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.: PACTR202212472091194 Date of Approval: 21/12/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Augmented Capacity Development Intervention (ACDI) on the Performance of the Data Quality and Information Utilization in the Routine Health Information System (RHIS) Among Public Health Facilities of Gofa Zone, Southern Ethiopia: A Cluster Randomized Controlled Trial
Official scientific title Effect of Augmented Capacity Development Intervention (ACDI) on the Performance of the Data Quality and Information Utilization in the Routine Health Information System (RHIS) Among Public Health Facilities of Gofa Zone, Southern Ethiopia: A Cluster Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: Consistent and timely available health data are a crucial source of public health actions both nationally and internationally. Routine health information system guide policy development, planning health projects, allocating health resources, governance, and regulation of the health system that support decision-makers and planners at all levels of a health system. Therefore, strengthening routine health information systems for improved data quality and information utilization is vital for evidence-based decision-making. However, currently, the quality of health system data and its utilization for decision-making is found poor in Ethiopia. The interventions implemented in the previous studies were narrow in scope, only involving a few packages like training and guideline provision; were done only on a single or very few facilities or districts; with design-related limitations such as no randomization and lack of controls. These studies are designed to implement the ACDI that are targeted to improve data quality and information utilization in RHIS among selected health facilities Objective: To evaluate the effect of Augmented Capacity Development interventions on the performance of data quality and information utilization in the RHIS among the public health facilities of the Gofa zone, Southern Ethiopia
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ACDI
Disease(s) or condition(s) being studied Data Quality and Information utilization in routine health information system
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/01/2023
Actual trial start date 01/01/2023
Anticipated date of last follow up 30/09/2023
Actual Last follow-up date 30/09/2023
Anticipated target sample size (number of participants) 248
Actual target sample size (number of participants) 248
Recruitment status Active, not recruiting
Publication URL
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Augmented Capacity Development Interventions 1. Initial basic training followed by subsequent gap based subsequent workshop 2. Every two months Supervision and mentorship 3. Monthly monitoring and every two months evaluation workshops 4. Motivation: individual and organizational certification of outstanding performance 8 months Routine service plus Augmented Capacity Development Interventions (ACDI). The ACDI will comprise gap-based training, supervision, mentorship, feedback, motivation, monitoring, and evaluation. 124
Control Group Routine Practice No dose applied No duration Routine Practice: Non-specific supervision and targeted training 124 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Functional health facilities and administrative institutions that give consent to participate in the study. 2. The health workers serving in Health Management Information System (HMIS) units, Outpatient Department (OPD), Maternal and Child Health (MCH) departments, Performance Management Team (PMT) members, managers, and health extension workers (HEW) of the facilities. 1. Those workers and facilities who are not willing to participate in the study 2. Newly established health facilities (less than a year of service) 3. The health workers who already had the intention to leave the health facilities in the coming eight months during the initiation of the study Adult: 19 Year-44 Year 19 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 08/06/2023 Institutional Review Board of Hawassa University
Ethics Committee Address
Street address City Postal code Country
Hawassa Hawassa 1560 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Data quality, Information Utilization Every three month
Primary Outcome Data quality, information utilization every three month
Secondary Outcome No secondary outcome No measurement
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hawassa University Not applicable Hawassa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Doris Duke Charitable Foundation and the Bill and Melinda Gates Foundation Addis Ababa Addis Ababa Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Regional Health Bureau Hawassa Hawassa 0149 Ethiopia Regional Government
COLLABORATORS
Name Street address City Postal code Country
Abebaw Gebeyehu Worku Addis Ababa Addis Ababa Ethiopia
Dejene Hailu Kassa Hawassa Hawassa Ethiopia
Keneni Gutema Negeri Hawassa Hawassa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bedilu Kucho bedilukucho54@gmail.com +251916725534 Hawassa
City Postal code Country Position/Affiliation
Hawassa 0149 Ethiopia Director of Health and Health Related Product Quality and Service Regulatory Authority
Role Name Email Phone Street address
Public Enquiries Dejene Hailu dejenkassa@yahoo.com +251916829271 Hawassa
City Postal code Country Position/Affiliation
Hawassa Ethiopia Associate Professor of Health System Specialty
Role Name Email Phone Street address
Scientific Enquiries Abebaw Gebeyehu abebaw_gebeyehu@et.jsi.com +251930415500 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Senior Health System Research Scientist at JSI Research and Training Institute
Role Name Email Phone Street address
Public Enquiries Keneni Gebeyehu kenenigut2000@yahoo.com +251911424467 Hawassa
City Postal code Country Position/Affiliation
Hawassa Ethiopia Assistant professor of health service management
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes PD data include demographic characteristics of respondents, factors responsible for data quality, and information utilization. All of the individual participant data collected during the study will be shared after de-identification. The Biodata of the participants will not be collected and analyzed. Individual participants’ data will be anonymized and made available via an online data repository. Informed Consent Form,Statistical Analysis Plan,Study Protocol The research team will share IPD data and other documents within one year after the publication of the article. It will be shared from October 2023 to September 2024. The IPD data will be accessed confidentially to protect the rights of study participants. Any interested body can officially request Hawassa university and can get the permission to access the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.hu.edu.et No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/12/2022 Result - 16/12/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information