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

Not Applicable

• Conditions: HIV
• Interventions: Other: EMR Only; Other: EMR+CDSS

• Registration Number: NCT01634802
• Lead Sponsor: Kenya Medical Research Institute

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.

Study Timeline

• Status Verified: 2012-07
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-05
• Last Update Submitted: 2012-07-05
• Study First Posted: 2012-07-06
• Last Update Posted: 2012-07-06
• Study Start: 2012-08
• Primary Completion: 2013-08
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1460

Inclusion Criteria

• All HIV patients enrolled in participating clinics

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMR Only	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.
EMR+CDSS	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.

Primary Outcome Measures

Name	Time	Method
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.	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

KEMRI/CDC Clinical Research Center; 🇰🇪 Kisumu, Nyanza, Kenya