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

June 2, 2020 updated by: Scott V. Monte, VascuScript Pharmacy
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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

  • United States
    • New York
      • Cheektowaga, New York, United States, 14225
        • VascuScript Pharmacy

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

Yes

Genders Eligible for Study

All

Description

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 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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Age 65 years or over AND at least 5 chronic medications
Behavioral: Medication adherence consultation
Patients will be counseled in person on day 0 then telephonically every month after until day 365.
Other: Medication problems assessment
Patients will be asked if they are having any issues that may be attributable to their current drug therapy on a monthly basis. Any issue that is identified will be addressed by the pharmacist.
Other: Beer's Criteria Assessment
The patient's drug therapy will be reviewed for Beer's criteria medications and possible alternatives will be addressed by the pharmacist if deemed appropriate.
Behavioral: Health Literacy Assessment
Patients will be given a Health Literacy Assessment on day 0 and day 365 using the Realm-SF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence
Time Frame: 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%.
Every 30 days for 12 months
Medication related problems
Time Frame: 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%.
Every 30 days for 12 months
Beers criteria medications
Time Frame: 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%.
Every month for 12 months
Economic impact
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health literacy
Time Frame: 12 months
To determine if an integrated clinical pharmacy service program in geriatric patients can improve health literacy as evidenced by the REALM-SF.
12 months
Optimizing Anthropometrics
Time Frame: 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).
12 months
Quality of Life
Time Frame: 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.
12 months

Collaborators and Investigators

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

Sponsor

VascuScript Pharmacy

Collaborators

Community Pharmacy Foundation

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 Start

May 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PHP1140411E

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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