Clinical trial NCT01634802: Evaluation of Use of Clinical Decision Support System in HIV Care in Resource Constrained Settings
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: Clinical Decision Support Systems
Electronic Medical Record
Resource constrained countries
HIV
Lead sponsor: Kenya Medical Research Institute
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 1460
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* All HIV patients enrolled in participating clinics

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: KEMRI/CDC Clinical Research Center
state: Nyanza
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Tom Oluoch, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: KEMRI-CDC
name: Daniel Kwaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.