Do Clinical Decision-support Reminders for Medical Providers Improve the Do Clinical Decision-support Reminders for Medical Providers Improve the Prevalence of IPT Initiation Among HIV Positive Adults in Western Kenya? - Full Text View

Purpose

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.

Condition	Intervention
Tuberculosis	Behavioral: TB reminders


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Do Clinical Decision-support Reminders for Medical Providers Improve the Prevalence of IPT Initiation Among HIV Positive Adults in Western Kenya?

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Tuberculosis

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:

Prescription of Isonazid [ Time Frame: within 3 months of initial encounter ]
Provider prescribes INH within 3 months of patient's initial encounter.

Secondary Outcome Measures:

Time to isoniazid prophylactic therapy (IPT) initiation [ Time Frame: within 3 months of initial encounter ]
The time in weeks from a patient's initial encounter to the week the patient picks up the initial batch of INH from the pharmacy.

Other Outcome Measures:

Initiation of isoniazid prophylactic therapy (IPT) [ Time Frame: within 3 months of initial encounter ]
IPT will be considered "initiated" when a patient picks up the initial batch of the prescribed medications within 3 months of the initial encounter.
Isoniazid prophylactic therapy (IPT) completion [ Time Frame: 9 months after treatment initiation ]
Patient completes 9-month course of IPT


Estimated Enrollment:	1000
Study Start Date:	September 2013
Study Completion Date:	August 2014
Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: TB reminders Receive existing reminders plus new patient-specific reminders about TB screening, prevention, and treatment	Behavioral: TB reminders 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.
No Intervention: No TB reminders Only receive existing reminders; no TB reminders

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


Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934309

Locations


Kenya
AMPATH
Eldoret, Kenya

Sponsors and Collaborators

Indiana University

Moi University

AMPATH

Regenstrief Institute, Inc.

InSTEDD

Kijani Consulting

Investigators


Principal Investigator:	Lameck O Diero, MBChB, MMed	Moi University College of Health Sciences

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Indiana University
ClinicalTrials.gov Identifier:	NCT01934309 History of Changes
Other Study ID Numbers:	AID-OAA-TO-11-00060
Study First Received:	August 29, 2013
Last Updated:	August 21, 2015

Keywords provided by Indiana University:


tuberculosis isoniazid preventative therapy clinical decision support	HIV Kenya eHealth

Additional relevant MeSH terms:


Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections

ClinicalTrials.gov processed this record on June 26, 2017

Do Clinical Decision-support Reminders for Medical Providers Improve the Do Clinical Decision-support Reminders for Medical Providers Improve the Prevalence of IPT Initiation Among HIV Positive Adults in Western Kenya? (TBTech)