Clinical trial NCT06042621: A Study of Communication Between Clinicians, Patients, and Families in the Intensive Care Unit (ICU)
Official title: Optimizing Time-Limited Trials of Mechanical Ventilation in Acute Respiratory Failure (The TIME Study): A Mixed Methods Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Respiratory Failure
Mechanical Ventilation
Life-Supporting Treatments
Communication
Decision Making
Critical Care
Palliative Care
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-09-18
Enrollment: 7818
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: This is a multi-site observational study that will investigate the time-limited trial approach to care for patients with critical illness, which is a trial of life support with milestones and a timeline to help evaluate whether the patient is improving. The primary objective of this study is to define the optimal care delivery processes of a time-limited trial for adult intensive care unit (ICU) patients who develop acute respiratory failure requiring mechanical ventilation. The two aims of this study are to:

Aim 1: Map the current processes of time-limited trial care delivery for patients with acute respiratory failure.

Aim 2: Elucidate the relationships between time-limited trials, their care delivery processes, and end-of-life outcomes for patients, surrogates, and ICU teams.

For Aim 1, a focused ethnography of approximately 50 time-limited trials will be done to characterize how trials are currently being done in the intensive care unit. This will include direct observation of ICU care provided to patients and real-time interviews with their surrogates and the ICU team members providing their care. Qualitative analyses will be used to characterize TLT activities and team member roles. This data will support the construction of a systems engineering process map, which is a visual tool that diagrams the sequence of process steps and serves as a time-limited trial process measure.

For Aim 2, a prospective cohort of 5,810 patients with acute respiratory failure will be followed to evaluate relationships between time-limited trial exposure and ICU outcomes through a chart review and electronic health record (EHR) data abstraction. The extent to which trial care processes influence surrogate and ICU team member outcomes will be investigated by conducting surveys. Additionally, semi-structured interviews will be conducted with surrogates and ICU team members to investigate how time-limited trial processes work.

The hypothesis is that optimal time-limited trial delivery will reduce intensive care unit length of stay for patients with acute respiratory failure and improve the intensive care unit experiences for their families and clinicians.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

Primary outcomes:
measure: Intensive Care Unit (ICU) length of stay
timeFrame: Through participant study completion, an average of 8 days
measure: Surrogate end-of-life intensive care unit (ICU) experience
timeFrame: Between 4 and 12 weeks after participant's hospital discharge
measure: Intensive Care Unit (ICU) team acute moral distress
timeFrame: Up to 14 days after participant's hospital discharge
measure: Direct observation of intensive care unit (ICU) care
timeFrame: Through participant study completion, an average of 8 days
Secondary outcomes:
measure: In-hospital mortality
timeFrame: Through participant study completion, an average of 8 days
measure: Length of mechanical ventilation
timeFrame: Through participant study completion, an average of 8 days
measure: Surrogate anxiety and depression
timeFrame: Between 4 and 12 weeks after participant's hospital discharge
measure: Patient and family centeredness of care
timeFrame: Between 4 and 12 weeks after participant's hospital discharge
measure: Surrogate Heard and Understood Measure
timeFrame: Between 4 and 12 weeks after participant's hospital discharge
measure: Surrogate decisional regret
timeFrame: Between 4 and 12 weeks after participant's hospital discharge
measure: Real-time semi-structured qualitative interviews (Surrogate experience)
timeFrame: Between participant ICU admission and ICU discharge, an average of 8 days
measure: Semi-structured qualitative interviews (Surrogate experience)
timeFrame: Between 4 and 12 weeks after participant's hospital discharge
measure: Structured qualitative interviews (ICU team members experience)
timeFrame: Between participant ICU admission and ICU discharge, an average of 8 days
measure: Semi-structured qualitative interviews (ICU team members experience)
timeFrame: Up to 4 weeks after participant's hospital discharge
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Madison
country: United States
facility: UnityPoint Health - Meriter Hospital
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Jacqueline M Kruser, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: