Clinical trial NCT05286580: Standardization of Non-academic Center Surgical Morbidity and Mortality Conference: a Type I Hybrid Implementation Non-clinical Trial.
Official title: Standardization of Non-academic Center Surgical Morbidity and Mortality Conference: a Type I Hybrid Implementation Non-clinical Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Surgery--Complications
Keywords: Morbidity and mortality conference
Quality Improvement
Implementation Science
Lead sponsor: Poudre Valley Health System
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

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.

Primary outcomes:
measure: Perception of effective M&M conference
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
Study officials:
References: