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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
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