xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06042621</url>
    </required_header>
    <id_info>
      <org_study_id>2022-1681</org_study_id>
      <secondary_id>1R01HL168474-01</secondary_id>
      <secondary_id>SMPH/MEDICINE/MEDICINE*P</secondary_id>
      <secondary_id>Protocol Version 3.0 (5/12/23)</secondary_id>
      <nct_id>NCT06042621</nct_id>
    </id_info>
    <brief_title>A Study of Communication Between Clinicians, Patients, and Families in the Intensive Care Unit (ICU)</brief_title>
    <acronym>TIME</acronym>
    <official_title>Optimizing Time-Limited Trials of Mechanical Ventilation in Acute Respiratory Failure (The TIME Study): A Mixed Methods Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Wisconsin, Madison</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Wisconsin, Madison</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to investigate a specific approach to patient care called a&#xD;
        time-limited trial (TLT). This approach is sometimes used for people who develop critical&#xD;
        illness and are cared for in an intensive care unit (ICU). A time-limited trial is a plan&#xD;
        made together by medical teams, patients with critical illness (if they can take part), and&#xD;
        their families or other important people helping to make their healthcare decisions. A&#xD;
        time-limited trial starts with a discussion of the patient's goals and wishes. Then, a plan&#xD;
        is made to use ICU treatments for a set period of time to give the patient the chance to&#xD;
        recover. After this time, the patient's response to treatment will be reviewed to help guide&#xD;
        what to do next.&#xD;
  &#xD;
        Medical teams consider this kind of plan when it is not clear if a patient can recover to a&#xD;
        quality of life that is acceptable to him or her. With a time-limited trial, patients,&#xD;
        families, and medical teams experience this uncertainty together.&#xD;
  &#xD;
        The main goal of this study is to find the best way to use TLTs for patients in the ICU who&#xD;
        have trouble breathing and need mechanical ventilation to help them breathe. The hypothesis&#xD;
        is that optimal time-limited trial delivery will reduce the time patients with acute&#xD;
        respiratory failure spend in the ICU and will improve the intensive care unit experiences for&#xD;
        their families and clinicians.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi-site observational study that will investigate the time-limited trial&#xD;
        approach to care for patients with critical illness, which is a trial of life support with&#xD;
        milestones and a timeline to help evaluate whether the patient is improving. The primary&#xD;
        objective of this study is to define the optimal care delivery processes of a time-limited&#xD;
        trial for adult intensive care unit (ICU) patients who develop acute respiratory failure&#xD;
        requiring mechanical ventilation. The two aims of this study are to:&#xD;
  &#xD;
        Aim 1: Map the current processes of time-limited trial care delivery for patients with acute&#xD;
        respiratory failure.&#xD;
  &#xD;
        Aim 2: Elucidate the relationships between time-limited trials, their care delivery&#xD;
        processes, and end-of-life outcomes for patients, surrogates, and ICU teams.&#xD;
  &#xD;
        For Aim 1, a focused ethnography of 50 time-limited trials will be done to characterize how&#xD;
        trials are currently being done in the intensive care unit. This will include direct&#xD;
        observation of ICU care provided to patients and real-time interviews with their surrogates&#xD;
        and the ICU team members providing their care. Qualitative analyses will be used to&#xD;
        characterize TLT activities and team member roles. These data will support the construction&#xD;
        of a systems engineering process map, which is a visual tool that diagrams the sequence of&#xD;
        process steps and serves as a time-limited trial process measure.&#xD;
  &#xD;
        For Aim 2, a prospective cohort of 5,810 patients with acute respiratory failure will be&#xD;
        followed to evaluate relationships between time-limited trial exposure and ICU outcomes&#xD;
        through a chart review and electronic health record (EHR) data abstraction. The extent to&#xD;
        which trial care processes influence surrogate and ICU team member outcomes will be&#xD;
        investigated by conducting surveys. Additionally, semi-structured interviews will be&#xD;
        conducted with surrogates and ICU team members to investigate how time-limited trial&#xD;
        processes work.&#xD;
  &#xD;
        The hypothesis is that optimal time-limited trial delivery will reduce intensive care unit&#xD;
        length of stay for patients with acute respiratory failure and improve the intensive care&#xD;
        unit experiences for their families and clinicians.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2028</completion_date>
    <primary_completion_date type="Anticipated">March 2028</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Intensive Care Unit (ICU) length of stay</measure>
      <time_frame>Through participant study completion, an average of 8 days</time_frame>
      <description>Cumulative number of days that participant stays in the intensive care unit.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Surrogate end-of-life intensive care unit (ICU) experience</measure>
      <time_frame>Between 4 and 12 weeks after participant's hospital discharge</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intensive Care Unit (ICU) team acute moral distress</measure>
      <time_frame>Up to 14 days after participant's hospital discharge</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Direct observation of intensive care unit (ICU) care</measure>
      <time_frame>Through participant study completion, an average of 8 days</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>In-hospital mortality</measure>
      <time_frame>Through participant study completion, an average of 8 days</time_frame>
      <description>A participant death occurring during the hospital stay.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of mechanical ventilation</measure>
      <time_frame>Through participant study completion, an average of 8 days</time_frame>
      <description>Cumulative number of days that participant receives invasive mechanical ventilation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surrogate anxiety and depression</measure>
      <time_frame>Between 4 and 12 weeks after participant's hospital discharge</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient and family centeredness of care</measure>
      <time_frame>Between 4 and 12 weeks after participant's hospital discharge</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surrogate decisional regret</measure>
      <time_frame>Between 4 and 12 weeks after participant's hospital discharge</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Real-time semi-structured qualitative interviews (Surrogate experience)</measure>
      <time_frame>Between participant ICU admission and ICU discharge, an average of 8 days</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Semi-structured qualitative interviews (Surrogate experience)</measure>
      <time_frame>Between 4 and 12 weeks after participant's hospital discharge</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Structured qualitative interviews (ICU team members experience)</measure>
      <time_frame>Between participant ICU admission and ICU discharge, an average of 8 days</time_frame>
      <description>Brief, real-time structured interviews will collect team members' knowledge, understanding, and approval of time-limited trials for patients in their care.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Semi-structured qualitative interviews (ICU team members experience)</measure>
      <time_frame>Up to 4 weeks after participant's hospital discharge</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">7818</enrollment>
    <condition>Acute Respiratory Failure</condition>
    <condition>Mechanical Ventilation</condition>
    <condition>Life-Supporting Treatments</condition>
    <condition>Communication</condition>
    <condition>Decision Making</condition>
    <condition>Critical Care</condition>
    <condition>Palliative Care</condition>
    <arm_group>
      <arm_group_label>Participants</arm_group_label>
      <description>Participants will be selected from patients who are admitted to an intensive care unit (ICU) at the University of Wisconsin Hospital, Unity Point-Meriter Hospital, Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, or Northwestern Memorial Hospital.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Surrogates</arm_group_label>
      <description>Surrogate participants will be the primary surrogate for an eligible patient.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ICU Team Members</arm_group_label>
      <description>ICU Team Member participants will be members of the hospital staff providing care for an eligible patient.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Participants will be selected from patients who are admitted to an intensive care unit&#xD;
          (ICU) at the University of Wisconsin Hospital, Unity Point-Meriter Hospital, Hospital of&#xD;
          the University of Pennsylvania, Penn Presbyterian Medical Center, or Northwestern Memorial&#xD;
          Hospital. Surrogate participants will be the primary surrogate for an eligible patient, and&#xD;
          ICU Team Member participants will be members of the hospital staff providing care for an&#xD;
          eligible patient.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Participants&#xD;
  &#xD;
            -  Adult (age ≥ 18 years)&#xD;
  &#xD;
            -  Acute respiratory failure:&#xD;
  &#xD;
                 -  Hypoxemic (low level of oxygen in the blood) or&#xD;
  &#xD;
                 -  Hypercapnic (high level of carbon dioxide in the blood)&#xD;
  &#xD;
            -  Receiving invasive mechanical ventilation (patient needs a breathing machine to help&#xD;
               them breathe)&#xD;
  &#xD;
          Surrogates&#xD;
  &#xD;
            -  The main person (primary surrogate, also known as legally authorized representative)&#xD;
               who is making medical decisions on behalf of an eligible patient&#xD;
  &#xD;
                 -  This person will be identified by the treating ICU team according to established&#xD;
                    legal and ethical standards&#xD;
  &#xD;
          ICU Team Members&#xD;
  &#xD;
            -  A member of the interprofessional hospital staff that is caring for an eligible&#xD;
               patient&#xD;
  &#xD;
                 -  Team members may include advanced practice providers (nurse practitioners/&#xD;
                    physicians assistants), case managers, chaplains, dietitians, nurses,&#xD;
                    pharmacists, physical and occupational therapists, physicians&#xD;
                    (attending/fellow/resident), respiratory therapists, and social workers.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Participants&#xD;
  &#xD;
            -  Receiving chronic, invasive mechanical ventilation before being admitted to a study&#xD;
               hospital&#xD;
  &#xD;
            -  Participant or their legally authorized representative declines participation or&#xD;
               opts-out of data collection&#xD;
  &#xD;
          Surrogates&#xD;
  &#xD;
            -  Cannot complete surveys and interviews in English&#xD;
  &#xD;
            -  Declines participation&#xD;
  &#xD;
          ICU Team Members&#xD;
  &#xD;
