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Impact of Intensive Care Unit Nurse Participation in Post - ICU Follow Up Clinic

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.
 
ClinicalTrials.gov Identifier: NCT04243356
Recruitment Status : Enrolling by invitation
First Posted : January 28, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Jakob McSparron, University of Michigan

Brief Summary:
The objective of this study is to learn more about the impact of a longitudinal encounter between critical care nurses and former intensive care unit patients. This study will enroll 10 patients that had been admitted in an ICU to meet with a former nurse that had taken care of them in the ICU. The study will enroll 20 nurses that had taken care of these patients in the ICU. The study will randomize 10 nurses to be in the encounter group and 10 nurses to be assigned to the control group. Only nurses assigned to the encounter group will meet with the patients at their post-ICU clinic.

Condition or disease Intervention/treatment Phase
Nurse-Patient Relations Nurse Role Behavioral: Nurse Encounter Group Other: Nurse control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Intensive Care Unit Nurse Participation in Post - ICU (Intensive Care Unit) Follow Up Clinic
Actual Study Start Date : February 11, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Experimental: Nurse Encounter Group
Nurses that are assigned to this group will be asked to take surveys before and immediately following the post-ICU clinic encounter with a patient that they had cared for in the ICU during a follow-up care visit with the former ICU - patient.
Behavioral: Nurse Encounter Group
Nurses in this group will meet with former ICU patients in a post ICU clinic visit. This will be a structured meeting for approximately 15 minutes with the nurse and former patient. The encounter will be observed by a member of the research team. Surveys will be completed before and after the visits. Additionally, nurses will be interviewed 4-7 days after meeting with their former patients.

Nurse Control Group
Nurses assigned to this group will only complete surveys and will not see a former patient in a post-ICU visit.
Other: Nurse control group
This group will complete surveys.




Primary Outcome Measures :
  1. Change in medical ICU nurse fulfillment toward the ICU following an encounter with a former ICU patient in the post-ICU clinic using an adapted Stanford Professional Fulfillment Index [ Time Frame: Baseline, at the follow-up ICU clinic visit for the encounter group (approximately 2-4 weeks after discharge) ]
    The survey consists of 6 questions that are measured on a 5 point Likert scale (scored 0 to 4, with 4 representing higher fulfillment). The scores for all 6 fulfillment questions are then averaged for a composite score for fulfillment (also ranging from 0-4). The surveys will be administered at the time of enrollment for both the encounter and control nurse groups. The post-intervention survey will be administered only to the encounter group immediately following the post-ICU clinic encounter.


Secondary Outcome Measures :
  1. Change in medical ICU nurse burnout following an encounter with a former ICU patient in the post-ICU clinic [ Time Frame: Baseline, at the follow-up ICU clinic visit for the encounter group (approximately 2-4 weeks after discharge) ]

    The survey includes 2 questions and is adapted from Maslach Burnout Inventory (MBI) and are single-item measures of emotional exhaustion and depersonalization.

    The assessment of burnout are measured on a 7 point Likert scale (scored 0 to 6, with 6 representing higher burnout). The surveys will be administered at the time of enrollment for both the encounter and control nurse groups. The post-intervention survey will be administered only to the encounter group immediately following the post-ICU clinic encounter.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients:

Inclusion Criteria:

  • Patients that were admitted to the ICU that are appropriate for follow-up.

Nurses:

Inclusion Criteria:

  • Registered nurse in the Critical Care Medicine Unit and took care of the enrolled patient

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): NCT04243356


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Jakob McSparron, MD University of Michigan
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Responsible Party: Jakob McSparron, Clinical Assistant Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT04243356    
Other Study ID Numbers: HUM00170939
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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