Reducing Transition Drug Risk

This study has been completed.
Sponsor:
Collaborators:
University of Victoria
Mount Sinai School of Medicine
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00370916
First received: August 30, 2006
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

Patient transfer between sites of care is regular practice during an episode of care in our current health care system. Yet inter-site transfer is associated with lapses in care quality that adversely affect patient outcomes. A common iatrogenic harm precipitated at the time of transfer is harm from drug prescribing, or adverse drug events (ADEs). In this study we will evaluate a medication reconciliation tool developed to help providers make effective prescribing decisions at the time of transfer between VA sites of care (Improved Prescribing after Transfer (IPT)). We will evaluate the quantitative effectiveness of the tool in reducing transition drug risk and ADEs. We additionally will conduct focus group discussions and cognitive task analysis among end-users to better understand how providers make drug-prescribing decisions at the time of transfer and to assess factors influencing effective use of the tool.


Condition Intervention
Hospitalization
Behavioral: Physician-initiated medication reconciliation
Behavioral: Pharmacist-initiated medication reconciliation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Reducing Transition Drug Risks After Patient Transfer

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • High risk drug discrepancies [ Time Frame: After hospital admission and discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug discrepancy adverse events [ Time Frame: During the hospital stay and 1 month after hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 612
Study Start Date: October 2005
Study Completion Date: September 2010
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Physician-initiated medication reconciliation
Behavioral: Physician-initiated medication reconciliation
Physician house staff performed and documented medication reconciliation after hospital admission with the assistance of a CPRS template
Experimental: Arm 2
Pharmacist-initiated medication reconciliation
Behavioral: Pharmacist-initiated medication reconciliation
Pharmacist performed and documented medication reconciliation
No Intervention: Arm 3
No formal medication reconciliation

Detailed Description:

This is a 2-phase study in which we will employ mixed quantitative and qualitative methods to conduct an evaluation of the IPT tool while improving our understanding of provider prescribing decisions at the time of patient transfer. In Phase 1 we will conduct a 5-month controlled trial among all admissions to 2 units at J.J. Peters (Bronx) VA Medical Center. We will compare IPT with usual care, and compare physician and pharmacist forms of IPT implementation with regard to, as primary outcome, transition drug risk, and, as secondary outcomes, ADEs, provider prescribing-decisions, and hospital utilization. In Phase 2, which will run concurrently with Phase 1, we will perform cognitive task analysis to examine providers' decision-making and to map IPT tool functions while providers interface with the tool, and perform focus group interviews with representative IPT users to identify factors that facilitate or hinder adoption. Results of cognitive analysis and focus groups will be used to identify tool deficiencies to consider for redesign.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients who were admitted to the JJ Peters (Bronx) VA Hospital general medical wards (units 7A and 7B) between 10/05-2/06 and stayed least 24 hours

Exclusion Criteria:

Patients who were transferred to one of the study units wards (units 7A and 7B) from another JJ Peters (Bronx) VA Hospital acute care unit (e.g., an intensive care unit), or who stayed in the hospital less than 24 hours

  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: NCT00370916

Locations
United States, New York
James J Peters VA Medical Center
Bronx, New York, United States, 10468
Sponsors and Collaborators
University of Victoria
Mount Sinai School of Medicine
Investigators
Principal Investigator: Kenneth S Boockvar, MD MS James J Peters VA Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00370916     History of Changes
Other Study ID Numbers: IAB 05-204
Study First Received: August 30, 2006
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Clinical Decision Support Systems
Continuity of Patient Care
Medication Errors
Drug Adverse Effects

ClinicalTrials.gov processed this record on September 18, 2014