Trial of Proactive Community Case Management to Reduce Child Mortality
Condition: Under-five Child Mortality; Access to Health Care
Study type: Interventional

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.
    

Intervention name(s): Proactive Community Case Management; Integrated Community Case Management; Removal of point-of-care user fees; Infrastructure improvements at primary health centre; Training of primary health centre staff
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): 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.; 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.; 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.; 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.; 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 name(s): ProCCM; iCCM; Removal of user fees; Improvements to health centre infrastructure; Clinical staff training at primary health centres
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Community Health Workers; Community Case Management; Proactive Case Detection; Under-five Child Mortality; Access to Health Care