Chronic DiseaseFCS2NCT03721952
Facilitating Communication Study
A study testing Facilitator-Based Intervention in people with Chronic Disease and Neoplasm Metastasis, run by University of Washington at 3 sites in United States.
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
- Chronic Disease, Neoplasm Metastasis, Lung Neoplasm
- 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
- 977 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Apr 2019to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- PATIENTS. Eligible patients 18 years of age or older, English-speaking, with a chronic life-limiting illness suggesting a median survival of approximately 2 years or a severe acute illness with a risk of hospital mortality of at least 15%. Chronic life-limiting illnesses include: cancer with a poor prognosis (e.g. metastatic cancer); chronic pulmonary disease (e.g. COPD, restrictive lung disease); coronary artery disease (CAD); congestive heart failure (CHF); peripheral vascular disease (PVD); severe liver disease (e.g. cirrhosis); diabetes with end-organ damage; renal failure (e.g. ESRD); and dementia. Acute illness criteria include a SOFA, APACHE or trauma severity score predicting a 15% or greater risk of hospital mortality. Acute illnesses and conditions also include: age >=80 years; acute respiratory distress syndrome (ARDS) with P/F ratio <=300; subarachnoid hemorrhage (SAH) Fisher grade 3/4 with Glasgow coma score (GCS) <=12; spontaneous hemorrhage (ICH, IPH, EDH, SDH) with GCS <=12; stroke or cardiovascular accident (CVA) with GCS <=12; decompressive/crash craniotomy (bone flap) with GCS <=12; traumatic brain injury (TBI) or diffuse axonal injury (DAI) based on MRI ~day 10; or anoxic brain injury due to cardiac arrest >48 hours. All potential participants screened for facility with English and absence of significant cognitive impairment (prior to their current hospitalization) that would limit their ability to complete survey instruments.
- FAMILY. Eligible family subjects18 years of age or older, English-speaking, and identified as someone involved in patient's medical care or decision-making. Eligible family may include any of the following: legal guardians, durable power of attorney for healthcare, spouses, adult children, parents, siblings, domestic partners, other relatives, and friends.
- CLINICIAN AND ADMINISTRATOR INTERVIEW SUBJECTS. Eligible clinicians and administrators 18 years of age or older, English-speaking, employed at a participating hospital and have a familiarity with the study and the intervention.
Who cannot join
- PATIENTS. We will exclude patients with an anticipated ICU stay of less than 2 days, as assessed by the critical care attending physician or his/her designee. We will exclude patients who have been in the ICU for more than 14 days.
- PATIENTS AND FAMILY. Reasons for exclusion for patient and family member subject groups include: legal or risk management concerns (as determined by the attending physician or via hospital record designation); psychological illness or morbidity; and physical or mental limitations preventing ability to complete questionnaires.
- CLINICIAN AND ADMINISTRATOR INTERVIEW SUBJECTS. n/a
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UW Medicine - Harborview Medical Center
Seattle, Washington, 98104
University of Washington Medical Center - Northwest
Seattle, Washington, 98133
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
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
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
- Chronic Disease, Neoplasm Metastasis, Lung Neoplasm, Pulmonary Disease, Chronic Obstructive, Heart Failure, Congestive, Liver Cirrhosis
- Being tested
- Facilitator-Based Intervention
- Medical subject headings
- Chronic Disease, Neoplasm Metastasis, Lung Neoplasms, Pulmonary Disease, Chronic Obstructive, Heart Failure, Liver Cirrhosis, Kidney Failure, Chronic, Multiple Organ Failure
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 or by telephone 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 5 days per week. 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.
Depression Symptoms, Family (HADS-D)
Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). 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.
