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

NCT ID: NCT03044548

Last Updated: 2017-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-12-31

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.

Conditions

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Malnutrition, Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental

Supportive supervision

Group Type EXPERIMENTAL

Supportive supervision

Intervention Type OTHER

" 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 .

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 .

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CUAMM Doctors for Africa

UNKNOWN

Sponsor Role collaborator

WHO Collaborating Centre for Maternal and Child Health, Trieste

OTHER

Sponsor Role lead

Responsible Party

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Marzia Lazzerini

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marzia Lazzerini, PhD

Role: PRINCIPAL_INVESTIGATOR

WHO CC

Locations

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Arua district

Arua, , Uganda

Site Status RECRUITING

Countries

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Uganda

Central Contacts

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Marzia Lazzerini, PhD

Role: CONTACT

Humphrey Wanzira, MSc

Role: CONTACT

Facility Contacts

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Humphrey Wanzira, Msc

Role: primary

Role: backup

Other Identifiers

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Prot 521/2016

Identifier Type: -

Identifier Source: org_study_id

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