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

NCT06042621 | Enrolling By Invitation DMC

• 4 other identifiers: 2022-16811R01HL168474-01SMPH/MEDICINE/MEDICINE*PProtocol Version 10/02/2025
• Study Type: observational
• Target: 7,818
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to investigate a specific approach to patient care called a time-limited trial (TLT). This approach is sometimes used for people who develop critical illness and are cared for in an intensive care unit (ICU). A time-limited trial is a plan made together by medical teams, patients with critical illness (if they can take part), and their families or other important people helping to make their healthcare decisions. A time-limited trial starts with a discussion of the patient's goals and wishes. Then, a plan is made to use ICU treatments for a set period of time to give the patient the chance to recover. After this time, the patient's response to treatment will be reviewed to help guide what to do next. Medical teams consider this kind of plan when it is not clear if a patient can recover to a quality of life that is acceptable to them. With a time-limited trial, patients, families, and medical teams experience this uncertainty together. The main goal of this study is to find the best way to use TLTs for patients in the ICU who have trouble breathing and need mechanical ventilation to help them breathe. The hypothesis is that optimal time-limited trial delivery will reduce the time patients with acute respiratory failure spend in the ICU and will improve the intensive care unit experiences for their families and clinicians.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Intensive Care Unit (ICU) length of stay

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

  Through participant study completion, an average of 8 days

• Surrogate end-of-life intensive care unit (ICU) experience

  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.

  Between 4 and 16 weeks after participant's hospital discharge

• Intensive Care Unit (ICU) team acute moral distress

  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.

  Up to 14 days after participant's hospital discharge

• Direct observation of intensive care unit (ICU) care

  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.

  Through participant study completion, an average of 8 days

Secondary Outcomes (10)

• In-hospital mortality

  Through participant study completion, an average of 8 days

• Length of mechanical ventilation

  Through participant study completion, an average of 8 days

• Surrogate anxiety and depression

  Between 4 and 16 weeks after participant's hospital discharge

• Patient and family centeredness of care

  Between 4 and 16 weeks after participant's hospital discharge

• Surrogate Heard and Understood Measure

  Between 4 and 16 weeks after participant's hospital discharge

Study Arms (3)

Participants

Participants will be selected from patients who are admitted to an intensive care unit (ICU) at the University of Wisconsin Hospital, UnityPoint Health - Meriter Hospital, Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, or Northwestern Memorial Hospital.

Surrogates

Surrogate participants will be the primary surrogate/s for an eligible patient.

ICU Team Members

ICU Team Member participants will be members of the hospital staff providing care for an eligible patient.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from patients who are admitted to an intensive care unit (ICU) at the University of Wisconsin Hospital, UnityPoint Health - Meriter Hospital, Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, or Northwestern Memorial Hospital. Surrogate participants will be the primary surrogate/s for an eligible patient, and ICU Team Member participants will be members of the hospital staff providing care for an eligible patient.

You may qualify if:

• Participants
• 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)
• Surrogates
• 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
• ICU Team Members
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

UnityPoint Health - Meriter Hospital

Madison, Wisconsin, 53715, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Kruser JM, Wiegmann DA, Nadig NR, Secunda KE, Hanlon BM, Moy JX, Ahmad A, Campbell EG, Donnelly HK, Martinez FJ, Polley M, Orhan C, Korth E, Stalter LN, Rowe TJ, Wu AL, Viglianti EM, Eisinger EC, Nguyen O, Halpern SD, Clapp JT. Optimising time-limited trials in acute respiratory failure: a multicentre focused ethnography protocol. BMJ Open. 2025 Dec 14;15(12):e106483. doi: 10.1136/bmjopen-2025-106483.

  PMID: 41397749 DERIVED

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jacqueline M Kruser, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: January 17, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)