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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Kenya Medical Research Institute.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Tom Oluoch, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01634802
First received: July 3, 2012
Last updated: July 5, 2012
Last verified: July 2012

July 3, 2012
July 5, 2012
August 2012
August 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01634802 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of Use of Clinical Decision Support System in HIV Care in Resource Constrained Settings
Evaluation of Use of Clinical Decision Support System for Early Detection of Immunological Treatment Failure Among HIV Patients in Resource Constrained Settings

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
HIV
  • 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.
    Other Names:
    • Clinical Decision Support Systems
    • Electronic Medical Records
  • 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.
    Intervention: Other: EMR Only
  • 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.
    Intervention: Other: EMR+CDSS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1460
December 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All HIV patients enrolled in participating clinics
Both
18 Months and older
No
Contact: Daniel Kwaro, MD +254 700 858 288 Dkwaro@kemricdc.org
Contact: Nicky Okeyo, MSc +254 721 864 474 Nokeyo@kemricdc.org
Kenya
 
NCT01634802
2073
No
Tom Oluoch, Centers for Disease Control and Prevention
Kenya Medical Research Institute
Not Provided
Principal Investigator: Tom Oluoch, MSc Centers for Disease Control and Prevention
Principal Investigator: Daniel Kwaro, MD KEMRI-CDC
Kenya Medical Research Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP