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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03044548
Enrollment
700
Registered
2017-02-07
Start date
2016-12-31
Completion date
2017-12-31
Last updated
2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition, Child

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.

Interventions

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 .

Sponsors

CUAMM Doctors for Africa
CollaboratorUNKNOWN
WHO Collaborating Centre for Maternal and Child Health, Trieste
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Months to 60 Months
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Cure rate12- 16 weeksRate 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.

Secondary

MeasureTime frameDescription
Rate of Not cured12- 16 weeksHas not reached Cured/discharged criteria in 3 months (4 months for HIV +)
Rate of transferred to ITC (inpatient treatment center)12- 16 weeksPatients transferred to another outpatient service
Rate of transferred to OTC (outpatient treatment center)12- 16 weeksPatients transferred to another outpatient service
Rate of defaulted12- 16 weeksAbsent (Not reported or followed up in the community) for 2 consecutive visits.
Dead rate12- 16 weekscases explicitly state as dead while in the program
Equity outcomesstudy start, than every month up to 15 monthsaccess 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
Coststudy start, than every month up to 15 monthsData 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).
Staff satisfaction scorestudy start, month 6 and month 15This 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)
Quality of datastudy start, than every month up to 15 monthsThis will be measured by cross-checking data collected from the study data collectors, and data as reported by the staff of the HC

Countries

Uganda

Contacts

Primary ContactMarzia Lazzerini, PhD
marzia.lazzerini@burlo.trieste.it
Backup ContactHumphrey Wanzira, MSc
humphrey.wanzira@burlo.trieste.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026