Acute Respiratory FailureTIMENCT06042621
A Study of Communication Between Clinicians, Patients, and Families in the Intensive Care Unit (ICU)
An observational study of Acute Respiratory Failure and Mechanical Ventilation, run by University of Wisconsin, Madison at 5 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Failure, Mechanical Ventilation, Life-Supporting Treatments
- How many people
- 7,818 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Jan 2024to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
UnityPoint Health - Meriter Hospital
Madison, Wisconsin, 53715
University of Wisconsin-Madison
Madison, Wisconsin, 53792
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Optimizing Time-Limited Trials of Mechanical Ventilation in Acute Respiratory Failure (The TIME Study): A Mixed Methods Observational Study
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.
Read the 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.
- Conditions
- Acute Respiratory Failure, Mechanical Ventilation, Life-Supporting Treatments, Communication, Decision Making, Critical Care
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive Care Unit (ICU) length of stay
Cumulative number of days that participant stays in the intensive care unit.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through participant study completion, an average of 8 days
Secondary outcomes (10)
In-hospital mortality
A participant death occurring during the hospital stay.
Measured: Through participant study completion, an average of 8 days
Length of mechanical ventilation
Cumulative number of days that participant receives invasive mechanical ventilation.
Measured: Through participant study completion, an average of 8 days
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).
Measured: Between 4 and 16 weeks after participant's hospital discharge
Patient and family centeredness of care
Patient and family centeredness of care will be measured using the Modified Patient Perceived Patient-Centeredness of Care (PPPC) Scale. The PPPC has 12 total items with a score range of 0 - 100, with higher scores indicating greater patient-centered care.
Measured: Between 4 and 16 weeks after participant's hospital discharge
Surrogate Heard and Understood Measure
The Heard and Understood Measure evaluates the degree to which the surrogate felt heard and understood. This measure has one item with 5 categorical response choices which range from feeling not at all to completely heard and understood by the doctors, nurses and staff in the ICU. Results are summarized by participant counts for each choice.
Measured: Between 4 and 16 weeks after participant's hospital discharge
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.
Measured: Between 4 and 16 weeks after participant's hospital discharge
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.
Measured: Between participant ICU admission and ICU discharge, an average of 8 days
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.
Measured: Between 4 and 16 weeks after participant's hospital discharge
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.
Measured: Between participant ICU admission and ICU discharge, an average of 8 days
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.
Measured: Up to 4 weeks after participant's hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start17 Jan 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,818 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jacqueline M Kruser, MD, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042621
- Sponsor's protocol ID
- 2022-1681
- Other IDs
- 1R01HL168474-01, SMPH/MEDICINE/MEDICINE*P, Protocol Version 10/02/2025
- Acronym
- TIME
- Status last verified
- Feb 2026
- First submitted
- 11 Sep 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41397749
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Time-Limited Trials of Mechanical Ventilation in Acute Respiratory Failure (The TIME Study): A Mixed Methods Observational Study
- ClinicalTrials.gov ID
- NCT06042621
- Acronym / sponsor ID
- TIME / 2022-1681
- Conditions
- Acute Respiratory Failure, Mechanical Ventilation, Life-Supporting Treatments, Communication, Decision Making, Critical Care
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 7,818 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Participants
- Adult (age ≥ 18 years)
- Acute respiratory failure:
- Receiving invasive mechanical ventilation (patient needs a breathing machine to help them breathe)
- Surrogates
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intensive Care Unit (ICU) length of stay
Time frame: Through participant study completion, an average of 8 days
Cumulative number of days that participant stays in the intensive care unit.
Surrogate end-of-life intensive care unit (ICU) experience
Time frame: Between 4 and 16 weeks after participant's hospital discharge
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.
Intensive Care Unit (ICU) team acute moral distress
Time frame: Up to 14 days after participant's hospital discharge
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.
Direct observation of intensive care unit (ICU) care
Time frame: Through participant study completion, an average of 8 days
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.
10 secondary outcomes
In-hospital mortality
Time frame: Through participant study completion, an average of 8 days
Length of mechanical ventilation
Time frame: Through participant study completion, an average of 8 days
Surrogate anxiety and depression
Time frame: Between 4 and 16 weeks after participant's hospital discharge
Patient and family centeredness of care
Time frame: Between 4 and 16 weeks after participant's hospital discharge
Surrogate Heard and Understood Measure
Time frame: Between 4 and 16 weeks after participant's hospital discharge
Surrogate decisional regret
Time frame: Between 4 and 16 weeks after participant's hospital discharge
Real-time semi-structured qualitative interviews (Surrogate experience)
Time frame: Between participant ICU admission and ICU discharge, an average of 8 days
Semi-structured qualitative interviews (Surrogate experience)
Time frame: Between 4 and 16 weeks after participant's hospital discharge
Structured qualitative interviews (ICU team members experience)
Time frame: Between participant ICU admission and ICU discharge, an average of 8 days
Semi-structured qualitative interviews (ICU team members experience)
Time frame: Up to 4 weeks after participant's hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 41397749Kruser 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacqueline M Kruser, MD, MS principal investigator
University of Wisconsin, Madison
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Mechanical Ventilation, run by University of Wisconsin, Madison at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive Care Unit (ICU) length of stay (time frame: Through participant study completion, an average of 8 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06042621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.