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)
