Viewing Study NCT00277173



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Last Modification Date: 2024-10-26 @ 9:22 AM
Study NCT ID: NCT00277173
Status: UNKNOWN
Last Update Posted: 2006-01-16
First Post: 2006-01-13

Brief Title: Improving Geriatric Drug Safety in Underserved Practices
Sponsor: Agency for Healthcare Research and Quality AHRQ
Organization: Agency for Healthcare Research and Quality AHRQ

Study Overview

Official Title: Improving Geriatric Drug Safety in Underserved Practices
Status: UNKNOWN
Status Verified Date: 2006-01
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 PEAs 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None