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NCT06042621

A Study of Communication Between Clinicians, Patients, and Families in the Intensive Care Unit (ICU)

Enrolling by Invitation
Not specifiedAges 18+Observational
University of Wisconsin, Madison
~7,818 participants
Updated 2026-02-05 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intensive Care Unit (ICU) length of stay
Measured over Through participant study completion, an average of 8 days
+3 more outcomes measured

Conditions

Acute Respiratory Failure
Mechanical Ventilation
Life-Supporting Treatments
Communication
Decision Making
Critical Care
Palliative Care

Explore related trials

Acute Respiratory Failure

Where it's being run

5 sites across 3 states
Pennsylvania2
Wisconsin2
Illinois1

Study leadership

  • Jacqueline M Kruser, MD, MS · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult (age ≥ 18 years)
Acute respiratory failure:
Hypoxemic (low level of oxygen in the blood) or
Hypercapnic (high level of carbon dioxide in the blood)
Receiving invasive mechanical ventilation (patient needs a breathing machine to help them breathe)
The main person/s (primary surrogate/s, also known as legally authorized representative/s) who are making medical decisions on behalf of an eligible patient
Will be identified by the treating ICU team according to established legal and ethical standards
A member of the interprofessional hospital staff that is caring for an eligible patient
Team members may include advanced practice providers (nurse practitioners/ physicians assistants), case managers, chaplains, dietitians, nurses, pharmacists, physical and occupational therapists, physicians (attending/fellow/resident), respiratory therapists, and social workers.

Exclusion

Participant or their legally authorized representative declines participation or opts-out of data collection
Cannot complete surveys and interviews in English or Spanish
Declines participation
Opts out of study participation

What this trial measures

  • Intensive Care Unit (ICU) length of stayThrough participant study completion, an average of 8 days

    Cumulative number of days that participant stays in the intensive care unit.

  • Surrogate end-of-life intensive care unit (ICU) experienceBetween 4 and 16 weeks after participant's hospital discharge

    Surrogate end-of-life intensive care unit (ICU) experience will be measured using the Family Satisfaction in the Intensive Care Unit (FS-ICU) questionnaire. The FS-ICU is a 24 item questionnaire that evaluates family members' satisfaction with their intensive care unit experience. Each question is scored on a 5-point scale from 1 (worst) to 5 (best). The total scores are then converted to a scale from 0 to 100, where 0 is the least satisfied and 100 is the most satisfied.

  • Intensive Care Unit (ICU) team acute moral distressUp to 14 days after participant's hospital discharge

    Intensive Care Unit (ICU) team acute moral distress will be measured using the Moral Distress Thermometer (MDT). The MDT first presents a definition of moral distress, then asks the respondent to rate their distress related to a specific context on a 10-point scale from 0 (none) to 10 (worst possible) moral distress.

  • Direct observation of intensive care unit (ICU) careThrough participant study completion, an average of 8 days

    Direct observations will include observations of interactions that are pertinent to time-limited trials (e.g., daily interprofessional rounds, nursing shift-change handoffs) and family meetings, including both formal (e.g., in a private conference room) or informal (e.g., on medical rounds or at the bedside) discussions between members of the ICU team, surrogates, patients (if able), and other family members. Observations will be documented using field notes, and family meetings will be audio-recorded and transcribed verbatim. Qualitative analysis of field notes and written transcripts will be done to look for themes and trends that emerge from the data.