Brief Summary
The general objective of this study is to optimize implementation and assess effectiveness of the integrated facility and community-based health systems strengthening (ICBHSS) model in four Northern Togo districts, using the RE-AIM implementation science framework. Specific study aims include: (1) Analyze longitudinal changes regarding maternal and child health outcomes, health service utilization rates, and public sector facility readiness in the ICBHSS model intervention sites catchment areas; (2) Identify barriers to and facilitators of access and quality services related to ICBHSS model; and (3) Assess changes in health care services coverage, effectiveness, and adoption of ICBHSS model. These findings are expected to contribute to continuous quality improvement initiatives, optimize implementation factors, provide generalizable knowledge regarding health service delivery, and accelerate health systems improvements in Togo and more broadly.
Brief Title
Integrated Community Based Health Systems Strengthening in Northern Togo
Detailed Description
Background: Over the past decade the burden of poor maternal and child health outcomes in Togo, particularly in the Northern regions, have remained high despite global progress. The principal causes of under-5 deaths in Togo are diseases with effective and low-cost prevention and or treatment strategies, including malaria (18%), acute lower respiratory infections (15%), and diarrheal diseases (8%).While Togo has an official plan for the integrated management of childhood illness (IMCI), including a permissive policy on integrated community case management (iCCM), challenges in implementation persist with low public sector health service utilization.There are critical gaps in access and quality of community health systems throughout the country and an urgent need to improve health outcomes through expanding access and quality of services.
Intervention: The investigators have adapted an integrated facility and community-based health systems strengthening (ICBHSS) model to improve primary healthcare services in Togo. The ICBHSS model includes a bundle of evidence based interventions including (1) community engagement meetings and feedback; (2) the elimination of facility user fees for children under five and pregnant women; (3) pro-active community based IMCI using Community Health Workers (CHWs) with additional services including linkage to family planning and counseling, HIV testing \& referrals; (4) clinical mentoring and enhanced supervision at public sector facilities; and (5) improved supply chain management and facility structures. In 2015, a pilot ICBHSS initiative was launched in partnership with the Ministry of Health (MOH) at four public sector clinics in Northern Togo. Preliminary results from this pilot intervention suggested a meaningful reduction in children under-5 deaths, with a trend in reduction for under-one deaths as well as increased health service utilization at all 4 sites. In collaboration with MOH and technical partners, IH developed a plan to expand the ICBHSS model to 21 distinct health facilities over a four-year period in four additional districts: Bassar, Binah, Dankpen, and Kéran. The planned roll out includes expanding into a new district every 12 months based on budgetary and feasibility considerations. As part of this expansion planned for 2018, Integrate Health (IH) and MOH partners are planning an implementation study to both improve service delivery at expansion sites and inform national scale strategies.
Study: The investigators will conduct a mixed methods assessment, using the RE-AIM framework to evaluate the impact and implementation of the ICBHSS initiative in 4 districts. Consists of three key components: (1) a stepped-wedge randomized cluster pragmatic control trial to obtain annual coverage, effectiveness, and adoption metrics using a population-based household survey, (2) health facility assessments to be completed at the cluster (district) level for each health facility prior to intervention launch and post-intervention, and (3) key informant interviews conducted at 12, 24, 48 months for each cluster. The primary outcome will be under 5 year old mortality rate, with secondary outcomes including under-one mortality rate, maternal mortality rate, as well as maternal and child health service utilization.
Intervention: The investigators have adapted an integrated facility and community-based health systems strengthening (ICBHSS) model to improve primary healthcare services in Togo. The ICBHSS model includes a bundle of evidence based interventions including (1) community engagement meetings and feedback; (2) the elimination of facility user fees for children under five and pregnant women; (3) pro-active community based IMCI using Community Health Workers (CHWs) with additional services including linkage to family planning and counseling, HIV testing \& referrals; (4) clinical mentoring and enhanced supervision at public sector facilities; and (5) improved supply chain management and facility structures. In 2015, a pilot ICBHSS initiative was launched in partnership with the Ministry of Health (MOH) at four public sector clinics in Northern Togo. Preliminary results from this pilot intervention suggested a meaningful reduction in children under-5 deaths, with a trend in reduction for under-one deaths as well as increased health service utilization at all 4 sites. In collaboration with MOH and technical partners, IH developed a plan to expand the ICBHSS model to 21 distinct health facilities over a four-year period in four additional districts: Bassar, Binah, Dankpen, and Kéran. The planned roll out includes expanding into a new district every 12 months based on budgetary and feasibility considerations. As part of this expansion planned for 2018, Integrate Health (IH) and MOH partners are planning an implementation study to both improve service delivery at expansion sites and inform national scale strategies.
