Clinical trial NCT03721952: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 977
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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 \<=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

Primary outcomes:
measure: Depression Symptoms, Family (HADS-D)
timeFrame: 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:
measure: Anxiety Symptoms, Family (HADS-A)
timeFrame: 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
measure: Quality of Family Experience - Relationship With Healthcare Providers (QUAL-E Fam)
timeFrame: 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
measure: Quality of Family Experience - Sense of Completion (QUAL-E Fam)
timeFrame: 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
measure: Quality of Family Experience - Preparation Issues (QUAL-E Fam)
timeFrame: 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
measure: Goal-Concordant Care, Family Assessment
timeFrame: 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
measure: Impact of Event, Family Assessment (IES-6)
timeFrame: 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
measure: Healthcare Utilization: Hospital Readmission - Patient
timeFrame: within 30 days after discharge from the index hospitalization
measure: Healthcare Utilization: Hospital Free Days, 30 Days - Patient
timeFrame: 30 days after randomization
measure: Healthcare Utilization: Hospital Free Days, 91 Days - Patient
timeFrame: 91 days after randomization
measure: Healthcare Utilization: Hospital Free Days, 183 Days - Patient
timeFrame: 183 days after randomization
measure: Healthcare Utilization: ICU Free Days, 30 Days - Patient
timeFrame: 30 days after randomization
measure: Healthcare Utilization: ICU Free Days, 91 Days - Patient
timeFrame: 91 days after randomization
measure: Healthcare Utilization: ICU Free Days, 183 Days - Patient
timeFrame: 183 days after randomization
measure: Healthcare Costs, Discharge - Patient
timeFrame: Randomization to discharge from index hospitalization, up to 183 days
measure: Healthcare Costs, 30 Days - Patient
timeFrame: Randomization to 30 days after randomization
Other outcomes:
measure: Perceived Competence Scale (PCS), 1 Month - Family
timeFrame: Assessed on 1-month questionnaires
measure: Perceived Competence Scale (PCS), 3 Months - Family
timeFrame: Assessed on 3-month questionnaires
measure: Perceived Competence Scale (PCS), 6 Months - Family
timeFrame: Assessed on 6-month questionnaires
measure: Measure of Acceptability of Intervention - Family in the Intervention Group
timeFrame: Assessed on 3-month questionnaires
measure: Key Implementation Factors
timeFrame: 6-months after randomization
measure: Key Implementation Outcomes
timeFrame: 6-months after randomization
Locations:
city: Seattle
country: United States
facility: UW Medicine - Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center - Northwest
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center - Montlake
state: Washington
Study officials:
affiliation: University of Washington
name: Ruth A Engelberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: