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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04243356
Other study ID # HUM00170939
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 11, 2020
Est. completion date February 2025

Study information

Verified date January 2024
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Other:
Nurse control group
This group will complete surveys.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 Change in medical ICU nurse burnout following an encounter with a former ICU patient in the post-ICU clinic 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)
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