NCT04276103

Brief Summary

Introduction: A baseline assessment of surgical capacity is recommended as a first-step to inform national policy on surgical system strengthening. In Ethiopia, the World Health Organization's Situational Analysis Tool (WHO SAT) was adapted to assess surgical capacity as part of a national initiative: Saving Lives Through Safe Surgery (SaLTS). This study describes the process of adapting this tool and initial results. Methods: The new tool was used to evaluate fourteen hospitals in the Southern Nations, Nationalities, and People's Region of Ethiopia between February and March 2017. Two analytic methods were employed. To compare this data to international metrics, the WHO Service Availability and Readiness Assessment (SARA) framework was used. To assess congruence with national policy, data was evaluated against Ethiopian SaLTS targets.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

January 21, 2020

Last Update Submit

February 17, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • General service readiness

    Measured by the number of hospital beds, major operating rooms, surgical/anesthesia/and obstetric providers, and basic infrastructure availability

    Cross-Sectional, assesses availability of this infrastructure within the past year in general

  • Basic surgery readiness

    Readiness for surgical services was assessed based on the presence of tracer items identified by WHO/USAID Service Availability and Readiness Assessment (SARA) as particularly important for providing basic surgical services. The service specific readiness score is defined as the mean availability of service specific tracer items in three domains (staff and training, equipment, and medicines and commodities).

    Cross-Sectional, assesses availability of tracer items within the past year in general

  • Comprehensive surgery readiness

    Readiness for surgical services was assessed based on the presence of additional tracer items identified by WHO/USAID Service Availability and Readiness Assessment (SARA) as necessary to provide comprehensive surgical services, beyond those needed for basic surgery.

    Cross-Sectional, assesses availability of tracer items within the past year in general

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Southern Nations, Nationalities and Peoples' (SNNP) Region is one of Ethiopia's eleven regions, occupying the southwest portion of the country. Public hospitals serve the region's population in this area within three tiers - primary, general, and specialized hospitals. An average of four providers were interviewed per facility and participants included hospital leadership (CEOs, medical directors, and matrons), surgeons, integrated emergency surgical officers, obstetrician-gynecologists, mid-level anesthesia providers, and operating room nurses.

You may qualify if:

  • Fourteen public hospitals (11 primary, 1 general, and 2 specialized) chosen by the regional health bureau
  • Hospital staff with willingness to participate in study
  • Hospital staff with availability to participate in study

You may not qualify if:

  • Hospital staff which did not volunteer to participate or refused to participate were excluded.
  • Hospital staff not available at the time of visit
  • Hospitals not chosen by the regional health bureau

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • John G Meara, MD, DMD, MBA

    Harvard Medical School & Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Program in Global Surgery and Social Change

Study Record Dates

First Submitted

January 21, 2020

First Posted

February 19, 2020

Study Start

November 1, 2016

Primary Completion

February 23, 2019

Study Completion

February 23, 2019

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Raw data from the survey is available in the study and appendices planned for publication. Additionally, the original source data without identification of the specific hospitals, is available upon request with author consensus.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Once the original study is published, de-identified results will be available by request to the authors.
Access Criteria
Original data may be provided upon request to the authors with consensus approval from all co-authors.