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

NCT ID: NCT01934309

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3782 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TB reminders

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

Group Type EXPERIMENTAL

TB reminders

Intervention Type BEHAVIORAL

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 TB reminders

Only receive existing reminders; no TB reminders

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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

Patients:


\- history of TB or IPT
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moi University

OTHER

Sponsor Role collaborator

Academic Model Providing Access to Healthcare (AMPATH)

OTHER

Sponsor Role collaborator

Regenstrief Institute, Inc.

OTHER

Sponsor Role collaborator

Innovative Support to Emergencies, Diseases and Disasters (InSTEDD)

UNKNOWN

Sponsor Role collaborator

Kijani Consulting

UNKNOWN

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Paul Biondich

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lameck O Diero, MBChB, MMed

Role: PRINCIPAL_INVESTIGATOR

Moi University College of Health Sciences

Locations

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AMPATH

Eldoret, , Kenya

Site Status

Countries

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Kenya

References

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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.

Reference Type DERIVED
PMID: 25885266 (View on PubMed)

Other Identifiers

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AID-OAA-TO-11-00060

Identifier Type: -

Identifier Source: org_study_id

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