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.: PACTR202001559723931 Date of Approval: 22/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Health Information System (HIS) training and Mentorship on the level of information use among health facility and department heads: A quasi-Experimental study.
Official scientific title Effectiveness of Health Information System (HIS) training and Mentorship on the level of information use among health facility and department heads: A quasi-Experimental study.
Brief summary describing the background and objectives of the trial Evidence-based decision making in healthcare is unsatisfactory in the majority of the health facilities of Amhara region. Healthcare providers, as well as department heads, have hardly utilized healthcare data to perform and monitor the day to day activities. Low capacity and commitment are the most identified factors for the low level of information use. The study aimed to investigate the effectiveness of Health Information training and Mentorship in improving health data use for decision making.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Information use for evidence base decision
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/03/2019
Actual trial start date 01/04/2019
Anticipated date of last follow up 30/04/2020
Actual Last follow-up date 31/05/2020
Anticipated target sample size (number of participants) 344
Actual target sample size (number of participants) 344
Recruitment status Closed to recruitment,follow-up continuing
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised 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 Health Information System training and Mentor ship 4 Mentorship session will be conducted in every three months 12 months duration The intervention has two components. One is providing a Health Information System (HIS) Mentorship. To make effective the mentorship program first mentors will be trained on the whole content of the health information system of Ethiopia. In addition, a five-day training on data quality and information use will be given to facility heads, department heads and Health information management system focal persons. 172
Control Group Current Health Management Information system with no Mentorship 4 times for every three months 12 months duration No intervention all 172 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For facilities providing healthcare services for at least the past three months For department heads, those who are working for more than three months in the selected departments For departments that are not providing health care services such as finance departments, human resource departments, audit section and a guard coordination office in the selected facilities. For individuals, those who are not able to hear or listen. 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 10/12/2018 Institutional Ethical Review Board of University of Gondar
Ethics Committee Address
Street address City Postal code Country
Not applicable Gondar 0196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of information used for an evidence-based decision making At the end of the intervention
Secondary Outcome Functional Performance monitoring team established At the end of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Gondar Not applicable Gondar 0196 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Gondar Chechela street Gondar 0196 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Gondar Not applicable Gondar 0196 Ethiopia University
Secondary Sponsor Amhara Region Health Bureau Not applicable Bahir Dar 0495 Ethiopia Government organization
COLLABORATORS
Name Street address City Postal code Country
Dr. Biniam Tilahun Chakilu Chechela street Gondar 0196 Ethiopia
Dr Mezigebu Yitayal Chechela street Gondar 0196 Ethiopia
Dr Asmamw Atnafu Chechela street Gondar 0196 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moges Chanyalew mogesabu@gmail.com +251911617734 Not applicable
City Postal code Country Position/Affiliation
Bahir Dar 0495 Ethiopia Amhara region Health bureau
Role Name Email Phone Street address
Scientific Enquiries Biniam Chakilu binigcms@gmail.com +251913875066 Not applicable
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia University of Gondar
Role Name Email Phone Street address
Public Enquiries Abebaw Gebeyehu gabebaw2worku@gmail.com +251930415500 Not applicable
City Postal code Country Position/Affiliation
Bahir Dar 0495 Ethiopia Amhara Region Health Bureau
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD data include demographic characteristics of individuals, technical factors responsible for data use, perceived organizational factors affecting data use and level of information used for decision making. The research team will not collect and analyze any biodata from individuals. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The research team will share IPD data and other documents within one year after completing the intervention. It will be shared from August 2020 to July 2021. The IPD data will be accessed based on a controlled manner to protect the rights of study participants. Anyone who will have an interest in the subject matter can request officially the university and can get the right to access the data. It is also allowed for researchers to conduct further analysis which will not be covered by the research team. For overall communication and reviewing the requests, Dr. Biniam Tilahun is responsible get him through this e-mail address binigcms@gmail.com.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://www.uog.edu.et/ No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information