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

HIV Clinical Trial

— CDSS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01634802
• Other study ID #: 2073
• Status: Not yet recruiting
• Phase: N/A
• First received: July 3, 2012
• Last updated: July 5, 2012
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2012
• Source: Kenya Medical Research Institute
• Contact: Daniel Kwaro, MD
• Phone: +254 700 858 288
• Email: Dkwaro[@]kemricdc.org
• Is FDA regulated: No
• Health authority: Kenya: Kenya Medical Research Institute ERC
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1460
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months and older

Eligibility

Inclusion Criteria:

• All HIV patients enrolled in participating clinics

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV

Intervention

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.
• 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.

Locations

Country	Name	City	State
Kenya	KEMRI/CDC Clinical Research Center	Kisumu	Nyanza

Sponsors (1)

Lead Sponsor	Collaborator
Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No