Trial of Proactive Community Case Management to Reduce Child Mortality
NCT ID: NCT02694055
Last Updated: 2023-06-12
Study Results
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Basic Information
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COMPLETED
NA
135149 participants
INTERVENTIONAL
2016-12-31
2020-07-31
Brief Summary
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Village-clusters will be randomised to receive Integrated Community Case Management (iCCM) from a passive CHW or Proactive Community Case Management (ProCCM) from a CHW that conducts daily active case finding home visits. All villages in both study arms will receive additional interventions that could significantly reduce under-five mortality, including removal of point-of-care fees, clinical staff training at primary health centres, and improvement in primary health centre infrastructure.
All women of reproductive age eligible for inclusion in the study will be surveyed at baseline, and again at 12, 24 and 36 months. The study hypothesis is a significant reduction in child mortality in both study arms, with a significantly larger reduction where there is proactive case detection, or ProCCM, by CHWs. A survey of all women enrolled in the three-year study (eligible and consenting) has 82% power to detect an absolute difference in under-five mortality of 0.75% (a relative difference of 25%) between the two study arms.
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Detailed Description
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Clusters were randomised to receive either iCCM from a stationary CHW based at a community health post (control) or ProCCM from a CHW who conducts daily active case-finding home visits for at least two hours a day, six days per week. Randomisation was stratified by distance to PHC (1.0-5.0 km vs. greater than 5.0 km); an additional stratum was defined for all villages where the PHC was located to ensure balanced assignment of PHC villages across arms. Within each strata, villages were randomly assigned to the control or treatment arm using a computer-generated random number, then rank ordered based on this number.
All clusters receive PHC infrastructure improvements and staff training, the removal of user fees at all levels of care, and CHW(s) who provide iCCM of common childhood illnesses in accordance with national and international standards, as well as other community-based services, including a reproductive health package for women of child-bearing age. CHW coverage is based on Mali's national iCCM strategy, which assigns each CHW to an average population of 700 in the southern region. Clusters with less than 200 people and within three kilometres of another cluster assigned to the same study arm share a CHW, provided there is no geographic barrier (i.e. river) between the two clusters and no linguistic barrier for the CHW. CHWs in both arms are required to be on call, available to receive and care for patients who seek them out, 24 hours per day, seven days per week.
The primary outcome is a cluster-level outcome, the under-five mortality rate. It is measured within each cluster as the number of deaths among children under five years of age per 1,000 person-years at risk of mortality. After 36 months, we hypothesize that there will be an absolute difference of 0.75% (or a relative difference of 25%) in under-five child mortality between the two study arms, as measured by the number of deaths per 1,000 person-years among children aged 0 to 59 months. Secondary endpoints include a number of reproductive, maternal, and child health outcomes, as well as access and service delivery outcomes. Secondary objectives also include an economic evaluation of the cost-effectiveness, equity, and affordability at scale of ProCCM compared to iCCM.
An exhaustive census will be administered to the population of the study area (both arms) at baseline. The census will assign a unique identification number to each person surveyed. At each household, a screening will take place to identify women eligible for inclusion. Eligible women identified in the study area will be asked to give written informed consent for their inclusion in the study (or their legal guardians in the case of unemancipated minors). The baseline survey will be administered after consent is obtained. Using the unique census ID number, the same participants will be identified and surveyed again at 12, 24 and 36 months.
The survey tool is excerpted and adapted from Mali's Demographic and Health Survey. The survey tool will collect qualitative and quantitative data on health seeking behaviour and health outcomes. It will include a life-table tracking all live births occurring in the 59 months prior to enrolment and during the 36 months of study follow up. Surveyors will not be members of the villages they survey, nor will they be members of the intervention health care delivery staff. All surveyors will be female, as the survey tool contains potentially sensitive questions on family planning.
Community Health Workers will collect data on the number of active case finding visits they conduct, the number of patients they treat, the delay from symptom onset to treatment onset for each patient, the gestational age at pregnancy diagnosis and first prenatal consultation, and the care services they provide. This data is collected during patient care by CHWs on smartphones using the Medic Mobile for CHWs platform customized for ProCCM. Primary care health centre providers will collect patient care data per village on an electronic medical records system.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Proactive Community Case Management (ProCCM)
Villages assigned to the experimental arm will receive the following health system strengthening interventions: training of primary health centre staff, infrastructure improvements at primary health centre, removal of point-of-care user fees, and the presence of Community Health Workers providing proactive case detection in addition to integrated Community Case Management (ProCCM).
Proactive Community Case Management
CHWs will be trained and deployed to conduct daily active case finding home visits door-to-door for at least two hours each day, with the goal of visiting each household at least two times each month. At these active case finding home visits, CHWs will screen each household of sick children and will offer home pregnancy testing and family planning services to reproductive aged women. For patients they identify, they will offer counselling, diagnostic services, care, accompaniment, and referral according to an iCCM service delivery package.
Removal of point-of-care user fees
User fees will be removed across the catchment areas for both study and control villages. No fees will be charged for care by CHWs or at all primary care centres.
Infrastructure improvements at primary health centre
Targeted infrastructure improvements to rehabilitate, expand and equip the capacity of the seven government primary care centres in the study area. Each health center will be equipped with solar power.
Training of primary health centre staff
Health center staff will receive targeted training in
* Integrated management of childhood illness
* Diagnosis and treatment of simple and severe cases of malaria
* Helping babies breathe
* Managing post-partum haemorrhage
* Gestational dating using frontal height, last menstrual period and ultrasound
* Family planning counselling and administration of long-acting contraceptives
* Pharmacy stock management
* Health center management
integrated Community Case Management (iCCM)
Villages assigned to the active comparator arm will receive the following health system strengthening interventions: training of primary health centre staff, infrastructure improvements at primary health centre, removal of point-of-care user fees, and the presence of Community Health Workers providing passive integrated Community Case Management (iCCM) exclusively at a fixed health post to patients who initiate their own care-seeking.
Integrated Community Case Management
CHWs will be trained offer counselling, diagnostic services, care, accompaniment, and referral according to an iCCM service delivery package to patients that visit them at their work post.
Removal of point-of-care user fees
User fees will be removed across the catchment areas for both study and control villages. No fees will be charged for care by CHWs or at all primary care centres.
Infrastructure improvements at primary health centre
Targeted infrastructure improvements to rehabilitate, expand and equip the capacity of the seven government primary care centres in the study area. Each health center will be equipped with solar power.
Training of primary health centre staff
Health center staff will receive targeted training in
* Integrated management of childhood illness
* Diagnosis and treatment of simple and severe cases of malaria
* Helping babies breathe
* Managing post-partum haemorrhage
* Gestational dating using frontal height, last menstrual period and ultrasound
* Family planning counselling and administration of long-acting contraceptives
* Pharmacy stock management
* Health center management
Interventions
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Proactive Community Case Management
CHWs will be trained and deployed to conduct daily active case finding home visits door-to-door for at least two hours each day, with the goal of visiting each household at least two times each month. At these active case finding home visits, CHWs will screen each household of sick children and will offer home pregnancy testing and family planning services to reproductive aged women. For patients they identify, they will offer counselling, diagnostic services, care, accompaniment, and referral according to an iCCM service delivery package.
Integrated Community Case Management
CHWs will be trained offer counselling, diagnostic services, care, accompaniment, and referral according to an iCCM service delivery package to patients that visit them at their work post.
Removal of point-of-care user fees
User fees will be removed across the catchment areas for both study and control villages. No fees will be charged for care by CHWs or at all primary care centres.
Infrastructure improvements at primary health centre
Targeted infrastructure improvements to rehabilitate, expand and equip the capacity of the seven government primary care centres in the study area. Each health center will be equipped with solar power.
Training of primary health centre staff
Health center staff will receive targeted training in
* Integrated management of childhood illness
* Diagnosis and treatment of simple and severe cases of malaria
* Helping babies breathe
* Managing post-partum haemorrhage
* Gestational dating using frontal height, last menstrual period and ultrasound
* Family planning counselling and administration of long-acting contraceptives
* Pharmacy stock management
* Health center management
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Permanently living in the study area
* No plans to leave the study area in the subsequent three years
* Written informed consent is obtained
Exclusion Criteria
* Plans to leave study area in the subsequent three years
15 Years
49 Years
FEMALE
Yes
Sponsors
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Muso, Inc.
