Clinical Officer Surgical Training in Africa (COST-Africa)

• Register: ISRCTN
• Last refreshed on: 5 January 2021
• Main ID: ISRCTN66099597
• Date of registration: 27/02/2014
• Prospective Registration: No
• Primary sponsor: Royal College of Surgeons in Ireland (Ireland)
• Public title: Clinical Officer Surgical Training in Africa (COST-Africa)
• Scientific title: Clinical Officer surgical training in Africa (COST-Africa): a cluster randomised controlled trial
• Date of first enrolment: 01/04/2011
• Target sample size: 18
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN66099597
• Study type: Interventional
• Study design: Cluster randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Malawi, Zambia

Contacts

• Name: Ruairi Brugha

Key inclusion & exclusion criteria

Inclusion criteria: District hospitals with the infrastructural capacity to delivery surgery
Exclusion criteria: Children under five years of age attending district hospitals

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Diseases / conditions amenable to surgery
Surgery

Intervention(s)

Random allocation of district hospitals to intervention and control arms within pairs of similar (matched) district hospitals in Malawi and Zambia.

1. Intervention arm: the selected clinical officers will be placed at treatment hospitals (8 in Malawi and 15 in Zambia) where they will perform general surgery, with periodic supervisory visits from trained surgeons.

2. Control arm: hospitals without trained clinical officers. The study will measure outcomes at different levels: the graduate clinical officers, the hospitals, surgical patients and their families. During the study period the control hospitals will continue with their normal patient care procedures.

Primary Outcome(s)

Increase in the types and volume (numbers) of general surgical procedures at the interventions hospitals

Secondary Outcome(s)

1 Improved competence of COs/MLs to undertake general surgery, measured in terms of enhancements in:
1.1. Their surgical skills
1.2. Clinical management of patients
1.3. Implementation of clinical best practice protocols
1.4. Health care of patients
2. Change in rates of referral for general surgical procedures.
3. Change in morbidity and mortality from surgical conditions, improved quality of life
4. Reduced expenditure, both for hospitals providing surgery and patients undergoing surgery
5. Cost effectiveness in delivering general surgery by COs/MLs at the district level

Secondary ID(s)

FP7-AFRICA-2010, no: 266417

Source(s) of Monetary Support

European Union (EU) - 7th Framework Programme for Research and Technological Development (FP7) Grant, Ref: FP7-AFRICA-2010, grant agreement no: 266417

Ethics review

Status:
Approval date:
Contact:

1. Research Ethics Committee of the Royal College of Surgeons in Ireland, 30th April 2012, ref: REC727 2. The University of Zambia Biomedical Research Ethics Committee, Zambia, 29th May 2012, ref: 018-03-12 3. University of Malawi, College of Medicine Research Ethics Committee (COMREC), Malawi, 31st July 2012, ref: P.03/12/1188.

Results

• Results available: Yes
• Date Completed: 30/03/2016