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

January 13, 2006
January 13, 2006
January 2006
Not Provided
  • Change in number of total and preventable ADEs.
  • Change in culture of safety
Same as current
No Changes Posted
Not Provided
Not Provided
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Improving Geriatric Drug Safety in Underserved Practices
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Cardiovascular Diseases
Behavioral: Adoption of Crew Resource Management approach
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4800
Not Provided
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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
Both
65 Years and older
No
Contact: Gurdev Singh, MScEng. PhD. 716 898 5640 gsingh4@buffalo.edu
Contact: Ranjit Singh, MD MBA 716 898 5517 rs10@buffalo.edu
United States
 
NCT00277173
R21HS14867
Not Provided
Not Provided
Agency for Healthcare Research and Quality (AHRQ)
Not Provided
Principal Investigator: Gurdev Singh, MScEng. PhD. State University of New York at Buffalo
Agency for Healthcare Research and Quality (AHRQ)
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP