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

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351441
• Other study ID #: PHP1140411E
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: June 2020
• Source: VascuScript Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Geriatric Patient Care Improvement
• Health Literacy
• Medication Adherence
• Pharmacy Economic Improvement

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	VascuScript Pharmacy	Cheektowaga	New York

Sponsors (2)

Lead Sponsor	Collaborator
VascuScript Pharmacy	Community Pharmacy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	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
Primary	Medication related problems	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
Primary	Beers criteria medications	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
Primary	Economic impact	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	Health literacy	To determine if an integrated clinical pharmacy service program in geriatric patients can improve health literacy as evidenced by the REALM-SF.	12 months
Secondary	Optimizing Anthropometrics	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
Secondary	Quality of Life	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