted:
Mar 18, 2022
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lacey LaGrone, Investigator, Poudre Valley Health System
Morbidity and mortality conference
Quality Improvement
Implementation Science

Study Results

No Results Posted as of Apr 28, 2022