Nurse-Patient RelationsNCT04243356
Impact of Intensive Care Unit Nurse Participation in Post - ICU Follow Up Clinic
A study testing Nurse Encounter Group in people with Nurse-Patient Relations and Nurse Role, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nurse-Patient Relations, Nurse Role
- What is being tested?
- Nurse Encounter Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2020to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Intensive Care Unit Nurse Participation in Post - ICU (Intensive Care Unit) Follow Up Clinic
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.
- Conditions
- Nurse-Patient Relations, Nurse Role
- Being tested
- Nurse Encounter Group, Nurse control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Encounter GroupBehavioural
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 control groupOther
This group will complete surveys.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Nurse control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, at the follow-up ICU clinic visit for the encounter group (approximately 2-4 weeks after discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start11 Feb 2020
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse-Patient RelationsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob McSparron, University of Michigan
- Investigators
- Jakob McSparron, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243356
- Sponsor's protocol ID
- HUM00170939
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2020
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intensive Care Unit Nurse Participation in Post - ICU (Intensive Care Unit) Follow Up Clinic
- ClinicalTrials.gov ID
- NCT04243356
- Acronym / sponsor ID
- HUM00170939
- Conditions
- Nurse-Patient Relations, Nurse Role
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse Encounter Group | Experimental | Behavioral: Nurse Encounter GroupNurses 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. |
| Nurse Control Group | Other | Other: Nurse control groupNurses assigned to this group will only complete surveys and will not see a former patient in a post-ICU visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients that were admitted to the ICU that are appropriate for follow-up.
- Registered nurse in an intensive care unit and took care of the enrolled patient
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse Encounter GroupNurses 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. | Behavioural | Nurse Encounter Group |
| Nurse control groupThis group will complete surveys. | Other | Nurse Control Group |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jakob McSparron, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Encounter Group in people with Nurse-Patient Relations and Nurse Role, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.