Facilitating Communication Study

Pulmonary Disease, Chronic Obstructive Clinical Trial

— FCS2  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03721952
• Other study ID #: STUDY00005369
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 17, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, beginning in the ICU and continuing to care in the community.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 954
• Est. completion date: June 30, 2024
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Cerebrovascular Disorders
• Chronic Disease
• Health Care Quality, Access, and Evaluation
• Heart Failure
• Heart Failure, Congestive
• Intensive Care Units
• Kidney Failure, Chronic
• Liver Cirrhosis
• Lung Diseases
• Lung Neoplasm
• Lung Neoplasms
• Multiple Organ Failure
• Neoplasm Metastasis
• Neoplasms
• Palliative Care, Health Services
• Palliative Care, Patient Care
• Pulmonary Disease, Chronic Obstructive
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	University of Washington Medical Center - Montlake	Seattle	Washington
United States	University of Washington Medical Center - Northwest	Seattle	Washington
United States	UW Medicine - Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Hospital Anxiety and Depression Scale (HADS) - family	Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS), which has become standard for ICU and post-ICU studies. 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) with scores for each subscale (anxiety and depression) ranging from 0-21. HADS has been used in over 700 studies with evidence of reliability, validity and responsiveness among critically ill patients and their family.	Change over time from baseline through 6 months
Secondary	Goal-concordant care (SUPPORT items)	Concordance between the care patients want and the care they are receiving will be measured with two questions from the SUPPORT study. The first defines patients' preferences: "If the patient had to make a choice at this time, would the patient prefer a course of treatment focused on extending life as much as possible, even if it means having more pain and discomfort, or would the patient want a plan of care focused on relieving pain and discomfort as much as possible, even if that means not living as long?" The second question assesses perceptions of current treatment using the same two options. The outcome is a dichotomous variable of whether the preference matches the report of care received. Although this creates a "false dichotomy" in that many patients want both, this "forced choice" helps identify patients' top priority. Based on prior studies, we expect only 50-60% of controls will report goal-concordant care. Items completed by family respondents.	1-, 3-, and 6-months after randomization
Secondary	Impact of Event Scale-6 (IES-6) - family	The Impact of Event Scale-6 (IES-6), derived from the IES-R, uses 6 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").	1-, 3-, and 6-months after randomization
Secondary	Perceived Competence Scale (PCS) - family	The Perceived Competence Scale (PCS) is a short, 4-item questionnaire assessesing participants' feelings of competence. Items can be worded differently for different target behaviors. Validity was established in a study of medical students, and then in studies of diabetes self-management. Cronbach's alpha has consistently been above 0.80 in multiple studies. The scale has been used in several studies.The mean of 4 items is used as the scale score. The 4 items have also been used to form a latent variable, and assessed for change over time. Responses range from "Not at all true" (1) to "Very True" (7); higher score on the latent variable would indicate greater competence.	1-, 3-, and 6-months after randomization
Secondary	Healthcare Costs and Utilization - patient	We will measure hospital readmission after initial hospital discharge through the electronic health record (EHR), institutional billing systems and, patient/family self-reports. All hospitals are in one system facilitating data collection. By using all three sources for data, we will capture hospitalizations regardless of healthcare system. Our primary focus will be readmission within 30 days as this is a national standard, but we will also collect data from the EHR and from patient/family interviews to record all readmissions, emergency department visits, clinic visits, inpatient and outpatient palliative care consults, and home care over 6 months. All occasions of healthcare use will be confirmed through chart review and valued using the Medical Expenditure Panel Survey and the Healthcare Cost and Utilization project, with additional information from institutional financial systems, to capture costs of care rather than charges.	1-, 3-, and 6-months after randomization
Secondary	Comprehensive Score for Financial Toxicity (COST) - family	Family member assessment of perceived financial stress will be measured with the 11-item COST instrument which has demonstrated reliability and validity in measuring financial toxicity.	1-, 3-, and 6-months after randomization
Secondary	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.	1-, 3-, and 6-months after randomization