UNKNOWN
Malaria Research and Training Center, Bamako, Mali
OTHER
University of California, Berkeley
OTHER
University of Michigan
OTHER
Instituto Nacional de Salud Publica, Mexico
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Ministère de la Santé et l'Hygiène Publique, Mali
UNKNOWN
London School of Hygiene and Tropical Medicine
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Ari D Johnson, MD
Role: STUDY_CHAIR
University California San Francisco
Kassoum Kayantao, PhD
Role: PRINCIPAL_INVESTIGATOR
Malaria Research & Training Centre, University of Bamako
Nancy S Padian, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Public Health University of California San Francisco
References
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Johnson AD, Thomson DR, Atwood S, Alley I, Beckerman JL, Kone I, Diakite D, Diallo H, Traore B, Traore K, Farmer PE, Murray M, Mukherjee J. Assessing early access to care and child survival during a health system strengthening intervention in Mali: a repeated cross sectional survey. PLoS One. 2013 Dec 11;8(12):e81304. doi: 10.1371/journal.pone.0081304. eCollection 2013.
Ogbuoji O, Shahid M, Zimmerman A, Liu JX, Kayentao K, Whidden C, Treleaven E, Traore C, Sogoba M, Doumbia S, Boettiger DC, Cisse AB, Keita Y, Berthe M, Johnson A. Cost-effectiveness analysis of proactive home visits compared with site-based community health worker care on antenatal care outcomes in Mali: a cluster-randomised trial. BMJ Glob Health. 2024 Dec 27;9(12):e014940. doi: 10.1136/bmjgh-2023-014940.
Ghosh R, Konipo AN, Treleaven E, Rozenshteyn S, Beckerman J, Whidden C, Johnson A, Kayentao K, Liu J. Factors influencing pregnancy care and institutional delivery in rural Mali: a secondary baseline analysis of a cluster-randomised trial. BMJ Open. 2024 Apr 9;14(4):e084315. doi: 10.1136/bmjopen-2024-084315.
Whidden C, Kayentao K, Kone N, Liu J, Traore MB, Diakite D, Coumare M, Berthe M, Guindo M, Greenwood B, Chandramohan D, Leyrat C, Treleaven E, Johnson A. Effects of proactive vs fixed community health care delivery on child health and access to care: a cluster randomised trial secondary endpoint analysis. J Glob Health. 2023 Apr 21;13:04047. doi: 10.7189/jogh.13.04047.
Kayentao K, Ghosh R, Guindo L, Whidden C, Treleaven E, Chiu C, Lassala D, Traore MB, Beckerman J, Diakite D, Tembely A, Idriss BM, Berthe M, Liu JX, Johnson A. Effect of community health worker home visits on antenatal care and institutional delivery: an analysis of secondary outcomes from a cluster randomised trial in Mali. BMJ Glob Health. 2023 Mar;8(3):e011071. doi: 10.1136/bmjgh-2022-011071.
Oliphant NP, Manda S, Daniels K, Odendaal WA, Besada D, Kinney M, White Johansson E, Doherty T. Integrated community case management of childhood illness in low- and middle-income countries. Cochrane Database Syst Rev. 2021 Feb 10;2(2):CD012882. doi: 10.1002/14651858.CD012882.pub2.
Whidden C, Treleaven E, Liu J, Padian N, Poudiougou B, Bautista-Arredondo S, Fay MP, Samake S, Cisse AB, Diakite D, Keita Y, Johnson AD, Kayentao K. Proactive community case management and child survival: protocol for a cluster randomised controlled trial. BMJ Open. 2019 Aug 26;9(8):e027487. doi: 10.1136/bmjopen-2018-027487.
Related Links
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Muso is an international non-governmental organization working to strengthen the health care system in Mali
Other Identifiers
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Pro-CCM-028
Identifier Type: -
Identifier Source: org_study_id
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