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OpenTrials
Completed

NCT Number: NCT01351441

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.

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Key information

Conditions

Medication Adherence Behavior Geriatric Patient Care Improvement Health Behavior Health Literacy Patient Acceptance of Health Care Patient Compliance Pharmacy Economic Improvement Treatment Adherence and Compliance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VascuScript Pharmacy

Cheektowaga, New York, 14225, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medication adherence consultation

Behavioral

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

Medication problems assessment

Other

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

Other

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.

Health Literacy Assessment

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

VascuScript Pharmacy

Other

Collaborators

  • Community Pharmacy Foundation

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 10, 2011
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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