- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01822171
Discharge Counseling and Medication Therapy Management (MTM) Services After Discharge for Heart Failure Patients (MTM)
May 21, 2013 updated by: Providence Health & Services
Multi-Disciplinary Discharge Counseling and MTM Services After Discharge for Heart Failure Patients
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.
Study Overview
Status
Terminated
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Centralia, Washington, United States, 98531
- Providence Centralia Hospital
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Olympia, Washington, United States, 98506
- Providence St. Peter Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Heart Failure with high risk for readmission.
- Enroll in study prior to hospital discharge.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Discharge counseling and MTM follow-up
At the time of hospital discharge the subject will receive:
|
Patient will be educated about proper dosing instructions, potential side effects, and when to recontact the treating physician office.
Patient will be provided with medication to take home, when needed.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in hospital readmissions
Time Frame: 30 day
|
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.
|
30 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient assessment of home medications knowledge at time of hospital discharge
Time Frame: 3 days
|
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.
|
3 days
|
|
Patient satisfaction with comprehensive discharge counseling service.
Time Frame: 7 Days
|
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.
|
7 Days
|
|
Number of interventions made at the MTM clinic.
Time Frame: 7 Days.
|
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.
|
7 Days.
|
|
Types of interventions made at the MTM clinic.
Time Frame: 7 days
|
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.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laura Hoekstra, Pharm.D., Providence St. Peter Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
January 7, 2013
First Submitted That Met QC Criteria
March 27, 2013
First Posted (Estimate)
April 2, 2013
Study Record Updates
Last Update Posted (Estimate)
May 22, 2013
Last Update Submitted That Met QC Criteria
May 21, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSPH-002-Pharm
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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