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Completed

NCT Number: NCT03969810

Rounding Summaries for Families of Critically Ill Patients

Many patients in intensive care units (ICUs) rely on family members or surrogates to make medical decisions on their behalf. One of the recommended ways to improve a surrogate's experience is to invite him or her to participate in daily, multidisciplinary ICU rounds. In practice, this is often a challenging way for clinicians to engage with the patient's surrogates.

Surrogates of non-decisional ICU patients will be randomized to receive a written rounding summary every day or every other day that the patient is in the ICU. The summary will be organized as follows for each of the most important ICU problems: 1) Description of the problem, 2) Ways the ICU team is addressing the problem i.e. consultations, diagnostic tests, and treatments. 3) An assessment of whether the problem is improving or worsening.

The investigators hypothesize that surrogates who receive written rounding summaries will be more satisfied with ICU care than surrogates who receive usual care. Satisfaction will be measured by the Critical Care Family Needs Inventory (CCFNI) questionnaire.

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Key information

Conditions

Acute Respiratory Failure Behavior Communication Intensive Care Unit Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients in the adult Medical and Cardiac ICUs at Rush University Medical Center will be prospectively screened.

Inclusion criteria

(Patient characteristics required for surrogate inclusion) At least one of the following

  • The patient has required invasive or non-invasive mechanical ventilation for at least three consecutive days.
  • The patient has an expected in-hospital mortality rate of at least 25% according to the primary ICU physician.

Exclusion criteria

(Patient characteristics that will exclude surrogates from study enrollment):

  • The patient possesses decisional capacity at the time of enrollment.
  • The patient has required invasive or non-invasive mechanical ventilation for more than the previous 14 days
  • The patient is expected to die or transition to comfort care within the next 48 hours based on ICU physician estimate.
  • The patient is expected to be liberated from mechanical ventilation (if applicable) or discharged from the ICU within the next 24 hours.
  • There is no identifiable surrogate.
  • The patient is member of a vulnerable population i.e. pregnant, prisoner.
  • The ICU physician refuses permission to approach surrogates for consent

The investigators will hand out fliers that describe the study to surrogates of patients who are expected to meet the above criteria. Surrogates can ask the nurse to contact the lead investigator if they are interested in learning more about the study. If no surrogate is present prior to the patient meeting the inclusion criteria, the investigators will attempt to contact the surrogate by phone to provide information on the study.

One surrogate will be approached for informed consent and enrolled based on the following criteria.

Inclusion criteria

for surrogate decision maker:

  • Age ≥ 18 years old
  • Self-identified as participating directly in health care decision making for the incapable patient

Exclusion criteria

for surrogate decision makers:

  • The surrogate does not agree to participate in study procedures (surveys, interviews)
  • The surrogate needs translation assistance because of poor English fluency
  • The surrogate has history of a clinically important neurological disorder (e.g., dementia)

Treatment and study plan

Rounding Summary

Behavioral

Written summary of rounds

Primary outcomes

  1. Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire

    Time frame: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.

    Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.

Secondary outcomes

  1. Surrogate Anxiety and Depression

    Time frame: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.

    Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.

  2. Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)

    Time frame: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.

    Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.

  3. Surrogate and physician agreement regarding the patient's condition

    Time frame: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.

    Surrogates and ICU physicians will be provided with a list of common medical ICU diagnoses. Respondents will be asked to indicate which of these diagnoses, if any, pertain to the patient. When the respondent picks a diagnosis, he or she will be prompted to indicate whether common treatments for that condition are being provided. Finally, for each checked diagnosis, the respondent will indicate whether he or she believes the problem is "getting better, getting worse, or staying the same." Members of the research team, blinded to the surrogates' treatment arm, will evaluate for inter-rater agreement between surrogates and ICU physician responses.

  4. Change in Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire

    Time frame: From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).

    Change in Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.

  5. Change in Surrogate Anxiety and Depression

    Time frame: From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).

