Evaluation of Use of Clinical Decision Support System in HIV Care in Resource Constrained Settings

Overview

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.

Full Title of Study: “Evaluation of Use of Clinical Decision Support System for Early Detection of Immunological Treatment Failure Among HIV Patients in Resource Constrained Settings”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: August 2013

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.

Interventions

  • Other: EMR Only
    • Clinics in this arm of the study will have a standard Electronic Medical Record (EMR) system installed – without a computerized decision support system.
  • Other: EMR+CDSS
    • Clinics in this arm of the study will have an Electronic Medical Record (EMR) system with Clinical Decision Support System (CDSS) enhancement implemented as alerts to aid the clinician in decision making.

Arms, Groups and Cohorts

  • No Intervention: EMR Only
    • Clinics in this arm of the study will have a standard Electronic Medical Record (EMR) system installed – without a computerized decision support system.
  • Experimental: EMR+CDSS
    • Clinics in this arm of the study will have an Electronic Medical Record (EMR) system with Clinical Decision Support System (CDSS) enhancement implemented as alerts to aid the clinician in decision making.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • All HIV patients enrolled in participating clinics

Gender Eligibility: All

Minimum Age: 18 Months

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kenya Medical Research Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tom Oluoch, Mr. – Centers for Disease Control and Prevention
  • Overall Official(s)
    • Tom Oluoch, MSc, Principal Investigator, Centers for Disease Control and Prevention
    • Daniel Kwaro, MD, Principal Investigator, KEMRI-CDC
  • Overall Contact(s)
    • Daniel Kwaro, MD, +254 700 858 288, Dkwaro@kemricdc.org

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