- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04243356
Impact of Intensive Care Unit Nurse Participation in Post - ICU Follow Up Clinic
Impact of Intensive Care Unit Nurse Participation in Post - ICU (Intensive Care Unit) Follow Up Clinic
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Patients:
Inclusion Criteria:
- Patients that were admitted to the ICU that are appropriate for follow-up.
Nurses:
Inclusion Criteria:
- Registered nurse in an intensive care unit and took care of the enrolled patient
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
Other: Nurse Control Group
Nurses assigned to this group will only complete surveys and will not see a former patient in a post-ICU visit.
|
This group will complete surveys.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, at the follow-up ICU clinic visit for the encounter group (approximately 2-4 weeks after discharge)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline, at the follow-up ICU clinic visit for the encounter group (approximately 2-4 weeks after discharge)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jakob McSparron, MD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HUM00170939
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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