Operational Research Management for Children With Severe Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      The investigators Study Hypothesis is introduction of modified IMCI guideline for managing
      severe pneumonia in first level health facilities will result in 40% increase in the
      appropriate management (appropriate case management at the first level facility and referral
      compliance by the caregivers) of severe pneumonia cases in the intervention arm compared to
      the comparison arm.
    

Detailed description: 
      The IMCI was implemented in Bangladesh in 2001. Bangladesh adapted the generic IMCI clinical
      guidelines which recommend that children with one or more danger signs, or any other severe
      condition, as identified by the health worker of the first level facility will be referred
      urgently. Although the quality of care achieved in ten IMCI facilities in Matlab, Bangladesh
      was assessed as high ( El Arifeen 2004) the rates of compliance with referral found to be
      low. In 2002-03 the compliance rates were less than 37% and had decreased to 17% by the end
      of 2003 (El Arifeen S, unpublished data). In many settings, children who are referred do not
      actually attend hospital, which severely limits their appropriate care. This is mainly
      because the higher level facilities are geographically inaccessible; financial and social
      constraints also prevent care givers to comply with the referral advice.

      The Govt of Bangladesh is presently planning to modify the current IMCI guideline. The
      modified guideline recommends that treatment of all severe pneumonia cases without danger
      signs unless there is another severe classification will be done at the first level facility.
      In 2004 the Govt. of Bangladesh in collaboration with ICCDR,B carried out a pilot study in
      rural Bangladesh (Chowdhury, El Arifeen et al. 2008) to assess the safety and effectiveness
      of a modified IMCI clinical management guideline for children with severe pneumonia aged
      2months - 5 years. The study concluded that appropriate management of severe pneumonia at
      local level could not only save lives but represent a major cost decrease through reduction
      of referral, treatment and admission costs. Another research conducted in Pakistan, a
      randomized equivalency trial revealed that community management of pneumonia through home
      treatment with high-dose oral amoxicillin was just as effective as current hospital based
      treatments for severe pneumonia (Hazir et al. 2008). Although all of these findings are very
      encouraging, none of the study really focused on the immediate outcomes of the IMCI such as
      improved care seeking, adherence of the health providers and household caregivers to the
      algorithmic protocol and understanding the barriers and facilitators to the use of this
      protocol. Moreover, these studies were conducted in controlled research settings and
      therefore do not provide adequate understanding of the challenges and potential of
      implementing IMCI in routine health systems. So there is need to carry out research in actual
      community settings to understand what components of this modified guideline will work in
      'real life situations' taking into account all the challenges and constraints faced by health
      systems of developing countries like Bangladesh.

      The primary objectives of our study are to assess adherence of service providers to the
      modified IMCI guideline for managing severe pneumonia among under-5 children and care-givers'
      compliance with referral advice given by the health providers after initial care-seeking for
      under-5 children with severe pneumonia. The secondary objectives will be to measure the
      resulting changes in the care-seeking pattern for childhood pneumonia due to the introduction
      of modified IMCI guideline

      Two MNCS programme upazilas will be purposively selected for this study in consultation with
      GoB and partners. The likely districts from where the two upazilas will be selected are
      Sherpur and Gopalganj. Twenty unions (average population of about 20,000) will be identified
      from the selected upazilas and randomly assigned to intervention or comparison arms. The
      intervention and evaluation will continue for 15 months. This will be a cluster randomized
      trial. Of the 20 selected study unions, 10 unions will be randomly assigned to intervention
      and 10 to comparison, that is, about 200,000 population (~40,000 households) in each arm.
      Each geographically delimited union has a Union Health and Family Welfare Centre (UHFWC) and
      family welfare centre (FWC), servicing the population residing within it. Health providers on
      the intervention arm will be trained regarding modification in the IMCI guideline. The
      training will not address any other aspect of the IMCI Training. Training on standard IMCI
      guideline will only be given to the health providers of both the arms, if not received
      before. Figure 1 (source: Chowdhury et al 2008) describes the modified and standard IMCI
      guideline. Under the modified guideline a sick child aged 2-59 months with severe pneumonia
      should be referred only if it accompanies with danger signs, stridor or any other sign or
      symptoms of other severe classification. All other children with severe pneumonia should be
      treated at the first level health facility with oral antibiotic (amoxicillin).

      The unions belonging to the comparison arm will continue following the standard IMCI
      guideline. To measure the outcome of the interventions, the study will involve the following
      methods: Health facility survey including health providers' survey; extraction and review of
      health facility service records for provider compliance; routine surveillance for collection
      of information on care-seeking for childhood pneumonia; tracking and structured interview of
      severe pneumonia cases seen at facilities Details of the MNCS intervention package and
      delivery systems can be found in Annex I. All the MNCS upazilas have also already implemented
      facility-based IMCI.

      All drugs in the study protocol are listed drugs of Bangladesh Government. The Study will
      ensure adequate and timely supplies of all drugs and other minimum essential logistics in all
      health facilities in the study area. The health facilities will be monitored on an ongoing
      basis by field supervisors, who will visit each facility once a month.
    

Intervention name(s): Amoxycilline, Cephradine followed by follow up on day 3; Injectable ampicillin followed by urgent referral
Intervention type(s): Other; Other
Intervention description(s): Modified IMCI Guideline for treating severe phnemonia will be implemented in the arm 1. The Modified IMCI guideline denotes that all severe pneumonia cases with only chest indrawing and no other danger signs will be treated at the first level health facilities with first line oral antibiotics followed by follow-up on 3rd day. On 3rd day the patient will be reassessed and if the condition improves the first line antiobiotic will be continued and if deteriorates or remain unchange second line antibiotic will be used. The patient will be further asked to come on day 3 for reassessment.; Existing IMCI guideline denotes all severe pneumonia cases will be referred to the 1st level referral facilities after giving first dose of injectable antibiotics
Other intervention name(s): Fimoxyl; Ficillin, ampicillin
Intervention MeSH terms: Ampicillin; Cephradine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Severe Pneumonia; Pneumonia; ARI; IMCI; Modified IMCI; 1st level Health facilities; Children; Operational Research; Bangladesh; Treatment of Severe Pneumonia