Reducing Transition Drug Risk

Hospitalization Clinical Trial

Official title:

Reducing Transition Drug Risks After Patient Transfer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370916
• Other study ID #: IAB 05-204
• Status: Completed
• Phase: N/A
• First received: August 30, 2006
• Last updated: April 6, 2015
• Start date: October 2005
• Est. completion date: September 2010

Study information

• Verified date: December 2010
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 612
• Est. completion date: September 2010
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hospitalization

Intervention

Behavioral:
• Physician-initiated medication reconciliation
Physician house staff performed and documented medication reconciliation after hospital admission with the assistance of a CPRS template
• Pharmacist-initiated medication reconciliation
Pharmacist performed and documented medication reconciliation

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Icahn School of Medicine at Mount Sinai, University of Victoria

Country where clinical trial is conducted

United States, 

References & Publications (3)

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/ar — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High risk drug discrepancies		After hospital admission and discharge	No
Secondary	Drug discrepancy adverse events		During the hospital stay and 1 month after hospital discharge	No