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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Tom Oluoch, Centers for Disease Control and Prevention.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01634802
First Posted: July 6, 2012
Last Update Posted: July 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tom Oluoch, Centers for Disease Control and Prevention
July 3, 2012
July 6, 2012
July 6, 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 ]
Same as current
No Changes Posted
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 ]
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
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
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
Oluoch T, Katana A, Kwaro D, Santas X, Langat P, Mwalili S, Muthusi K, Okeyo N, Ojwang JK, Cornet R, Abu-Hanna A, de Keizer N. Effect of a clinical decision support system on early action on immunological treatment failure in patients with HIV in Kenya: a cluster randomised controlled trial. Lancet HIV. 2016 Feb;3(2):e76-84. doi: 10.1016/S2352-3018(15)00242-8. Epub 2015 Dec 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1460
December 2013
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All HIV patients enrolled in participating clinics
Sexes Eligible for Study: All
18 Months and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
 
NCT01634802
2073
No
Not Provided
Not Provided
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