NCT01351441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

1.5 years

First QC Date

May 9, 2011

Last Update Submit

June 2, 2020

Conditions

Medication AdherenceHealth LiteracyGeriatric Patient Care ImprovementPharmacy Economic Improvement

Keywords

GeriatricPharmacoeconomicsHealth LiteracyAdherence

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Health literacy

    12 months

  • Optimizing Anthropometrics

    12 months

  • Quality of Life

    12 months

Study Arms (1)

Age 65 years or over AND at least 5 chronic medications

OTHER
Behavioral: Medication adherence consultationOther: Medication problems assessmentOther: Beer's Criteria AssessmentBehavioral: Health Literacy Assessment

Interventions

Medication adherence consultationBEHAVIORAL

Patients will be counseled in person on day 0 then telephonically every month after until day 365.

Age 65 years or over AND at least 5 chronic medications
Medication problems assessmentOTHER

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.

Age 65 years or over AND at least 5 chronic medications
Beer's Criteria AssessmentOTHER

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.

Age 65 years or over AND at least 5 chronic medications
Health Literacy AssessmentBEHAVIORAL

Patients will be given a Health Literacy Assessment on day 0 and day 365 using the Realm-SF.

Age 65 years or over AND at least 5 chronic medications

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VascuScript Pharmacy

Cheektowaga, New York, 14225, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 10, 2011

Study Start

May 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

June 4, 2020

Record last verified: 2020-06

Locations

US(1)