NCT04373850

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
Last Updated

May 5, 2020

Status Verified

April 1, 2020

Enrollment Period

3.8 years

First QC Date

April 30, 2020

Last Update Submit

April 30, 2020

Conditions

Keywords

Reducing readmissions

Outcome Measures

Primary Outcomes (1)

  • 30-Day readmission rate

    Rate of readmissions within 30 days after discharge

    Up to 30 days post discharge

Study Arms (2)

Home visit group

EXPERIMENTAL

Will receive a home visit after discharge in addition to the standard discharge planning.

Behavioral: Home Visit

Control group

NO INTERVENTION

Will receive only the standard discharge planning.

Interventions

Home VisitBEHAVIORAL

Physical exam, medication dose titration

Home visit group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

House Calls

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Sharon Owens, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 5, 2020

Study Start

May 23, 2016

Primary Completion

March 26, 2020

Study Completion

March 26, 2020

Last Updated

May 5, 2020

Record last verified: 2020-04