Improving Geriatric Drug Safety in Underserved Practices

Cardiovascular Diseases Clinical Trial

Official title:

Improving Geriatric Drug Safety in Underserved Practices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00277173
• Other study ID #: R21HS014867
• Status: Recruiting
• Phase: N/A
• First received: January 13, 2006
• Last updated: January 13, 2006
• Start date: January 2006

Study information

• Verified date: January 2006
• Source: Agency for Healthcare Research and Quality (AHRQ)
• Contact: Gurdev Singh, MScEng. PhD.
• Phone: 716 898 5640
• Email: gsingh4[@]buffalo.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4800
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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:

Patient Inclusion Criteria (for chart review):

• Aged >64

• Cardiovascular disease

• Seen at the practice within the past year

Patient Exclusion Criteria (for chart review):

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Adoption of Crew Resource Management approach

Locations

Country	Name	City	State
United States	Family Medicine Research Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of total and preventable ADEs.
Primary	Change in culture of safety