            -  Opts out of study participation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jacqueline M Kruser, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Wisconsin, Madison</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jacqueline M Kruser, MD, MS</last_name>
      <phone>608-890-4044</phone>
      <email>jkruser@wisc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Northwestern Memorial Hospital</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60611</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Nandita Nadig, MD, MSCR, ATSF</last_name>
        <phone>312-694-7331</phone>
        <email>nandita.nadig@northwestern.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital of the University of Pennsylvania</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Justin Clapp, PhD, MPH</last_name>
        <phone>215-898-0861</phone>
        <email>Justin.Clapp@pennmedicine.upenn.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Penn Presbyterian Medical Center</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Justin Clapp, PhD, MPH</last_name>
        <phone>215-898-0861</phone>
        <email>Justin.Clapp@pennmedicine.upenn.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>UnityPoint Health-Meriter Hospital</name>
        <address>
          <city>Madison</city>
          <state>Wisconsin</state>
          <zip>53715</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Joy Moy, MD, MPH</last_name>
        <phone>608-263-1741</phone>
        <email>jmoy@medicine.wisc.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Wisconsin-Madison</name>
        <address>
          <city>Madison</city>
          <state>Wisconsin</state>
          <zip>53792</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Joy Moy, MD, MPH</last_name>
        <phone>608-263-1741</phone>
        <email>jmoy@medicine.wisc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Insufficiency</mesh_term>
      <mesh_term>Respiratory Distress Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06042621
  org study id: 2022-1681
  secondary id: 1R01HL168474-01
  secondary id: SMPH/MEDICINE/MEDICINE*P
  secondary id: Protocol Version 3.0 (5/12/23)
  nct id: NCT06042621
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Intensive Care Unit (ICU) length of stay
  time frame: Through participant study completion, an average of 8 days
  description: Cumulative number of days that participant stays in the intensive care unit.
  measure: Surrogate end-of-life intensive care unit (ICU) experience
  time frame: Between 4 and 12 weeks after participant's hospital discharge
  description: 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.
  measure: Intensive Care Unit (ICU) team acute moral distress
  time frame: Up to 14 days after participant's hospital discharge
  description: 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.
  measure: Direct observation of intensive care unit (ICU) care
  time frame: Through participant study completion, an average of 8 days
  description: 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.
  measure: In-hospital mortality
  time frame: Through participant study completion, an average of 8 days
  description: A participant death occurring during the hospital stay.
  measure: Length of mechanical ventilation
  time frame: Through participant study completion, an average of 8 days
  description: Cumulative number of days that participant receives invasive mechanical ventilation.
  measure: Surrogate anxiety and depression
  time frame: Between 4 and 12 weeks after participant's hospital discharge
  description: 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).
  measure: Patient and family centeredness of care
  time frame: Between 4 and 12 weeks after participant's hospital discharge
  description: 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.
  measure: Surrogate decisional regret
  time frame: Between 4 and 12 weeks after participant's hospital discharge
  description: 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.
  measure: Real-time semi-structured qualitative interviews (Surrogate experience)
  time frame: Between participant ICU admission and ICU discharge, an average of 8 days
  description: 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.
  measure: Semi-structured qualitative interviews (Surrogate experience)
  time frame: Between 4 and 12 weeks after participant's hospital discharge
  description: 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.
  measure: Structured qualitative interviews (ICU team members experience)
  time frame: Between participant ICU admission and ICU discharge, an average of 8 days
  description: Brief, real-time structured interviews will collect team members' knowledge, understanding, and approval of time-limited trials for patients in their care.
  measure: Semi-structured qualitative interviews (ICU team members experience)
  time frame: Up to 4 weeks after participant's hospital discharge
  description: 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.
  arm group label: Participants
  description: Participants will be selected from patients who are admitted to an intensive care unit (ICU) at the University of Wisconsin Hospital, Unity Point-Meriter Hospital, Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, or Northwestern Memorial Hospital.
  arm group label: Surrogates
  description: Surrogate participants will be the primary surrogate for an eligible patient.
  arm group label: ICU Team Members
  description: ICU Team Member participants will be members of the hospital staff providing care for an eligible patient.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jacqueline M Kruser, MD, MS
  role: Principal Investigator
  affiliation: University of Wisconsin, Madison
  last name: Jacqueline M Kruser, MD, MS
  phone: 608-890-4044
  email: jkruser@wisc.edu
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  country: United States
  responsible party type: Sponsor
  mesh term: Respiratory Insufficiency
  mesh term: Respiratory Distress Syndrome
  sharing ipd: No