- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05713669
Impact of Resident Participation in Post-ICU Follow Up Clinic
This study is being conducted to describe the impact of a meeting between patients that were admitted to the intensive care unit (ICU) and a provider that cared for the patients during the period of critical illness. The study team is aiming to describe the effect this meeting has on the physician that previously cared for the patient.
The study team hypothesizes that facilitating involvement in post-ICU clinic and creating longitudinal relationships between providers of critical care and survivors of critical illness will have positive effects on trainees, both in professional fulfillment and burnout scores and in perceptions of critical care.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maddie Lagina, MD
- Phone Number: 734-763-9077
- Email: laginam@med.umich.edu
Study Contact Backup
- Name: Jakob McSparron, MD
- Phone Number: 734-763-9077
- Email: jmcsparr@med.umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Contact:
- Maddie Lagina, MD
- Phone Number: 734-763-9077
- Email: laginam@med.umich.edu
-
Sub-Investigator:
- Maddie Lagina, MD
-
Principal Investigator:
- Jakob McSparron, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria for Patients:
- Must be eligible for Post ICU Longitudinal Survivor Experience (PULSE) clinic follow up and/or have received referral to clinic
Inclusion criteria for Residents:
- Must have completed at least one 2-week rotation in the medical ICU at the University of Michigan
- Must have cared for an enrolled patient in the study
Exclusion Criteria for Patients:
- Died during ICU stay
Exclusion Criteria for Residents:
- Provided only "cross-cover" for the patient.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Residents meet ICU patients during follow-up visit (encounter)
Residents will be paired according to the patient that were cared.
|
Participants in this encounter group will be asked to complete a pre and post-intervention survey, participate in a meeting with a former ICU patient at a post-ICU clinic, and undergo an in-person interview within fourteen days following the encounter.
|
|
Other: Residents in the non-encounter group
Residents will not meet with patients that were in the ICU.
|
Surveys will be completed pre and post patient follow-up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the Professional Fulfillment Scale
Time Frame: Baseline (pre-post ICU follow-up visit), approximately 14 days post patient's follow-up visit
|
The survey consists of 6 questions that are measured on a 5 point Likert scale (scored 0 to 4, with 4 representing higher fulfillment).
|
Baseline (pre-post ICU follow-up visit), approximately 14 days post patient's follow-up visit
|
|
Changes in the Burnout Scale
Time Frame: Baseline (pre-post ICU follow-up visit), approximately 14 days post patient's follow-up visit
|
This scale has 4 questions that will indicate the level of burnout with scores from not at all =0 - extremely =4.
A higher score indicates a higher sense of burnout.
|
Baseline (pre-post ICU follow-up visit), approximately 14 days post patient's follow-up visit
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00225631
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
product manufactured in and exported from the U.S.
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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