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Identification of Dominate Stressors in the Intensive Care Unit (ICU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00645008
First Posted: March 27, 2008
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
  Purpose

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.


Condition
Cardiac Surgery Intensive Care Treatment

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: Stressors Associated With Cardiac Surgery Intensive Care Treatment

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Identification of stressors present in the CT-ICU (as recognized by completed surveys) [ Time Frame: Analysis after completion of 80 surveys ]

Secondary Outcome Measures:
  • Reduction and/or elimination of dominate stressors present in the CT-ICU [ Time Frame: Analysis after completion of 160 surveys ]

Enrollment: 160
Actual Study Start Date: April 2008
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Hypothesis: Identification of events and conditions considered stressful by the cardiopulmonary bypass patient would allow the professional team to determine which stressors are amendable to intervention and tailor patient care accordingly in order to improve future patient care experience in the intensive care unit.

Research Question: What are the dominant stressors associated with intensive care treatment as perceived by the patient, and what measures can be taken by the professional team members of the unit to decrease or eliminate these stressors entirely?

Purpose: The purpose of this study is to reduce or completely eliminate stressors present in the CT-ICU as identified by the coronary 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.

Design: Analytical survey

Protocol: Patients will be selected based on admission to the ICU following cardiopulmonary bypass surgery. We plan to survey 160 patients in order to identify the main stressors in the ICU as perceived by the patient themselves. A study investigator will enroll subjects after obtaining oral informed consent. We plan to approach eligible candidates once they have been discharged from the ICU to the step-down unit (4C). Subjects will be asked to complete a short questionnaire that will ask them to assess stressors associated with their stay in the CT-ICU. Preliminary analysis will be done to appraise the leading stressors after enrolling 80 patients in the study. Once dominate stressors have been identified, we will conduct several in-services in order to educate the CT-ICU team members of the amendable stressors. We will then enroll another 80 patients in order to evaluate whether or not the stressors have been reduced and/or eliminated.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Admitted to the CT-ICU for greater than 4 days (>96 hours)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645008


Locations
United States, New York
The NewYork-Presbyterian Hospital-Weill Cornell Medical College, Cardiothoracic Intensive Care Unit (4W) - NYPH
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Gregory Kerr, MD, MBA The NewYork-Presbyterian Hospital-Weill Cornell Medical College
  More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00645008     History of Changes
Other Study ID Numbers: 0801009626
First Submitted: March 19, 2008
First Posted: March 27, 2008
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will not be shared

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:
Stressors
Patient Satisfaction
Cardiothoracic-Intensive Care Unit
Coronary bypass patient