Evaluation of Patient-Centered Pharmacotherapy Management
and the Impact on Health and Economic Outcomes

Primary Investigator

Dr. Gene D. Morse, Pharm.D.

Associate Dean, Clinical Education and Research

Professor, Department of Pharmacy Practice

Director, Pharmacotherapy Research Center

Background

The Department of Pharmacy Practice faculty of the UB School of Pharmacy and Pharmaceutical Sciences is conducting a multicenter research project entitled “Evaluation of Patient-Centered Pharmacotherapy Management and the Impact on Health and Economic Outcomes” in acute care, long-term care and ambulatory health care environments. In these settings, pharmacotherapy is considered to play a key role in attaining beneficial health outcomes with reduced economic burden.

Objectives:

• To determine if Patient-Centered Pharmacotherapy Management achieves more desirable health and economic outcomes when compared to the standard of care with regard to:
• patient education
• selection and dosing of prescription medications
• adverse drug reactions and medication safety
• undesirable drug-drug interactions
• therapeutic drug monitoring
• pharmacoeconomics

Research Investigators and Study Personnel:

• The investigators that will conduct this research project are faculty of the UB Department of Pharmacy Practice. Research assistants participating in this project will include post-doctoral pharmacy practice residents and fellows and Doctor of Pharmacy students at the University of Buffalo.

• Collaborating health professionals including physicians, nurses, pharmacists and dentists may also be involved in conducting this project.

Research Study Sites:

Initial Implementation Site:

Lifetime Health Centers

Additional Collaborating sites to be included at later date following implementation are:

• University at Buffalo School of Medicine and Biomedical Sciences and affiliated sites.
• University at Buffalo School of Public Health and Allied Health Professions and affiliated sites.
• University at Buffalo School of Dentistry
• Veterans Administration Health System of Western New York and designated Veterans Statewide Network sites
• Erie County Medical Center and the Erie County Health Network
• Kaleida Healthcare Inc.
• Roswell Park Cancer Institute
• Metcare Rx Pharmaceutical Care Inc.
• Buffalo Psychiatric Center
• Monroe County Community Hospital
• Bassett Healthcare
• University of Rochester School of Medicine and Dentistry
• Via Health Network
• Children’s Hospital of Buffalo
• Wyoming County Community Hospital
• Lakeshore Community Hospital
• Brylin Hospital
• Research Institute on Addictions
• Erie County Department of Health
• Niagara Hospice
• Buffalo Hospice
• Community Health Center of Buffalo and other regional designated federal health centers
• Eckerd Drug Co
• Rite Aid Corporation
• Kinney Drug Corp
• Tops Markets Pharmacy Program
• Wegmans Pharmacy Program
• CVS Pharmacies
• Walgreen Pharmacies
• Walmart Pharmacies
• Designated Independent Pharmacy practices
• Designated Independent Medical practices

Methods

Identification of potential subjects:

Physicians/providers will identify patients that might benefit from participating in the UB Patient-Centered Pharmacotherapy Management research project. After reviewing the patients medical record and current prescription medications, the patient may be asked to schedule an appointment to meet with a UB Pharmacy Practice member. A written summary of the assessment of the current medications will then be provided to the physician.

The UB Pharmacy Practice member will record the baseline status at the time of medication review and then record changes in patient medication adherence, pharmacologic outcomes (such as blood pressure lowering, blood glucose control) and maintain a record of these patterns over the period of this project.

Patient-centered pharmacotherapy management will be evaluated to determine the impact on health and economic outcomes by implementing innovative systems for pharmacotherapy assessments before and after the introduction of Patient-Centered Pharmacotherapy Management:

• optimizing patient education: Baseline and follow up assessments of medication awareness will be conducted utilizing brief, patient-friendly questionnaires.
• providing medication reviews of complex pharmacotherapy regimens: Patients receiving more than six prescription medications will participate in a medication review evaluations.
• utilizing web-based methods for networking patient care environments to optimize medication safety: Rural health providers will submit de-identified medication profiles for review.
• collect selected health outcomes data to determine the cost, personnel requirements and potential advantages or disadvantages of Patient-centered Pharmacotherapy Management as described in 1-3.

Inclusion Criteria: Subjects may meet one or more of the following criteria:

• Patients receiving > 6 chronic medications
• Patients > 70 years old
• Patients identified by their provider as having complex medication regimens

Exclusion Criteria:

• Patients who are unable to participate in the medication questionnaire component of the project.
• Patients with complex living arrangements that would preclude participation in the project.
• Patients who are unable to receive informed consent

Definition of Research Protocol Intervention:

Protocol Interventions will be defined as information identified as contributing to sub-optimal medication use obtained as part of:

• Review of chronic medications
• Patient session and medication questionnaire
• Pharmacokinetics (drug dosing considerations)
• Drug-drug interaction identification
• Adverse effect identification
• Medication duplication
• Lack of patient knowledge about adherence
• Other medication related items that are identified as possible causes complicating long-term medication management

Risk/Benefit:

Patients who participate in this research project will not receive any immediate benefit. However, if factors that complicate long-term medication management are identified it may eventually help other patients to receive optimal drug therapy. There are no risks to the patients because they are already receiving the medications to be reviewed and no investigational or alternative therapies are part of this study.

Data Collection

Data will be collected from 2000 subjects utilizing electronic spreadsheets and relational databases. All data will collected in a HIPPA compliant format. Subjects participating in this project will complete a written authorization form at each participating clinical site. All data will be maintained in a confidential manner by the investigators.

Data Analysis: This will be an unblinded, observational study using a historic case control approach. Outcomes will be assessed as change in baseline scores on educational questionnaires, number of medications at baseline and during subsequent visits after medication reviews are provided to the prescriber, and change in biomarkers depending on the disease that is being monitored (e.g., serum creatinine, blood pressure, hemoglobin A1C). Descriptive statistics will be used to summarize the numbers of medications, the number of drug interactions and medication duplications that are observed. Within subject comparisons will be conducted with a paired t-test for baseline and follow-up evaluations. Significant differences will be determined using alpha = 0.05. Since this is an observational study the targeted enrollment of 2000 subjects is anticipated to detect important trends in the data over the anticipated study period (3 years). Additional non-parametric analyses will be conducted using outcome parameters defined as desired outcome/control achieved (yes/no), optimal outcome/control achieved

Data Storage: All data collected will stored electronically within the administrative offices of the UB Department of Pharmacy Practice, Hochstetter Hall, North Campus, Room 313.