For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of 7 items measuring depression, weighted for the number of items with valid responses. The sum could range from 0 to 21, with higher values indicating greater depression (i.e., worse outcome),
Measured: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Secondary outcomes (15)
Anxiety Symptoms, Family (HADS-A)
Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). 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. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of 7 items measuring anxiety, weighted for the number of items with valid responses. The sum could range from 0 to 21, with higher values indicating greater anxiety (i.e., worse outcome)
Measured: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Quality of Family Experience - Relationship With Healthcare Providers (QUAL-E Fam)
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, with four subscales and two general items. This study is using 11 items from three subscales: Relationship with Health Care Provider, Completion, and Preparation subscales. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the mean of the valid responses to QUAL-E (Fam) items #5, 6, 7, and 8. The mean could range from 1 to 5, with higher values indicating higher quality of relationship (i.e., better outcome).
Measured: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Quality of Family Experience - Sense of Completion (QUAL-E Fam)
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, with four subscales and two general items. This study is using 11 items from three subscales: Relationship with Health Care Provider, Completion, and Preparation subscales. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the mean of the valid responses to QUAL-E (Fam) items #9, 10, and 11. The mean could range from 1 to 5, with higher values indicating higher sense of completion (i.e., better outcome).
Measured: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Quality of Family Experience - Preparation Issues (QUAL-E Fam)
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, with four subscales and two general items. This study is using 11 items from three subscales: Relationship with Health Care Provider, Completion, and Preparation subscales. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of valid responses to QUAL-E (Fam) items #12, 13, 14, and 15, weighted for the number of items with valid responses. The sum could range from 4 to 20, with higher values indicating greater preparation (i.e., better outcome).
Measured: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Goal-Concordant Care, Family Assessment
Concordance between the care patients want and the care they receive is measured with two questions from the SUPPORT study. The first defines preference (care focused on extending life even with more pain and discomfort vs. care focused on relieving pain and discomfort even with not living as long.) The second assesses perception of current treatment using the same options. The outcome is a dichotomous variable of whether preference matches care received. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was coded 1 if the respondent's perception of the focus of care the patient received (comfort vs. life extension) matched their perception of the patient's preferred focus of care; and 0 if the perceived focus of care received did not match the perceived patient's care preference. If the response to either item was "don't know," the outcome was coded 0. The higher value indicated goal-concordant care (the better outcome).
Measured: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Impact of Event, Family Assessment (IES-6)
The Impact of Event Scale-6 (IES-6), derived from the IES-R, uses six self-report items to assess subjective distress caused by a traumatic event. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of 6 items measuring the traumatic impact of events, weighted for the number of items with valid responses. The sum could range from 0 to 24, with higher values indicating greater traumatic impact (i.e., worse outcome)
Measured: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome
Healthcare Utilization: Hospital Readmission - Patient
Documentation in the patient's electronic health record of hospital readmission within 30 days after discharge from the index hospitalization: 0=no readmission, 1=one or more readmissions; missing if index hospitalization still ongoing at the end of the 183-day follow-up period, patient death during index hospitalization, or randomization occurred after index hospitalization discharge. Valid outcomes could be either 0 or 1, with higher value indicating a worse outcome.
Measured: within 30 days after discharge from the index hospitalization
Healthcare Utilization: Hospital Free Days, 30 Days - Patient
Number of full days on which the patient was alive and not in the hospital between the randomization date and 29 days after the randomization date. Values could range from 0 to 30, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Measured: 30 days after randomization
Healthcare Utilization: Hospital Free Days, 91 Days - Patient
Number of full days on which the patient was alive and not in the hospital between the randomization date and 90 days after the randomization date. Values could range from 0 to 91, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Measured: 91 days after randomization
Healthcare Utilization: Hospital Free Days, 183 Days - Patient
Number of full days on which the patient was alive and not in the hospital between the randomization date and 182 days after the randomization date. Values could range from 0 to 183, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Measured: 183 days after randomization
Healthcare Utilization: ICU Free Days, 30 Days - Patient
Number of full days on which the patient was alive and not in an ICU between the randomization date and 29 days after the randomization date. Values could range from 0 to 30, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Measured: 30 days after randomization
Healthcare Utilization: ICU Free Days, 91 Days - Patient
Number of full days on which the patient was alive and not in an ICU between the randomization date and 90 days after the randomization date. Values could range from 0 to 91, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Measured: 91 days after randomization
Healthcare Utilization: ICU Free Days, 183 Days - Patient
Number of full days on which the patient was alive and not in an ICU between the randomization date and 182 days after the randomization date. Values could range from 0 to 183, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Measured: 183 days after randomization
Healthcare Costs, Discharge - Patient
Total hospitalization costs from date of randomization to index hospitalization discharge. Costs ranged from $1,631.73 to $1,299,781.53, with higher value indicating a worse outcome; missing if the patient was randomized after discharge from the index hospitalization.
