Improving Geriatric Drug Safety in Underserved Practices
|ClinicalTrials.gov Identifier: NCT00277173|
Recruitment Status : Unknown
Verified January 2006 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was: Recruiting
First Posted : January 16, 2006
Last Update Posted : January 16, 2006
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Behavioral: Adoption of Crew Resource Management approach||Not Applicable|
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:
- 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
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
- with a practice enhancement assistant (PEA) and
- 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 (Clinical Trial)|
|Enrollment :||4800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Geriatric Drug Safety in Underserved Practices|
|Study Start Date :||January 2006|
- Change in number of total and preventable ADEs.
- Change in culture of safety
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277173
|Contact: Gurdev Singh, MScEng. PhD.||716 898 email@example.com|
|Contact: Ranjit Singh, MD MBA||716 898 firstname.lastname@example.org|
|United States, New York|
|Family Medicine Research Institute||Recruiting|
|Buffalo, New York, United States, 14215|
|Principal Investigator:||Gurdev Singh, MScEng. PhD.||State University of New York at Buffalo|