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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01822171
Other study ID # PSPH-002-Pharm
Secondary ID
Status Terminated
Phase N/A
First received January 7, 2013
Last updated May 21, 2013
Start date January 2013
Est. completion date May 2013

Study information

Verified date May 2013
Source Providence Health & Services
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Heart Failure with high risk for readmission.

- Enroll in study prior to hospital discharge.

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Providence Centralia Hospital Centralia Washington
United States Providence St. Peter Hospital Olympia Washington

Sponsors (1)

Lead Sponsor Collaborator
Providence Health & Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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. 3 days No
Secondary 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. 7 Days No
Secondary 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. 7 Days. No
Secondary 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. 7 days No
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