---
title: Facilitating Communication Study
nct_id: NCT03721952
overall_status: COMPLETED
phase: NA
sponsor: University of Washington
study_type: INTERVENTIONAL
primary_condition: Chronic Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03721952.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03721952"
ct_last_update_post_date: 2025-02-07
last_seen_at: "2026-05-12T07:29:29.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Facilitating Communication 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

**NCT ID:** [NCT03721952](https://clinicaltrials.gov/study/NCT03721952)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 977
- **Lead Sponsor:** University of Washington
- **Conditions:** Chronic Disease, Neoplasm Metastasis, Lung Neoplasm, Pulmonary Disease, Chronic Obstructive, Heart Failure, Congestive, Liver Cirrhosis, Kidney Failure, Chronic, Multiple Organ Failure, Health Care Quality, Access, and Evaluation, Intensive Care Units, Palliative Care, Health Services, Palliative Care, Patient Care, Lung Diseases, Cerebrovascular Disorders, Brain Injuries
- **Start Date:** 2019-04-17
- **Completion Date:** 2024-06-30
- **CT.gov Last Update:** 2025-02-07

## Brief Summary

This study is a randomized clinical trial of an intervention to improve outcomes for patients and their family by using ICU nurse facilitators to support, model, and teach communication strategies that enable patients and their families to secure care in line with patients' goals of care over an illness trajectory, beginning in the ICU and continuing to care in the community.

## Detailed Description

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

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

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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Facilitator-Based Intervention** (EXPERIMENTAL) — The 'Facilitator-Based Intervention' includes patient and family member subjects.
- **Usual Care** (NO_INTERVENTION) — The 'Usual Care' arm includes patient and family member subjects.

## Interventions

- **Facilitator-Based Intervention** (BEHAVIORAL) — 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.

## Primary Outcomes

- **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),

## 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)_

## Locations (3)

- UW Medicine - Harborview Medical Center, Seattle, Washington, United States
- University of Washington Medical Center - Northwest, Seattle, Washington, United States
- University of Washington Medical Center - Montlake, Seattle, Washington, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.uw medicine - harborview medical center|seattle|washington|united states` — added _(2026-05-12)_
- `locations.university of washington medical center - northwest|seattle|washington|united states` — added _(2026-05-12)_
- `locations.university of washington medical center - montlake|seattle|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03721952.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03721952*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*