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

Sponsor
University of Michigan (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04243356
Collaborator
(none)
30
1
2
35.7
0.8

Study Details

Study Description

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
  • Behavioral: Nurse Encounter Group
  • Other: Nurse control group
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 11, 2020
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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.

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.

Other: Nurse control group
This group will complete surveys.

Outcome Measures

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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan

Investigators

  • Principal Investigator: Jakob McSparron, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jakob McSparron, Clinical Assistant Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier:
NCT04243356
Other Study ID Numbers:
  • HUM00170939
First Posted:
Jan 28, 2020
Last Update Posted:
Jan 25, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 25, 2022