Prospective Evaluation of Family Care Rituals in the ICU

Depression Clinical Trial

— FCR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875912
• Other study ID #: 763434-9
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: July 11, 2017
• Start date: September 2015
• Est. completion date: June 12, 2017

Study information

• Verified date: July 2017
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: June 12, 2017
• Est. primary completion date: March 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Family Care Rituals
Family members being enrolled are given a 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. Family members are then surveyed at enrollment, and 90 days post ICU discharge for symptoms of PTSD, as well as depression, and anxiety. Family members, day-time nursing, and attending physicians are surveyed for concordance of care at enrollment and ICU day 5. Demographic information is also collected on the patient and the family members at enrollment Nursing completes surveys while the patient is in the ICU noting what care rituals, if any, are being performed. Additionally, they are asked to complete a survey indicating their opinion of the impact on the care they deliver

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Careggi	Florence
United States	Rush University Medical Center	Chicago	Illinois
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	James M. Cox Foundation

Countries where clinical trial is conducted

United States,  Italy, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of Post-Traumatic Stress Disorder in family members of intensive care patients	Symptoms of PTSD are measured by the Impact of Events Scale revised (IES-r). This survey is conducted via phone 90 days after patient discharge.	90 days post patient discharge from ICU
Secondary	Symptoms of depression in family members of intensive care patients	Symptoms of Depression are measured by the Hospital Anxiety and Depression Screen (HADS). These surveys are conducted via phone 90 days after patient discharge	90 days post patient discharge from ICU
Secondary	Symptoms of anxiety in family members of intensive care patients	Symptoms of Anxiety are measured by the Hospital Anxiety and Depression Screen (HADS). These surveys are via phone 90 days after patient discharge	90 days post patient discharge from the ICU
Secondary	Family satisfaction with ICU care	Measured by the Family Satisfaction in the ICU- 24 (FS-ICU-24) questionnaire via phone communication at 90 days	90 days post discharge from ICU
Secondary	Congruency of goals of care	Enrolled family members, day time nurse and attending physician are surveyed on enrollment day (day 0) and day 5 with a questionnaire designed to evaluate comfort with the care plan and identify why, if uncomfortable, they are uncomfortable with the care plan	Evaluated at enrollment and if patient is still in the ICU on hospital day 5 during active enrollment
Secondary	Validation of the End of Life Scoring System (ENDING-S)	Multicenter prospective validation of ENDING-S. This score produces a number based on the following calculation: [ENDING-S = (7.25 · Days of Mechanical ventilation/ICU Length of stay) + (10.45 · Days of Vasoactive drugs/ICU length of stay) + (3 · Sepsis) + (0.3 · ICU Length of stay)] where "sepsis" is binary yes/no as to whether or not the patient is septic. Will also include evaluation of the addition of multi-parametric variables (such as functional status, spiritual and communicative variables) to the ENDING-S to generate a final score based on in hospital morbidity combined with prehospital comorbidities	Through study completion, anticipated to be 18 months
Secondary	ICU length of stay	In an effort to evaluate resources used during study period, ICU length of stay will be collected to ascertain whether or not the intervention reduces length of stay	Through study completion, anticipated to be 18 months
Secondary	Use of palliative/spiritual care during ICU stay	In an effort to evaluate resources used during study period, data on whether or not a palliative/spiritual care order was placed will be collected to ascertain whether or not the intervention impacts use of these resources	Through study completion, anticipated to be 18 months
Secondary	Location of discharge from ICU	In an effort to understand type of discharge (death, another hospital floor, nursing home, hospice, etc), charts will be reviewed for location of discharge from the ICU to ascertain whether or not the intervention impacted discharge	Through study completion, anticipated to be 18 months