Improving Geriatric Drug Safety in Underserved Practices

NCT ID: NCT00277173

Last Updated: 2006-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 4800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31

Brief Summary

The purpose of this study is to determine whether a CRM (adapted Crew Resource Management approach proven successful in aviation as well as some inpatient medical settings) intervention is effective for reducing medication errors among older adults in primary care settings.

Detailed Description

Adverse drug events (ADEs) are among the most common and serious medication use concerns among older patients in primary care practices, yet they are often preventable. This translational research into practice (TRIP) pilot study uses a randomized trial to evaluate the effect of a site-level intervention in a sample of practices in medically underserved communities within the Upstate New York Practice Based Research Network (UNYNET). These sites are located in rural and urban areas and include an over-sample of minority patients. The specific aims of this study are to:

1. Examine the feasibility of objectively assessing the impact of a CRM (adapted Crew Resource Management approach proven successful in aviation as well as some inpatient medical settings) intervention on reducing medication errors among geriatric patients in primary care settings; and

2. Assess office staff internalization and application of CRM principles for reducing geriatric medication errors in primary care settings by examining changes in safety attitude constructs achieved

1. with a practice enhancement assistant (PEA) and

2. without a PEA.

Outcomes measured for Aim #1 will be change in number, severity, consequence, and stage of process of preventable ADEs. Outcomes for Aim # 2 will be change in safety climate, teamwork climate, stress recognition, and working conditions.

Fifteen sites will be randomized into one of three intervention arms: usual care, CRM only, or CRM plus a PEA. A random sample of charts of older adults (aged >64) with cardiovascular disease will be reviewed for adverse drug events over prior-year periods at baseline and post-intervention endpoints. Participatory research methods will be used to assess provider- and staff-identified barriers to implementation. This study will test the feasibility of incorporating PEA's into the practice setting to improve geriatric medication safety. The information gathered will serve as a basis for an ongoing translational research program that will lead to an RO1 application.

Conditions

Cardiovascular Diseases

Keywords

Medication Safety; Adverse Drug Events; Preventable Adverse Drug Events; Culture of Safety; Failure Modes and Effects Analysis; Teambuilding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: ECT
• Blinding Strategy: NONE

Interventions

Adoption of Crew Resource Management approach

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Practice must located in Health Professional Shortage Area or Physician Scarcity Area.
• Practice must be a member of the Western New York Practice-Based Research Network

• Aged >64
• Cardiovascular disease
• Seen at the practice within the past year

Exclusion Criteria

• None

• None

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: lead

Principal Investigators

Gurdev Singh, MScEng. PhD.

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

Family Medicine Research Institute

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gurdev Singh, MScEng. PhD.

Role: CONTACT

Phone: 716 898 5640

Email: gsingh4@buffalo.edu

Ranjit Singh, MD MBA

Role: CONTACT

Phone: 716 898 5517

Email: rs10@buffalo.edu

Other Identifiers

R21HS014867

Identifier Type: AHRQ

Identifier Source: org_study_id

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