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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by VascuScript Pharmacy.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Community Pharmacy Foundation
Information provided by:
VascuScript Pharmacy
ClinicalTrials.gov Identifier:
NCT01351441
First received: May 9, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted

May 9, 2011
May 9, 2011
May 2011
November 2012   (final data collection date for primary outcome measure)
  • Medication adherence [ Time Frame: Every 30 days for 12 months ] [ Designated as safety issue: No ]
    To determine if an integrated clinical pharmacy service program in geriatric patients can maintain a medication adherence rate ≥80%.
  • Medication related problems [ Time Frame: Every 30 days for 12 months ] [ Designated as safety issue: Yes ]
    To determine if an integrated clinical pharmacy service program in geriatric patients can reduce the number of medication related problems by ≥10%.
  • Beers criteria medications [ Time Frame: Every month for 12 months ] [ Designated as safety issue: Yes ]
    To determine if an integrated clinical pharmacy service program in geriatric patients can reduce the number of Beers criteria medications by ≥10%.
  • Economic impact [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.
Same as current
No Changes Posted
  • Health literacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To determine if an integrated clinical pharmacy service program in geriatric patients can improve health literacy as evidenced by the REALM-SF.
  • Optimizing Anthropometrics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Minimizing Risk and Maximizing Outcomes in Geriatric Patients Through Integrated Clinical Pharmacy Services in an Innovative Model of Community Practice
Minimizing Risk and Maximizing Outcomes in Geriatric Patients Through Integrated Clinical Pharmacy Services in an Innovative Model of Community Practice

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.

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).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Medication Adherence
  • Health Literacy
  • Geriatric Patient Care Improvement
  • Pharmacy Economic Improvement
  • 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.
Age 65 years or over AND at least 5 chronic medications
Interventions:
  • Behavioral: Medication adherence consultation
  • Other: Medication problems assessment
  • Other: Beer's Criteria Assessment
  • Behavioral: Health Literacy Assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
65 Years and older
Yes
Not Provided
United States
 
NCT01351441
PHP1140411E
No
Scott V. Monte, Pharm.D, VascuScript Pharmacy
VascuScript Pharmacy
Community Pharmacy Foundation
Not Provided
VascuScript Pharmacy
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP