Clinical trial NCT01934309: Clinical Decision-support Reminders to Improve IPT Initiation Among HIV Positive Adults in Western Kenya
Official title: Does Providing Medical Personnel in the AMPATH Network With Patient-specific Reminders Regarding TB That Are Generated From a Patient's EMR Improve the Prevalence of IPT Initiation and Decrease the Time From Screening to Treatment?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: tuberculosis
isoniazid preventative therapy
clinical decision support
HIV
Kenya
eHealth
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Moi University
name: Academic Model Providing Access to Healthcare (AMPATH)
name: Regenstrief Institute, Inc.
name: Innovative Support to Emergencies, Diseases and Disasters (InSTEDD)
name: Kijani Consulting
First posted: 2013-09-04
Enrollment: 3782
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall research objective is to evaluate the impact of implementing a reminder system for medical providers to improve TB case-finding and isoniazid preventative therapy (IPT) for adults living with HIV in western Kenya

Detailed description: The purpose of this study is to evaluate the impact of implementing a clinical decision support reminder system for medical providers (i.e., nurses, clinical officers, medical officers, consultants) to improve tuberculosis case-ﬁnding and the use of isoniazid preventative therapy for adults living with HIV in western Kenya.

Eligibility criteria: Clusters:

Inclusion Criteria

* active
* uses HIV initial and return encounter paper forms
* enters data into the AMPATH medical records system (AMRS) or sends forms to central location for data entry
* prints or receives printed paper summary sheets with reminders
* interprets chest x-rays
* interprets sputum smear results
* prescribes IPT and dispenses INH
* completed an average of 10 initial adult HIV positive encounters per month in 2012
* HIV Care Clinic

Exclusion Criteria -

Patients:

Inclusion Criteria

* HIV positive
* complete an adult initial encounter at an HIV Care Clinic during the enrollment period
* attend at least one additional appointment within 90 days after the initial encounter

Exclusion Criteria

- history of TB or IPT

Primary outcomes:
measure: Prescription of Isoniazid
timeFrame: within 3 months of initial encounter
Secondary outcomes:
measure: Time to isoniazid prophylactic therapy (IPT) initiation
timeFrame: within 3 months of initial encounter
Other outcomes:
measure: Initiation of isoniazid prophylactic therapy (IPT)
timeFrame: within 3 months of initial encounter
measure: Isoniazid prophylactic therapy (IPT) completion
timeFrame: 9 months after treatment initiation
Locations:
city: Eldoret
country: Kenya
facility: AMPATH
Study officials:
affiliation: Moi University College of Health Sciences
name: Lameck O Diero, MBChB, MMed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Green EP, Catalani C, Diero L, Carter EJ, Gardner A, Ndwiga C, Keny A, Owiti P, Israelski D, Biondich P. Do clinical decision-support reminders for medical providers improve isoniazid preventative therapy prescription rates among HIV-positive adults? Study protocol for a randomized controlled trial. Trials. 2015 Apr 9;16:141. doi: 10.1186/s13063-015-0558-8.