Community Case Management of Chest Indrawing Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 4

Summary: 
      This one-arm safety intervention study is aimed at increasing access to treatment of
      pneumonia by training CHWs, locally referred to as Community Oriented Resource Persons
      (CORPs), to manage chest indrawing pneumonia using oral amoxicillin, conducting follow-ups
      and recording their findings in case report forms. CORPs will also be involved in improving
      care seeking for pneumonia in children by training them to conduct health education sessions
      for men and women in their respective communities.

      The primary objective is to assess if CORPs can safely and appropriately manage chest
      indrawing pneumonia in 2-59 month old children, and refer children with danger signs. The
      primary outcomes will be the proportion of children under five with chest indrawing pneumonia
      who were managed appropriately by CORPs and the clinical treatment failure of chest indrawing
      pneumonia. Secondary outcomes will include proportion of children with chest indrawing
      followed up by CORPs on day 3 and caregiver adherence to treatment for CI, and clinical
      relapse of pneumonia between day 7 to 14 among children whose signs of pneumonia disappeared
      by day 6. Approximately 308 children 2-59 months of age with chest indrawing pneumonia would
      be needed for this safety intervention study.
    

Detailed description: 
      OBJECTIVES AND RATIONALE This one-arm safety intervention study aims to establish whether
      CHWs in Nigeria can safely manage chest indrawing pneumonia in 2-59 month old children. The
      primary outcomes will be the proportion of children under five with chest indrawing pneumonia
      who were managed appropriately by Community Oriented Resources Persons (CORPs) and the
      clinical treatment failure by day 6. Secondary outcomes will include proportion of children
      with chest indrawing followed up by CORPs on day 3, clinical relapse of pneumonia between day
      7 to 14 and acceptability and satisfaction with outpatient management of chest indrawing
      pneumonia. A total of 308 children 2-59 months of age with chest indrawing pneumonia will be
      needed for this safety intervention study.

      EXPERIMENTAL DESIGN AND METHODOLOGY Introduction Malaria Consortium (MC) intends to implement
      the WHO study, funded under the Rapid Access Expansion 2015 programme (RAcE 2015), on
      community case management of chest indrawing pneumonia with oral amoxicillin in children aged
      2-59 months old by CORPs and submits this proposal for Niger state, Nigeria.

      Study area Proposed study population Niger State, located in Nigeria's North Central Zone, is
      geographically the largest of the country's states, covering 76,263 km2. The state has a
      projected population of almost 5 million. Children under five years make up 21% of the
      population, and pregnant women constitute 5%. The population is made up of Muslims,
      Christians with a small minority practising traditional beliefs. The majority of the
      population are spread across rural areas, with 30% of the population living in urban areas.
      Under WHO RAcE 2015 project MC is working with the Federal Ministry of Health (FMoH) to
      strengthen the iCCM programme in six (LGAs) in the three zones in Niger state: Paikoro; Rafi;
      Mariga; Rijau; Lapai; and Edati. The total population of the six LGAs is 1,245,939 of whom
      approximately 249,200 are children aged 2-59 months. Pneumonia remains the leading cause of
      under 5 child mortality in Nigeria which, together with India, contributes the highest
      absolute numbers of pneumonia deaths in the world, with 804,429 deaths in children under five
      years in 2013 (2). The expected incidence of clinical pneumonia in this area in Nigeria is
      0.28/child/year with an estimated 12% progressing to severe disease.

      Objectives and outcomes This one-arm safety intervention study aims to establish whether CHWs
      in Nigeria can safely and appropriately manage chest indrawing pneumonia in 2-59 month old
      children.

      Primary outcomes will be the proportion of children under five classified with chest
      indrawing pneumonia who were managed appropriately by Community Oriented Resources Persons
      (CORPs) and the clinical treatment failure of chest indrawing pneumonia by day 6.

