Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model

Heart Failure Clinical Trial

Official title:

Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047448
• Other study ID #: CPF
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 24, 2014
• Last updated: April 28, 2017
• Start date: January 2014
• Est. completion date: April 28, 2017

Study information

• Verified date: April 2017
• Source: Wilkes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 28, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Heart Failure
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Moses Taylor Hospital	Scranton	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Wilkes University	Commonwealth Health, Community Pharmacy Foundation, Moses Taylor Hospital Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Hospital readmissions or ED visits	Hospital readmissions are defined as an unplanned and overnight admission to the hospital	6 months