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?

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

Study Overview

• Status: Completed
• Conditions: Tuberculosis
• Intervention / Treatment: Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 3782
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Eldoret, Kenya
    • AMPATH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prescription of Isoniazid	Provider prescribes INH within 3 months of patient's initial encounter.	within 3 months of initial encounter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Isoniazid prophylactic therapy (IPT) completion	Patient completes 9-month course of IPT	9 months after treatment initiation

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Regenstrief Institute, Inc.; Moi University; Kijani Consulting; Academic Model Providing Access to Healthcare (AMPATH); Innovative Support to Emergencies, Diseases and Disasters (InSTEDD)
• Investigators: Principal Investigator: Lameck O Diero, MBChB, MMed, Moi University College of Health Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: August 29, 2013
• First Submitted That Met QC Criteria: September 3, 2013
• First Posted (Estimate): September 4, 2013

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Kenya; eHealth; tuberculosis; clinical decision support; isoniazid preventative therapy
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: AID-OAA-TO-11-00060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO