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Regional Data Exchange to Improve Medication Safety

This study has been completed.
Sponsor:
Collaborators:
University of Victoria
Weill Medical College of Cornell University
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01239121
First received: November 9, 2010
Last updated: July 14, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Drug Toxicity
Other: HIE-Enhanced Medication Reconciliation
Other: Optimal Medication Reconciliation without HIE

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Implementing a Regional Data Exchange Tool to Improve Medication Use and Safety

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Transition Drug Risk [ Time Frame: During hospital stay and up to 1 month after hospital discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: During hospital stay and up to 1 month after hospital discharge ] [ Designated as safety issue: Yes ]
    Actual harm to patient from hospital medication discrepancies by record review

  • Medication-related Symptoms [ Time Frame: Up to 1 month after hospital discharge ] [ Designated as safety issue: Yes ]
    Patient's self-report of medication-related symptoms by telephone questionnaire


Enrollment: 402
Study Start Date: February 2012
Study Completion Date: June 2016
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIE-Enhanced Medication Reconciliation
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)
Other: HIE-Enhanced Medication Reconciliation
Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist
Active Comparator: Optimal Medication Reconciliation without HIE
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)
Other: Optimal Medication Reconciliation without HIE
Medication reconciliation implemented by a pharmacist without regional health information exchange
Pilot HIE-Enhanced Outpatient Medication Reconciliation
Health Information Exchange (HIE)-Enhanced Medication Reconciliation for Veterans seen as outpatients in Geriatrics Primary care clinic
Other: HIE-Enhanced Medication Reconciliation
Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01239121

Locations
United States, New York
James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
University of Victoria
Weill Medical College of Cornell University
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Kenneth S Boockvar, MD MS VA Office of Research and Development
  More Information

Publications:
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.

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01239121     History of Changes
Other Study ID Numbers: IIR 10-146 
Study First Received: November 9, 2010
Results First Received: March 16, 2016
Last Updated: July 14, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
drug toxicity
drug interactions
electronic health records
medical errors

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on December 02, 2016