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N/A N=977 Randomized Single-blind Supportive Care

Facilitating Communication Study

Chronic Disease · Neoplasm Metastasis · Lung Neoplasm · Pulmonary Disease, Chronic Obstructive · Heart Failure, Congestive

Enrolled (actual)
977
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Depression Symptoms, Family (HADS-D) — 6.4; 6.5; 6.3; 5.9 score on a scale — p=0.688

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Facilitator-Based Intervention (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Washington
Primary completion
Oct 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Depression Symptoms, Family (HADS-D)
6.4; 6.5; 6.3; 5.9; 5.9; 5.9 0.688
SECONDARY
Anxiety Symptoms, Family (HADS-A)
8.2; 8.4; 8.4; 8.2; 8.1; 7.9 0.658
SECONDARY
Quality of Family Experience - Relationship With Healthcare Providers (QUAL-E Fam)
3.94; 4.10; 3.51; 3.87; 3.54; 3.64 0.010 sig
SECONDARY
Quality of Family Experience - Sense of Completion (QUAL-E Fam)
3.68; 3.75; 3.98; 3.94; 4.05; 4.01 0.817
SECONDARY
Quality of Family Experience - Preparation Issues (QUAL-E Fam)
13.5; 13.9; 13.3; 14.0; 13.6; 14.0 0.060
SECONDARY
Goal-Concordant Care, Family Assessment
0.57; 0.63; 0.57; 0.65; 0.59; 0.64 0.053
SECONDARY
Impact of Event, Family Assessment (IES-6)
11; 9.4; 9; 8.9; 9; 8.1 0.239
SECONDARY
Healthcare Utilization: Hospital Readmission - Patient
0.10; 0.19 0.029 sig
SECONDARY
Healthcare Utilization: Hospital Free Days, 30 Days - Patient
5.65; 6.78 0.183
SECONDARY
Healthcare Utilization: Hospital Free Days, 91 Days - Patient
39.63; 41.43 0.593
SECONDARY
Healthcare Utilization: Hospital Free Days, 183 Days - Patient
93.66; 98.13 0.533
SECONDARY
Healthcare Utilization: ICU Free Days, 30 Days - Patient
18.54; 19.62 0.318
SECONDARY
Healthcare Utilization: ICU Free Days, 91 Days - Patient
58.20; 62.32 0.241
SECONDARY
Healthcare Utilization: ICU Free Days, 183 Days - Patient
113.96; 122.15 0.273
SECONDARY
Healthcare Costs, Discharge - Patient
124,358.13; 129,058.54 0.710
SECONDARY
Healthcare Costs, 30 Days - Patient
103,731.28; 99,087.38 0.599

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.

Eligibility Criteria

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03721952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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