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Regional Data Exchange to Improve Medication Safety

Primary Purpose

Drug Toxicity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIE-Enhanced Medication Reconciliation
Optimal Medication Reconciliation without HIE
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Drug Toxicity focused on measuring drug toxicity, drug interactions, electronic health records, medical errors

Eligibility Criteria

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

Inclusion Criteria:

  • Veterans admitted to James J. Peters VA hospital units 6B, 7B, 7C, or 8B or seen as outpatients in the Geriatrics Primary care clinic, who have an identity match in the Bronx RHIO, who consent to participate in the Bronx RHIO, and who stay on the unit at least 24 hours

Exclusion Criteria:

  • Cannot be transferred from another James J. Peters VA hospital unit

Sites / Locations

  • James J. Peters VA Medical Center, Bronx, NY

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

HIE-Enhanced Medication Reconciliation

Optimal Medication Reconciliation without HIE

Pilot HIE-Enhanced Outpatient Medication Reconciliation

Arm Description

Health Information Exchange (HIE)-Enhanced Medication Reconciliation for Veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)

Optimal Medication Reconciliation without Health Information Exchange (HIE) for Veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)

Health Information Exchange (HIE)-Enhanced Medication Reconciliation for Veterans seen as outpatients in Geriatrics Primary care clinic

Outcomes

Primary Outcome Measures

Transition Drug Risk
Rating of potential for harm to patient from hospital medication discrepancies by record review. Minimum=0 Maximum=no maximum. Higher values represent increased detection of medication discrepancies. Although medication discrepancies are undesirable, increasing their detection might facilitate prevention of adverse drug events.

Secondary Outcome Measures

Adverse Drug Events
Actual harm to patient from hospital medication discrepancies by record review
Medication-related Symptoms
Patient's self-report of medication-related symptoms by telephone questionnaire

Full Information

First Posted
November 9, 2010
Last Updated
July 14, 2016
Sponsor
VA Office of Research and Development
Collaborators
University of Victoria, Weill Medical College of Cornell University, Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT01239121
Brief Title
Regional Data Exchange to Improve Medication Safety
Official Title
Implementing a Regional Data Exchange Tool to Improve Medication Use and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Victoria, Weill Medical College of Cornell University, Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Medication reconciliation, a process by which a provider obtains and documents a thorough medication history with specific attention to comparing current and previous medication use, can prevent medication-related errors and harm. The aims of this study are: 1) To adapt medication reconciliation to include information from a computerized regional health information exchange (RHIO) in the Bronx, 2) To conduct a trial of the adapted medication reconciliation process and examine effects on medication errors, harm, and hospital costs, and 3) To identify factors that are barriers to adoption of the RHIO tool by James J. Peters (Bronx) VA providers. Findings from this project will provide an understanding of the effect of the RHIO tool on reducing harmful VA and non-VA medication use. It will also provide information on the feasibility of incorporating RHIO tool use into every day work flow for pharmacists and physicians.
Detailed Description
Medication reconciliation, a process by which a provider obtains and documents a thorough medication history with specific attention to comparing current and previous medication use, can prevent medication-related errors and harm. The most important barrier to effective medication reconciliation is the unreliability of patients' own reports about their medication use and incomplete provider history-taking. The James J. Peters VA (JJP VA) participates in the Bronx RHIO, a New York State-funded health information exchange organization that in October 2008 implemented clinical data information exchange among the largest healthcare providers in the Bronx. JJP VA providers can now access clinical data, including medication use, from non-VA facilities with patients' consent. The aims of this study are: 1) To adapt a medication reconciliation process to include information from a regional health information exchange (RHIO), 2) To conduct a controlled trial of a medication reconciliation process at the time of hospital admission either enhanced or not enhanced with data from a regional health information exchange, and examine effects on transition drug risk, adverse drug events, and total inpatient costs, and 3) To identify system and provider factors that impede and facilitate adoption of the information exchange tool for routine use by VA providers. The investigators plan to conduct qualitative and quantitative studies. First the investigators will perform cognitive task analysis (CTA) to examine providers' decision-making and to map RHIO tool functions while providers interface with the tool, with interview questions to identify factors that facilitate or hinder use. Second, the investigators will enroll patients admitted to 2 inpatient units at the JJP VA, and assign them to receive usual medication reconciliation or RHIO-enhanced medication reconciliation with a notification to physicians about the patient's non-VA services that can be viewed in the RHIO. The investigators will measure transition drug risk and ADEs by medical record review and patient interview, and measure inpatient costs with administrative cost data from national VA datasets. Third, the investigators will conduct CTA with pharmacists and physicians at the end of the quantitative study who are expert in use of the tool to characterize differences in cognitive processes from prior to the quantitative study. This will supply information on system and provider factors that impede and facilitate adoption of the tool for routine use, and on potential improvements in the tool. Findings from this project will provide an understanding of the effect of real-time review of Veteran's non-VA medication use -- enabled by a Regional Health Information Organization (RHIO) tool -- on reducing duplicative VA and non-VA medication use and adverse drug events in Veterans. It will also provide information on the feasibility and effectiveness of incorporating RHIO tool access and use into every day work flow for VA pharmacist and physician providers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Toxicity
Keywords
drug toxicity, drug interactions, electronic health records, medical errors

