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.

Study Overview

• Status: Completed
• Conditions: Communication; Acute Respiratory Failure; Intensive Care Unit Syndrome
• Intervention / Treatment: Behavioral: Rounding Summary

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rounding Summary; Surrogates who are assigned to the intervention group will 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. For patients assigned to the intervention group, the investigators will forward the previous day's summary to the ICU nurse at the beginning of each day shift. After participating in morning rounds, ICU nurses will be asked to modify the summary based on the plan for the day. Nurses will be asked to use the written summary to guide communication with surrogates that day.	Behavioral: Rounding Summary; Written summary of rounds
No Intervention: Usual Care; Usual ICU care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire	Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surrogate Anxiety and Depression	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.	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.
Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)	Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.	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.
Surrogate and physician agreement regarding the patient's condition	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.	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.
Change in Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire	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.	From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
Change in Surrogate Anxiety and Depression	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.	From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
Change in Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)	Change in score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.	From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative feedback from participating surrogates	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.	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.
Feedback from participating nurses	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.	Daily while patient is in the ICU
Surrogate Satisfaction with Patient Care	Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.	Measured once 10-14 days after enrollment if patient still in ICU
Surrogate Anxiety and Depression	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.	Measured once 10-14 days after enrollment if patient still in ICU
Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)	Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.	Measured once 10-14 days after enrollment if patient still in ICU
Surrogate and physician agreement regarding the patient's condition	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.	Measured once 10-14 days after enrollment if patient still in ICU
Patient length of mechanical ventilation (if applicable)	Patient length of mechanical ventilation (if applicable)	Measured during hospitalization, up to 90 days after enrollment.
Patient failed extubation attempt (yes/no) (if applicable)	Failed extubation attempt (yes/no) (if applicable)	Measured during hospitalization, up to 90 days after enrollment.
Tracheostomy placement during ICU admission (yes/no)	Tracheostomy placement during ICU admission (yes/no)	Measured during hospitalization, up to 90 days after enrollment.
Days from intubation to tracheostomy placement (if applicable)	Days from intubation to tracheostomy placement (if applicable)	Measured during hospitalization, up to 90 days after enrollment.
ICU discharge requiring invasive mechanical ventilation (yes/no)	ICU discharge requiring invasive mechanical ventilation (yes/no)	Measured during hospitalization, up to 90 days after enrollment.
ICU discharge requiring new artificial nutritional supplementation (yes/no)	ICU discharge requiring new artificial nutritional supplementation (yes/no)	Measured during hospitalization, up to 90 days after enrollment.
ICU discharge requiring new renal replacement therapy (yes/no)	ICU discharge requiring new renal replacement therapy (yes/no)	Measured during hospitalization, up to 90 days after enrollment.
Change in code status or limitations to care during ICU stay (yes/no)	Change in code status or limitations to care during ICU stay (yes/no)	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)	Days from ICU admission to change in code status or new limitations to care (if applicable)	Measured during hospitalization, up to 90 days after enrollment.
ICU length of stay (days)	ICU length of stay (days)	Measured during hospitalization, up to 90 days after enrollment.
Hospital length of stay (days)	Hospital length of stay (days)	Measured during hospitalization, up to 90 days after enrollment.
Hospital disposition	Hospital disposition	Measured during hospitalization, up to 90 days after enrollment.

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): January 11, 2021
• Study Completion (Actual): February 12, 2021

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 19042604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No