Randomized Controlled Trial of Enhanced Pharmacy Care in Older Veteran Outpatients

April 6, 2015 updated by: US Department of Veterans Affairs

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Background:

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.

Objectives:

The study has the following six aims: 1) Compare changes in prescribing practices-as measured by medication appropriateness, number of medications, and cost of prescribed medications-between baseline and follow-up in patients randomized to Enhanced Pharmacy Care and patients randomized to usual care; 2) Compare other medication-based endpoints in the two groups, including the occurrence of potential ADEs, medication compliance, and patient knowledge of medications; 3) Compare changes in health-related-quality-of-life in the two groups; 4) Compare patient perceptions of the quality of VA outpatient care in the two groups; 5) Compare health care utilization during the one-year study period in the two groups; and 6) Examine attitudes of primary care providers (PCPs) about the intervention.

Methods:

Patients were eligible for the trial if they were 65 years and older and receiving prescriptions for > 5 medications in a VA primary care clinic. Patients were randomized to usual care or to the intervention, which included a structured medication history and medical records review. For intervention patients, therapeutic recommendations were developed and presented to primary care providers. Baseline and 3-month measures were obtained and change was assessed by analysis of covariance.

Status:

493 patients have been enrolled in the trial and 12-month follow-up has been completed on over 95% of patients. Preliminary results have been evaluated and abstracts have been submitted to national meetings, including the 2004 VA HSR&D and 2004 SGIM Annual Meetings where it will be presented as an oral presentation. We are completing all the data cleaning and will be performing final analyses on the data, with manuscript preparation. Final outcome assessment using the Medication Appropriateness Index is in the final stage.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Iowa
      • Iowa City, Iowa, United States, 52246-2208
        • Iowa City VA Health Care System, Iowa City, IA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gary E. Rosenthal, MD, Iowa City VA Health Care System, Iowa City, IA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

July 18, 2005

First Submitted That Met QC Criteria

July 18, 2005

First Posted (Estimate)

July 21, 2005

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

February 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • SAF 98-152

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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