A Study of Communication Between Clinicians, Patients, and Families in the Intensive Care Unit (ICU) (NCT06042621) | Clinical Trial Compass
By InvitationNot Applicable
A Study of Communication Between Clinicians, Patients, and Families in the Intensive Care Unit (ICU)
United States7,818 participantsStarted 2024-01-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intensive Care Unit (ICU) length of stay
Timeframe: Through participant study completion, an average of 8 days
2
Surrogate end-of-life intensive care unit (ICU) experience
Timeframe: Between 4 and 16 weeks after participant's hospital discharge
3
Intensive Care Unit (ICU) team acute moral distress
Timeframe: Up to 14 days after participant's hospital discharge
4
Direct observation of intensive care unit (ICU) care
Timeframe: Through participant study completion, an average of 8 days