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

NCT ID: NCT01634802

Last Updated: 2012-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

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.

Conditions

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HIV

Keywords

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Clinical Decision Support Systems Electronic Medical Record Resource constrained countries HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type NO_INTERVENTION

EMR Only

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

EMR+CDSS

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Clinical Decision Support Systems Electronic Medical Records

Eligibility Criteria

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Inclusion Criteria

* All HIV patients enrolled in participating clinics
Minimum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kenya Medical Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Tom Oluoch

Mr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tom Oluoch, MSc

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Daniel Kwaro, MD

Role: PRINCIPAL_INVESTIGATOR

KEMRI-CDC

Locations

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KEMRI/CDC Clinical Research Center

Kisumu, Nyanza, Kenya

Site Status

Countries

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Kenya

Central Contacts

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Daniel Kwaro, MD

Role: CONTACT

Phone: +254 700 858 288

Email: [email protected]

Nicky Okeyo, MSc

Role: CONTACT

Phone: +254 721 864 474

Email: [email protected]

Facility Contacts

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Patrick Langat, BSc

Role: primary

References

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Oluoch T, Cornet R, Muthusi J, Katana A, Kimanga D, Kwaro D, Okeyo N, Abu-Hanna A, de Keizer N. A clinical decision support system is associated with reduced loss to follow-up among patients receiving HIV treatment in Kenya: a cluster randomized trial. BMC Med Inform Decis Mak. 2021 Dec 20;21(1):357. doi: 10.1186/s12911-021-01718-0.

Reference Type DERIVED
PMID: 34930228 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26847229 (View on PubMed)

Other Identifiers

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2073

Identifier Type: -

Identifier Source: org_study_id