Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model

The purpose of this pilot study is to determine if medication adherence is improved by a transitional care pharmacy practice model designed to integrate hospital and community pharmacists in the care and education of patients with heart failure or COPD who are discharged from a community hospital to home. The hospital and community pharmacists will collaborate with each other, the patient, and other practitioners including the primary care physician, nurse, and case manager to prevent and correct medication-related problems and attempt to improve patient outcomes especially during the error-prone transition from hospital to home.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Procedure: Pharmacist Counseling

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Scranton, Pennsylvania, United States, 18510
      • Moses Taylor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• admitted to hospital with a primary or secondary diagnosis of heart failure or COPD
• anticipated eventual discharge to home
• agreeable to participate in monthly counseling sessions (if randomized to intervention group) from a participating community pharmacist

Exclusion Criteria:

• presence of cognitive impairment or dementia that would significantly prevent effective patient education and counseling
• non English-speaking
• anticipated discharge to a long-term care or skilled nursing facility on a permanent basis
• permanent long-term care facility residents
• surgical patients
• hospice patients
• patients who die within 30 days of initial study hospitalization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The control group will receive the current standard of care including medication reconciliation during hospitalization performed by a nurse or physician and education about discharge medications provided by the inpatient nurse. There will not be a pharmacist discharge care plan developed for this group. The patients will not be required to choose a participating community pharmacist and no counseling and education appointments will be scheduled. Any medication-related problems identified by the pharmacists and will be communicated as appropriate and resolved as is the standard of care. Any other interaction between the patient and their pharmacist will be according to the current standard of care.
Experimental: Pharmacist Counseling; The hospital pharmacist will meet with the patient and complete medication reconciliation, assess the patient's understanding of the medications, and identify medication-related problems. The hospital pharmacist will complete a pharmacist discharge care plan and a copy will be sent to the participating community pharmacist. The patients will be scheduled for the first meeting with their community pharmacist within 1 week of hospital discharge. The community pharmacist will interview the patient about their general health and any current symptoms of heart failure or COPD, identify any additional medication-related problems, follow-up on any issues as described in the pharmacist discharge care plan, and provide patient education. The patients will then meet with their community pharmacist for counseling and patient education at monthly intervals for 6 months following hospital discharge.	Procedure: Pharmacist Counseling; The hospital pharmacist will meet with the patient and complete medication reconciliation, assess the patient's understanding of the medications, and identify medication-related problems. The hospital pharmacist will complete a pharmacist discharge care plan and a copy will be sent to the participating community pharmacist. The patients will be scheduled for the first meeting with their community pharmacist within 1 week of hospital discharge. The community pharmacist will interview the patient about their general health and any current symptoms of heart failure or COPD, identify any additional medication-related problems, follow-up on any issues as described in the pharmacist discharge care plan, and provide patient education. The patients will then meet with their community pharmacist for counseling and patient education at monthly intervals for 6 months following hospital discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	The primary endpoint will be medication adherence as measured by the Proportion of Days Covered (PDC) calculation. This is calculated by dividing the total days' supply dispensed by 180 days. Medications considered in this calculation will include those used for the treatment of heart failure or COPD and known to improve outcomes. The composite PDC will be an average of the individual PDC for each drug class.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication related problems	Actual or potential medication-related problems (MRP) that are identified by the hospital and participating community pharmacists will be categorized based on an MRP classification tool.	6 months
Patient Satisfaction	The Care Transitions Measure (CTM-3) is a validated survey to assess the patient's satisfaction with the quality of transitional care during hospitalization and will be completed by the patient following hospital discharge. The patient's satisfaction with the services provided by the community pharmacies will be assessed with the Consumer Experience with Pharmacy Services survey (© Pharmacy Quality Alliance).	6 months
Hospital readmissions or ED visits	Hospital readmissions are defined as an unplanned and overnight admission to the hospital	6 months

Collaborators and Investigators

• Sponsor: Wilkes University
• Collaborators: Community Pharmacy Foundation; Moses Taylor Hospital Foundation; Commonwealth Health
• Investigators: Principal Investigator: Judith Kristeller, PharmD, Wilkes University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): April 28, 2017
• Study Completion (Actual): April 28, 2017

Study Registration Dates

• First Submitted: January 24, 2014
• First Submitted That Met QC Criteria: January 27, 2014
• First Posted (Estimate): January 28, 2014

Study Record Updates

• Last Update Posted (Actual): May 2, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: adherence; medication; pharmacist; care transitions; readmission; transition of care; medication reconciliation; patient counseling; medication management
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CPF