NCT01822171

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

Enrollment Period

4 months

First QC Date

January 7, 2013

Last Update Submit

May 21, 2013

Conditions

Keywords

Heart FailureMedication Therapy Management

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 day

Secondary Outcomes (4)

  • Patient assessment of home medications knowledge at time of hospital discharge

    3 days

  • Patient satisfaction with comprehensive discharge counseling service.

    7 Days

  • Number of interventions made at the MTM clinic.

    7 Days.

  • Types of interventions made at the MTM clinic.

    7 days

Study Arms (1)

Discharge counseling and MTM follow-up

EXPERIMENTAL

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 pharmacistOther: Home medication if neededOther: Follow-up visit at Medication Therapy Management clinic

Interventions

Patient will be educated about proper dosing instructions, potential side effects, and when to recontact the treating physician office.

Discharge counseling and MTM follow-up

Patient will be provided with medication to take home, when needed.

Discharge counseling and MTM follow-up

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.

Discharge counseling and MTM follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Providence Centralia Hospital

Centralia, Washington, 98531, United States

Location

Providence St. Peter Hospital

Olympia, Washington, 98506, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Laura Hoekstra, Pharm.D.

    Providence St. Peter Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2013

First Posted

April 2, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 22, 2013

Record last verified: 2013-05

Locations