Clinical trial NCT02694055: Trial of Proactive Community Case Management to Reduce Child Mortality
Official title: Proactive Community Case Management and Child Survival: A Cluster-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Under-five Child Mortality
Access to Health Care
Keywords: Community Health Workers
Community Case Management
Proactive Case Detection
Under-five Child Mortality
Access to Health Care
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Muso, Inc.
name: Malaria Research and Training Center, Bamako, Mali
name: University of California, Berkeley
name: University of Michigan
name: Instituto Nacional de Salud Publica, Mexico
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Ministère de la Santé et l'Hygiène Publique, Mali
name: London School of Hygiene and Tropical Medicine
First posted: 2016-02-29
Enrollment: 135149
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate whether the addition of Proactive Case Detection to Community Case Management will provide an increase in early access to health care and a reduction in deaths among children aged 0-59 months. Integrated Community Case Management is the package of community-based services for children delivered by Community Health Workers (CHW), including diagnosis and treatment of malaria, pneumonia, diarrheal disease and malnutrition. In many iCCM interventions, CHWs are stationed in their villages and available in a passive, reactive manner to provide care to patients who seek them out. This study seeks to determine whether the addition of proactive case detection by CHWs to a standard iCCM intervention (ProCCM), in which they conduct daily door-to-door home visits to find and care for patients, will improve early access to care and reduce child mortality.

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.

Detailed description: The trial is an un-blinded, cluster-randomised controlled trial, with 69 clusters in the intervention arm and 68 clusters in the comparison arm. The cluster is defined as a geographical grouping of homes greater than one kilometre from the next nearest geographical grouping of homes (determined by the cardinal distances between GPS coordinates collected at the public gathering space). In practice, this means a cluster can consist of one village or one hamlet, or a collection of neighbouring villages and/or hamlets.

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.

Eligibility criteria: Inclusion Criteria:

* Reproductive age women (aged 15-49 years)
* 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:

* Non-permanent community members (i.e. seasonal migrants)
* Plans to leave study area in the subsequent three years

Primary outcomes:
measure: Difference in the under-five child mortality rate between the two study arms
timeFrame: 36 months
Secondary outcomes:
measure: Difference in the infant mortality rate between the two study arms
timeFrame: 36 months
measure: Difference in the newborn mortality rate between the two study arms
timeFrame: 36 months
measure: Difference in the maternal mortality rate between the two study arms
timeFrame: 36 months
measure: Difference in the percentage of women receiving 3 or more doses of SP during their last pregnancy between the two study arms
timeFrame: 36 months
measure: Difference in the percentage of under-five children with fever in the prior two weeks who receive testing and/or effective treatment for malaria within 24 hours of symptom onset between the two study arms
timeFrame: 36 months
measure: Difference in the percentage of children under five with diarrhea in the past two weeks who received zinc and oral rehydration therapy within 24 hours of symptom onset between the two study arms
timeFrame: 36 months
measure: Difference in the percentage of children with acute respiratory illness evaluated by a qualified provider within 24 hours of symptom onset between the two study arms
timeFrame: 36 months
measure: Difference in the percentage of the population accessing CHW or health centre care per month between the two study arms
timeFrame: 36 months
measure: Difference in the percentage of the population visiting the health centre per month between the two study arms
timeFrame: 36 months
measure: Difference in the percentage of population receiving CHW health care per month between the two study arms
timeFrame: 36 months
measure: Difference in the percentage of the health care seeking population who receive CHW care per month between the two study arms
timeFrame: 36 months
measure: Difference in the number of curative consultations per year at the community and health centre level between the two study arms
timeFrame: 36 months
measure: Difference in the percentage pregnant women completing four or more prenatal consultations between the two study arms
timeFrame: 36 months
measure: Difference in the average gestational age at first prenatal consultation between the two study arms
timeFrame: 36 months
measure: Difference in the percentage of participants using modern method of a family planning between the two study arms
timeFrame: 36 months
Other outcomes:
measure: Cost-effectiveness ratios of i-CCM and Pro-CCM
timeFrame: 36 months
measure: Equity implications of i-CCM and Pro-CCM
timeFrame: 36 months
measure: Affordability of Pro-CCM at scale
timeFrame: 36 months
Locations:
Study officials:
affiliation: University California San Francisco
name: Ari D Johnson, MD
role: STUDY_CHAIR
affiliation: Malaria Research & Training Centre, University of Bamako
name: Kassoum Kayantao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Public Health University of California San Francisco
name: Nancy S Padian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.