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

Официальное название

Optimizing Time-Limited Trials of Mechanical Ventilation in Acute Respiratory Failure (The TIME Study): A Mixed Methods Observational Study

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Intensive Care Unit (ICU) length of stay [Срок оценки: Through participant study completion, an average of 8 days]
• Surrogate end-of-life intensive care unit (ICU) experience [Срок оценки: Between 4 and 16 weeks after participant's hospital discharge]
• Intensive Care Unit (ICU) team acute moral distress [Срок оценки: Up to 14 days after participant's hospital discharge]
• Direct observation of intensive care unit (ICU) care [Срок оценки: Through participant study completion, an average of 8 days]

Вторичные конечные точки (10)

• In-hospital mortality [Срок оценки: Through participant study completion, an average of 8 days]
• Length of mechanical ventilation [Срок оценки: Through participant study completion, an average of 8 days]
• Surrogate anxiety and depression [Срок оценки: Between 4 and 16 weeks after participant's hospital discharge]
• Patient and family centeredness of care [Срок оценки: Between 4 and 16 weeks after participant's hospital discharge]
• Surrogate Heard and Understood Measure [Срок оценки: Between 4 and 16 weeks after participant's hospital discharge]
• Surrogate decisional regret [Срок оценки: Between 4 and 16 weeks after participant's hospital discharge]
• Real-time semi-structured qualitative interviews (Surrogate experience) [Срок оценки: Between participant ICU admission and ICU discharge, an average of 8 days]
• Semi-structured qualitative interviews (Surrogate experience) [Срок оценки: Between 4 and 16 weeks after participant's hospital discharge]
• Structured qualitative interviews (ICU team members experience) [Срок оценки: Between participant ICU admission and ICU discharge, an average of 8 days]
• Semi-structured qualitative interviews (ICU team members experience) [Срок оценки: Up to 4 weeks after participant's hospital discharge]

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 5 центров

• Northwestern Memorial Hospital — Chicago
• Hospital of the University of Pennsylvania — Philadelphia
• Penn Presbyterian Medical Center — Philadelphia
• UnityPoint Health - Meriter Hospital — Madison
• University of Wisconsin-Madison — Madison

Публикации

• 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-2025-106 PMID 41397749

Идентификаторы

NCT: NCT06042621 · 2022-1681 · 1R01HL168474-01 · SMPH/MEDICINE/MEDICINE*P · Protocol Version 10/02/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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