Rounding Summaries for Families of Critically Ill Patients | NCT03969810

NCT03969810

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rounding Summary	Experimental	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
Usual Care	No Intervention	Usual ICU care

Name	Type	Description	Arm Group Labels	Other Names
Rounding Summary	Behavioral	Written summary of rounds	Rounding Summary

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

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.

Eligibility Module

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	Status	City	State	ZIP	Country	Contacts
Rush University Medical Center		Chicago	Illinois	60612	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22080636	Background	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.
28387538	Background	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.