Reducing Transition Drug Risk

Reducing Transition Drug Risks After Patient Transfer

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.

Study Overview

• Status: Completed
• Conditions: Hospitalization
• Intervention / Treatment: Behavioral: Physician-initiated medication reconciliation; Behavioral: Pharmacist-initiated 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.

• Study Type: Interventional
• Enrollment (Actual): 612
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10468
      • James J. Peters VA Medical Center, Bronx, NY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
High risk drug discrepancies	After hospital admission and discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Drug discrepancy adverse events	During the hospital stay and 1 month after hospital discharge

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Collaborators: Icahn School of Medicine at Mount Sinai; University of Victoria
• Investigators: Principal Investigator: Kenneth S Boockvar, MD MS, James J. Peters Veterans Affairs Medical Center

Publications and helpful links

General Publications

• Boockvar KS, Santos SL, Kushniruk A, Johnson C, Nebeker JR. Medication reconciliation: barriers and facilitators from the perspectives of resident physicians and pharmacists. J Hosp Med. 2011 Jul-Aug;6(6):329-37. doi: 10.1002/jhm.891.
• Kushniruk AW, Santos SL, Pourakis G, Nebeker JR, Boockvar KS. Cognitive analysis of a medication reconciliation tool: applying laboratory and naturalistic approaches to system evaluation. Stud Health Technol Inform. 2011;164:203-7.
• Boockvar KS, Blum S, Kugler A, Livote E, Mergenhagen KA, Nebeker JR, Signor D, Sung S, Yeh J. Effect of admission medication reconciliation on adverse drug events from admission medication changes. Arch Intern Med. 2011 May 9;171(9):860-1. doi: 10.1001/archinternmed.2011.163. No abstract available.
• Mergenhagen KA, Blum SS, Kugler A, Livote EE, Nebeker JR, Ott MC, Signor D, Sung S, Yeh J, Boockvar KS. Pharmacist- versus physician-initiated admission medication reconciliation: impact on adverse drug events. Am J Geriatr Pharmacother. 2012 Aug;10(4):242-50. doi: 10.1016/j.amjopharm.2012.06.001. Epub 2012 Jul 20.

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: August 30, 2006
• First Submitted That Met QC Criteria: August 30, 2006
• First Posted (Estimate): September 1, 2006

Study Record Updates

• Last Update Posted (Estimate): April 7, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Continuity of Patient Care; Clinical Decision Support Systems; Medication Errors; Drug Adverse Effects
• Other Study ID Numbers: IAB 05-204