Clinical trial NCT02875912: Prospective Evaluation of Family Care Rituals in the ICU
Official title: PROSPECTIVE EVALUATION OF FAMILY CARE RITUALS IN THE ICU AND VALIDATION OF THE END-of-Life ScorING-System (ENDING-S), a Multicenter, Multinational Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Depression
Anxiety
Keywords: Family
Care Rituals
End of Life
Discordance of care
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: James M. Cox Foundation
First posted: 2016-08-23
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective before and after intervention evaluation
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will evaluate whether or not engaging family members of patients admitted to the ICU in "Family Care Rituals" will reduce stress related symptoms of PTSD, depression and anxiety 90 days after patient death or discharge from the ICU. Family Care Rituals are defined as several domains in which family participation may be of benefit, focusing on the 5 physical senses as well as the personal care of the patient and spirituality of the patient

Detailed description: Over the previous century, the location of where people die has shifted from home to either hospitals or nursing homes, with 20% of patients dying in the ICU. Several deficiencies for End-of-Life (EOL) care provided in the ICU have been identified in literature; most of them are related to communication, decision making, sense of control, spirituality, preparation for death, pain and symptom management. Symptoms of stress, anxiety or depression as well as discordance between the perceptions of care by the health care providers (physicians and nurses) and the family members may all be related to these shortcomings. These symptoms are likely from multiple factors in the ICU that strip the family of the ability to provide any direct care or nurturing for their loved one, as families did when people died at home. Moreover, qualitative studies suggest that families want and value a role as a care provider for their loved ones in the ICU. In a pilot study, the investigators identified several domains in which family participation may be of benefit, focusing on the 5 physical senses, personal care of the patient, and spirituality of the patient and family. These areas were incorporated as Family Care Rituals (FCR) in which family members can participate while their loved one is in the ICU

The investigators are conducting a multi-center, multinational prospective evaluation of FCR with the hypothesis that FCR will primarily reduce symptoms of PTSD, as well as anxiety and depression in the surviving family members at 90 days after death or discharge from the ICU. Additionally, the intervention's effect on concordance of care as measured on day of enrollment and ICU day 5 via a questionnaire administered to the family members, the day-time nurse and the attending physician will be evaluated. ICU utilization, family satisfaction, and validation of the END of live scorING System (ENDING-S) are also being evaluated. To understand what care rituals are being performed at the bedside as well as the impact on bedside nursing care, nursing is also completing daily surveys.

The investigators are planning a study of independent cases and controls with 1 control(s) per case. Prior data indicate that the incidence of PTSD in family members is 33%. To reduce the rate of PTSD for family members in the interventional arm to 17%, 114 experimental subjects and 114 control subjects will need to be enrolled to be able to reject the null hypothesis that the failure rates for experimental and control subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. An uncorrected chi-squared statistic will be used to evaluate this null hypothesis.

Eligibility criteria: Inclusion Criteria:

* Families of patients admitted to the intensive care unit (ICU) with attending physician predicted ICU mortality of greater than 30%.
* Patients with ICU length of stay greater than 4 days, regardless of mortality, are considered for ENDING-S score

Exclusion Criteria:

* Families of patients with an anticipated ICU length of stay less than 24 hours
* Families of patients admitted to the ICU for palliative/comfort care only
* Families of patients with age less than 18
* Families of patients who are pregnant
* Families of patients who are incarcerated
* Family members who are less than 18
* Family members who are pregnant
* Family members who are incarcerated

Primary outcomes:
measure: Symptoms of Post-Traumatic Stress Disorder in family members of intensive care patients
timeFrame: 90 days post patient discharge from ICU
Secondary outcomes:
measure: Symptoms of depression in family members of intensive care patients
timeFrame: 90 days post patient discharge from ICU
measure: Symptoms of anxiety in family members of intensive care patients
timeFrame: 90 days post patient discharge from the ICU
measure: Family satisfaction with ICU care
timeFrame: 90 days post discharge from ICU
measure: Congruency of goals of care
timeFrame: Evaluated at enrollment and if patient is still in the ICU on hospital day 5 during active enrollment
measure: Validation of the End of Life Scoring System (ENDING-S)
timeFrame: Through study completion, anticipated to be 18 months
measure: ICU length of stay
timeFrame: Through study completion, anticipated to be 18 months
measure: Use of palliative/spiritual care during ICU stay
timeFrame: Through study completion, anticipated to be 18 months
measure: Location of discharge from ICU
timeFrame: Through study completion, anticipated to be 18 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Providence
country: United States
facility: Brown University
state: Rhode Island
city: Florence
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
Study officials:
affiliation: Brown University
name: Mitchell M Levy, MD
role: PRINCIPAL_INVESTIGATOR
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