Quality ImprovementNCT05286411
Evaluation of the Implementation of a Quality Improvement Program Through Morbidity and Mortality Reviews
An observational study of Quality Improvement, run by Moroccan Society of Surgery at 1 site in Morocco.
Trial summary
Morbidity and mortality reviews represent an opportunity to discuss adverse events and healthcare issues. Aim is to report the first experience of implementing a standardized procedure of morbidity and mortality reviews, and assess its impact on quality improvement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality Improvement
- How many people
- 13 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Jan 2019to 31 Jan 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent a curative surgical procedure for a digestive cancer in our department during the study period and who presented severe adverse events in 90 post operative day
Who may be able to join
- severe adverse events defined as postoperative morbidity > 3a according to the Clavien Dindo grading system
- within the first 90 postoperative days of surgery
- Cases discussed in a morbidity and mortality review
Who cannot join
- Cases not discussed in a morbidity mortality review
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Implementation of a Quality Improvement Program Through Morbidity and Mortality Reviews in a Developing Country
Morbidity and mortality reviews represent an opportunity to discuss adverse events and healthcare issues. Aim is to report the first experience of implementing a standardized procedure of morbidity and mortality reviews, and assess its impact on quality improvement.
Read the detailed description
From July 2019 to December 2019, members of the surgical and intensive care unit departments designed and implemented a regular procedure of morbidity and mortality reviews. Cases of severe postoperative complications after curative resection for digestive cancer were selected to be presented by a surgical resident and discussed in an interdisciplinary conference following a standardized presentation based on an analysis tool adapted from the ALARM framework. Process was assessed by the number of morbidity and mortality reviews held, number and type of recommendations issued and implemented.
Among 13 serious complications during the study period, 10 were discussed. The "Tasks" category was activated in 90% of the cases where lack or misuse of protocols was identified in 90% of the events discussed. Test results availability or accuracy were incarnated in 30% of cases. Poor communication was a contributing factor in 60% of the cases. Written medical records were defective in 40% of the cases. From 16 recommendations for improvement emitted, 87.5% (14/16) were translated into projects and successfully implemented.
Thus, a standardized and regular procedure of morbidity and mortality reviews in a tertiary care facility in a developing country allowed a significant improvement in patient care through quality initiatives implementation. Morbidity and mortality reviews might be a strong tool for the improvement of surgical care particularly for low-mid income countries
- Conditions
- Quality Improvement
- Keywords
- morbidity and mortality reviews, implementation, quality improvement, patient safety
What is being measured
The primary outcome is the main question the study is designed to answer.
Process assessment
evaluation of the number of MMRs, numbers and categories of identified contributing factors, number and types of recommendations and number and types of implemented recommendations.
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 start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Quality ImprovementStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moroccan Society of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anass Majbar, Moroccan Society of Surgery
- Investigators
- Oumayma Lahnaoui, MD, Principal investigator, National Institute of OncologyAnass Majbar, MD, Study director, National Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286411
- Sponsor's protocol ID
- RMM_INO
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Houssaini K, Lahnaoui O, Souadka A, Majbar MA, Ghanam A, El Ahmadi B, Belkhadir Z, Amrani L, Mohsine R, Benkabbou A. Contributing factors to severe complications after liver resection: an aggregate root cause analysis in 105 consecutive patients. Patient Saf Surg. 2020 Sep 29;14:36. doi: 10.1186/s13037-020-00261-7. eCollection 2020.
PubMed 33014137Souadka A, Benkabbou A, Al Ahmadi B, Boutayeb S, Majbar MA. Preparing African anticancer centres in the COVID-19 outbreak. Lancet Oncol. 2020 May;21(5):e237. doi: 10.1016/S1470-2045(20)30216-3. Epub 2020 Apr 3. No abstract available.
PubMed 32251622Souadka A, Majbar MA, Essangri H, Amrani L, Benkabbou A, Mohsine R, Souadka A. Functional outcomes over time following perineal pseudocontinent colostomy reconstruction after abdominoperineal resection for ultralow rectal adenocarcinoma. J Surg Oncol. 2020 Sep;122(4):753-759. doi: 10.1002/jso.26074. Epub 2020 Jun 20.
PubMed 32563198Majbar MA, Courtot L, Dahbi-Skali L, Rafik A, Jouppe PO, Moussata D, Benkabbou A, Mohsine R, Ouaissi M, Souadka A. Two-step pull-through colo-anal anastomosis aiming to avoid stoma in rectal cancer surgery: A "real life" study in a developing country. J Visc Surg. 2022 Jun;159(3):187-193. doi: 10.1016/j.jviscsurg.2021.04.004. Epub 2021 Jun 4.
