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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: WHO Collaborating Centre for Maternal and Child Health, Trieste

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Dead rate [ Time Frame: 12- 16 weeks ]
    cases explicitly state as " dead" while in the program
  • Rate of Not cured [ Time Frame: 12- 16 weeks ]
    Has not reached Cured/discharged criteria in 3 months (4 months for HIV +)
  • Rate of transferred to ITC (inpatient treatment center) [ Time Frame: 12- 16 weeks ]
    Patients transferred to another outpatient service
  • Rate of transferred to OTC (outpatient treatment center) [ Time Frame: 12- 16 weeks ]
    Patients transferred to another outpatient service
  • Rate of defaulted [ Time Frame: 12- 16 weeks ]
    Absent (Not reported or followed up in the community) for 2 consecutive visits.
  • 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
  • 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
  • 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).
  • 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)


Original Secondary Outcome: Same as current

Information By: WHO Collaborating Centre for Maternal and Child Health, Trieste

Dates:
Date Received: December 20, 2016
Date Started: December 2016
Date Completion: December 31, 2017
Last Updated: February 2, 2017
Last Verified: February 2017