Evaluation of the Implementation of a Quality Improvement... | NCT05286411

Studies
Evaluation of the Implementation of a Quality Improvement Program Through Morbidity and Mortality Reviews

NCT05286411

Sponsor

Moroccan Society of Surgery

Status

Completed

Last Update Posted

Apr 5, 2022Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Quality Improvement

Interventions

Not provided

Countries

Morocco

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Jan 31, 2020Actual

First Submitted Date

Mar 9, 2022

First Submission Date that Met QC Criteria

Mar 9, 2022

First Posted Date

Mar 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2022

Last Update Posted Date

Apr 5, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anass Majbar, Professor MA Majbar, Moroccan Society of SurgeryPrincipal Investigator

Lead Sponsor

Moroccan Society of SurgeryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Cases not discussed in a morbidity mortality review

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oumayma Lahnaoui, MD	National Institute of Oncology	Principal Investigator
Anass Majbar, MD	National Institute of Oncology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Oncology		Rabat		10090	Morocco

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33014137	Background	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.
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