    Change in Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.

  6. Change in Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)

    Time frame: From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).

    Change in score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.

Other outcomes

  1. Qualitative feedback from participating surrogates

    Time frame: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.

    All surrogates will be asked to participate in a 10-15 minute phone or in-person interview. This interview will deal with their satisfaction with the patient's care and communication with the ICU staff.

  2. Feedback from participating nurses

    Time frame: Daily while patient is in the ICU

    Nurses of enrolled patients/surrogates will be asked to complete an online survey regarding communication with the patient and/or surrogates that day. Nurses will also be invited to participate in focus groups to provide feedback.

  3. Surrogate Satisfaction with Patient Care

    Time frame: Measured once 10-14 days after enrollment if patient still in ICU

    Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.

  4. Surrogate Anxiety and Depression

    Time frame: Measured once 10-14 days after enrollment if patient still in ICU

    Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.

  5. Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)

    Time frame: Measured once 10-14 days after enrollment if patient still in ICU

    Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.

  6. Surrogate and physician agreement regarding the patient's condition

    Time frame: Measured once 10-14 days after enrollment if patient still in ICU

    Surrogates and ICU physicians will be provided with a list of common medical ICU diagnoses. Respondents will be asked to indicate which of these diagnoses, if any, pertain to the patient. When the respondent picks a diagnosis, he or she will be prompted to indicate whether common treatments for that condition are being provided. Finally, for each checked diagnosis, the respondent will indicate whether he or she believes the problem is "getting better, getting worse, or staying the same." Members of the research team, blinded to the surrogates' treatment arm, will evaluate for inter-rater agreement between surrogates and ICU physician responses.

  7. Patient length of mechanical ventilation (if applicable)

    Time frame: Measured during hospitalization, up to 90 days after enrollment.

    Patient length of mechanical ventilation (if applicable)

  8. Patient failed extubation attempt (yes/no) (if applicable)

    Time frame: Measured during hospitalization, up to 90 days after enrollment.

    Failed extubation attempt (yes/no) (if applicable)

  9. Tracheostomy placement during ICU admission (yes/no)

    Time frame: Measured during hospitalization, up to 90 days after enrollment.

    Tracheostomy placement during ICU admission (yes/no)

  10. Days from intubation to tracheostomy placement (if applicable)

    Time frame: Measured during hospitalization, up to 90 days after enrollment.

    Days from intubation to tracheostomy placement (if applicable)

  11. ICU discharge requiring invasive mechanical ventilation (yes/no)

    Time frame: Measured during hospitalization, up to 90 days after enrollment.

    ICU discharge requiring invasive mechanical ventilation (yes/no)

  12. ICU discharge requiring new artificial nutritional supplementation (yes/no)

    Time frame: Measured during hospitalization, up to 90 days after enrollment.

    ICU discharge requiring new artificial nutritional supplementation (yes/no)

  13. ICU discharge requiring new renal replacement therapy (yes/no)

    Time frame: Measured during hospitalization, up to 90 days after enrollment.

    ICU discharge requiring new renal replacement therapy (yes/no)

  14. Change in code status or limitations to care during ICU stay (yes/no)

    Time frame: Measured during hospitalization, up to 90 days after enrollment.

    Change in code status or limitations to care during ICU stay (yes/no)

  15. Days from ICU admission to change in code status or new limitations to care (if applicable)

    Time frame: Measured during hospitalization, up to 90 days after enrollment.

    Days from ICU admission to change in code status or new limitations to care (if applicable)

  16. ICU length of stay (days)

    Time frame: Measured during hospitalization, up to 90 days after enrollment.

    ICU length of stay (days)

  17. Hospital length of stay (days)

    Time frame: Measured during hospitalization, up to 90 days after enrollment.

    Hospital length of stay (days)

  18. Hospital disposition

    Time frame: Measured during hospitalization, up to 90 days after enrollment.

    Hospital disposition

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 31, 2019
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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