Improving Geriatric Drug Safety in Underserved Practices

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Adoption of Crew Resource Management approach

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.

• Study Type: Interventional
• Enrollment: 4800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14215
      • Recruiting
      • Family Medicine Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Practice 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

Practice Exclusion Criteria:

• None

Patient Inclusion Criteria (for chart review):

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

Patient Exclusion Criteria (for chart review):

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Educational/Counseling/Training
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in number of total and preventable ADEs.
Change in culture of safety

Collaborators and Investigators

• Sponsor: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Gurdev Singh, MScEng. PhD., State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start: January 1, 2006

Study Registration Dates

• First Submitted: January 13, 2006
• First Submitted That Met QC Criteria: January 13, 2006
• First Posted (Estimate): January 16, 2006

Study Record Updates

• Last Update Posted (Estimate): January 16, 2006
• Last Update Submitted That Met QC Criteria: January 13, 2006
• Last Verified: January 1, 2006

More Information

Terms related to this study

• Keywords: Medication Safety; Adverse Drug Events; Preventable Adverse Drug Events; Culture of Safety; Failure Modes and Effects Analysis; Teambuilding
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: R21HS014867 (U.S. AHRQ Grant/Contract)