Measured: Randomization to discharge from index hospitalization, up to 183 days
Healthcare Costs, 30 Days - Patient
Total hospitalization costs for the 30-day period beginning with the date of randomization, adjusted to their value in December 2023 based on the Consumer Price Index for Medical Care. Values ranged from $1,631.73 to $585,386.34, with higher values indicating worse outcomes; missing if the patient was randomized after index hospitalization discharge.
Measured: Randomization to 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start17 Apr 2019
- Primary completion26 Oct 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 977 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Engelberg, University of Washington
- Investigators
- Ruth A Engelberg, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721952
- Sponsor's protocol ID
- STUDY00005369
- Acronym
- FCS2
- Status last verified
- Feb 2025
- First submitted
- 16 Oct 2018
- Last updated
- 7 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Creutzfeldt CJ, Brumback LC, Im J, Pollak KI, Vasconcelos AG, Song Y, Sibley J, Ungar AM, Garzio G, Treece PD, Hudson LM, Martini R, Hanson S, Khandelwal N, Abu-Rish Blakeney E, Kentish-Barnes N, Azoulay E, Nielsen EL, Engelberg RA, Curtis JR. Facilitating Communication for Family Members of Critically Ill Patients During and Following a Hospital Stay: A Randomized Controlled Trial. Crit Care Med. 2026 Oct 1;54(10):2521-2535. doi: 10.1097/CCM.0000000000007268. Epub 2026 Jul 22.
PubMed 42484383
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. 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
- ClinicalTrials.gov ID
- NCT03721952
- Acronym / sponsor ID
- FCS2 / STUDY00005369
- Conditions
- Chronic Disease, Neoplasm Metastasis, Lung Neoplasm, Pulmonary Disease, Chronic Obstructive, Heart Failure, Congestive, Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 977 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Posted 7 Feb 2025
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 (3 listed)
- PATIENTS. Eligible patients 18 years of age or older, English-speaking, with a chronic life-limiting illness suggesting a median survival of approximately 2 years or a severe acute illness with a risk of hospital mortality of at least 15%. Chronic life-limiting illnesses include: cancer with a poor prognosis (e.g. metastatic cancer); chronic pulmonary disease (e.g. COPD, restrictive lung disease); coronary artery disease (CAD); congestive heart failure (CHF); peripheral vascular disease (PVD); severe liver disease (e.g. cirrhosis); diabetes with end-organ damage; renal failure (e.g. ESRD); and dementia. Acute illness criteria include a SOFA, APACHE or trauma severity score predicting a 15% or greater risk of hospital mortality. Acute illnesses and conditions also include: age >=80 years; acute respiratory distress syndrome (ARDS) with P/F ratio <=300; subarachnoid hemorrhage (SAH) Fisher grade 3/4 with Glasgow coma score (GCS) <=12; spontaneous hemorrhage (ICH, IPH, EDH, SDH) with GCS <=12; stroke or cardiovascular accident (CVA) with GCS <=12; decompressive/crash craniotomy (bone flap) with GCS <=12; traumatic brain injury (TBI) or diffuse axonal injury (DAI) based on MRI ~day 10; or anoxic brain injury due to cardiac arrest >48 hours. All potential participants screened for facility with English and absence of significant cognitive impairment (prior to their current hospitalization) that would limit their ability to complete survey instruments.
