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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Use of Clinical Decision Support System for Early Detection of Immunological Treatment Failure Among HIV Patients in Resource Constrained Settings

Conditions
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HIV

Intervention / Treatment
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* Other: EMR Only
* Other: EMR+CDSS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All HIV patients enrolled in participating clinics

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: EMR Only<br>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<br>* Clinics in this arm of the study will have a standard Electronic Medical Record (EMR) system installed - without a computerized decision support system.<br>|
| Experimental: EMR+CDSS<br>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<br>* 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.<br>* Other names: Electronic Medical Records;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical Decision Support Systems, Electronic Medical Record, Resource constrained countries, HIV