Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model

NCT02047448 | Completed Phase 2

• 1 other identifier: CPF
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Keywords

transition of care; care transitions; readmission; medication; adherence; medication management; medication reconciliation; patient counseling; pharmacist

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Medication related problems

  6 months

• Patient Satisfaction

  6 months

• Hospital readmissions or ED visits

  6 months

Study Arms (2)

Control Group

NO INTERVENTION

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.

Pharmacist Counseling

EXPERIMENTAL

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

Interventions

Pharmacist Counseling PROCEDURE

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.

Pharmacist Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wilkes University: lead
• Moses Taylor Hospital Foundation: collaborator
• Commonwealth Health: collaborator
• Community Pharmacy Foundation: collaborator

Study Sites (1)

Moses Taylor Hospital

Scranton, Pennsylvania, 18510, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Judith Kristeller, PharmD

  Wilkes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: January 1, 2014
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: May 2, 2017

Record last verified: 2017-04

Locations

US (1)