Discharge Counseling and Medication Therapy Management (MTM) Services After Discharge for Heart Failure Patients (MTM)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Discharge medication counseling from a pharmacist
Home medication if needed
Follow-up visit at Medication Therapy Management clinic
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Heart Failure, Medication Therapy Management
Eligibility Criteria
Inclusion Criteria:
- Heart Failure with high risk for readmission.
- Enroll in study prior to hospital discharge.
Exclusion Criteria:
-
Sites / Locations
- Providence Centralia Hospital
- Providence St. Peter Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Discharge counseling and MTM follow-up
Arm Description
At the time of hospital discharge the subject will receive: Discharge medication counseling from a pharmacist Home medication if needed Approximately 7 days after hospital discharge the subject have a Follow-up visit at Medication Therapy Management clinic.
Outcomes
Primary Outcome Measures
Reduction in hospital readmissions
The readmission rate for the 50 subjects involved in this study will be compared to an equal number patients retrospectively reviewed from a 2011 patient list and matched for heart failure severity. The primary outcome will based on a comparison of the ratio of patients readmitted to the hospital before the discharge instruction program started and after.
Secondary Outcome Measures
Patient assessment of home medications knowledge at time of hospital discharge
Post hospital discharge the subject are asked to rate their knowledge regarding the medication they are taking at home on a scale of 1 to 10. The data obtained in this study will be compared to the same data and patient matched population obtained in 2011.
Patient satisfaction with comprehensive discharge counseling service.
The satisfaction survey consists of five interview questions, where the subject subjectively scores each question on a scale of 1 to 10, developed specifically for this study.
Number of interventions made at the MTM clinic.
The number of drug related therapy interventions the pharmacist makes during the 7 day follow-up visit will be counted. Interventions may include: identifying: an inappropriate drug, inappropriate dose, duplication of medications, or a missing medication to optimize drug therapy.
Types of interventions made at the MTM clinic.
The types of intervention the pharmacist may work on during the 7 day follow-up visit include inappropriate drug, inappropriate dose, duplication of medications, missing medication to optimize drug therapy. Other types of interventions may be revealed during this study.
Full Information
NCT ID
NCT01822171
First Posted
January 7, 2013
Last Updated
May 21, 2013
Sponsor
Providence Health & Services
1. Study Identification
Unique Protocol Identification Number
NCT01822171
Brief Title
Discharge Counseling and Medication Therapy Management (MTM) Services After Discharge for Heart Failure Patients
Acronym
MTM
Official Title
Multi-Disciplinary Discharge Counseling and MTM Services After Discharge for Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll and study intended patient population.
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Providence Health & Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Readmission to a hospital shortly after discharge is a common and costly problem. In the United States patients with a diagnosis of heart failure currently experience an elevated 30 day readmission rate of approximately 20%. By providing patients with medication related counseling at discharge by a pharmacist, home medications at discharge, and seeing the patient again in a pharmacist-run Medication Therapy Management (MTM) clinic 7 days after discharge, the study anticipates achieving its primary goal of showing a reduction in the readmission rate. Secondary goals are: 1) to determine patients understanding of the medication they are taking, 2) to evaluate satisfaction with the comprehensive discharge counseling service, and 3) determine the number of interventions made and benefit of the MTM clinic.
Detailed Description
The active arm of this study (medication related hospital discharge counseling by a pharmacist, home medications, and 7 day follow-up visit at a pharmacist run MTM clinic) is available to all subjects. To study the primary goal of reducing the 30 day readmission rate the data obtained from the active arm subjects will be compared to a match group of hospitalized patients that were previously discharged with a diagnosis of heart failure. The data for all secondary study goals will be obtained directly from the active arm subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Medication Therapy Management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Discharge counseling and MTM follow-up
Arm Type
Experimental
Arm Description
At the time of hospital discharge the subject will receive:
Discharge medication counseling from a pharmacist
Home medication if needed
Approximately 7 days after hospital discharge the subject have a Follow-up visit at Medication Therapy Management clinic.
Intervention Type
Other
Intervention Name(s)
Discharge medication counseling from a pharmacist
Intervention Description
Patient will be educated about proper dosing instructions, potential side effects, and when to recontact the treating physician office.
Intervention Type
Other
Intervention Name(s)
Home medication if needed
Intervention Description
Patient will be provided with medication to take home, when needed.
Intervention Type
Other
Intervention Name(s)
Follow-up visit at Medication Therapy Management clinic
Intervention Description
This comprehensive Medication Therapy Management clinic follow-up visit is scheduled for 7 days post hospital discharge. The approximately 1 hour visit is scheduled with a pharmacist to review current drug therapy and make recommendations, if needed, to improve medication utilization.
Primary Outcome Measure Information:
Title
Reduction in hospital readmissions
Description
The readmission rate for the 50 subjects involved in this study will be compared to an equal number patients retrospectively reviewed from a 2011 patient list and matched for heart failure severity. The primary outcome will based on a comparison of the ratio of patients readmitted to the hospital before the discharge instruction program started and after.
Time Frame
30 day
Secondary Outcome Measure Information:
Title
Patient assessment of home medications knowledge at time of hospital discharge
Description
Post hospital discharge the subject are asked to rate their knowledge regarding the medication they are taking at home on a scale of 1 to 10. The data obtained in this study will be compared to the same data and patient matched population obtained in 2011.
Time Frame
3 days
Title
Patient satisfaction with comprehensive discharge counseling service.
Description
The satisfaction survey consists of five interview questions, where the subject subjectively scores each question on a scale of 1 to 10, developed specifically for this study.
Time Frame
7 Days
Title
Number of interventions made at the MTM clinic.
Description
The number of drug related therapy interventions the pharmacist makes during the 7 day follow-up visit will be counted. Interventions may include: identifying: an inappropriate drug, inappropriate dose, duplication of medications, or a missing medication to optimize drug therapy.
Time Frame
7 Days.
Title
Types of interventions made at the MTM clinic.
Description
The types of intervention the pharmacist may work on during the 7 day follow-up visit include inappropriate drug, inappropriate dose, duplication of medications, missing medication to optimize drug therapy. Other types of interventions may be revealed during this study.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Heart Failure with high risk for readmission.
Enroll in study prior to hospital discharge.
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Hoekstra, Pharm.D.
Organizational Affiliation
Providence St. Peter Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Centralia Hospital
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States
Facility Name
Providence St. Peter Hospital
City
Olympia
State/Province
Washington
ZIP/Postal Code
98506
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Discharge Counseling and Medication Therapy Management (MTM) Services After Discharge for Heart Failure Patients
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