NCT04243356

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2020Feb 2027

First Submitted

Initial submission to the registry

January 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

February 11, 2020

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

7 years

First QC Date

January 23, 2020

Last Update Submit

February 2, 2026

Conditions

Outcome Measures

Primary Outcomes (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

    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 Outcomes (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)

Study Arms (2)

Nurse Encounter Group

EXPERIMENTAL

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

Nurse Control Group

OTHER

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

Interventions

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 Encounter Group

This group will complete surveys.

Nurse Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients that were admitted to the ICU that are appropriate for follow-up.
  • Nurses:
  • Registered nurse in an intensive care unit and took care of the enrolled patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

  • Jakob McSparron, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor of Internal Medicine

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 28, 2020

Study Start

February 11, 2020

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations