Evaluation of Use of Clinical Decision Support System for Early Detection of Immunological Treatment Failure Among HIV Patients in Resource Constrained Settings

Kenya Medical Research Institute1 site in 1 country1,460 target enrollmentAugust 2012

ConditionsHIV

Overview

Phase: N/A
Intervention: Not specified
Conditions: HIV
Sponsor: Kenya Medical Research Institute
Enrollment: 1460
Locations: 1
Primary Endpoint: The main end-point of the study will be the proportion of patients on treatment who have experienced treatment failure and appropriate clinical action taken according to the guidelines.
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether the use of a Computerized Decision Support System (CDSS) in form of alerts to clinicians enhances early detection of immunological treatment failure in HIV patients.

Detailed Description

We hypothesize that there is no difference in the time to detecting immunological treatment failure among HIV patients in resource poor settings whether the clinicians use an Electronic Medical Record (EMR) system with a Computerized Decision Support (CDSS) or an EMR without a CDSS. In this study, 20 clinics were assigned to the intervention (EMR+CDSS) arm and non-intervention arm (EMR only) and will be followed up for 12 months to assess whether there are any differences in time taken to detect immunological treatment failure based on CD4 cell count.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

December 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kenya Medical Research Institute

Responsible Party

Principal Investigator

Tom Oluoch

Mr.

Centers for Disease Control and Prevention

Eligibility Criteria

Inclusion Criteria

•All HIV patients enrolled in participating clinics

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

The main end-point of the study will be the proportion of patients on treatment who have experienced treatment failure and appropriate clinical action taken according to the guidelines.

Time Frame: 12 months

Secondary Outcomes

Other outcome measures will be the proportion of CD4 cell counts done on time and proportion of pre-ART patient eligible for treatment that are initiated within 30 days of eligibility. The median time taken to clinical action will be measured.(12 months)