Clinical Decision-support Reminders to Improve IPT Initiation Among HIV Positive Adults in Western Kenya
TBTech
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?
1 other identifier
interventional
3,782
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2013
1 active site
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
August 29, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedFirst Posted
Study publicly available on registry
September 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMarch 27, 2023
March 1, 2023
11 months
August 29, 2013
March 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prescription of Isoniazid
Provider prescribes INH within 3 months of patient's initial encounter.
within 3 months of initial encounter
Secondary Outcomes (1)
Time to isoniazid prophylactic therapy (IPT) initiation
within 3 months of initial encounter
Other Outcomes (2)
Initiation of isoniazid prophylactic therapy (IPT)
within 3 months of initial encounter
Isoniazid prophylactic therapy (IPT) completion
9 months after treatment initiation
Study Arms (2)
TB reminders
EXPERIMENTALReceive existing reminders plus new patient-specific reminders about TB screening, prevention, and treatment
No TB reminders
NO INTERVENTIONOnly receive existing reminders; no TB reminders
Interventions
The intervention to be studied involves providing clinic-based medical care providers (e.g., nurses, clinical officers, medical officers, consultants) with patient-specific clinical reminders regarding TB that are generated from a patient's electronic medical record and based on accepted clinical algorithms for TB screening and treatment.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients:
- 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
- \- history of TB or IPT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- Moi Universitycollaborator
- Academic Model Providing Access to Healthcare (AMPATH)collaborator
- Regenstrief Institute, Inc.collaborator
- Innovative Support to Emergencies, Diseases and Disasters (InSTEDD)collaborator
- Kijani Consultingcollaborator
Study Sites (1)
AMPATH
Eldoret, Kenya
Related Publications (1)
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.
PMID: 25885266DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lameck O Diero, MBChB, MMed
Moi University College of Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
August 29, 2013
First Posted
September 4, 2013
Study Start
September 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
March 27, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share