PubMed 34092526
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implementation of a Quality Improvement Program Through Morbidity and Mortality Reviews in a Developing Country
- ClinicalTrials.gov ID
- NCT05286411
- Acronym / sponsor ID
- RMM_INO
- Conditions
- Quality Improvement
- Keywords
- morbidity and mortality reviews, implementation, quality improvement, patient safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Moroccan Society of SurgeryUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (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.
Morbidity and mortality reviews represent an opportunity to discuss adverse events and healthcare issues. Aim is to report the first experience of implementing a standardized procedure of morbidity and mortality reviews, and assess its impact on quality improvement.
Detailed description
From July 2019 to December 2019, members of the surgical and intensive care unit departments designed and implemented a regular procedure of morbidity and mortality reviews. Cases of severe postoperative complications after curative resection for digestive cancer were selected to be presented by a surgical resident and discussed in an interdisciplinary conference following a standardized presentation based on an analysis tool adapted from the ALARM framework. Process was assessed by the number of morbidity and mortality reviews held, number and type of recommendations issued and implemented.
Among 13 serious complications during the study period, 10 were discussed. The "Tasks" category was activated in 90% of the cases where lack or misuse of protocols was identified in 90% of the events discussed. Test results availability or accuracy were incarnated in 30% of cases. Poor communication was a contributing factor in 60% of the cases. Written medical records were defective in 40% of the cases. From 16 recommendations for improvement emitted, 87.5% (14/16) were translated into projects and successfully implemented.
Thus, a standardized and regular procedure of morbidity and mortality reviews in a tertiary care facility in a developing country allowed a significant improvement in patient care through quality initiatives implementation. Morbidity and mortality reviews might be a strong tool for the improvement of surgical care particularly for low-mid income countries
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent a curative surgical procedure for a digestive cancer in our department during the study period and who presented severe adverse events in 90 post operative day
Key inclusion criteria (3 listed)
- severe adverse events defined as postoperative morbidity > 3a according to the Clavien Dindo grading system
- within the first 90 postoperative days of surgery
- Cases discussed in a morbidity and mortality review
Key exclusion criteria (1 listed)
- Cases not discussed in a morbidity mortality review
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Process assessment
Time frame: one year
evaluation of the number of MMRs, numbers and categories of identified contributing factors, number and types of recommendations and number and types of implemented recommendations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Background: PubMed 33014137Houssaini K, Lahnaoui O, Souadka A, Majbar MA, Ghanam A, El Ahmadi B, Belkhadir Z, Amrani L, Mohsine R, Benkabbou A. Contributing factors to severe complications after liver resection: an aggregate root cause analysis in 105 consecutive patients. Patient Saf Surg. 2020 Sep 29;14:36. doi: 10.1186/s13037-020-00261-7. eCollection 2020.
- Background: PubMed 32251622Souadka A, Benkabbou A, Al Ahmadi B, Boutayeb S, Majbar MA. Preparing African anticancer centres in the COVID-19 outbreak. Lancet Oncol. 2020 May;21(5):e237. doi: 10.1016/S1470-2045(20)30216-3. Epub 2020 Apr 3. No abstract available.
- Background: PubMed 32563198Souadka A, Majbar MA, Essangri H, Amrani L, Benkabbou A, Mohsine R, Souadka A. Functional outcomes over time following perineal pseudocontinent colostomy reconstruction after abdominoperineal resection for ultralow rectal adenocarcinoma. J Surg Oncol. 2020 Sep;122(4):753-759. doi: 10.1002/jso.26074. Epub 2020 Jun 20.
- Background: PubMed 34092526Majbar MA, Courtot L, Dahbi-Skali L, Rafik A, Jouppe PO, Moussata D, Benkabbou A, Mohsine R, Ouaissi M, Souadka A. Two-step pull-through colo-anal anastomosis aiming to avoid stoma in rectal cancer surgery: A "real life" study in a developing country. J Visc Surg. 2022 Jun;159(3):187-193. doi: 10.1016/j.jviscsurg.2021.04.004. Epub 2021 Jun 4.
- Individual participant dataSharing planned: Undecided
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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.
Oumayma Lahnaoui, MD principal investigator
National Institute of Oncology
Anass Majbar, MD study director
National Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality Improvement, run by Moroccan Society of Surgery at 1 site in Morocco.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 5 Apr 2022. 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 Morocco. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Process assessment (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05286411, which also lists 4 linked publications.
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 5 Apr 2022.