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

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ClinicalTrials.gov Identifier: NCT01634802
Recruitment Status : Unknown
Verified July 2012 by Tom Oluoch, Centers for Disease Control and Prevention.
Recruitment status was:  Not yet recruiting
First Posted : July 6, 2012
Last Update Posted : July 6, 2012
Sponsor:
Information provided by (Responsible Party):
Tom Oluoch, Centers for Disease Control and Prevention

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Other: EMR Only Other: EMR+CDSS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Evaluation of Use of Clinical Decision Support System for Early Detection of Immunological Treatment Failure Among HIV Patients in Resource Constrained Settings
Study Start Date : August 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All HIV patients enrolled in participating clinics
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634802


Contacts
Contact: Daniel Kwaro, MD +254 700 858 288 Dkwaro@kemricdc.org
Contact: Nicky Okeyo, MSc +254 721 864 474 Nokeyo@kemricdc.org

Locations
Kenya
KEMRI/CDC Clinical Research Center Not yet recruiting
Kisumu, Nyanza, Kenya
Contact: Patrick Langat, BSc    +254 722 750 072    Plangat@kemricdc.org   
Principal Investigator: Daniel Kwaro, MD         
Sponsors and Collaborators
Kenya Medical Research Institute
Investigators
Principal Investigator: Tom Oluoch, MSc Centers for Disease Control and Prevention
Principal Investigator: Daniel Kwaro, MD KEMRI-CDC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tom Oluoch, Mr., Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01634802     History of Changes
Other Study ID Numbers: 2073
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012

Keywords provided by Tom Oluoch, Centers for Disease Control and Prevention:
Clinical Decision Support Systems
Electronic Medical Record
Resource constrained countries
HIV