NCT01634802

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,460

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
26 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 6, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

July 3, 2012

Last Update Submit

July 5, 2012

Conditions

HIV

Keywords

Clinical Decision Support SystemsElectronic Medical RecordResource constrained countriesHIV

Outcome Measures

Primary Outcomes (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.

    12 months

Secondary Outcomes (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.

    12 months

Study Arms (2)

EMR Only

NO INTERVENTION

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

EMR+CDSS

EXPERIMENTAL

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

Interventions

EMR OnlyOTHER

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

EMR Only
EMR+CDSSOTHER

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.

Also known as: Clinical Decision Support Systems, Electronic Medical Records
EMR+CDSS

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All HIV patients enrolled in participating clinics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KEMRI/CDC Clinical Research Center

Kisumu, Nyanza, Kenya

Location

Related Publications (2)

  • 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.

    PMID: 34930228DERIVED

  • 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.

    PMID: 26847229DERIVED

MeSH Terms

Interventions

Electronic Health Records

Intervention Hierarchy (Ancestors)

Medical Records Systems, ComputerizedMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Tom Oluoch, MSc

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Daniel Kwaro, MD

    KEMRI-CDC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Kwaro, MD

CONTACT

+254 700 858 288Dkwaro@kemricdc.org

Nicky Okeyo, MSc

CONTACT

+254 721 864 474Nokeyo@kemricdc.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr.

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 6, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

July 6, 2012

Record last verified: 2012-07

Locations

KE(1)