Clinical Decision-support Reminders to Improve IPT Initiation Among HIV Positive Adults in Western Kenya

Tuberculosis Clinical Trial

— TBTech  

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934309
• Other study ID #: AID-OAA-TO-11-00060
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: March 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3782
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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-speci?c 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.

Locations

Country	Name	City	State
Kenya	AMPATH	Eldoret

Sponsors (6)

Lead Sponsor	Collaborator
Indiana University	Academic Model Providing Access to Healthcare (AMPATH), Innovative Support to Emergencies, Diseases and Disasters (InSTEDD), Kijani Consulting, Moi University, Regenstrief Institute, Inc.

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Initiation of isoniazid prophylactic therapy (IPT)	IPT will be considered "initiated" when a patient picks up the initial batch of the prescribed medications within 3 months of the initial encounter.	within 3 months of initial encounter
Other	Isoniazid prophylactic therapy (IPT) completion	Patient completes 9-month course of IPT	9 months after treatment initiation
Primary	Prescription of Isoniazid	Provider prescribes INH within 3 months of patient's initial encounter.	within 3 months of initial encounter
Secondary	Time to isoniazid prophylactic therapy (IPT) initiation	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.	within 3 months of initial encounter