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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Medication Adherence, Health Literacy, Geriatric Patient Care Improvement, Pharmacy Economic Improvement

Intervention / Treatment
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* Behavioral: Medication adherence consultation
* Other: Medication problems assessment
* Other: Beer's Criteria Assessment
* Behavioral: Health Literacy Assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Age 65 years or over AND at least 5 chronic medications<br> | Behavioral: Medication adherence consultation<br>* Patients will be counseled in person on day 0 then telephonically every month after until day 365.<br>Other: Medication problems assessment<br>* 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.<br>Other: Beer's Criteria Assessment<br>* 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.<br>Behavioral: Health Literacy Assessment<br>* Patients will be given a Health Literacy Assessment on day 0 and day 365 using the Realm-SF.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacoeconomics, Health Literacy, Adherence, Geriatric