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Improving Geriatric Drug Safety in Underserved Practices

Improving Geriatric Drug Safety in Underserved Practices

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00277173
Enrollment
4800
Registered
2006-01-16
Start date
2006-01-31
Completion date
Unknown
Last updated
2006-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

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

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.

Interventions

BEHAVIORALAdoption of Crew Resource Management approach

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
ECT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change in number of total and preventable ADEs.
Change in culture of safety

Countries

United States

Contacts

Primary ContactGurdev Singh, MScEng. PhD.
gsingh4@buffalo.edu716 898 5640
Backup ContactRanjit Singh, MD MBA
rs10@buffalo.edu716 898 5517

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026