Clinical trial NCT03044548: Improving the Quality of Care for Children With Acute Malnutrition in Uganda
Official title: Improving the Quality of Care for Children With Acute Malnutrition: Cluster Randomised Controlled Trial in West Nile Region, Uganda
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition, Child
Lead sponsor: WHO Collaborating Centre for Maternal and Child Health, Trieste
Sponsor class: OTHER
Collaborators: name: CUAMM Doctors for Africa
First posted: 2017-02-07
Enrollment: 700
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: For the primary outcomes, the study sample will consists of children with malnutrition treated at in health center (HC) in Arua district

Inclusion Criteria:

1. Children 6 months-5 years
2. 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:

1. Not matching the above criteria for SAM and MAM
2. Refusal to participate/ consent
3. Unable to adhere to study follow up procedures

Primary outcomes:
measure: Cure rate
timeFrame: 12- 16 weeks
Secondary outcomes:
measure: Dead rate
timeFrame: 12- 16 weeks
measure: Rate of Not cured
timeFrame: 12- 16 weeks
measure: Rate of transferred to ITC (inpatient treatment center)
timeFrame: 12- 16 weeks
measure: Rate of transferred to OTC (outpatient treatment center)
timeFrame: 12- 16 weeks
measure: Rate of defaulted
timeFrame: 12- 16 weeks
measure: Quality of data
timeFrame: study start, than every month up to 15 months
measure: Equity outcomes
timeFrame: study start, than every month up to 15 months
measure: Cost
timeFrame: study start, than every month up to 15 months
measure: Staff satisfaction score
timeFrame: study start, month 6 and month 15
Other outcomes:
Locations:
city: Arua
country: Uganda
facility: Arua district
Study officials:
affiliation: WHO CC
name: Marzia Lazzerini, PhD
role: PRINCIPAL_INVESTIGATOR
References: