Prospective Evaluation of Family Care Rituals in the ICU

NCT02875912 | Completed

• 1 other identifier: 763434-9
• Study Type: interventional
• Target: 452
• Locations: 2 countries
• Sites: 3

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

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety

Keywords

Family; Care Rituals; End of Life; Discordance of care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Symptoms of depression in family members of intensive care patients

  90 days post patient discharge from ICU

• Symptoms of anxiety in family members of intensive care patients

  90 days post patient discharge from the ICU

• Family satisfaction with ICU care

  90 days post discharge from ICU

• Congruency of goals of care

  Evaluated at enrollment and if patient is still in the ICU on hospital day 5 during active enrollment

• Validation of the End of Life Scoring System (ENDING-S)

  Through study completion, anticipated to be 18 months

Study Arms (2)

Usual Care

NO INTERVENTION

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

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

Behavioral: Family Care Rituals

Interventions

Family Care Rituals BEHAVIORAL

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

Family Care Rituals Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• James M. Cox Foundation: collaborator

Study Sites (3)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Brown University

Providence, Rhode Island, 02903, United States

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

Location

Related Publications (28)

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  PMID: 32164567 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders; Death

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mitchell M Levy, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Division of Pulmonary, Critical Care and Sleep Medicine Rhode Island Hospital, Brown University

Model Details: Prospective before and after intervention evaluation

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 23, 2016
• Study Start: September 1, 2015
• Primary Completion: March 12, 2017
• Study Completion: June 12, 2017
• Last Updated: July 13, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); US (2)