Improving the Quality of Care for Children With Acute Malnutrition in Uganda

Study Overview
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Brief Summary
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This is a cluster RCT in 6 health centres in Uganda, testing supportive supervision to improve health outcomes and quality of care of children with malnutrition

Detailed Description
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Introduction Malnutrition in children is highly prevalent in West Nile Region. According to a recent analysis of data available from the health management information system (HMIS) and official registers, the health outcomes of children suffering from malnutrition and treated at health center (HC) level in Arua Region are not reaching the international standards (75% cured rate as for the international SPHERE standards). This despite the availability of clear national guidelines for treatment, thus suggesting possible deficiencies in the quality of care provided. Lack of supportive supervision may be one of the reason explaining substandard outcomes. Methods This is a cluster randomised controlled trail (RCT) with health centers (HC) as unit of randomisation. The six largest HC in Arua district will be randomised in two groups, intervention (quality improvement group) and control. The intervention will aim at improving the quality of care provided at HC level, and as a consequence, the health outcomes of children. The main intervention will consist of enhances nutritional supervision (high frequency supervision, specific to nutritional services), while the control will be standard care (no intervention). Complementary intervention will include training and networking activities for HC staff. Outcomes of the study will include: health outcomes (recovered, non recovered, defaulters, transferred, died); process outcomes (satisfaction and knowledge of staff); cost outcomes (cost for the health system and for the families) and equity outcomes (access to care and health outcomes by wealth quintile). Relevance of the study The study will inform, with a robust design, about the efficacy and cost-efficacy of a quality improvement intervention for ameliorating the health of children suffering from malnutrition in Uganda. Currently no other study with RCT design explored the efficacy of supportive supervision as a quality improvement intervention. This study will therefore fill an important knowledge gap.

Official Title
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Improving the Quality of Care for Children With Acute Malnutrition: Cluster Randomised Controlled Trial in West Nile Region, Uganda

Conditions
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Malnutrition, Child

Intervention / Treatment
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* Other: Supportive supervision


Participation Criteria
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Eligibility Criteria
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For the primary outcomes, the study sample will consists of children with malnutrition treated at in health center (HC) in Arua district Inclusion Criteria: Children 6 months-5 years Diagnosis of SAM or MAM according to National criteria (10) SAM: weight-for-height <- 3 standard deviation (SD) from the mean based on the WHO 2006 standards (11). MAM: weight-for-height <- 2 and > -3 standard deviation (SD) from the mean based on the WHO 2006 growth reference standards . Exclusion Criteria: Not matching the above criteria for SAM and MAM Refusal to participate/ consent Unable to adhere to study follow up procedures

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Supportive supervision | Other: Supportive supervision<br>*  Supportive supervision. The specific characteristics of the supportive supervision as intended in this project are outlined below. Frequency: Biweekly in the first 3-5 months, than monthly. Duration: approximately 2 hours in each HC at each visit. Provider: local staff (nutritionist, DHO) trained in integrated management acute malnutrition (IMAM) guidelines and in methods of  supportive supervision. Receivers: nurses working at HC level with children with malnutrition. Reference guidelines: • Current National IMAM guidelines Attitude and philosophy: • Participatory peer-to-peer model based on the Plan - Do- Study- Act quality improvement (QI) Cycle .<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate | Rate of cured among children diagnosed with acute malnutrition (SAM and MAM) Cured/discharged is defined as Weight-for-height > -2 standard deviation (SD) from the mean based on the World Health Organisation (WHO) 2006 standards (11) on 2 consecutive visits and no oedema. | 12- 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dead rate | cases explicitly state as  dead while in the program | 12- 16 weeks | 
| Rate of Not cured | Has not reached Cured/discharged criteria in 3 months (4 months for HIV +) | 12- 16 weeks | 
| Rate of transferred to ITC (inpatient treatment center) | Patients transferred to another outpatient service | 12- 16 weeks | 
| Rate of transferred to OTC (outpatient treatment center) | Patients transferred to another outpatient service | 12- 16 weeks | 
| Rate of defaulted | Absent (Not reported or followed up in the community) for 2 consecutive visits. | 12- 16 weeks | 
| Quality of data | This will be measured by cross-checking data collected from the study data collectors, and data as reported by the staff of the HC | study start, than every month up to 15 months | 
| Equity outcomes | access to care (supposing that the total population in the coverage area will not change in the intervention period, this will be measured by the crude number of children accessing the HC; efforts will also be made to retrieve, if available, accurate data on changes in the population in the coverage area | study start, than every month up to 15 months | 
| Cost | Data on cost from the patients (cost of travels to HC, cost of drugs, lab exams etc) and cost for the health services (number of visits in the HC, hospitalisations, foods and other treatments delivered). | study start, than every month up to 15 months | 
| Staff satisfaction score | This will be measured in all staff working with children with malnutrition in the HC participating in the study, using a score system pre-validated for use in Uganda (Hagopian et al, 2014) | study start, month 6 and month 15 |