Intensive Care UnitFamirea - FCSNCT04133753
Evaluating Effectiveness of a Communication Facilitator : A Randomized Trial
A study testing Facilitator-Based Intervention in people with Intensive Care Unit and Life Stress, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Life Stress, Family Members
- What is being tested?
- Facilitator-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Patient:
- Non-French speaking patient or relative
- Pregnant or breastfeeding patient
- No social security coverage Family Member
- Non-French speaking
Trial locations and contacts
1 site in 1 country.
France1 site
Saint-Louis Hospital
Paris, 75010
Nancy KENTISH-BARNES, PhD, 142499995 ext. +33, nancy.kentish@aphp.fr
Elie AZOULAY, MD-PhD, 142499995 ext. +33, elie.azoulay@sls.aphp.fr
About this study
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
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.
Read the 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.
- Conditions
- Intensive Care Unit, Life Stress, Family Members, Facilitation, Social
- Being tested
- Facilitator-Based Intervention
- Medical subject headings
- Stress, Psychological, Social Facilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitator-Based InterventionBehavioural
Also called Communication Facilitator
Facilitators interact in person with patients, family, and clinicians both during and following the patient's ICU stay for 3 months. In-person contacts include visits to patients' homes and/or care facilities; phone contacts include calls to patients, families and clinicians. Patients and families have access to facilitators through phone and email. Facilitators may attend clinic visits with patients. In addition to checking directly with patients/families during regular contacts, facilitators also access the electronic health record to ensure they have accurate information about appointments and treatment plans and to document key points for the clinical team. Facilitators encourage referral to inpatient or outpatient palliative care services when needs are identified.
| Study group | Role | What they receive |
|---|---|---|
| Facilitator-Based Intervention | Experimental | The 'Facilitator-Based Intervention' includes patient and family member subjects. Receives: Behavioral: Facilitator-Based Intervention |
| Usual Care | No intervention | The 'Usual Care' arm includes patient and family member subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS) - family
Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS), which has become standard for ICU and post-ICU studies. The HADS is a reliable and valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety and seven evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. HADS has been used in over 700 studies with evidence of reliability, validity and responsiveness among critically ill patients and their family.
Measured: 6 months after randomization
Secondary outcomes (15)
Hospital Anxiety and Depression Scale (HADS) - family 1, 3
Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS), which has become standard for ICU and post-ICU studies. The HADS is a reliable and valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety.
Measured: 1- and 3- months after randomization
Hospital Anxiety and Depression Scale (HADS) - patient 1, 3, 6
Patient symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS), which has become standard for ICU and post-ICU studies. The HADS is a reliable and valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety and seven evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. HADS has been used in over 700 studies with evidence of reliability, validity and responsiveness among critically ill patients and their family.
Measured: 1-, 3-, and 6-months after randomization
Hospital Anxiety and Depression Scale - Anxiety subscale - family 1, 3, 6
Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS), which has become standard for ICU and post-ICU studies. The HADS is a reliable and valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety.
Measured: 1-, 3-, and 6-months after randomization
Hospital Anxiety and Depression Scale - Anxiety subscale - patient 1, 3, 6
Patient symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS), which has become standard for ICU and post-ICU studies. The HADS is a reliable and valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety.
Measured: 1-, 3-, and 6-months after randomization
Goal-concordant care (SUPPORT items) - patient and family
Concordance between the care patients want and the care they are receiving will be measured with two questions from the SUPPORT study. The first defines patients' preferences: "If the patient had to make a choice at this time, would the patient prefer a course of treatment focused on extending life as much as possible, even if it means having more pain and discomfort, or would the patient want a plan of care focused on relieving pain and discomfort as much as possible, even if that means not living as long?" The second question assesses perceptions of current treatment using the same two options. The outcome is a dichotomous variable of whether the preference matches the report of care received. Although this creates a "false dichotomy" in that many patients want both, this "forced choice" helps identify patients' top priority. Based on prior studies, we expect only 50-60% of controls will report goal-concordant care.
Measured: 1-, 3-, and 6-months after randomization
PTSD Checklist-Civilian (PCL) - Post-traumatic Stress Symptoms - patient
The PTSD Checklist-Civilian (PCL) uses 17 self-report items to assess the intrusive, avoidant, and arousal PTSD symptom clusters. Responses are recorded on a 5 points scale that ranges from "not at all" to "extremely". The measure can be scored continuously or for symptoms consistent with a diagnosis of PTSD. The measure is reliable and valid across diverse populations. It has also demonstrated responsiveness in a randomized trial of stepped collaborative care for trauma survivors.
