Impact of Enhanced Health Facility Care in Uganda

NCT01024426 | Completed Phase 4 DMC

• 1 other identifier: ITGBVG01
• Study Type: interventional
• Target: 25,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria

Keywords

Uganda; malaria; enhanced health facility-based care; febrile illnesses; health services

Outcome Measures

Primary Outcomes (1)

• Prevalence of anemia in children under five in the cross-sectional surveys

  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).

  annually

Secondary Outcomes (15)

• Prevalence of parasitemia in children under five in the cross-sectional surveys

  annually

• All-cause mortality

  Annually

• Incidence of hospitalizations in children under five in the cohort study

  two years

• Incidence of illness episodes in children under five in the cohort study

  Two years

• Incidence of febrile episodes in children under five in the cohort study

  Two years

Other Outcomes (2)

• Antimalarial treatment incidence density for children under five in the cohort study

  2 years

• Inappropriate treatment of malaria in children under five in the Patient Exit Interviews

  Every six months

Study Arms (2)

Health Facility intervention

EXPERIMENTAL

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

Standard of care

OTHER

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

Interventions

Enhanced health facility-based care PROCEDURE

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.

Also known as: HFI

Health Facility intervention

Standard care OTHER

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.

Standard of care

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age \< 5 years
• agreement of parents or guardians to provide informed consent

You may not qualify if:

• \) intention to move during the follow-up period
• FOR THE CROSS-SECTIONAL SURVEY:
• age \< 15 years
• agreement of parents or guardians to provide informed consent
• agreement of a child aged 8 years or older to provide assent.
• \) inability to locate the child.

Sponsors & Collaborators

• Uganda Malaria Surveillance Project: lead
• London School of Hygiene and Tropical Medicine: collaborator
• University of California, San Francisco: collaborator
• Infectious Diseases Research Collaboration, Uganda: collaborator

Study Sites (1)

Infectious Diseases Research Collaboration

Kampala, Uganda

Location

Related Publications (4)

• Staedke SG, Mwebaza N, Kamya MR, Clark TD, Dorsey G, Rosenthal PJ, Whitty CJ. Home management of malaria with artemether-lumefantrine compared with standard care in urban Ugandan children: a randomised controlled trial. Lancet. 2009 May 9;373(9675):1623-31. doi: 10.1016/S0140-6736(09)60328-7. Epub 2009 Apr 9.

  PMID: 19362361 BACKGROUND

• Hopkins H, Talisuna A, Whitty CJ, Staedke SG. Impact of home-based management of malaria on health outcomes in Africa: a systematic review of the evidence. Malar J. 2007 Oct 8;6:134. doi: 10.1186/1475-2875-6-134.

  PMID: 17922916 BACKGROUND

• Chandler CI, DiLiberto D, Nayiga S, Taaka L, Nabirye C, Kayendeke M, Hutchinson E, Kizito J, Maiteki-Sebuguzi C, Kamya MR, Staedke SG. The PROCESS study: a protocol to evaluate the implementation, mechanisms of effect and context of an intervention to enhance public health centres in Tororo, Uganda. Implement Sci. 2013 Sep 30;8:113. doi: 10.1186/1748-5908-8-113.

  PMID: 24079992 DERIVED

• Staedke SG, Chandler CI, DiLiberto D, Maiteki-Sebuguzi C, Nankya F, Webb E, Dorsey G, Kamya MR. The PRIME trial protocol: evaluating the impact of an intervention implemented in public health centres on management of malaria and health outcomes of children using a cluster-randomised design in Tororo, Uganda. Implement Sci. 2013 Sep 30;8:114. doi: 10.1186/1748-5908-8-114.

  PMID: 24079295 DERIVED

Related Links

• Infectious Diseases Research Collaboration (UMSP, MU-UCSF)

MeSH Terms

Conditions

Malaria

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sarah G Staedke, MD, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: December 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

UG (1)