Checklist Based Box System Interventions

NCT ID: NCT03891030

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-22
• Study Completion Date: 2019-11-30

Brief Summary

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.

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.

Conditions

Maternal Health Service

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Checklist Based Box system intervention

Intervention Type: OTHER

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.

Routine maternal health care

Pregnant mothers in this arm will receive the usual routine maternal health care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Checklist Based Box system intervention

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Armauer Hansen Research Institute (AHRI)

UNKNOWN

Sponsor Role: collaborator

Jimma University

OTHER

Sponsor Role: lead

Responsible Party

Netsanet Belete

Msc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Netsanet Belete, Msc

Role: PRINCIPAL_INVESTIGATOR

Jimma University

Mulusew Gerbaba, PhD

Role: STUDY_DIRECTOR

Jimma University

Gurmesa Tura, PhD

Role: STUDY_DIRECTOR

Jimma University

Locations

East Gojjam zone

Debre Markos, Northwest, Ethiopia

Site Status: RECRUITING

Countries

Ethiopia

Central Contacts

Netsanet Belete, Msc

Role: CONTACT

netsanetb2009@gmail.com

+25148075941

Mulusew Gerbaba, PhD

Role: CONTACT

mulusew.gerbaba@gmail.com

+251940625429

Facility Contacts

Aklog Nigussie, Bsc

Role: primary

Aklog.nigussie@gmail.com

Feteh Sendek, Bsc

Role: backup

References

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.

Reference Type: DERIVED

PMID: 35397607 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34983665 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34801045 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32033576 (View on PubMed)

Other Identifiers

CBBSI/2019

Identifier Type: -

Identifier Source: org_study_id