Measured: 1-, 3-, and 6-months after randomization
PTSD Checklist-Civilian (PCL) - Post-traumatic Stress Symptoms - family
The PTSD Checklist-Civilian (PCL) uses 17 self-report items to assess the intrusive, avoidant, and arousal PTSD symptom clusters. Responses are recorded on a 5 points scale that ranges from "not at all" to "extremely". The measure can be scored continuously or for symptoms consistent with a diagnosis of PTSD. The measure is reliable and valid across diverse populations. It has also demonstrated responsiveness in a randomized trial of stepped collaborative care for trauma survivors.
Measured: 1-, 3-, and 6-months after randomization
QUAL-E - patient
Measuring the quality of life of seriously ill patients. The QUAL-E is a validated instrument with ~25 items measuring of quality of life at the end of life with a four-domain structure: life completion, symptoms impact, relationship with health care provider, and preparation for end of life.
Measured: 1-, 3-, and 6-months after randomization
QUAL-E - family
Measure of family experience of patients with serious illness. The QUAL-E (Fam) is a validated ~17-item companion instrument to the patient QUAL-E measure of quality of life at the end of life.
Measured: 1-, 3-, and 6-months after randomization
Perceived Health Competence Scale (PHCS) - family
We will use the Perceived Health Competence Scale (PHCS), an 8-item questionnaire assesses family self-efficacy, outcome expectations, and behavioral capacity for healthcare. It has been used to predict health behaviors and outcomes in older adults, people with chronic disease, women with breast cancer, and patients in dialysis. It has internal consistency reliability from 0.82-0.90. Construct validity was supported with a single factor structure underlying the total score and concurrent validity was supported by significant correlations with health status. It is a mediator of psychosocial outcomes and found to be an important explanatory variable linking access to information and psychosocial health outcomes.
Measured: 1-, 3-, and 6-months after randomization
Perceived Health Competence Scale (PHCS) - patient
We will use the Perceived Health Competence Scale (PHCS), an 8-item questionnaire assesses patient self-efficacy, outcome expectations, and behavioral capacity for healthcare. It has been used to predict health behaviors and outcomes in older adults, people with chronic disease, women with breast cancer, and patients in dialysis. It has internal consistency reliability from 0.82-0.90. Construct validity was supported with a single factor structure underlying the total score and concurrent validity was supported by significant correlations with health status. It is a mediator of psychosocial outcomes and found to be an important explanatory variable linking access to information and psychosocial health outcomes.
Measured: 1-, 3-, and 6-months after randomization
SF-1 - Health related quality of life - family
We will use the SF-1 on family members, a shorter version of the functional health status scale adapted from the SF12 which has been used with patients with chronic illness and with older populations, and has good psychometric characteristics including internal reliability (Cronbach alphas >=0.70), test-retest reliability (r>0.73), and validity supported by confirmatory factor analysis and hypothesis testing.
Measured: 1-, 3-, and 6-months after randomization
SF-1 - Health related quality of life - patient
We will use the SF-1 on patients, a shorter version of the functional health status scale adapted from the SF12 which has been used with patients with chronic illness and with older populations, and has good psychometric characteristics including internal reliability (Cronbach alphas >=0.70), test-retest reliability (r>0.73), and validity supported by confirmatory factor analysis and hypothesis testing.
Measured: 1-, 3-, and 6-months after randomization
ICU length of stay
Delay between randomization and ICU discharge
Measured: 6-months after randomization
Hospital length of stay
Delay between randomization and hospital discharge
Measured: 6-months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study startJan 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133753
- Sponsor's protocol ID
- APHP180586
- Acronym
- Famirea - FCS
- Status last verified
- Oct 2019
- First submitted
- 18 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Renet A, Azoulay E, Reignier J, Cariou A, Renault A, Huet O, Pochard F, Engelberg RA, Kentish-Barnes N. "It's all about setting the stage." The nurse facilitator trial: perceived outcomes and implementation issues. A qualitative study among ICU clinicians and nurse facilitators. Intensive Care Med. 2024 Oct;50(10):1657-1667. doi: 10.1007/s00134-024-07589-z. Epub 2024 Aug 19.
PubMed 39158706Kentish-Barnes N, Azoulay E, Reignier J, Cariou A, Lafarge A, Huet O, Gargadennec T, Renault A, Souppart V, Clavier P, Dilosquer F, Leroux L, Lege S, Renet A, Brumback LC, Engelberg RA, Pochard F, Resche-Rigon M, Curtis JR. A randomised controlled trial of a nurse facilitator to promote communication for family members of critically ill patients. Intensive Care Med. 2024 May;50(5):712-724. doi: 10.1007/s00134-024-07390-y. Epub 2024 Apr 4.
