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

Primary Purpose

Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
TB reminders
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tuberculosis focused on measuring tuberculosis, isoniazid preventative therapy, clinical decision support, HIV, Kenya, eHealth

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AMPATH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TB reminders

No TB reminders

Arm Description

Receive existing reminders plus new patient-specific reminders about TB screening, prevention, and treatment

Only receive existing reminders; no TB reminders

Outcomes

Primary Outcome Measures

Prescription of Isoniazid
Provider prescribes INH within 3 months of patient's initial encounter.

Secondary Outcome Measures

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.

Full Information

First Posted
August 29, 2013
Last Updated
March 23, 2023
Sponsor
Indiana University
Collaborators
Moi University, Academic Model Providing Access to Healthcare (AMPATH), Regenstrief Institute, Inc., Innovative Support to Emergencies, Diseases and Disasters (InSTEDD), Kijani Consulting
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1. Study Identification

Unique Protocol Identification Number
NCT01934309
Brief Title
Clinical Decision-support Reminders to Improve IPT Initiation Among HIV Positive Adults in Western Kenya
Acronym
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?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Moi University, Academic Model Providing Access to Healthcare (AMPATH), Regenstrief Institute, Inc., Innovative Support to Emergencies, Diseases and Disasters (InSTEDD), Kijani Consulting

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
tuberculosis, isoniazid preventative therapy, clinical decision support, HIV, Kenya, eHealth

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3782 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TB reminders
Arm Type
Experimental
Arm Description
Receive existing reminders plus new patient-specific reminders about TB screening, prevention, and treatment
Arm Title
No TB reminders
Arm Type
No Intervention
Arm Description
Only receive existing reminders; no TB reminders
Intervention Type
Behavioral
Intervention Name(s)
TB reminders
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prescription of Isoniazid
Description
Provider prescribes INH within 3 months of patient's initial encounter.
Time Frame
within 3 months of initial encounter
Secondary Outcome Measure Information:
Title
Time to isoniazid prophylactic therapy (IPT) initiation
Description
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.
Time Frame
within 3 months of initial encounter
Other Pre-specified Outcome Measures:
Title
Initiation of isoniazid prophylactic therapy (IPT)
Description
IPT will be considered "initiated" when a patient picks up the initial batch of the prescribed medications within 3 months of the initial encounter.
Time Frame
within 3 months of initial encounter
Title
Isoniazid prophylactic therapy (IPT) completion
Description
Patient completes 9-month course of IPT
Time Frame
9 months after treatment initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lameck O Diero, MBChB, MMed
Organizational Affiliation
Moi University College of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
AMPATH
City
Eldoret
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25885266
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.
Results Reference
derived

Learn more about this trial

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

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