      Secondary outcomes will include:

        -  Proportion of children classified with chest indrawing who were followed up by the CORPs
           on day 3

        -  Clinical relapse of pneumonia between day 7 to 14 among children whose signs of
           pneumonia disappeared by day 6

        -  CORPs' acceptability of and caregiver satisfaction with outpatient management of chest
           indrawing pneumonia

      Sample size and sampling Using the sample size calculation for a prevalence survey with
      finite population correction; an assumption that the proportion of the main indicator is 50%
      (to give the most conservative sample size); and a confidence interval of 95%, a total of 196
      children with chest indrawing will be needed to estimate overall proportion of children with
      chest indrawing pneumonia who experience treatment failure by day 6 with ±7% precision.
      Adjusting for a 10% non-response rate for caregivers, 10% erroneous enrolments, and a cluster
      effect of 1.3 in case more than one child is enrolled by one CORP, a total sample size of 308
      children under five with chest indrawing will be required. After 12 months of data
      collection, an interim analysis of the event rates (primary outcome) and enrolment rates is
      planned to assess progress towards the sample size target. Should it be discovered that the
      event rate is far off from the assumption of 0.5, the final sample size may be modified.

      With approximately 28,000 children 2-59 months old in the study area, assuming 7,840 fast
      breathing cases per year (0.28 episodes/child/year), and a 12% chest indrawing incidence the
      area would have approximately 940 chest indrawing cases per year. To enrol the 308 children
      with chest indrawing needed for the study during a 12 months study period we would need all
      the 203 CORPs in the LGA to see approximately 30% of the sick children in the community,
      which we believe is highly feasible given our experience with iCCM programmes uptake in other
      parts of Africa and the fact that we shall implement community mobilisation activities to
      support engagement with the study.

      Case identification by CORPs will be mainly through passive case detection and through
      periodic community outreach activities. Based on epidemiological data, over a period of study
      data collection of 12 months maximum, each CORP is anticipated to enrol 1-2 children with
      chest indrawing. CORPs will assess all children presenting to their house and manage them
      according to study protocol. All sick infants younger than 2 months will be referred to the
      reference facility. All children 2-59 months of age with chest indrawing but no danger signs
      will be considered eligible for enrolment in the study and consent will be obtained from the
      primary caregiver. CORPs will screen the children for study enrolment, and takes consent from
      the guardian of the child to take part in the study. If the caregiver of the eligible child
      has consented, the CORP prescribes dispersible amoxicillin according to age-specific
      standards, schedules follow-up visits for day 0 (<12hrs), 3, 6 and 15 with caregiver of
      enrolled child, attaches a unique identifier (UI) to the sick child recording form of
      enrolled child and copies the UI number onto all copies of the consent form and gives a
      missed call to the RA to notify them of enrolled child.

      The RA will visit the household of the child as soon as possible after the child has been
      enrolled and latest within 12 hours of enrolment by the CORP. Before going to the child's
      household, the RA will go to the CORP to verify the enrolment and get details of the child's
      location. The CORP will visit the child three days after enrolment (day 3) to ensure there is
      no deterioration in the child's condition and if necessary, refer the child to a health
      facility if symptoms have deteriorated. On day 6 and 15 after enrolment, RAs together with
      CORPs will visit all children enrolled and interview the caregivers using a mobile phone data
      collection form. Clinical relapse of pneumonia will be determined based on child's clinical
      condition assessed on day 15 (see table 4 for detailed definition of primary and secondary
      outcomes). If on any of the follow-up days, enrolled children cannot be found at home, the
      CORP/RA will follow up with the caregiver to find out where the child is, and make every
      effort to see the child, even if they are classified as lost to follow-up.

      Data collection, supervision and outcome assessment

      DAY 1:

      The CORPs' performance will be established through a re-assessment of the child by a research
      assistant (RA) who will visit the household of the child as soon as possible after the child
      has been enrolled and latest within 12 hours of enrolment by the CORP. The RA will use a
      tablet based sick child assessment tool which walks the RA through questions about the child,
      including current health status and symptoms present at the time of care seeking at the
      CORPs, treatment given by CORP, and other treatments provided for the current illness
      episode. A handheld pulse oximeter will be used by the RAs to detect symptoms of hypoxemia.
      If a child is found to have danger signs or hypoxemia, or any other illness that was not
      treated by the CORP, the RA will facilitate referral to the nearest health facility and will
      be excluded from the study. For children with chest indrawings referred by the CORPs because
      of suspected presence of danger signs, the RA will trace the child in the referral facility
      (or at home in case of referral refusal) to conduct the re-assessment visit. Children found
      not to have chest indrawing will continue the course of antibiotic they were already
      prescribed.

      DAY 3:

      Families of enrolled children will be encouraged to return to the CORPs on 3 days after
      enrolment for reassessment by the CORP, as is standard under iCCM. During the this visit, the
      CORP will reassess the child, record findings (including temperature and presence/absence of
      chest indrawing and other treatments, if any, received by the child), inquire and record if
      the caretaker provided the amoxicillin tablets according to the recommended treatment
      schedule, and counsel the mother to administer the next doses. If a child is not brought back
      on the scheduled visit day, the CORP will visit the child at home on day 3 and 6. If the CORP
      determines that the condition of an enrolled child has deteriorated, s/he will refer the
      child to the reference facility or call the supervisor for further evaluation. Data on a
      standard set of variables will be collected during each visit. The study supervisors will
      verify that visits are being made and information is being collected by reviewing data
      uploads on the back-end server.

      DAYS 6-15:

      On day 6 and 15 after enrolment, RAs and CORPs will visit all children enrolled and interview
      the caregivers using the mobile phone data collection form. Questions will include current
      health status (using the IMCI algorithm), adherence to treatment (using pill count), care
      providers visited after visiting the CORP, alternative treatments given (other than what CORP
      provided), and hospitalisation. Clinical relapse of pneumonia will be determined based on
      child's clinical condition assessed on day 15. If enrolled children cannot be found at home
      during the day 6 and day 15 visits, the RA will follow up with a phone call to the caregiver
      to ensure that there is no loss-to follow-up.

      Following the household visits on day 6 and 15, a selection of 25 CORPs and 25 child
      caregivers will be asked to participate in unstructured interviews to document CORPs'
      acceptability of and caregiver satisfaction with outpatient management of chest indrawing
      pneumonia.

      The study coordinator will visit all of the treatment failures (secondary outcome) for
      reassessment of the child.

      Monitoring and evaluation, including a summary of the data analysis plan A system for regular
      monitoring will be introduced to ensure that study activities are implemented as per plan,
      using approved operating procedures. CORP service statistics on patients seen and referrals
      made will be captured from both CORPs paper-based reports. This data will be compiled by a
      data manager, interpreted by the study coordinator and shared with program managers on a
      regular basis. The data manager will regularly review all data submissions for enrolled
      children, including checklists submitted by RAs on Day 0-1, 6 and 15, as well as follow-up
      forms submitted by CORPs on day 3. These submissions will be checked for completeness and
      accuracy before being anonymised by assigning each enrolled child a unique study number and
      using this number to store the case data in a project database. While all data collection
      forms will have inbuilt consistency and range checks, any additional discrepancies identified
      will be raised during supervision visits. An automatically generated report containing
      information on children enrolled, children followed up and children who died, had clinical
      treatment failure or who had a clinical relapse of pneumonia will be generated for review on
      a monthly basis and be made available to the PIs, co-investigators and the donor.
    

Intervention name(s): Oral amoxicillin for CI pneumonia
Intervention type(s): Drug
Intervention description(s): CHW management of chest indrawing (CI) pneumonia in children 2-59 months old using oral amoxicillin, given in the following age specific dosage:
2 months ≤ children age <12 months (4 - <10kg): one (1) tablet 250mg dispersible amoxicillin twice daily (morning and evening) for 5 days.
12 months≥ children age <3 years (10 kg - <14 kg): two (2) tablets 250mg dispersible amoxycillin taken twice daily (morning and evening) for 5 days.
≥ 3 years of age children <5 years (14kg - 19kg): three (3) tablets 250mg dispersible amoxycillin taken twice daily (morning and evening) for 5 days.
Other intervention name(s): Intervention arm
Intervention MeSH terms: Amoxicillin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Integrated Community Case Management; Community Health Worker; Nigeria