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

February 2, 2017 updated by: Marzia Lazzerini, WHO Collaborating Centre for Maternal and Child Health, Trieste

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: Experimental
Supportive supervision
Other: Supportive supervision

" 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure rate
Time Frame: 12- 16 weeks
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
Time Frame: 12- 16 weeks
cases explicitly state as " dead" while in the program
12- 16 weeks
Rate of Not cured
Time Frame: 12- 16 weeks
Has not reached Cured/discharged criteria in 3 months (4 months for HIV +)
12- 16 weeks
Rate of transferred to ITC (inpatient treatment center)
Time Frame: 12- 16 weeks
Patients transferred to another outpatient service
12- 16 weeks
Rate of transferred to OTC (outpatient treatment center)
Time Frame: 12- 16 weeks
Patients transferred to another outpatient service
12- 16 weeks
Rate of defaulted
Time Frame: 12- 16 weeks
Absent (Not reported or followed up in the community) for 2 consecutive visits.
12- 16 weeks
Quality of data
Time Frame: study start, than every month up to 15 months
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
Time Frame: study start, than every month up to 15 months
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
Time Frame: study start, than every month up to 15 months
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
Time Frame: study start, month 6 and month 15
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WHO Collaborating Centre for Maternal and Child Health, Trieste

Collaborators

CUAMM Doctors for Africa

Investigators

  • Principal Investigator: Marzia Lazzerini, PhD, WHO CC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

February 2, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prot 521/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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