Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model

NCT ID: NCT02047448

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-04-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Pharmacist Counseling

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moses Taylor Hospital Foundation

UNKNOWN

Sponsor Role: collaborator

Commonwealth Health

UNKNOWN

Sponsor Role: collaborator

Community Pharmacy Foundation

OTHER

Sponsor Role: collaborator

Wilkes University

OTHER

Sponsor Role: lead

Responsible Party

Judith L. Kristeller

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judith Kristeller, PharmD

Role: PRINCIPAL_INVESTIGATOR

Wilkes University

Locations

Moses Taylor Hospital

Scranton, Pennsylvania, United States

Countries

United States

Other Identifiers

CPF

Identifier Type: -

Identifier Source: org_study_id