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIE-Enhanced Medication Reconciliation
Arm Type
Experimental
Arm Description
Health Information Exchange (HIE)-Enhanced Medication Reconciliation for Veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
Arm Title
Optimal Medication Reconciliation without HIE
Arm Type
Active Comparator
Arm Description
Optimal Medication Reconciliation without Health Information Exchange (HIE) for Veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
Arm Title
Pilot HIE-Enhanced Outpatient Medication Reconciliation
Arm Type
Other
Arm Description
Health Information Exchange (HIE)-Enhanced Medication Reconciliation for Veterans seen as outpatients in Geriatrics Primary care clinic
Intervention Type
Other
Intervention Name(s)
HIE-Enhanced Medication Reconciliation
Intervention Description
Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist
Intervention Type
Other
Intervention Name(s)
Optimal Medication Reconciliation without HIE
Intervention Description
Medication reconciliation implemented by a pharmacist without regional health information exchange
Primary Outcome Measure Information:
Title
Transition Drug Risk
Description
Rating of potential for harm to patient from hospital medication discrepancies by record review. Minimum=0 Maximum=no maximum. Higher values represent increased detection of medication discrepancies. Although medication discrepancies are undesirable, increasing their detection might facilitate prevention of adverse drug events.
Time Frame
During hospital stay and up to 1 month after hospital discharge
Secondary Outcome Measure Information:
Title
Adverse Drug Events
Description
Actual harm to patient from hospital medication discrepancies by record review
Time Frame
During hospital stay and up to 1 month after hospital discharge
Title
Medication-related Symptoms
Description
Patient's self-report of medication-related symptoms by telephone questionnaire
Time Frame
Up to 1 month after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans admitted to James J. Peters VA hospital units 6B, 7B, 7C, or 8B or seen as outpatients in the Geriatrics Primary care clinic, who have an identity match in the Bronx RHIO, who consent to participate in the Bronx RHIO, and who stay on the unit at least 24 hours Exclusion Criteria: Cannot be transferred from another James J. Peters VA hospital unit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth S Boockvar, MD MS
Organizational Affiliation
James J. Peters Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
James J. Peters VA Medical Center, Bronx, NY
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Hung WW, Morano B, Moodhe N, Boockvar K. Regional Health Information Organization (RHIO): its potential uses to improve veteran health care. Federal practitioner : for the health care professionals of the VA, DoD, and PHS. 2011 Jan 1; 28(3):33-36.
Results Reference
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Regional Data Exchange to Improve Medication Safety

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