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Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Heart Failure

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pharmacist Counseling
Sponsored by
Wilkes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Disease, Chronic Obstructive focused on measuring transition of care, care transitions, readmission, medication, adherence, medication management, medication reconciliation, patient counseling, pharmacist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Moses Taylor Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Pharmacist Counseling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
Hospital readmissions or ED visits
Hospital readmissions are defined as an unplanned and overnight admission to the hospital

Full Information

First Posted
January 24, 2014
Last Updated
April 28, 2017
Sponsor
Wilkes University
Collaborators
Moses Taylor Hospital Foundation, Commonwealth Health, Community Pharmacy Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02047448
Brief Title
Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model
Official Title
Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 28, 2017 (Actual)
Study Completion Date
April 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wilkes University
Collaborators
Moses Taylor Hospital Foundation, Commonwealth Health, Community Pharmacy Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Heart Failure
Keywords
transition of care, care transitions, readmission, medication, adherence, medication management, medication reconciliation, patient counseling, pharmacist

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Pharmacist Counseling
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Pharmacist Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Adherence
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Medication related problems
Description
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.
Time Frame
6 months
Title
Patient Satisfaction
Description
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).
Time Frame
6 months
Title
Hospital readmissions or ED visits
Description
Hospital readmissions are defined as an unplanned and overnight admission to the hospital
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Kristeller, PharmD
Organizational Affiliation
Wilkes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moses Taylor Hospital
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States

12. IPD Sharing Statement

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Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model

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