Study: The investigators will conduct a mixed methods assessment, using the RE-AIM framework to evaluate the impact and implementation of the ICBHSS initiative in 4 districts. Consists of three key components: (1) a stepped-wedge randomized cluster pragmatic control trial to obtain annual coverage, effectiveness, and adoption metrics using a population-based household survey, (2) health facility assessments to be completed at the cluster (district) level for each health facility prior to intervention launch and post-intervention, and (3) key informant interviews conducted at 12, 24, 48 months for each cluster. The primary outcome will be under 5 year old mortality rate, with secondary outcomes including under-one mortality rate, maternal mortality rate, as well as maternal and child health service utilization.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
646-397-0217
Central Contact Email
mlauria@integratehealth.org
Central Contact Role
Contact
Central Contact Email
kfiori@integratehealth.org
Completion Date
Completion Date Type
Estimated
Conditions
Maternal and Child Health
Health Service Utilization
Eligibility Criteria
Inclusion Criteria:
* Female of reproductive age (aged 15-49 years)
* Individuals aged 15-17 years will only be included if they have children and/or are pregnant
* Lives in selected household within study catchment area
* Informed consent is obtained for participants 18-49
* Waiver of parental permission is obtained for 15-17 year-old participants
Exclusion Criteria:
* None
* Female of reproductive age (aged 15-49 years)
* Individuals aged 15-17 years will only be included if they have children and/or are pregnant
* Lives in selected household within study catchment area
* Informed consent is obtained for participants 18-49
* Waiver of parental permission is obtained for 15-17 year-old participants
Exclusion Criteria:
* None
Inclusion Criteria
Inclusion Criteria:
* Female of reproductive age (aged 15-49 years)
* Individuals aged 15-17 years will only be included if they have children and/or are pregnant
* Lives in selected household within study catchment area
* Informed consent is obtained for participants 18-49
* Waiver of parental permission is obtained for 15-17 year-old participants
* Female of reproductive age (aged 15-49 years)
* Individuals aged 15-17 years will only be included if they have children and/or are pregnant
* Lives in selected household within study catchment area
* Informed consent is obtained for participants 18-49
* Waiver of parental permission is obtained for 15-17 year-old participants
Gender
Female
Gender Based
false
Keywords
Child Mortality
Reproductive, Maternal, Newborn, and Child Health
Community Health Workers
Implementation Research
Health Systems Strengthening
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
49 Years
Minimum Age
15 Years
NCT Id
NCT03694366
Org Class
Other
Org Full Name
Integrate Health
Org Study Id
ICBHSS
Overall Status
Unknown status
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Integrated Community Based Health Systems Strengthening in Northern Togo: A Stepped-Wedge Randomized Cluster Pragmatic Control Trial
Primary Outcomes
Outcome Description
The under-five mortality rate (expressed as a rate per 1,000 live births) is the probability of a child dying in a specified year between birth and 5 years of age.
Outcome Measure
Under-five year old mortality rate
Outcome Time Frame
48 months
Secondary Outcomes
Outcome Description
The under-one mortality rate (expressed as a rate per 1,000 live births) is the probability of a child dying in a specified year between birth and 1 year of age.
Outcome Time Frame
48 months
Outcome Measure
Under-one year old mortality rate
Outcome Description
The maternal mortality rate (expressed as a rate per 100,000 live births) is the probability of a mother dying in a specified year within 42 days of pregnancy termination .
Outcome Time Frame
48 months
Outcome Measure
Maternal mortality rate
Outcome Description
The number of febrile children under-five who received an effective antimalarial treatment within 24 hours of symptom onset out of the total number of children under age five reported to be febrile in the prior two weeks.
Outcome Time Frame
48 months
Outcome Measure
Proportion of children under age five reported to be febrile in the prior two weeks who received an effective antimalarial treatment within 24 hours of symptom onset.
Outcome Description
The number of children under-five who received an effective pneumonia treatment within 24 hours of symptom onset out of the total number of children under age five reported to have a cough in the prior two weeks.
Outcome Time Frame
48 months
Outcome Measure
Proportion of children under age five reported to have a cough in the prior two weeks who received an effective pneumonia treatment within 24 hours of symptom onset.
Outcome Description
The number of children under-five who received an effective treatment for diarrheal disease within 24 hours of symptom onset out of the total number of children under age five reported to have diarrhea in the prior two weeks.
Outcome Time Frame
48 months
Outcome Measure
Proportion of children under age five reported to have diarrhea in the prior two weeks who received an effective treatment for diarrheal disease within 24 hours of symptom onset.
Outcome Description
The proportion of women reported to have delivered in a health facility.
Outcome Time Frame
48 months
Outcome Measure
Maternal facility based birth delivery incidence rate
Outcome Description
The average adherence by IH community health workers to evidence based protocols for iCCM and maternal consultations.
Outcome Time Frame
48 months
Outcome Measure
Protocol Adherence by IH community health workers in iCCM and maternal consultations
Outcome Description
The average adherence by public sector clinical staff at IH intervention sites to evidence based protocols for iCCM and maternal consultations.
Outcome Time Frame
48 months
Outcome Measure
Protocol adherence by clinical staff at IH intervention facilities in iCCM and maternal consultations
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Females of reproductive age (aged 15-49 years) who reside in a selected household within the study catchment area.
Std Ages
Child
Adult
Locked Fields
Render the field
Maximum Age Number (converted to Years and rounded down)
49
Minimum Age Number (converted to Years and rounded down)
15
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kevin Fiori
Investigator Email
kfiori@montefiore.org
Investigator Phone
718-920-8133