SurgeryNCT05286580
Standardization of Non-academic Center Surgical Morbidity and Mortality Conference: a Type I Hybrid Implementation Non-clinical Trial.
A study testing Morbidity and mortality conference toolkit in people with Surgery and Surgery--Complications, run by Poudre Valley Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Surgery--Complications
- What is being tested?
- Morbidity and mortality conference toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2022to 6 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- M\&M conference attendees at enrolled level II and III trauma centers, inclusive of trainees, administrative staff, providers.
Who cannot join
- Age < 18
- Anticipated attendance at <= one M\&M conference at study site.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Center of the Rockies
Loveland, Colorado, 80538
About this study
- 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.
Read the detailed description
Design:
- Pre-, post- intervention mixed-methods trial.
- Inclusion:
- 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:
- 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.
- 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
- 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
- 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
- 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)
- Conditions
- Surgery, Surgery--Complications
- Being tested
- Morbidity and mortality conference toolkit
- Keywords
- Morbidity and mortality conference, Quality Improvement, Implementation Science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morbidity and mortality conference toolkitBehavioural
- Standardized slide deck
- Code of conduct
- Conference planning checklist
- Case documentation form
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | o Sequential deployment of standardized M\&M toolkit at a regional M\&M conference. Receives: Behavioral: Morbidity and mortality conference toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of effective M&M conference
Participant endorses having seen a change at their institution attributable to a discussion at an M\&M conference
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start24 Mar 2022
- Primary completion6 Feb 2023
- Study completion6 Feb 2023
Why it stopped: We lost some staffing and were unable to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poudre Valley Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lacey LaGrone, Poudre Valley Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286580
- Sponsor's protocol ID
- 22-0261
- Status last verified
- May 2023
- First submitted
- 9 Mar 2022
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization of Non-academic Center Surgical Morbidity and Mortality Conference: a Type I Hybrid Implementation Non-clinical Trial.
- ClinicalTrials.gov ID
- NCT05286580
- Acronym / sponsor ID
- 22-0261
- Conditions
- Surgery, Surgery--Complications
- Keywords
- Morbidity and mortality conference, Quality Improvement, Implementation Science
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We lost some staffing and were unable to continue the study.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Poudre Valley Health SystemUniversity, hospital or other
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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:
- 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:
- 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.
- 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
- 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
- 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
- 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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Morbidity and mortality conference toolkito Sequential deployment of standardized M\&M toolkit at a regional M\&M conference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- M\&M conference attendees at enrolled level II and III trauma centers, inclusive of trainees, administrative staff, providers.
Key exclusion criteria (2 listed)
- Age < 18
- Anticipated attendance at <= one M\&M conference at study site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morbidity and mortality conference toolkit* Standardized slide deck * Code of conduct * Conference planning checklist * Case documentation form | Behavioural | Intervention |
Primary outcome
Perception of effective M&M conference
Time frame: one year
Participant endorses having seen a change at their institution attributable to a discussion at an M\&M conference
Results and safety
The study was stopped early (reason given: We lost some staffing and were unable to continue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morbidity and mortality conference toolkit in people with Surgery and Surgery--Complications, run by Poudre Valley Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We lost some staffing and were unable to continue the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of effective M&M conference (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.