Facilitating Communication Study (FCS2)

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis; Cerebrovascular Disorders; Lung Diseases; Brain Injuries; Neoplasm Metastasis; Pulmonary Disease, Chronic Obstructive; Kidney Failure, Chronic; Chronic Disease; Multiple Organ Failure; Heart Failure, Congestive; Lung Neoplasm; Intensive Care Units; Health Care Quality, Access, and Evaluation; Palliative Care, Health Services; Palliative Care, Patient Care
• Intervention / Treatment: Behavioral: Facilitator-Based Intervention

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 Type: Interventional
• Enrollment (Actual): 977
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center - Montlake
    • Seattle, Washington, United States, 98133
      • University of Washington Medical Center - Northwest
    • Seattle, Washington, United States, 98104
      • UW Medicine - Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Facilitator-Based Intervention; The 'Facilitator-Based Intervention' includes patient and family member subjects.	Behavioral: Facilitator-Based Intervention; 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.; Other Names: Communication Facilitator
No Intervention: Usual Care; The 'Usual Care' arm includes patient and family member subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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),	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	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).	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).	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).	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)	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.	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.	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.	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.	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.	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.	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.	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.	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.	Randomization to 30 days after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Key Implementation Factors	Qualitative interviews after individual participation. Interviews will be guided by the Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation, including aspects of the intervention, inner and outer settings, individuals, and processes of care. Individual constructs within these domains were chosen to fit this specific intervention and context.	6-months after randomization
Key Implementation Outcomes	Qualitative interviews after individual participation. Interviews will also explore three key implementation outcomes (acceptability, fidelity, penetration) that will guide future dissemination of the intervention.	6-months after randomization
Perceived Competence Scale (PCS), 1 Month - Family	The Perceived Competence Scale (PCS) is a 4-item questionnaire assessing participants' feelings of competence. Items can be worded differently for different target behaviors. Responses range from "Not at all true" (1) to "Very True" (7); higher score on the latent variable would indicate greater competence. We will evaluate this mediator cross-sectionally.	Assessed on 1-month questionnaires
Perceived Competence Scale (PCS), 3 Months - Family	The Perceived Competence Scale (PCS) is a 4-item questionnaire assessing participants' feelings of competence. Items can be worded differently for different target behaviors. Responses range from "Not at all true" (1) to "Very True" (7); higher score on the latent variable would indicate greater competence. We will evaluate this mediator cross-sectionally.	Assessed on 3-month questionnaires
Perceived Competence Scale (PCS), 6 Months - Family	The Perceived Competence Scale (PCS) is a 4-item questionnaire assessing participants' feelings of competence. Items can be worded differently for different target behaviors. Responses range from "Not at all true" (1) to "Very True" (7); higher score on the latent variable would indicate greater competence. We will evaluate this mediator cross-sectionally.	Assessed on 6-month questionnaires
Measure of Acceptability of Intervention - Family in the Intervention Group	The "Acceptability of Intervention Measure" (AIM) is a 4 item measure with proven reliability, validity and responsiveness to change. It is designed to assess participants' perception of the intervention in which they participated as agreeable ("meets my approval"), palatable ("appealing to me") or satisfactory ("like it", "welcome it"). Response options include "completely disagree", "disagree", "neither agree nor disagree", "agree" and "completely agree". These items were asked of the intervention participants at the conclusion of the 3-month intervention phase.	Assessed on 3-month questionnaires

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Ruth A Engelberg, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (Actual): October 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Disease Attributes; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases, Obstructive; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Craniocerebral Trauma; Trauma, Nervous System; Renal Insufficiency, Chronic; Fibrosis; Shock; Neoplasms; Heart Failure; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Neoplasm Metastasis; Brain Injuries; Renal Insufficiency; Liver Cirrhosis; Kidney Failure, Chronic; Cerebrovascular Disorders; Multiple Organ Failure; Chronic Disease
• Other Study ID Numbers: STUDY00005369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No