Global SurgeryNCT04276103
Surgical Assessment Tool for Ethiopia National Policy Monitoring & Evaluation
An observational study of Global Surgery and Health System, run by Harvard Medical School (HMS and HSDM).
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Global Surgery, Health System, Health Planning
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 23 Feb 2019
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Development of a Surgical Assessment Tool for National Policy Monitoring & Evaluation in Ethiopia: A Quality Improvement Study
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.
- Conditions
- Global Surgery, Health System, Health Planning, Global Anesthesia, Public Health
What is being measured
The primary outcome is the main question the study is designed to answer.
General service readiness
Measured by the number of hospital beds, major operating rooms, surgical/anesthesia/and obstetric providers, and basic infrastructure availability
Measured: 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).
Measured: 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.
Measured: Cross-Sectional, assesses availability of tracer items within the past year in general
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Nov 2016
- Primary completion23 Feb 2019
- Study completion23 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Global 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric, Federal Minstry of Health of Ethiopia, Jhpiego
- Responsible party
- Principal investigator, John Meara, Harvard Medical School (HMS and HSDM)
- Investigators
- John G Meara, MD, DMD, MBA, Principal investigator, Harvard Medical School & Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276103
- Sponsor's protocol ID
- IJS-D-19-00363R1
- Status last verified
- Feb 2020
- First submitted
- 21 Jan 2020
- Last updated
- 19 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Surgical Assessment Tool for National Policy Monitoring & Evaluation in Ethiopia: A Quality Improvement Study
- ClinicalTrials.gov ID
- NCT04276103
- Acronym / sponsor ID
- IJS-D-19-00363R1
- Conditions
- Global Surgery, Health System, Health Planning, Global Anesthesia, Public Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- General Electric, Federal Minstry of Health of Ethiopia, Jhpiego
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 23 Feb 2019 (actual)
- Study completion
- 23 Feb 2019 (actual)
- First posted
- 19 Feb 2020 (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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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
General service readiness
Time frame: Cross-Sectional, assesses availability of this infrastructure within the past year in general
Measured by the number of hospital beds, major operating rooms, surgical/anesthesia/and obstetric providers, and basic infrastructure availability
Basic surgery readiness
Time frame: Cross-Sectional, assesses availability of tracer items within the past year in general
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).
Comprehensive surgery readiness
Time frame: Cross-Sectional, assesses availability of tracer items within the past year in general
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.
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 19 Feb 2020.
- Individual participant dataSharing planned: Yes. 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.
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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.
John G Meara, MD, DMD, MBA principal investigator
Harvard Medical School & Boston Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Global Surgery and Health System, run by Harvard Medical School (HMS and HSDM).
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 3 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 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
General service readiness (time frame: Cross-Sectional, assesses availability of this infrastructure within the past year in general). The study lists 3 primary outcomes in all. 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 19 Feb 2020.