NCT00122122

Brief Summary

Complications resulting from medications, or adverse drug events (ADEs), are prevalent and are a major source of excess morbidity and costs. ADEs are particularly problematic in older patients because of their higher burden of comorbidity and diminished physiologic reserve. In addition, older patients are more likely to be exposed to polypharmacy, a major risk factor for ADEs. While ADEs may be idiosyncratic, many result from medical errors and inadequate systems for ensuring the safe and effective use of medications. The goal of the proposed study is to test the efficacy of a potentially potent intervention to improve the use of medications in older outpatients enrolled in VA primary care clinics. The intervention-Enhanced Pharmacy Care-involves a formal, multi-dimensional evaluation of patients� medication regimens by a trained clinical pharmacist and board-certified geriatrician.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
Last Updated

April 7, 2015

Status Verified

February 1, 2007

First QC Date

July 18, 2005

Last Update Submit

April 6, 2015

Conditions

GeriatricsDrug TherapyPoly Pharmacy

Study Arms (1)

Arm 1

OTHER
Behavioral: Enhanced Pharmacy Care

Interventions

Enhanced Pharmacy CareBEHAVIORAL
Arm 1

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients enrolled in VA primary care clinics who are 65 years and older and who are receiving prescriptions for 5 or more scheduled medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

Related Publications (2)

  • Steinman MA, Rosenthal GE, Landefeld CS, Bertenthal D, Kaboli PJ. Agreement between drugs-to-avoid criteria and expert assessments of problematic prescribing. Arch Intern Med. 2009 Jul 27;169(14):1326-32. doi: 10.1001/archinternmed.2009.206.

    PMID: 19636035RESULT

  • Steinman MA, Rosenthal GE, Landefeld CS, Bertenthal D, Sen S, Kaboli PJ. Conflicts and concordance between measures of medication prescribing quality. Med Care. 2007 Jan;45(1):95-9. doi: 10.1097/01.mlr.0000241111.11991.62.

    PMID: 17279026RESULT

Study Officials

  • Gary E. Rosenthal, MD

    Iowa City VA Health Care System, Iowa City, IA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2005

First Posted

July 21, 2005

Study Completion

March 1, 2004

Last Updated

April 7, 2015

Record last verified: 2007-02

Locations

US(1)