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

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ClinicalTrials.gov Identifier: NCT01351441
Recruitment Status : Unknown
Verified May 2011 by VascuScript Pharmacy.
Recruitment status was:  Recruiting
First Posted : May 10, 2011
Last Update Posted : May 10, 2011
Sponsor:
Collaborator:
Community Pharmacy Foundation
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Medication Adherence Health Literacy Geriatric Patient Care Improvement Pharmacy Economic Improvement Behavioral: Medication adherence consultation Other: Medication problems assessment Other: Beer's Criteria Assessment Behavioral: Health Literacy Assessment Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Minimizing Risk and Maximizing Outcomes in Geriatric Patients Through Integrated Clinical Pharmacy Services in an Innovative Model of Community Practice
Study Start Date : May 2011
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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%.

  2. 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%.

  3. 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%.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351441


Locations
United States, New York
VascuScript Pharmacy Recruiting
Cheektowaga, New York, United States, 14225
Contact: Scott V Monte, Pharm.D    716-713-0368    svmonte@buffalo.edu   
Contact: Patrick T Comerford, Pharm.D    716-984-0457    pcomerford@vascuscript.com   
Principal Investigator: Scott V Monte, Pharm.D         
Sub-Investigator: Patrick T Comerford, Pharm.D         
Sub-Investigator: Yen Nien Hou, BA         
Sub-Investigator: Dean Trzewieczynski, BS         
Sub-Investigator: Kenneth Andrus, BS         
Sub-Investigator: Nicole Paolini-Albanese, Pharm.D         
Sponsors and Collaborators
VascuScript Pharmacy
Community Pharmacy Foundation

Additional Information:
Responsible Party: Scott V. Monte, Pharm.D, VascuScript Pharmacy
ClinicalTrials.gov Identifier: NCT01351441     History of Changes
Other Study ID Numbers: PHP1140411E
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: May 2011

Keywords provided by VascuScript Pharmacy:
Geriatric
Pharmacoeconomics
Health Literacy
Adherence