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

Malnutrition, Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03044548
• Other study ID #: Prot 521/2016
• Status: Recruiting
• Phase: N/A
• First received: December 20, 2016
• Last updated: February 2, 2017
• Start date: December 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2017
• Source: WHO Collaborating Centre for Maternal and Child Health, Trieste
• Contact: Marzia Lazzerini, PhD
• Email: marzia.lazzerini[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 60 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child

Intervention

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 .

Locations

Country	Name	City	State
Uganda	Arua district	Arua

Sponsors (2)

Lead Sponsor	Collaborator
WHO Collaborating Centre for Maternal and Child Health, Trieste	CUAMM Doctors for Africa

Country where clinical trial is conducted

Uganda, 

Outcome

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