Checklist Based Box System Interventions (CBBSI)
March 25, 2019 updated by: Netsanet Belete, Jimma University
Effectiveness of Checklist Based Box System Interventions (CBBSI) on Improving Utilization of Maternal Health Service in North West, Ethiopia: a Cluster Randomized Controlled Trial
Maternal mortality is still high in Ethiopia. Antenatal care (ANC), use of skilled delivery attendants and postnatal care (PNC) services are key maternal health care services that can significantly reduce maternal mortality. However, interventions applied to the continued utilization of these key maternal heath services in a continuum of care approach (i.e. early initiation of ANC and continued utilization up to four plus vists, health facility delivery attended by skilled health care providers and attending three PNC visits) were not well applied and studied.
Hence, the purpose of this study is to test the effectiveness of checklist based box system interventions on improving utilization of maternal health service (Antenatal care, skilled birth attendance and postnatal care) utilization.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Cluster Randomized controlled trial study design will be employed.
The sample size for this study was calculated based on the recommendations for sample size calculations for cluster randomized controlled trials with fixed number of clusters, by using STATA.
The following assumptions were considered: to detect an increase of postnatal care three utilization from 16% to 28% from previous study, number of clusters available-30, with 95% confidence interval and 80% power, intra-cluster correlation coefficient of 0.04849 from similar studies, 15 clusters per arm.
The sample size was calculated to determine number of observations required per cluster, for two-sample comparison of proportions (using normal approximation), Assuming individual randomization, sample size per arm is 194.
Then allowing for cluster randomization, average cluster size required is 40, and the final sample size is 1200 pregnant mothers (600 in intervention, and 600 in control).
Data analysis will take place in two levels (cluster and individual).
Risk ration will be computed at cluster level, and the results of this cluster summary will be compared using t-test.
Primary and secondary outcomes will be compared between intervention and control groups with random effects logistic regression models, taking account of clustering.
Study Type
Interventional
Enrollment (Anticipated)
1200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Northwest
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Debre Markos, Northwest, Ethiopia
- Recruiting
- East Gojjam zone
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Contact:
- Aklog Nigussie, Bsc
- Email: Aklog.nigussie@gmail.com
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Contact:
- Feteh Sendek, Bsc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 49 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Mothers residing in three of the selected districts Debre-Markos, Gozamin and Machakel districts Mother who are positive for Stanback et al, 1999 pregnancy screening criteria and found HCG positive (confirmed pregnancy) Gestational age of less than 16 weeks Mothers willing to participate in the study
Exclusion Criteria:
- Women who have severe psychological illness, which could interfere with, consent and study participation, Those who have sever clinical complications that need hospitalization Mothers who need special type of ANC follow-up, other than the recommended focused ANC
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Checklist Based Box system
Pregnant mothers will receive scheduled person-centered health educations starting from: they are identified as suspected pregnant mother up to attending their third PNC visit.
In between the first ANC and the third PNC drop out tracing mechanisms will be applied, for mothers who fail to utilize the recommended maternal health services.
|
The intervention has both behavioural change and service utilization drop out tracing mechanism.
Special type of boxes designed to schedule health educations and continued service utilization monitoring boxes will be placed at health posts and health centers respectively.
Community level survey will be conducted to identify suspected pregnant mothers using stanback et al, 1999 checklist, and mothers are linked to health centers.
Then, they will be followed for their subsequent attendance of consecutive maternal health services (ANC 2nd-third PNC).
Mothers who fail to utilize the service will be traced; will get person-centered health education to continue the service.
|
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No Intervention: Routine maternal health care
Pregnant mothers in this arm will receive the usual routine maternal health care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Continued maternal health service utilization (ANC 1-4), Institutional Delivery, PNC (1-3)
Time Frame: 42 days after delivery
|
Proportion of mothers receiving continued maternal health service (four ANC, skilled birth attendance and PNC three) in the intervention and control clusters, assessed using standard questionnaire
|
42 days after delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Early Initiation of Antenatal care (Before 16 Weeks of Gestation)
Time Frame: 16 weeks of gestation
|
Proportion of mothers attending ANC before 16 weeks of gestation in the intervention and control clusters, assessed using 4-visit WHO ANC Model
|
16 weeks of gestation
|
|
Attending four antenatal care follow up, (36-40 weeks of gestation)
Time Frame: 40 weeks of gestation
|
Proportion of mothers attending the fourth ANC in the intervention and control clusters, assessed using 4-visit WHO ANC Model
|
40 weeks of gestation
|
|
Institutional delivery attended by skilled Birth attendance
Time Frame: after 40 weeks of gestation
|
Proportion of mothers attending institutional delivery in the intervention and control clusters, assessed using standard questionnaire
|
after 40 weeks of gestation
|
|
Postnatal care follow-up (First 6 hours, 6 days and 6 weeks of delivery)
Time Frame: 42 days after delivery
|
Proportion of mothers attending the third PNC in the intervention and control clusters: assessed using standard questionnaire
|
42 days after delivery
|
|
Knowledge towards maternal health service
Time Frame: 42 days after delivery
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Knowledge of mothers towards healthy pregnancy, delivery and the postnatal care period in the intervention and control clusters: assessed using Knowledge questionnaire
|
42 days after delivery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Netsanet Belete, Msc, Jimma University
- Study Director: Mulusew Gerbaba, PhD, Jimma University
- Study Director: Gurmesa Tura, PhD, Jimma University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Andargie NB, Debelew GT. Effectiveness of checklist-based box system intervention (CBBSI) versus routine care on improving utilization of antenatal care visits in Northwest Ethiopia: a cluster randomized controlled trial. BMC Health Serv Res. 2022 Apr 9;22(1):466. doi: 10.1186/s12913-022-07894-7.
- Andargie NB, Debelew GT. Effect of checklist based box system interventions on improving institutional delivery among reproductive age women in Northwest Ethiopia: generalized structural equation modeling. Arch Public Health. 2022 Jan 4;80(1):5. doi: 10.1186/s13690-021-00774-2.
- Andargie NB, Debelew GT. Effectiveness of checklist-based box system intervention (CBBSI) versus routine care on improving postnatal care utilization in Northwest Ethiopia: a cluster randomized controlled trial. Reprod Health. 2021 Nov 20;18(1):234. doi: 10.1186/s12978-021-01283-9.
- Andargie NB, Jebena MG, Debelew GT. Effectiveness of Checklist-Based Box System Interventions (CBBSI) versus routine care on improving utilization of maternal health services in Northwest Ethiopia: study protocol for a cluster randomized controlled trial. Trials. 2020 Feb 7;21(1):151. doi: 10.1186/s13063-019-4002-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 22, 2018
Primary Completion (Anticipated)
October 1, 2019
Study Completion (Anticipated)
November 1, 2019
Study Registration Dates
First Submitted
March 25, 2019
First Submitted That Met QC Criteria
March 25, 2019
First Posted (Actual)
March 26, 2019
Study Record Updates
Last Update Posted (Actual)
March 26, 2019
Last Update Submitted That Met QC Criteria
March 25, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- CBBSI/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Participant flow, outcome measure statistical analysis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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