Impact of Enhanced Health Facility Care in Uganda - Full Text View

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:

MedlinePlus related topics: Anemia Fever Malaria

Drug Information available for: Artemether Lumefantrine

U.S. FDA Resources

Further study details as provided by Uganda Malaria Surveillance Project:

Primary Outcome Measures:

Prevalence of anemia [ 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).
Antimalarial treatment incidence density [ 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 [ Time Frame: 2 years ] [ 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.

Secondary Outcome Measures:

Prevalence of parasitemia [ 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 [ Time Frame: two years ] [ Designated as safety issue: No ]
Overnight admission to a hospital or clinic
Incidence of illness episodes [ Time Frame: Two years ] [ Designated as safety issue: No ]
Episode of illness as reported by primary caregiver
Incidence of febrile episodes [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ Time Frame: Annually ] [ Designated as safety issue: No ]
Proportion of questions answered correctly by clinicians following training in fever case management

Estimated Enrollment:	25000
Study Start Date:	December 2010
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	May 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 standard of care arm, the team will asses the impact of quality of care currently available at the health facility supplemented by services provided through the private sector and community-based interventions on the health of children	Other: Standard care In the clusters randomized to standard care, medical care currently available at health facilities, supplemented by services provided through the private sector and community-based interventions will be studied.

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 standard of care arm, the team will asses the impact of quality of care currently available at the health facility supplemented by services provided through the private sector and community-based interventions on the health of children

Other: Standard care

In the clusters randomized to standard care, medical care currently available at health facilities, supplemented by services provided through the private sector and community-based interventions will be studied.

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:

age < 5 years
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:

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

Exclusion Criterion:

1) inability to locate the child.

Contacts and Locations

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

Contacts

Contact: Sarah G Staedke, MD, PhD	+256 782507132	sarah.staedke@lshtm.ac.uk
Contact: Deborah DiLiberto, MSc	+256 785891225	deborah.diliberto@lshtm.ac.uk

Locations

Uganda
Infectious Diseases Research Collaboration	Recruiting
Kampala, Uganda
Contact: Moses R Kamya, MBChB, PhD +256 414 530692 mkamya@infocom.co.ug
Contact: Catherine Tugaineyo +256 414 530692 ctugaineyo@muucsf.org
Principal Investigator: Sarah G Staedke, MD, PhD
Sub-Investigator: Moses R Kamya, MBChB, PhD
Sub-Investigator: Grant Dorsey, MD, PhD
Sub-Investigator: Clare Chandler, PhD

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:

ACT Consortium This link exits the ClinicalTrials.gov site

Infectious Diseases Research Collaboration (UMSP, MU-UCSF) This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2009 Apr 9.

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. Review.

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:	December 11, 2012
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
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antimalarials

Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013