Impact of Enhanced Health Facility Care in Uganda

This study has been completed.
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
University of California, San Francisco
Infectious Diseases Research Collaboration, Uganda
Information provided by (Responsible Party):
Sarah Staedke, Uganda Malaria Surveillance Project
ClinicalTrials.gov Identifier:
NCT01024426
First received: December 1, 2009
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

The investigators propose to assess whether an intervention to build capacity and improve delivery of drugs and diagnostics at government-run health facilities improves the health of children and quality of care delivered, as compared to 'standard care' currently available at health facilities, supplemented by services provided through the private sector and community-based interventions. The target population will be divided into 20 clusters, defined as the catchment area of lower-level public health facilities. Clusters will be randomized to the health facility intervention (HFI) or to standard care delivered from government-run health facilities, supplemented by services provided through the private sector and community-based interventions. The intervention is designed to address barriers to delivering quality care at health centers and will focus on three components: (1) training in-charges in health center management, (2) providing training to health workers in fever case management and patient-centered services, and (3) ensuring adequate supplies of artemether-lumefantrine and RDTs. Outcomes will be measured in three distinct populations: (1) cross-sectional surveys of children under 15 years randomly selected from households within the clusters; (2) a cohort of children under five randomly selected from households within the clusters and followed for 2 years; and (3) patients attending all government-run health facilities, including children under five and their caregivers participating in exit interviews on selected days every six months. The primary outcome of the study is prevalence of anemia in children under five.


Condition Intervention Phase
Malaria
Procedure: Enhanced health facility-based care
Other: Standard care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evaluating the Impact of Enhanced Health Facility-based Care for Malaria and Febrile Illnesses in Children in Tororo, Uganda

Resource links provided by NLM:


Further study details as provided by Uganda Malaria Surveillance Project:

Primary Outcome Measures:
  • Prevalence of anemia in children under five in the cross-sectional surveys [ Time Frame: annually ] [ Designated as safety issue: No ]
    Proportion of hemoglobin measurements < 11.0 g/dL as measured in cross sectional surveys. Anemia will be classified according to severity: mild (Hb 8.0 - 10.9), moderate (Hb 5.0 - 7.9), severe (Hb < 5.0).


Secondary Outcome Measures:
  • Prevalence of parasitemia in children under five in the cross-sectional surveys [ Time Frame: annually ] [ Designated as safety issue: No ]
    Proportion of thick blood smears that are positive for asexual parasites

  • All-cause mortality [ Time Frame: Annually ] [ Designated as safety issue: No ]
    Probability of dying between birth and five years of age, expressed per 1,000 live births

  • Incidence of hospitalizations in children under five in the cohort study [ Time Frame: two years ] [ Designated as safety issue: No ]
    Overnight admission to a hospital or clinic

  • Incidence of illness episodes in children under five in the cohort study [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Episode of illness as reported by primary caregiver

  • Incidence of febrile episodes in children under five in the cohort study [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Episode of illness associated with fever as reported by primary caregiver

  • Prompt effective treatment of fever in children under five in the cohort study [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    Proportion of children with fever treated within 24 hours of onset of symptoms with an ACT

  • Incidence of serious adverse events in children under five in the cohort study [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    Any experience that results in death, life-threatening experience, hospitalization, persistent or significant disability or incapacity, or specific medical or surgical intervention to prevent one of the other serious outcomes

  • Prompt effective treatment of malaria in children under five in the cohort study [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Proportion of children with malaria (confirmed by a parasitological test) treated within 24 hours of onset of symptoms with an ACT

  • Appropriate treatment of malaria in children under five in the Patient Exit Interviews [ Time Frame: Every six months ] [ Designated as safety issue: No ]
    Proportion of children under five with suspected malaria and a positive RDT result who are appropriately given an ACT + Proportion of children under five with suspected malaria and a negative RDT result who are not prescribed an ACT

  • Inappropriate treatment of malaria in children under five in the Patient Exit Interviews [ Time Frame: Every six months ] [ Designated as safety issue: No ]
    Proportion of children under five with suspected malaria and a positive RDT result who are inappropriately given a non-ACT regimen

  • Patient satisfaction with health care in caregivers of children under five in the Patient Exit Interviews [ Time Frame: Every six months ] [ Designated as safety issue: No ]
    Proportion of patients indicating they were satisfied with care provided at the health center in exit interviews

