Rounding Summaries for Families of Critically Ill Patients

Study Overview
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Brief Summary
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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.

Official Title
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Rounding Summaries for Families of Critically Ill Patients

Conditions
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Acute Respiratory Failure, Intensive Care Unit Syndrome, Communication

Intervention / Treatment
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* Behavioral: Rounding Summary


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rounding Summary<br>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<br>* Written summary of rounds<br>|
| No Intervention: Usual Care<br>Usual ICU care | |

What is the study measuring?
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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). |