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

Primary Purpose

Malnutrition, Child

Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Supportive supervision
Sponsored by
WHO Collaborating Centre for Maternal and Child Health, Trieste
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition, Child

Eligibility Criteria

6 Months - 60 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arua districtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

Supportive supervision

No intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Dead rate
cases explicitly state as " dead" while in the program
Rate of Not cured
Has not reached Cured/discharged criteria in 3 months (4 months for HIV +)
Rate of transferred to ITC (inpatient treatment center)
Patients transferred to another outpatient service
Rate of transferred to OTC (outpatient treatment center)
Patients transferred to another outpatient service
Rate of defaulted
Absent (Not reported or followed up in the community) for 2 consecutive visits.
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
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
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).
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)

Full Information

First Posted
December 20, 2016
Last Updated
February 2, 2017
Sponsor
WHO Collaborating Centre for Maternal and Child Health, Trieste
Collaborators
CUAMM Doctors for Africa
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1. Study Identification

Unique Protocol Identification Number
NCT03044548
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
WHO Collaborating Centre for Maternal and Child Health, Trieste
Collaborators
CUAMM Doctors for Africa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Supportive supervision
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Supportive supervision
Intervention Description
" 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 .
Primary Outcome Measure Information:
Title
Cure rate
Description
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.
Time Frame
12- 16 weeks
Secondary Outcome Measure Information:
Title
Dead rate
Description
cases explicitly state as " dead" while in the program
Time Frame
12- 16 weeks
Title
Rate of Not cured
Description
Has not reached Cured/discharged criteria in 3 months (4 months for HIV +)
Time Frame
12- 16 weeks
Title
Rate of transferred to ITC (inpatient treatment center)
Description
Patients transferred to another outpatient service
Time Frame
12- 16 weeks
Title
Rate of transferred to OTC (outpatient treatment center)
Description
Patients transferred to another outpatient service
Time Frame
12- 16 weeks
Title
Rate of defaulted
Description
Absent (Not reported or followed up in the community) for 2 consecutive visits.
Time Frame
12- 16 weeks
Title
Quality of data
Description
This will be measured by cross-checking data collected from the study data collectors, and data as reported by the staff of the HC
Time Frame
study start, than every month up to 15 months
Title
Equity outcomes
Description
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
Time Frame
study start, than every month up to 15 months
Title
Cost
Description
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).
Time Frame
study start, than every month up to 15 months
Title
Staff satisfaction score
Description
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)
Time Frame
study start, month 6 and month 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marzia Lazzerini, PhD
Email
marzia.lazzerini@burlo.trieste.it
First Name & Middle Initial & Last Name or Official Title & Degree
Humphrey Wanzira, MSc
Email
humphrey.wanzira@burlo.trieste.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marzia Lazzerini, PhD
Organizational Affiliation
WHO CC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arua district
City
Arua
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Humphrey Wanzira, Msc
Email
humphrey.wanzira@burlo.trieste.it

12. IPD Sharing Statement

Plan to Share IPD
No

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

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