Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 74 for:    mtm

Discharge Counseling and Medication Therapy Management (MTM) Services After Discharge for Heart Failure Patients (MTM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01822171
Recruitment Status : Terminated (Unable to enroll and study intended patient population.)
First Posted : April 2, 2013
Last Update Posted : May 22, 2013
Sponsor:
Information provided by (Responsible Party):
Providence Health & Services

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Discharge medication counseling from a pharmacist Other: Home medication if needed Other: Follow-up visit at Medication Therapy Management clinic Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Multi-Disciplinary Discharge Counseling and MTM Services After Discharge for Heart Failure Patients
Study Start Date : January 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Discharge counseling and MTM follow-up

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.
Other: Discharge medication counseling from a pharmacist
Patient will be educated about proper dosing instructions, potential side effects, and when to recontact the treating physician office.

Other: Home medication if needed
Patient will be provided with medication to take home, when needed.

Other: Follow-up visit at Medication Therapy Management clinic
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heart Failure with high risk for readmission.
  • Enroll in study prior to hospital discharge.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822171


Locations
Layout table for location information
United States, Washington
Providence Centralia Hospital
Centralia, Washington, United States, 98531
Providence St. Peter Hospital
Olympia, Washington, United States, 98506
Sponsors and Collaborators
Providence Health & Services
Investigators
Layout table for investigator information
Principal Investigator: Laura Hoekstra, Pharm.D. Providence St. Peter Hospital
Layout table for additonal information
Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT01822171    
Other Study ID Numbers: PSPH-002-Pharm
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013
Keywords provided by Providence Health & Services:
Heart Failure
Medication Therapy Management
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases