Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202111807740758 Date of Approval: 18/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of a prescription audit, feedback, and small group education intervention on prescribing indicators in Eswatini – a controlled before and after study
Official scientific title The effect of a prescription audit, feedback, and small group education intervention on prescribing indicators in Eswatini – a controlled before and after study
Brief summary describing the background and objectives of the trial Irrational use of medicines is a long-standing concern in health systems, particularly in low-and-middle-income countries. This study examined the effects of a short intervention consisting of a prescription audit and feedback coupled with small group education on prescribing practices in health facilities in Eswatini.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Circulatory System,Digestive System,Ear, Nose and Throat,Eye Diseases,Genetic Diseases,Haematological Disorders,Musculoskeletal Diseases,Nutritional, Metabolic, Endocrine,Oral Health,Paediatrics,Respiratory,Skin and Connective Tissue Diseases,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 03/10/2016
Actual trial start date 03/04/2017
Anticipated date of last follow up 31/10/2018
Actual Last follow-up date 31/03/2019
Anticipated target sample size (number of participants) 33
Actual target sample size (number of participants) 32
Recruitment status Completed
Publication URL https://scholar.google.co.za/citations?view_op=view_citation&hl=en&user=Ryess6kAAAAJ&citation_for_view=Ryess6kAAAAJ:qjMakFHDy7sC
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Prescription audit coupled with small group education One visit to each of the 16 facilities every two months. Two visits in total 6 months Two visits, two months apart, to each intervention facility were conducted to evaluate the impact of the intervention. During a visit, 30 prescriptions from the previous month would be randomly sampled from prescription books and registers and analyzed using the WHO/INRUD prescribing indicators. Findings from the analyses were then used to conduct feedback sessions with facility staff; these sessions were coupled with education on rational use of medicines, particularly, antibiotics. A 6-months follow-up period, during which there were no visits to neither intervention nor control facilities was implemented. At the end of the follow-up period evaluation data for two-time points: post-intervention (October 2018), and post-follow up (April 2019), was collected. 16
Control Group No intervention NA 6 months Facilities were left to continue operating as they normally do with no prescription audits and feedback sessions coupled with small group education. 16 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Public sector (government owned) and faith-based not-for-profit health facilities Specialized health facilities Tertiary facilities Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/10/2016 Biomedical Science Research Ethics Committee of the University of the Western Cape
Ethics Committee Address
Street address City Postal code Country
Robert Sobukwe Road, Bellville Cape Town 7535 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improved prescribing patterns determined by WHO/INRUD prescribing Indicators, with a focus on the use of antibiotics, and by facility Baseline, post intervention, post follow up period
Secondary Outcome Improved prescribing measured against WHO/INRUD prescribing indicators by the level of care. Baseline, post intervention, post follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ministry of Health Mhlambanyatsi Road Mbabane H100 Swaziland
FUNDING SOURCES
Name of source Street address City Postal code Country
Framework Agreement between the Belgian Directorate General for Development Cooperation and the University of the Western Cape School of public health, University of the Western Cape, Robert Sobukwe Road, Bellville Cape Town 7535 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of the Western Cape Robert Sobukwe Road, Bellville Cape Town 7535 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Hazel Bradley School of public health, University of the Western Cape, Robert Sobukwe Road Cape Town 7535 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nondumiso Ncube nncube@uwc.ac.za +26876640888 Fonteyn Road, Dalriach East
City Postal code Country Position/Affiliation
Mbabane H100 Swaziland Lecturer
Role Name Email Phone Street address
Scientific Enquiries Hazel Bradley hbradley@uwc.ac.za +27722979932 Robert Sobukwe Road, Belville
City Postal code Country Position/Affiliation
Cape Town 7535 South Africa Senior Lecturer and Researcher
Role Name Email Phone Street address
Public Enquiries Nondumiso Nucbe nncube@uwc.ac.za +26876640888 Fonteyn Road, Dalriach East
City Postal code Country Position/Affiliation
Mbabane H100 Swaziland Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes There were no individual participant data collected during this study as participants were healthcare facilities and analyses for appropriate prescribing were conducted at facility not prescriber level. Clinical Study Report 1 year Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 12/10/2021 31/12/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 12/10/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information