Prospective Evaluation of Family Care Rituals in the ICU (FCR)

Brown University

Status: Completed

Conditions: Stress Disorders, Post-Traumatic; Depression; Anxiety

Treatments: Behavioral: Family Care Rituals

Study type: Interventional

Funder types: Other

Identifiers

NCT02875912

763434-9

Details and patient eligibility

About

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

Full 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.

Enrollment: 452 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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452 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Family members are surveyed at enrollment, day 5 (if patient is still in ICU), and 90 days post ICU discharge for symptoms of PTSD, depression, and anxiety as well as for concordance of care at enrollment and ICU day 5. Nursing completes surveys while the patient is in the ICU noting what care rituals, if any, are being performed to establish baseline data

Family Care Rituals Intervention

Experimental group

Description:

At enrollment, family members are given a handout/pamphlet outlining the Family Care Rituals. They are informed of the opportunity to perform these rituals, but that they are in no way obligated to do so. The families are then surveyed in the same way as they were during the usual care, with nursing completing the same surveys as well to compare against the baseline data

Treatment:

Behavioral: Family Care Rituals