Facilitating Communication Study

Not Applicable

Completed

• Conditions: Chronic Disease; Neoplasm Metastasis; Liver Cirrhosis; Palliative Care, Patient Care; Health Care Quality, Access, and Evaluation; Heart Failure, Congestive; Kidney Failure, Chronic; Intensive Care Units; Lung Neoplasm; Multiple Organ Failure
• Interventions: Behavioral: Facilitator-Based Intervention

• Registration Number: NCT03721952
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-26
• Study Start: 2019-04-17
• Primary Completion: 2023-10-26
• Study Completion: 2024-06-30
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 977

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Facilitator-Based Intervention	Facilitator-Based Intervention	The 'Facilitator-Based Intervention' includes patient and family member subjects.

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS) - family, Depression Subscale	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), 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.

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS) - family, Anxiety Subscale	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), 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.
QUAL-E (Fam) - family, Relationship Subscale	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 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.
QUAL-E (Fam) - family, Completion Subscale	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 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.
QUAL-E (Fam) - family, Preparation Subscale	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 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.
Goal-concordant care (SUPPORT items) - family	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	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.
Impact of Event Scale-6 (IES-6) - family	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	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").
Healthcare Utilization: Hospital readmission - patient	30 days after discharge from the index hospitalization	Occurrence of any hospital readmissions within 30 days of the index hospitalization discharge.; The hospital readmission outcome is a binary variable indicating whether the patient was readmitted to the hospital at any time during the 30 days after discharge from the index hospitalization. (Patients who died during the index hospitalization, along with those whose index hospitalization was ongoing at the end of the 6-month study follow-up period were excluded from this outcome.)
Healthcare Utilization: Hospital free days, 30 days - patient	30 days after randomization	Number of days that patient was alive and out of the hospital following randomization to 30 days (1-month) after randomization.; Hospital free days: the number of full days in the 30-day period after randomization when the patient was alive and not in the hospital.
Healthcare Utilization: Hospital free days, 91 days - patient	91 days after randomization	Number of days that patient was alive and out of the hospital following randomization to 91 days (3-months) after randomization.; Hospital free days: the number of full days in the 91-day period after randomization when the patient was alive and not in the hospital.
Healthcare Utilization: Hospital free days, 183 days - patient	183 days after randomization	Number of days that patient was alive and out of the hospital following randomization to 183 days (6-months) after randomization.; Hospital free days: the number of full days in the 183-day period after randomization when the patient was alive and not in the hospital.
Healthcare Utilization: ICU free days, 30 days - patient	30 days after randomization	Number of days that patient was alive and out of the ICU following randomization to 30 days (1-months) after randomization.; ICU free days: the number of full days in the 30-day period after randomization when the patient was alive and not in an ICU.
Healthcare Utilization: ICU free days, 91 days - patient	91 days after randomization	Number of days that patient was alive and out of the ICU following randomization to 91 days (3-months) after randomization.; ICU free days: the number of full days in the 91-day period after randomization when the patient was alive and not in an ICU.
Healthcare Utilization: ICU free days, 183 days - patient	183 days after randomization	Number of days that patient was alive and out of the ICU following randomization to 183 days (6-months) after randomization.; ICU free days: the number of full days in the 183-day period after randomization when the patient was alive and not in an ICU.
Healthcare Costs, Discharge - patient	Randomization to discharge from index hospitalization, up to 183 days	We evaluated three cost components (total costs, direct costs, and indirect costs) for costs assessed for the patient's index hospitalization from the date of randomization through hospital discharge. All three cost measures are adjusted for inflation to represent their value on December 1, 2023. Multipliers were computed from the Consumer Price Index, Urban Consumers, Medical Care, City Average Seasonally Adjusted. These data are obtained from institutional financial records.
Healthcare Costs, 30 days - patient	Randomization to 30 days after randomization	We evaluated three cost components (total costs, direct costs, and indirect costs) for costs assessed for index hospitalization costs beginning on the day of randomization and ending 30 days later. All three cost measures are adjusted for inflation to represent their value on December 1, 2023. Multipliers were computed from the Consumer Price Index, Urban Consumers, Medical Care, City Average Seasonally Adjusted. These data are obtained from institutional financial records.

Trial Locations

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