CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 452 enrolled
Drug / intervention
Family Care Ritualsbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02875912
NCT02875912N/ACompleted

PROSPECTIVE EVALUATION OF FAMILY CARE RITUALS IN THE ICU AND VALIDATION OF THE END-of-Life ScorING-System (ENDING-S), a Multicenter, Multinational Trial

Brown University·interventional·Posted Aug 23, 2016·Updated Jul 13, 2017

In Brief

A clinical study evaluating Family Care Rituals for Stress Disorders, Post-Traumatic and 2 related conditions. Completed, enrolled 452 participants across 3 sites in 2 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly, United States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 23, 2016
Enrollment StartSep 1, 2015
Primary CompletionMar 12, 2017
Study CompletionJun 12, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.9 years ago

Interventions

Family Care Ritualsbehavioral

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