- FAMILY. Eligible family subjects18 years of age or older, English-speaking, and identified as someone involved in patient's medical care or decision-making. Eligible family may include any of the following: legal guardians, durable power of attorney for healthcare, spouses, adult children, parents, siblings, domestic partners, other relatives, and friends.
- CLINICIAN AND ADMINISTRATOR INTERVIEW SUBJECTS. Eligible clinicians and administrators 18 years of age or older, English-speaking, employed at a participating hospital and have a familiarity with the study and the intervention.
Key exclusion criteria (3 listed)
- PATIENTS. We will exclude patients with an anticipated ICU stay of less than 2 days, as assessed by the critical care attending physician or his/her designee. We will exclude patients who have been in the ICU for more than 14 days.
- PATIENTS AND FAMILY. Reasons for exclusion for patient and family member subject groups include: legal or risk management concerns (as determined by the attending physician or via hospital record designation); psychological illness or morbidity; and physical or mental limitations preventing ability to complete questionnaires.
- CLINICIAN AND ADMINISTRATOR INTERVIEW SUBJECTS. n/a
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 or by telephone 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 5 days per week. 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
Depression Symptoms, Family (HADS-D)
Time frame: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). 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. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of 7 items measuring depression, weighted for the number of items with valid responses. The sum could range from 0 to 21, with higher values indicating greater depression (i.e., worse outcome),
15 secondary outcomes
Anxiety Symptoms, Family (HADS-A)
Time frame: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Quality of Family Experience - Relationship With Healthcare Providers (QUAL-E Fam)
Time frame: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Quality of Family Experience - Sense of Completion (QUAL-E Fam)
Time frame: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Quality of Family Experience - Preparation Issues (QUAL-E Fam)
Time frame: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Goal-Concordant Care, Family Assessment
Time frame: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Impact of Event, Family Assessment (IES-6)
Time frame: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome
Healthcare Utilization: Hospital Readmission - Patient
Time frame: within 30 days after discharge from the index hospitalization
Healthcare Utilization: Hospital Free Days, 30 Days - Patient
Time frame: 30 days after randomization
Healthcare Utilization: Hospital Free Days, 91 Days - Patient
Time frame: 91 days after randomization
Healthcare Utilization: Hospital Free Days, 183 Days - Patient
Time frame: 183 days after randomization
Healthcare Utilization: ICU Free Days, 30 Days - Patient
Time frame: 30 days after randomization
Healthcare Utilization: ICU Free Days, 91 Days - Patient
Time frame: 91 days after randomization
Healthcare Utilization: ICU Free Days, 183 Days - Patient
Time frame: 183 days after randomization
Healthcare Costs, Discharge - Patient
Time frame: Randomization to discharge from index hospitalization, up to 183 days
Healthcare Costs, 30 Days - Patient
Time frame: Randomization to 30 days after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42484383Creutzfeldt CJ, Brumback LC, Im J, Pollak KI, Vasconcelos AG, Song Y, Sibley J, Ungar AM, Garzio G, Treece PD, Hudson LM, Martini R, Hanson S, Khandelwal N, Abu-Rish Blakeney E, Kentish-Barnes N, Azoulay E, Nielsen EL, Engelberg RA, Curtis JR. Facilitating Communication for Family Members of Critically Ill Patients During and Following a Hospital Stay: A Randomized Controlled Trial. Crit Care Med. 2026 Oct 1;54(10):2521-2535. doi: 10.1097/CCM.0000000000007268. Epub 2026 Jul 22.
- Individual participant dataSharing planned: No
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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.
Ruth A Engelberg, PhD principal investigator
University of Washington
3 sites 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 Chronic Disease and Neoplasm Metastasis, run by University of Washington at 3 sites in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 7 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Symptoms, Family (HADS-D) (time frame: 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value). 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 NCT03721952, which also lists 1 linked publication.
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 7 Feb 2025.