Clinical trial NCT03969810: Rounding Summaries for Families of Critically Ill Patients
Official title: Rounding Summaries for Families of Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Intensive Care Unit Syndrome
Communication
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
timeFrame: 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.
Secondary outcomes:
measure: Surrogate Anxiety and Depression
timeFrame: 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.
measure: Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
timeFrame: 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.
measure: Surrogate and physician agreement regarding the patient's condition
timeFrame: 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.
measure: Change in Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
timeFrame: From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
measure: Change in Surrogate Anxiety and Depression
timeFrame: From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
measure: Change in Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
timeFrame: From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
Other outcomes:
measure: Qualitative feedback from participating surrogates
timeFrame: 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.
measure: Feedback from participating nurses
timeFrame: Daily while patient is in the ICU
measure: Surrogate Satisfaction with Patient Care
timeFrame: Measured once 10-14 days after enrollment if patient still in ICU
measure: Surrogate Anxiety and Depression
timeFrame: Measured once 10-14 days after enrollment if patient still in ICU
measure: Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
timeFrame: Measured once 10-14 days after enrollment if patient still in ICU
measure: Surrogate and physician agreement regarding the patient's condition
timeFrame: Measured once 10-14 days after enrollment if patient still in ICU
measure: Patient length of mechanical ventilation (if applicable)
timeFrame: Measured during hospitalization, up to 90 days after enrollment.
measure: Patient failed extubation attempt (yes/no) (if applicable)
timeFrame: Measured during hospitalization, up to 90 days after enrollment.
measure: Tracheostomy placement during ICU admission (yes/no)
timeFrame: Measured during hospitalization, up to 90 days after enrollment.
measure: Days from intubation to tracheostomy placement (if applicable)
timeFrame: Measured during hospitalization, up to 90 days after enrollment.
measure: ICU discharge requiring invasive mechanical ventilation (yes/no)
timeFrame: Measured during hospitalization, up to 90 days after enrollment.
measure: ICU discharge requiring new artificial nutritional supplementation (yes/no)
timeFrame: Measured during hospitalization, up to 90 days after enrollment.
measure: ICU discharge requiring new renal replacement therapy (yes/no)
timeFrame: Measured during hospitalization, up to 90 days after enrollment.
measure: Change in code status or limitations to care during ICU stay (yes/no)
timeFrame: Measured during hospitalization, up to 90 days after enrollment.
measure: Days from ICU admission to change in code status or new limitations to care (if applicable)
timeFrame: Measured during hospitalization, up to 90 days after enrollment.
measure: ICU length of stay (days)
timeFrame: Measured during hospitalization, up to 90 days after enrollment.
measure: Hospital length of stay (days)
timeFrame: Measured during hospitalization, up to 90 days after enrollment.
measure: Hospital disposition
timeFrame: Measured during hospitalization, up to 90 days after enrollment.
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
citation: Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.
citation: Nelson JE, Hanson LC, Keller KL, Carson SS, Cox CE, Tulsky JA, White DB, Chai EJ, Weiss SP, Danis M. The Voice of Surrogate Decision-Makers. Family Responses to Prognostic Information in Chronic Critical Illness. Am J Respir Crit Care Med. 2017 Oct 1;196(7):864-872. doi: 10.1164/rccm.201701-0201OC.
citation: Brown SM, Rozenblum R, Aboumatar H, Fagan MB, Milic M, Lee BS, Turner K, Frosch DL. Defining patient and family engagement in the intensive care unit. Am J Respir Crit Care Med. 2015 Feb 1;191(3):358-60. doi: 10.1164/rccm.201410-1936LE. No abstract available.
citation: Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
citation: Greenberg JA, Basapur S, Quinn TV, Bulger JL, Schwartz NH, Oh SK, Shah RC, Glover CM. Challenges faced by families of critically ill patients during the first wave of the COVID-19 pandemic. Patient Educ Couns. 2022 Feb;105(2):297-303. doi: 10.1016/j.pec.2021.08.029. Epub 2021 Aug 27.