Improving Geriatric Drug Safety in Underserved Practices

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00277173
First received: January 13, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Behavioral: Adoption of Crew Resource Management approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Improving Geriatric Drug Safety in Underserved Practices

Further study details as provided by Agency for Healthcare Research and Quality (AHRQ):

Primary Outcome Measures:
  • Change in number of total and preventable ADEs.
  • Change in culture of safety

Estimated Enrollment: 4800
Study Start Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Exclusion Criteria (for chart review):

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277173

Contacts
Contact: Gurdev Singh, MScEng. PhD. 716 898 5640 gsingh4@buffalo.edu
Contact: Ranjit Singh, MD MBA 716 898 5517 rs10@buffalo.edu

Locations
United States, New York
Family Medicine Research Institute Recruiting
Buffalo, New York, United States, 14215
Sponsors and Collaborators
Investigators
Principal Investigator: Gurdev Singh, MScEng. PhD. State University of New York at Buffalo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00277173     History of Changes
Other Study ID Numbers: R21HS14867
Study First Received: January 13, 2006
Last Updated: January 13, 2006
Health Authority: United States: Federal Government

Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
Medication Safety
Adverse Drug Events
Preventable Adverse Drug Events
Culture of Safety
Failure Modes and Effects Analysis
Teambuilding

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014