Geriatrics Clinical Trial
Official title:
Randomized Controlled Trial of Enhanced Pharmacy Care in Older Veteran Outpatients
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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