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
Results First Received: March 16, 2016  
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
Condition: Drug Toxicity
Interventions: Other: HIE-Enhanced Medication Reconciliation
Other: Optimal Medication Reconciliation without HIE

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)

HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist

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)

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

HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist


Participant Flow:   Overall Study
    HIE-Enhanced Medication Reconciliation     Optimal Medication Reconciliation Without HIE     Pilot HIE-Enhanced Outpatient Medication Reconciliation  
STARTED     188     199     15  
COMPLETED     186     195     15  
NOT COMPLETED     2     4     0  
Withdrawal by Subject                 2                 4                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)

HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist

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)

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

HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist

Total Total of all reporting groups

Baseline Measures
    HIE-Enhanced Medication Reconciliation     Optimal Medication Reconciliation Without HIE     Pilot HIE-Enhanced Outpatient Medication Reconciliation     Total  
Number of Participants  
[units: participants]
  186     195     15     396  
Age  
[units: years]
Mean (Standard Deviation)
  59.7  (14.4)     60.8  (14.5)     86.4  (6.8)     60.5  (14.1)  
Gender  
[units: participants]
       
Female     6     7     0     13  
Male     180     188     15     383  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     44     55     1     100  
Not Hispanic or Latino     138     138     11     287  
Unknown or Not Reported     4     2     3     9  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     1     2     1     4  
Black or African American     121     120     4     245  
White     57     64     9     130  
More than one race     1     3     1     5  
Unknown or Not Reported     6     6     0     12  
Region of Enrollment  
[units: participants]
       
United States     186     195     15     396  



  Outcome Measures
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1.  Primary:   Transition Drug Risk   [ Time Frame: During hospital stay and up to 1 month after hospital discharge ]

2.  Secondary:   Adverse Drug Events   [ Time Frame: During hospital stay and up to 1 month after hospital discharge ]

3.  Secondary:   Medication-related Symptoms   [ Time Frame: Up to 1 month after hospital discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
In the HIE-enhanced medication reconciliation intervention arm, the Health Information Exchange (HIE) capabilities were reduced from what was planned, limiting the potency of the intervention relative to control.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kenneth Boockvar
Organization: James J. Peters VA Medical Center
phone: 718-584-9000 ext 3807
e-mail: kenneth.boockvar@va.gov


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