Clinical trial NCT04133753: Evaluating Effectiveness of a Communication Facilitator : A Randomized Trial
Official title: Evaluating Effectiveness of a Communication Facilitator to Reduce Distress and Improve Goal Concordant Care for Critically Ill Patients and Their Families: A Randomized Trial. Famiréa - FCS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intensive Care Unit
Life Stress
Family Members
Facilitation, Social
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 that enable patients and their families to secure care in line with patients' goals of care over an illness trajectory, beginning in the ICU and continuing to care in the community.

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 burden of symptoms of depression, anxiety, and post-traumatic stress due, in part, to fragmented medical care that is often poorly aligned with their goals. Fragmented care includes numerous transitions for patients and families across clinicians and across settings, starting in the intensive care unit (ICU) and extending to acute care, skilled nursing facilities, or home. As illness progresses, patients and families struggle to navigate the spectrum of goals of care, to match their values and goals with treatments, to communicate their goals to their clinicians, and to make difficult medical decisions without letting unmet emotional needs interfere. Poor communication exacerbated by these transitions compounds an already stressful experience, causing distress to patients and their families. Taken together, these issues lead to ineffective communication during and after the ICU which can often result in high intensity "default" care that may be unwanted.

Using a randomized trial, this project aims to evaluate an innovative model of care in which ICU nurse facilitators support, model, and teach communication strategies that enable patients and families to secure care in line with their goals over an illness trajectory, beginning in the ICU and continuing into the community. Facilitators use communication skills, attachment theory, and mediation to improve: 1) patients' and families' self-efficacy to communicate with clinicians within and across settings; 2) patients' and families' outcome expectation that communication with clinicians can improve their care; and 3) patients' and families' behavioral capability through skill building to resolve barriers to effective communication and mediate conflict. Facilitators work with seriously ill patients and their families beginning with a critical care unit stay and following them over the course of three months.

The intervention's effectiveness will be measured with patient- and family-centered outcomes at 1-, 3-, and 6-months post-randomization. The primary outcome is family members' burden of symptoms of depression over the 6 months. The investigators also evaluate whether the intervention improves the value of healthcare by reducing healthcare costs while improving patient and family outcomes. Finally, investigators use qualitative methods to explore implementation factors (intervention, settings, individuals, processes) associated with improved implementation outcomes (acceptability, fidelity, penetration) to inform dissemination of this type of intervention to support patients and their families. This study aims to address key knowledge gaps while evaluating a methodologically rigorous intervention to improve outcomes for patients with serious illness and their families across the trajectory of care and the spectrum of goals of care.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

Patient:

* Non-French speaking patient or relative
* Pregnant or breastfeeding patient
* No social security coverage Family Member
* Non-French speaking

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS) - family
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS) - family 1, 3
timeFrame: 1- and 3- months after randomization
measure: Hospital Anxiety and Depression Scale (HADS) - patient 1, 3, 6
timeFrame: 1-, 3-, and 6-months after randomization
measure: Hospital Anxiety and Depression Scale - Anxiety subscale - family 1, 3, 6
timeFrame: 1-, 3-, and 6-months after randomization
measure: Hospital Anxiety and Depression Scale - Anxiety subscale - patient 1, 3, 6
timeFrame: 1-, 3-, and 6-months after randomization
measure: Goal-concordant care (SUPPORT items) - patient and family
timeFrame: 1-, 3-, and 6-months after randomization
measure: PTSD Checklist-Civilian (PCL) - Post-traumatic Stress Symptoms - patient
timeFrame: 1-, 3-, and 6-months after randomization
measure: PTSD Checklist-Civilian (PCL) - Post-traumatic Stress Symptoms - family
timeFrame: 1-, 3-, and 6-months after randomization
measure: QUAL-E - patient
timeFrame: 1-, 3-, and 6-months after randomization
measure: QUAL-E - family
timeFrame: 1-, 3-, and 6-months after randomization
measure: Perceived Health Competence Scale (PHCS) - family
timeFrame: 1-, 3-, and 6-months after randomization
measure: Perceived Health Competence Scale (PHCS) - patient
timeFrame: 1-, 3-, and 6-months after randomization
measure: SF-1 - Health related quality of life - family
timeFrame: 1-, 3-, and 6-months after randomization
measure: SF-1 - Health related quality of life - patient
timeFrame: 1-, 3-, and 6-months after randomization
measure: ICU length of stay
timeFrame: 6-months after randomization
measure: Hospital length of stay
timeFrame: 6-months after randomization
Other outcomes:
measure: Qualitative interviews
timeFrame: 6-months after randomization
measure: return to work - family
timeFrame: 6-months after randomization
measure: return to work - patient
timeFrame: 6-months after randomization
measure: hospital utilization after hospital discharge
timeFrame: 6-months after randomization
Locations:
city: Paris
country: France
facility: Saint-Louis Hospital
Study officials:
References: