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Trial record 15 of 35 for:    " June 27, 2012":" July 27, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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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 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
History of Changes
  Purpose
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 Intervention
HIV
 Other: EMR Only
Other: EMR+CDSS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Kenya Medical Research Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
Estimated Enrollment: 1460
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility
Ages Eligible for Study:   18 Months and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All HIV patients enrolled in participating clinics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 
Study First Received: July 3, 2012
Last Updated: July 5, 2012
Health Authority: Kenya: Kenya Medical Research Institute ERC

Keywords provided by Kenya Medical Research Institute:
Clinical Decision Support Systems
Electronic Medical Record
Resource constrained countries
HIV

ClinicalTrials.gov processed this record on September 27, 2016