Back to resultsRounding Summaries for Families of Critically Ill Patients
Primary Purpose
Acute Respiratory Failure, Intensive Care Unit Syndrome, Communication
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rounding Summary
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Respiratory Failure
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)
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rounding Summary
Usual Care
Arm Description
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.
Usual ICU care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03969810
First Posted
May 10, 2019
Last Updated
March 8, 2021
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03969810
Brief Title
Rounding Summaries for Families of Critically Ill Patients
Official Title
Rounding Summaries for Families of Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
January 11, 2021 (Actual)
Study Completion Date
February 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Intensive Care Unit Syndrome, Communication
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rounding Summary
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual ICU care
Intervention Type
Behavioral
Intervention Name(s)
Rounding Summary
Intervention Description
Written summary of rounds
Primary Outcome Measure Information:
Title
Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
Description
Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.
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.
Secondary Outcome Measure Information:
Title
Surrogate Anxiety and Depression
Description
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.
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.
Title
Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
Description
Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.
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.
Title
Surrogate and physician agreement regarding the patient's condition
Description
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.
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.
Title
Change in Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
Description
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.
Time Frame
From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
Title
Change in Surrogate Anxiety and Depression
Description
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.
Time Frame
From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
Title
Change in Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
Description
Change in score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.
Time Frame
From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
Other Pre-specified Outcome Measures:
Title
Qualitative feedback from participating surrogates
Description
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.
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.
Title
Feedback from participating nurses
Description
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.
Time Frame
Daily while patient is in the ICU
Title
Surrogate Satisfaction with Patient Care
Description
Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.
Time Frame
Measured once 10-14 days after enrollment if patient still in ICU
Title
Surrogate Anxiety and Depression
Description
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.
Time Frame
Measured once 10-14 days after enrollment if patient still in ICU
Title
Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
Description
Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.
Time Frame
Measured once 10-14 days after enrollment if patient still in ICU
Title
Surrogate and physician agreement regarding the patient's condition
Description
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.
Time Frame
Measured once 10-14 days after enrollment if patient still in ICU
Title
Patient length of mechanical ventilation (if applicable)
Description
Patient length of mechanical ventilation (if applicable)
Time Frame
Measured during hospitalization, up to 90 days after enrollment.
Title
Patient failed extubation attempt (yes/no) (if applicable)
Description
Failed extubation attempt (yes/no) (if applicable)
Time Frame
Measured during hospitalization, up to 90 days after enrollment.
Title
Tracheostomy placement during ICU admission (yes/no)
Description
Tracheostomy placement during ICU admission (yes/no)
Time Frame
Measured during hospitalization, up to 90 days after enrollment.
Title
Days from intubation to tracheostomy placement (if applicable)
Description
Days from intubation to tracheostomy placement (if applicable)
Time Frame
Measured during hospitalization, up to 90 days after enrollment.
Title
ICU discharge requiring invasive mechanical ventilation (yes/no)
Description
ICU discharge requiring invasive mechanical ventilation (yes/no)
Time Frame
Measured during hospitalization, up to 90 days after enrollment.
Title
ICU discharge requiring new artificial nutritional supplementation (yes/no)
Description
ICU discharge requiring new artificial nutritional supplementation (yes/no)
Time Frame
Measured during hospitalization, up to 90 days after enrollment.
Title
ICU discharge requiring new renal replacement therapy (yes/no)
Description
ICU discharge requiring new renal replacement therapy (yes/no)
Time Frame
Measured during hospitalization, up to 90 days after enrollment.
Title
Change in code status or limitations to care during ICU stay (yes/no)
Description
Change in code status or limitations to care during ICU stay (yes/no)
Time Frame
Measured during hospitalization, up to 90 days after enrollment.
Title
Days from ICU admission to change in code status or new limitations to care (if applicable)
Description
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.
Title
ICU length of stay (days)
Description
ICU length of stay (days)
Time Frame
Measured during hospitalization, up to 90 days after enrollment.
Title
Hospital length of stay (days)
Description
Hospital length of stay (days)
Time Frame
Measured during hospitalization, up to 90 days after enrollment.
Title
Hospital disposition
Description
Hospital disposition
Time Frame
Measured during hospitalization, up to 90 days after enrollment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22080636
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.
Results Reference
background
PubMed Identifier
28387538
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.
Results Reference
background
PubMed Identifier
25635496
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.
Results Reference
background
PubMed Identifier
27984278
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.
Results Reference
background
PubMed Identifier
34507866
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.
Results Reference
derived
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Rounding Summaries for Families of Critically Ill Patients
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