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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)

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ClinicalTrials.gov Identifier: NCT01934309
Recruitment Status : Completed
First Posted : September 4, 2013
Last Update Posted : August 25, 2015
Sponsor:
Collaborators:
Moi University
AMPATH
Regenstrief Institute, Inc.
InSTEDD
Kijani Consulting
Information provided by (Responsible Party):
Indiana University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Tuberculosis Behavioral: TB reminders Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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?
Study Start Date : September 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. 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.

  2. Isoniazid prophylactic therapy (IPT) completion [ Time Frame: 9 months after treatment initiation ]
    Patient completes 9-month course of IPT


Eligibility Criteria
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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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01934309     History of Changes
Other Study ID Numbers: AID-OAA-TO-11-00060
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 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