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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01634802

Acronym

CDSS

Enrollment

1460

Registered

2012-07-06

Start date

2012-08-31

Completion date

2013-12-31

Last updated

2012-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Clinical Decision Support Systems, Electronic Medical Record, Resource constrained countries, HIV

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.

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.

Interventions

OTHEREMR Only

Clinics in this arm of the study will have a standard Electronic Medical Record (EMR) system installed - without a computerized decision support system.

OTHEREMR+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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Months to No maximum

Healthy volunteers

Inclusion criteria

* All HIV patients enrolled in participating clinics

Design outcomes

Primary

Measure	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

Measure	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

Countries

Kenya

Contacts

Primary ContactDaniel Kwaro, MD

Dkwaro@kemricdc.org+254 700 858 288

Backup ContactNicky Okeyo, MSc

Nokeyo@kemricdc.org+254 721 864 474

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026