Evaluating Effectiveness of a Communication Facilitator : A Randomized Trial (Famirea - FCS)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Facilitation, Social; Family Members; Life Stress; Intensive Care Unit

Treatments: Behavioral: Facilitator-Based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04133753

APHP180586

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

400 participants in 2 patient groups

Facilitator-Based Intervention

Experimental group

Description:

The 'Facilitator-Based Intervention' includes patient and family member subjects.

Treatment:

Behavioral: Facilitator-Based Intervention

Usual Care

No Intervention group

Description:

The 'Usual Care' arm includes patient and family member subjects.