Randomized Controlled Trial of Enhanced Pharmacy Care in Older Veteran Outpatients

Geriatrics Clinical Trial

Official title: Randomized Controlled Trial of Enhanced Pharmacy Care in Older Veteran Outpatients

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Therapy
• Geriatrics
• Poly Pharmacy

• NCT number: NCT00122122
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: Phase 3
• Completion date: March 2004