Status:
UNKNOWN
Evaluating Effectiveness of a Communication Facilitator : A Randomized Trial
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Intensive Care Unit
Life Stress
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a randomized clinical trial of an intervention to improve outcomes for patients and their family by using ICU nurse facilitators to support, model, and teach communication strategies tha...
Detailed Description
The impact of critical illness is increasing due to an aging population as well as advances in effectiveness and availability of critical care. Critically ill patients and their families suffer a high...
Eligibility Criteria
Inclusion
- Patient:
- Age \>=18 years
- Admitted to the ICU with an expected length of stay of at least 2 days
- A chronic life-limiting illness suggesting a median survival of approximately 2 years or a risk of hospital mortality of \>15% using either SOFA score, APACHE score or Injury Severity Score (with any one or more score predicting hospital mortality \>15%)
- Patient informed consent or relative or trusted person of patient consent (when lacking patient decisional capacity)
- Patient with visiting relatives
- Family member:
- Age \>=18 years
- Family will be identified by the patient. If the patient does not have decisional capacity, family will be identified by a legal surrogate decision-maker. We will not limit the number of family members who can participate but anticipate 1-3 family members per patient (average 1.5 based on prior studies).
- Family informed consent
Exclusion
- Patient:
- Non-French speaking patient or relative
- Pregnant or breastfeeding patient
- No social security coverage Family Member
- Non-French speaking
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04133753
Start Date
January 1 2020
End Date
June 1 2021
Last Update
October 21 2019
Active Locations (1)
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1
Saint-Louis Hospital
Paris, France, 75010