Analysis of Surgical Mortalities Using the Fishbone Model... | NCT05015959

Studies
Analysis of Surgical Mortalities Using the Fishbone Model for Quality Improvement

NCT05015959

Sponsor

University of Witwatersrand, South Africa

Status

Completed

Last Update Posted

Aug 23, 2021Actual

Enrollment

859Actual

Phase

Not provided

Conditions

Complication of Surgical and Medical Care, Unspecified

Interventions

observation

Countries

South Africa

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

Aug 2021

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, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Aug 3, 2021

First Submission Date that Met QC Criteria

Aug 14, 2021

First Posted Date

Aug 23, 2021Actual

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

Aug 14, 2021

Last Update Posted Date

Aug 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maeyane Stephens Moeng, Prof, University of Witwatersrand, South AfricaPrincipal Investigator

Lead Sponsor

University of Witwatersrand, South AfricaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Retrospective data analysis of mortalities and the evaluation of the quality of care offered, using the Fishbone method.

Detailed Description

Evaluation of mortalities seen between 01 January 2017 and 31 December 2018. Analysis of the mortality decision into preventable, non-preventable and potentially preventable categories. Identifying the associated risk factors and co-morbidities in a single centre study in Johannesburg. Further analysing was performed on the subset of preventable mortalities and further do the fishbone model of quality of care. RedCap data was utilized for all data points. A further comparison was done to the MNM classification based on the team and an independent senior surgeon.

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

859Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mortality outcomes		mortality classification into preventable, potentially preventable and non-prevenatable	Other: observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observation	Other	quality	mortality outcomes	mortality outcomes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality outcomes	in-hospital mortality	study period (Jan 2017 to Dec 2018)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: All mortality of patients seen in the Department who were 18yrs or older

Exclusion Criteria:

incomplete data death in the Emergency department

Accepts Healthy Volunteers

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

all adults 18 years or older that presented to our institution and died withing the study period.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maeyane Moeng, MBBCH, FCS	University of Witwatersrand, South Africa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charlotte Maxeke Johannesburg Academic Hospital		Johannesburg	Gauteng	2123	South Africa

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided