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

Mechanical Ventilation Clinical Trial

— TIME  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06042621
• Other study ID #: 2022-1681
• Secondary ID: 1R01HL168474-01S
• Status: Enrolling by invitation
• Start date: January 17, 2024
• Est. completion date: March 2028

Study information

• Verified date: January 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 him or her. 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.

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 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. These 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7818
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (primary surrogate, also known as legally authorized representative) who is making medical decisions on behalf of an eligible patient

• This person 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

• Receiving chronic, invasive mechanical ventilation before being admitted to a study hospital

• Participant or their legally authorized representative declines participation or opts-out of data collection

Surrogates

• Cannot complete surveys and interviews in English

• Declines participation

ICU Team Members

• Opts out of study participation

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Communication
• Critical Care
• Decision Making
• Life-Supporting Treatments
• Mechanical Ventilation
• Palliative Care
• Respiratory Distress Syndrome
• Respiratory Insufficiency

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	UnityPoint Health-Meriter Hospital	Madison	Wisconsin
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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 12 weeks after participant's hospital discharge
Primary	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
Primary	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	In-hospital mortality	A participant death occurring during the hospital stay.	Through participant study completion, an average of 8 days
Secondary	Length of mechanical ventilation	Cumulative number of days that participant receives invasive mechanical ventilation.	Through participant study completion, an average of 8 days
Secondary	Surrogate anxiety and depression	Surrogate anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS), a self-rated scale that aims to measure symptoms of anxiety and depression. The HADS has 14 total items, 7 items measuring anxiety and 7 items measuring depression. Each item is scored on a 4-point Likert scale where scores range from 0 (less anxious or depressed) to 3 (more anxious or depressed).	Between 4 and 12 weeks after participant's hospital discharge
Secondary	Patient and family centeredness of care	Patient and family centeredness of care will be measured using the Patient Perceived Patient-Centeredness of Care (PPPC) Scale, a self-rated scale that aims to measure symptoms of anxiety and depression. The PPPC has 14 total items scored on a 4-point Likert scale where scores range from 1 (indicating more) to 4 (indicating less) patient-centered experiences.	Between 4 and 12 weeks after participant's hospital discharge
Secondary	Surrogate decisional regret	Surrogate decisional regret will be measured using the Decision Regret Scale (DRS) that measures distress or remorse after a health care decision. The DRS has 5 total items scored on a 5-point Likert scale where scores range from 1 (strongly agree) to 4 (strongly disagree). A higher score indicates more regret.	Between 4 and 12 weeks after participant's hospital discharge
Secondary	Real-time semi-structured qualitative interviews (Surrogate experience)	Serial, real-time interviews will be conducted following an interview guide that will be iteratively revised as necessary during data collection, according to methodological standards of qualitative interview research. The interviews will be audio-recorded and transcribed verbatim.	Between participant ICU admission and ICU discharge, an average of 8 days
Secondary	Semi-structured qualitative interviews (Surrogate experience)	Interviews will be conducted following an interview guide that will be iteratively revised as necessary during data collection, according to methodological standards of qualitative interview research. Surrogate interviews will also use an adapted form of chart-stimulated recall, a case-based interviewing method using prompts to help participants remember and reflect on past events. The interviews will be audio-recorded and transcribed verbatim.	Between 4 and 12 weeks after participant's hospital discharge
Secondary	Structured qualitative interviews (ICU team members experience)	Brief, real-time structured interviews will collect team members' knowledge, understanding, and approval of time-limited trials for patients in their care.	Between participant ICU admission and ICU discharge, an average of 8 days
Secondary	Semi-structured qualitative interviews (ICU team members experience)	Semi-structured interviews will be conducted following an interview guide that will be iteratively revised as necessary during data collection, according to methodological standards of qualitative interview research. Interviews will also use an adapted form of chart-stimulated recall, a case-based interviewing method using prompts to help participants remember and reflect on past events. The interviews will be audio-recorded and transcribed verbatim.	Up to 4 weeks after participant's hospital discharge