Prospective Evaluation of Family Care Rituals in the ICU
NCT ID: NCT02875912
Last Updated: 2017-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
452 participants
INTERVENTIONAL
2015-09-30
2017-06-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Usual Care
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
No interventions assigned to this group
Family Care Rituals Intervention
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Patients with ICU length of stay greater than 4 days, regardless of mortality, are considered for ENDING-S score
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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James M. Cox Foundation
UNKNOWN
Brown University
OTHER
Responsible Party
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Mitchell Levy
Chief of the Division of Pulmonary, Critical Care and Sleep Medicine Rhode Island Hospital, Brown University
Principal Investigators
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Mitchell M Levy, MD
Role: PRINCIPAL_INVESTIGATOR
Brown University
Locations
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Rush University Medical Center
Chicago, Illinois, United States
Brown University
Providence, Rhode Island, United States
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Countries
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References
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Other Identifiers
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763434-9
Identifier Type: -
Identifier Source: org_study_id
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