Reducing Readmission Rates by Providing a Comprehensive Transition Plan From Hospital to Home for Cardiac Surgery Patients.

April 30, 2020 updated by: Johns Hopkins University
Patients who undergo cardiac surgery will be screened by a team member with the risk score once the patient has been admitted to the Cardiovascular Progressive Care Unit (CVPCU) after surgery. Participants will be randomized to the intervention or the control group. Both groups will receive standard discharge planning. In addition, the intervention group will have a nurse practitioner (NP) who will be responsible to verify that each essential step of the discharge process has been completed and will visit the patient in patient's home after discharge to complete a physical, review medications, titrate medications as needed, prescribe any necessary treatments, and perform education. The primary outcome variable will be a decrease in the 30 day readmission rate comparing high risk patients at pre and post intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients 18 years of age or greater who have had cardiac surgery procedures including coronary artery bypass surgery (CABG), valve replacement, aortic aneurysm repair, and combined CABG and valve procedures.

Exclusion Criteria:

  • Patients who have undergone orthotopic heart transplantation, orthotopic lung transplantation, or orthotopic heart-lung transplantation
  • Patients who have undergone ventricular assist device placement
  • Patients who do not reside in Maryland
  • Non English speaking patients
  • Patients discharged to a facility.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home visit group
Will receive a home visit after discharge in addition to the standard discharge planning.
Behavioral: Home Visit
Physical exam, medication dose titration
No Intervention: Control group
Will receive only the standard discharge planning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-Day readmission rate
Time Frame: Up to 30 days post discharge
Rate of readmissions within 30 days after discharge
Up to 30 days post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Sharon Owens, PhD, Johns Hopkins University

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 (Actual)

May 23, 2016

Primary Completion (Actual)

March 26, 2020

Study Completion (Actual)

March 26, 2020

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

May 5, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00097613

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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