Minimizing Risk and Maximizing Outcomes in Geriatric Patients Through Integrated Clinical Pharmacy Services in an Innovative Model of Community Practice

Not Applicable

Completed

• Conditions: Health Literacy; Medication Adherence; Geriatric Patient Care Improvement; Pharmacy Economic Improvement
• Interventions: Behavioral: Medication adherence consultation; Other: Medication problems assessment; Other: Beer's Criteria Assessment; Behavioral: Health Literacy Assessment

• Registration Number: NCT01351441
• Lead Sponsor: VascuScript Pharmacy

Brief Summary

It has been shown that patients can improve their safety through informed choice, safe medication use, and complication reporting. This includes not only the potential problems that occur from prescription medication use but also issues that may arise through the improper use of over-the-counter medications. The willingness of a patient to take on safety action is known to be complicated by an unwillingness to behave in a manner that might challenge a physician's judgment or actions. Community pharmacists are in the unique position to provide perspective on the physician's recommendation and act as an advocate to facilitate necessary change. Through supportive and repeated interaction with their community pharmacist patients will develop assertiveness toward their own health care, an increased frequency and quality of interaction with their physician, and thus a minimized risk of harm and maximized opportunity to optimize clinical outcomes.

Detailed Description

This is a single center, observational study to determine if geriatric patients who are on five or more chronic medications will have a difference in clinical, humanistic, and/or economic outcome through an integrated clinical pharmacy service intervention. The primary efficacy objective will be assessed through a single cohort, paired research design measuring the change from baseline in the adherence rate, number of medication related problems, and Beers criteria medications. The primary economic objective will be assessed through prescription revenue to validate the employment of a 0.5-1.0 Full-time equivalent (FTE). Secondary efficacy objectives will be assessed through a single cohort, paired research design measuring the change from baseline in the health literacy, optimization in the anthropometrics, and health related quality of life (HRQOL).

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients who are at least 65 years of age
• Have at least 5 medications that they take on a chronic basis
• Willing to have their prescriptions filled by VascuScript Pharmacy
• Understand the terms of the informed consent

Exclusion Criteria

• Any patient who does not meet the requirements of the Inclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Age 65 years or over AND at least 5 chronic medications	Medication adherence consultation	-
Age 65 years or over AND at least 5 chronic medications	Medication problems assessment	-
Age 65 years or over AND at least 5 chronic medications	Health Literacy Assessment	-
Age 65 years or over AND at least 5 chronic medications	Beer's Criteria Assessment	-

Primary Outcome Measures

Name	Time	Method
Beers criteria medications	Every month for 12 months	To determine if an integrated clinical pharmacy service program in geriatric patients can reduce the number of Beers criteria medications by ≥10%.
Economic impact	12 months	To determine the number of patients required to validate a part-time or full-time pharmacist to perform the required clinical functions of the clinical pharmacy service geriatric program.
Medication adherence	Every 30 days for 12 months	To determine if an integrated clinical pharmacy service program in geriatric patients can maintain a medication adherence rate ≥80%.
Medication related problems	Every 30 days for 12 months	To determine if an integrated clinical pharmacy service program in geriatric patients can reduce the number of medication related problems by ≥10%.

Secondary Outcome Measures

Name	Time	Method
Health literacy	12 months	To determine if an integrated clinical pharmacy service program in geriatric patients can improve health literacy as evidenced by the REALM-SF.
Optimizing Anthropometrics	12 months	To determine if an integrated clinical pharmacy service program in geriatric patients can demonstrate ≥10% improvement and/or greater optimization of patient weight, blood pressure, cholesterol, and blood glucose (if applicable).
Quality of Life	12 months	To determine if an integrated clinical pharmacy service program in geriatric patients can improve quality of life as evidenced by the CDC HRQOL Healthy Days Core Module.

Trial Locations

Locations (1)

VascuScript Pharmacy; 🇺🇸 Cheektowaga, New York, United States