  • Patient attendance in the Health facility surveillance [ Time Frame: Every two months ] [ Designated as safety issue: No ]
    Total number of patients attending health facilities and their characteristics, including age, sex,village of residence, and diagnosis

  • Stock-outs of ACTs in the Health facility surveillance [ Time Frame: Every two months ] [ Designated as safety issue: No ]
    Days per month that AL supplied by NMS via the district is not available

  • Knowledge questionnaire scores for Health workers [ Time Frame: Annually ] [ Designated as safety issue: No ]
    Proportion of questions answered correctly by clinicians following training in fever case management

  • Prevalence of anemia in children aged 5-15years in the cross-sectional surveys [ Time Frame: annually ] [ Designated as safety issue: No ]
    Proportion of hemoglobin measurements < 11.0 g/dL as measured in cross sectional surveys. Anemia will be classified according to severity: mild (Hb 8.0 - 10.9), moderate (Hb 5.0 - 7.9), severe (Hb < 5.0).


Other Outcome Measures:
  • Antimalarial treatment incidence density for children under five in the cohort study [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Number of antimalarial treatments given for treatment of fever/malaria over the period of follow-up

  • Inappropriate treatment of malaria in children under five in the Patient Exit Interviews [ Time Frame: Every six months ] [ Designated as safety issue: No ]
    Proportion of children under five with suspected malaria and a negative RDT result who are inappropriately given an ACT + Proportion of children under five with suspected malaria and a positive RDT result who are not prescribed an ACT.


Enrollment: 25000
Study Start Date: December 2010
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Health Facility intervention
In the clusters randomized to enhanced health facility-based care, the intervention is designed to address these barriers and will focus on three components: (1) training in-charges in health center management, (2) providing training to health workers in fever case management and patient-centered services, and (3) ensuring adequate supplies of artemether-lumefantrine and RDTs.
Procedure: Enhanced health facility-based care
The intervention is designed to address barriers to delivering quality care at health centers and will focus on three components: (1) training in-charges in health center management, (2) providing training to health workers in fever case management and patient-centered services, and (3) ensuring adequate supplies of artemether-lumefantrine and RDTs.
Other Name: HFI
Standard of care
In the clusters randomized to standard care, standard care will include services typically provided by government-run facilities; we will not provide any additional support to these facilities. Health care will be provided to patients attending these facilities according to the usual standards; in-charges will continue to manage the facilities using their standard approach, no additional training will be provided to the health workers stationed at these facilities; and no support for staffing or supplies will be provided beyond what is supplied by the district and MoH.
Other: Standard care
In the clusters randomized to standard care, standard care will include services typically provided by government-run facilities; we will not provide any additional support to these facilities. Health care will be provided to patients attending these facilities according to the usual standards; in-charges will continue to manage the facilities using their standard approach, no additional training will be provided to the health workers stationed at these facilities; and no support for staffing or supplies will be provided beyond what is supplied by the district and MoH.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

FOR THE COHORT STUDY

Inclusion Criteria:

  1. age < 5 years
  2. agreement of parents or guardians to provide informed consent

Exclusion Criteria:

1) intention to move during the follow-up period

FOR THE CROSS-SECTIONAL SURVEY:

Inclusion Criteria:

  1. age < 15 years
  2. agreement of parents or guardians to provide informed consent
  3. agreement of a child aged 8 years or older to provide assent.

Exclusion Criterion:

1) inability to locate the child.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024426

Locations
Uganda
Infectious Diseases Research Collaboration
Kampala, Uganda
Sponsors and Collaborators
Uganda Malaria Surveillance Project
London School of Hygiene and Tropical Medicine
University of California, San Francisco
Infectious Diseases Research Collaboration, Uganda
Investigators
Principal Investigator: Sarah G Staedke, MD, PhD London School of Hygiene and Tropical Medicine
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sarah Staedke, Principal Investigator, Uganda Malaria Surveillance Project
ClinicalTrials.gov Identifier: NCT01024426     History of Changes
Other Study ID Numbers: ITGBVG01
Study First Received: December 1, 2009
Last Updated: October 31, 2013
Health Authority: Uganda: National Council for Science and Technology
Uganda: Research Ethics Committee

Keywords provided by Uganda Malaria Surveillance Project:
Uganda
malaria
enhanced health facility-based care
febrile illnesses
health services

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on October 23, 2014