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)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Indiana University
Sponsor:
Collaborators:
Moi University
AMPATH
Regenstrief Institute, IU Center for Aging Research
InSTEDD
Kijani Consulting
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01934309
First received: August 29, 2013
Last updated: September 3, 2013
Last verified: August 2013
  Purpose

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 Intervention
Tuberculosis
Behavioral: TB reminders

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Prescription of Isonazid [ Time Frame: within 3 months of initial encounter ] [ Designated as safety issue: No ]
    Provider prescribes INH within 3 months of patient's initial encounter.


Secondary Outcome Measures:
  • Time to isoniazid prophylactic therapy (IPT) initiation [ Time Frame: within 3 months of initial encounter ] [ Designated as safety issue: No ]
    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:
  • Initiation of isoniazid prophylactic therapy (IPT) [ Time Frame: within 3 months of initial encounter ] [ Designated as safety issue: No ]
    IPT will be considered "initiated" when a patient picks up the initial batch of the prescribed medications within 3 months of the initial encounter.

  • Isoniazid prophylactic therapy (IPT) completion [ Time Frame: 9 months after treatment initiation ] [ Designated as safety issue: No ]
    Patient completes 9-month course of IPT


Estimated Enrollment: 1000
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934309

Contacts
Contact: Aggrey K Keny, MBChB, MSc +254-722-571562 agris57@yahoo.com

Locations
Kenya
AMPATH Not yet recruiting
Eldoret, Kenya
Contact: Adrian F Gardner, MD, MPH    +254-708-400176    adriangardner1@gmail.com   
Contact: Philip O Owiti, MBChB    +254-720-678625    p_owiti@yahoo.com   
Sponsors and Collaborators
Indiana University
Moi University
AMPATH
Regenstrief Institute, IU Center for Aging Research
InSTEDD
Kijani Consulting
Investigators
Principal Investigator: Lameck O Diero, MBChB, MMed Moi University College of Health Sciences
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01934309     History of Changes
Other Study ID Numbers: AID-OAA-TO-11-00060
Study First Received: August 29, 2013
Last Updated: September 3, 2013
Health Authority: Kenya: Division of Leprosy,TB and Lung Disease

Keywords provided by Indiana University:
tuberculosis
isoniazid preventative therapy
clinical decision support
HIV
Kenya
eHealth

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 18, 2014