PubMed 38573403
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04133753
- Acronym / sponsor ID
- Famirea - FCS / APHP180586
- Conditions
- Intensive Care Unit, Life Stress, Family Members, Facilitation, Social
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facilitator-Based Intervention | Experimental | Behavioral: Facilitator-Based InterventionThe 'Facilitator-Based Intervention' includes patient and family member subjects. |
| Usual Care | No intervention | –The 'Usual Care' arm includes patient and family member subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- Non-French speaking patient or relative
- Pregnant or breastfeeding patient
- No social security coverage Family Member
- Non-French speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facilitator-Based InterventionAlso: Communication FacilitatorFacilitators interact in person with patients, family, and clinicians both during and following the patient's ICU stay for 3 months. In-person contacts include visits to patients' homes and/or care facilities; phone contacts include calls to patients, families and clinicians. Patients and families have access to facilitators through phone and email. Facilitators may attend clinic visits with patients. In addition to checking directly with patients/families during regular contacts, facilitators also access the electronic health record to ensure they have accurate information about appointments and treatment plans and to document key points for the clinical team. Facilitators encourage referral to inpatient or outpatient palliative care services when needs are identified. | Behavioural | Facilitator-Based Intervention |
Primary outcome
Hospital Anxiety and Depression Scale (HADS) - family
Time frame: 6 months after randomization
Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS), which has become standard for ICU and post-ICU studies. The HADS is a reliable and valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety and seven evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. HADS has been used in over 700 studies with evidence of reliability, validity and responsiveness among critically ill patients and their family.
15 secondary outcomes
Hospital Anxiety and Depression Scale (HADS) - family 1, 3
Time frame: 1- and 3- months after randomization
Hospital Anxiety and Depression Scale (HADS) - patient 1, 3, 6
Time frame: 1-, 3-, and 6-months after randomization
Hospital Anxiety and Depression Scale - Anxiety subscale - family 1, 3, 6
Time frame: 1-, 3-, and 6-months after randomization
Hospital Anxiety and Depression Scale - Anxiety subscale - patient 1, 3, 6
Time frame: 1-, 3-, and 6-months after randomization
Goal-concordant care (SUPPORT items) - patient and family
Time frame: 1-, 3-, and 6-months after randomization
PTSD Checklist-Civilian (PCL) - Post-traumatic Stress Symptoms - patient
Time frame: 1-, 3-, and 6-months after randomization
PTSD Checklist-Civilian (PCL) - Post-traumatic Stress Symptoms - family
Time frame: 1-, 3-, and 6-months after randomization
QUAL-E - patient
Time frame: 1-, 3-, and 6-months after randomization
QUAL-E - family
Time frame: 1-, 3-, and 6-months after randomization
Perceived Health Competence Scale (PHCS) - family
Time frame: 1-, 3-, and 6-months after randomization
Perceived Health Competence Scale (PHCS) - patient
Time frame: 1-, 3-, and 6-months after randomization
SF-1 - Health related quality of life - family
Time frame: 1-, 3-, and 6-months after randomization
SF-1 - Health related quality of life - patient
Time frame: 1-, 3-, and 6-months after randomization
ICU length of stay
Time frame: 6-months after randomization
Hospital length of stay
Time frame: 6-months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Derived from this study: PubMed 39158706Renet A, Azoulay E, Reignier J, Cariou A, Renault A, Huet O, Pochard F, Engelberg RA, Kentish-Barnes N. "It's all about setting the stage." The nurse facilitator trial: perceived outcomes and implementation issues. A qualitative study among ICU clinicians and nurse facilitators. Intensive Care Med. 2024 Oct;50(10):1657-1667. doi: 10.1007/s00134-024-07589-z. Epub 2024 Aug 19.
- Derived from this study: PubMed 38573403Kentish-Barnes N, Azoulay E, Reignier J, Cariou A, Lafarge A, Huet O, Gargadennec T, Renault A, Souppart V, Clavier P, Dilosquer F, Leroux L, Lege S, Renet A, Brumback LC, Engelberg RA, Pochard F, Resche-Rigon M, Curtis JR. A randomised controlled trial of a nurse facilitator to promote communication for family members of critically ill patients. Intensive Care Med. 2024 May;50(5):712-724. doi: 10.1007/s00134-024-07390-y. Epub 2024 Apr 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitator-Based Intervention in people with Intensive Care Unit and Life Stress, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy KENTISH-BARNES, PhD (142499995 ext. +33, nancy.kentish@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) - family (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04133753, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019; AzTrials last refreshed its copy on 30 Oct 2026.