NCT00645008

Brief Summary

Undergoing cardiopulmonary bypass surgery and the subsequent admission to the intensive care unit (ICU) is known to be a stressful event to the patient. As patients prepare for open-heart surgery it is natural for them to feel anxious and concerned about all the various procedures involved in the process. Members of both the surgical and anesthesia team explain the purpose of each procedure and all issues associated with the procedures in great detail in order to better prepare the patient, ease their anxiety and aid their recovery. The underlying assumption for past investigations into overall patient satisfaction has been that the stressors inherent in the experience of illness and hospitalization have an adverse effect on patient recovery and can possibly prolong the recuperative process. Previous studies have shown that the specific performance of a team in regard to the effects of the stressors on the patient's status is key to providing optimal patient care in the ICU environment. Since the ICU stay is a difficult experience in the life of a patient, stressor predictability might allow for better physical and psychological conditions for the patient's recovery. Although there is a myriad of published research available on the potential stressors related to an ICU stay, there is a dearth of investigation into the inherently more intense circumstances surrounding a stay in the Cardiothoracic Intensive Care Unit (CT-ICU). By examining the stressors in the CT-ICU changes can be made by the medical care team and/or hospital that can ultimately enhance the patient experience in the CT-ICU. The purpose of this study is to reduce or completely eliminate stressors present in the CT-ICU as identified by the cardiac bypass patient. Identification of events and conditions considered stressful in the ICU will allow the professional team to determine which stressors are amendable to intervention and tailor patient care accordingly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 19, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2017

Enrollment Period

4.7 years

First QC Date

March 19, 2008

Last Update Submit

February 2, 2017

Conditions

Keywords

StressorsPatient SatisfactionCardiothoracic-Intensive Care UnitCoronary bypass patient

Outcome Measures

Primary Outcomes (1)

  • Identification of stressors present in the CT-ICU (as recognized by completed surveys)

    Analysis after completion of 80 surveys

Secondary Outcomes (1)

  • Reduction and/or elimination of dominate stressors present in the CT-ICU

    Analysis after completion of 160 surveys

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study involves patients both male and female who are admitted to the intensive care unit immediately following cardiopulmonary bypass for either myocardial revascularization or valvular surgery.

You may qualify if:

  • Admitted to the ICU following cardiopulmonary bypass surgery (AVR/MVR and/or CABG)
  • Conscious, alert and having the capacity to consent and answer survey questions, i.e. no dementia
  • Adults \> 18 years old

You may not qualify if:

  • Admitted to the CT-ICU for greater than 4 days (\>96 hours)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The NewYork-Presbyterian Hospital-Weill Cornell Medical College, Cardiothoracic Intensive Care Unit (4W) - NYPH

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Gregory Kerr, MD, MBA

    The NewYork-Presbyterian Hospital-Weill Cornell Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 27, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

February 6, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Will not be shared

Locations