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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05286580
Other study ID # 22-0261
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 24, 2022
Est. completion date February 6, 2023

Study information

Verified date May 2023
Source Poudre Valley Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Terminated
Enrollment 28
Est. completion date February 6, 2023
Est. primary completion date February 6, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Morbidity and mortality conference toolkit
Standardized slide deck Code of conduct Conference planning checklist Case documentation form

Locations

Country Name City State
United States Medical Center of the Rockies Loveland Colorado

Sponsors (1)

Lead Sponsor Collaborator
Poudre Valley Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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