Brain Injuries, Cerebrovascular Disorders, Chronic Disease, Health Care Quality, Access, and Evaluation, Heart Failure, Congestive, Intensive Care Units, Kidney Failure, Chronic, Liver Cirrhosis, Lung Diseases, Lung Neoplasm, Multiple Organ Failure, Neoplasm Metastasis, Palliative Care, Health Services, Palliative Care, Patient Care, Pulmonary Disease, Chronic Obstructive
Conditions
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.
Interventions
BEHAVIORALFacilitator-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.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Symptoms, Family (HADS-D) | 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
| Measure | Time frame | Description |
|---|---|---|
| Impact of Event, Family Assessment (IES-6) | 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 six 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). For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of 6 items measuring the traumatic impact of events, weighted for the number of items with valid responses. The sum could range from 0 to 24, with higher values indicating greater traumatic impact (i.e., worse outcome) |
| Healthcare Utilization: Hospital Free Days, 183 Days - Patient | 183 days after randomization | Number of full days on which the patient was alive and not in the hospital between the randomization date and 182 days after the randomization date. Values could range from 0 to 183, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge. |
| Healthcare Utilization: ICU Free Days, 30 Days - Patient | 30 days after randomization | Number of full days on which the patient was alive and not in an ICU between the randomization date and 29 days after the randomization date. Values could range from 0 to 30, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge. |
| Healthcare Utilization: ICU Free Days, 91 Days - Patient | 91 days after randomization | Number of full days on which the patient was alive and not in an ICU between the randomization date and 90 days after the randomization date. Values could range from 0 to 91, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge. |
| Healthcare Utilization: ICU Free Days, 183 Days - Patient | 183 days after randomization | Number of full days on which the patient was alive and not in an ICU between the randomization date and 182 days after the randomization date. Values could range from 0 to 183, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge. |
| Healthcare Costs, Discharge - Patient | Randomization to discharge from index hospitalization, up to 183 days | Total hospitalization costs from date of randomization to index hospitalization discharge. Costs ranged from $1,631.73 to $1,299,781.53, with higher value indicating a worse outcome; missing if the patient was randomized after discharge from the index hospitalization. |
| Healthcare Costs, 30 Days - Patient | Randomization to 30 days after randomization | Total hospitalization costs for the 30-day period beginning with the date of randomization, adjusted to their value in December 2023 based on the Consumer Price Index for Medical Care. Values ranged from $1,631.73 to $585,386.34, with higher values indicating worse outcomes; missing if the patient was randomized after index hospitalization discharge. |
| Anxiety Symptoms, Family (HADS-A) | 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 anxiety, weighted for the number of items with valid responses. The sum could range from 0 to 21, with higher values indicating greater anxiety (i.e., worse outcome) |
| Quality of Family Experience - Relationship With Healthcare Providers (QUAL-E Fam) | 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. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the mean of the valid responses to QUAL-E (Fam) items #5, 6, 7, and 8. The mean could range from 1 to 5, with higher values indicating higher quality of relationship (i.e., better outcome). |
| Quality of Family Experience - Sense of Completion (QUAL-E Fam) | 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. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the mean of the valid responses to QUAL-E (Fam) items #9, 10, and 11. The mean could range from 1 to 5, with higher values indicating higher sense of completion (i.e., better outcome). |
| Quality of Family Experience - Preparation Issues (QUAL-E Fam) | 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. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of valid responses to QUAL-E (Fam) items #12, 13, 14, and 15, weighted for the number of items with valid responses. The sum could range from 4 to 20, with higher values indicating greater preparation (i.e., better outcome). |
| Goal-Concordant Care, Family Assessment | 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 receive is measured with two questions from the SUPPORT study. The first defines preference (care focused on extending life even with more pain and discomfort vs. care focused on relieving pain and discomfort even with not living as long.) The second assesses perception of current treatment using the same options. The outcome is a dichotomous variable of whether preference matches care received. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was coded 1 if the respondent's perception of the focus of care the patient received (comfort vs. life extension) matched their perception of the patient's preferred focus of care; and 0 if the perceived focus of care received did not match the perceived patient's care preference. If the response to either item was don't know, the outcome was coded 0. The higher value indicated goal-concordant care (the better outcome). |
| Healthcare Utilization: Hospital Readmission - Patient | within 30 days after discharge from the index hospitalization | Documentation in the patient's electronic health record of hospital readmission within 30 days after discharge from the index hospitalization: 0=no readmission, 1=one or more readmissions; missing if index hospitalization still ongoing at the end of the 183-day follow-up period, patient death during index hospitalization, or randomization occurred after index hospitalization discharge. Valid outcomes could be either 0 or 1, with higher value indicating a worse outcome. |
| Healthcare Utilization: Hospital Free Days, 30 Days - Patient | 30 days after randomization | Number of full days on which the patient was alive and not in the hospital between the randomization date and 29 days after the randomization date. Values could range from 0 to 30, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge. |
| Healthcare Utilization: Hospital Free Days, 91 Days - Patient | 91 days after randomization | Number of full days on which the patient was alive and not in the hospital between the randomization date and 90 days after the randomization date. Values could range from 0 to 91, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Perceived Competence Scale (PCS), 6 Months - Family | Assessed on 6-month questionnaires | The Perceived Competence Scale (PCS) is a 4-item questionnaire assessing participants' feelings of competence. Items can be worded differently for different target behaviors. Responses range from Not at all true (1) to Very True (7); higher score on the latent variable would indicate greater competence. We will evaluate this mediator cross-sectionally. |
| Measure of Acceptability of Intervention - Family in the Intervention Group | Assessed on 3-month questionnaires | The Acceptability of Intervention Measure (AIM) is a 4 item measure with proven reliability, validity and responsiveness to change. It is designed to assess participants' perception of the intervention in which they participated as agreeable (meets my approval), palatable (appealing to me) or satisfactory (like it, welcome it). Response options include completely disagree, disagree, neither agree nor disagree, agree and completely agree. These items were asked of the intervention participants at the conclusion of the 3-month intervention phase. |
| Key Implementation Factors | 6-months after randomization | 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. |
| Key Implementation Outcomes | 6-months after randomization | Qualitative interviews after individual participation. Interviews will also explore three key implementation outcomes (acceptability, fidelity, penetration) that will guide future dissemination of the intervention. |
| Perceived Competence Scale (PCS), 3 Months - Family | Assessed on 3-month questionnaires | The Perceived Competence Scale (PCS) is a 4-item questionnaire assessing participants' feelings of competence. Items can be worded differently for different target behaviors. Responses range from Not at all true (1) to Very True (7); higher score on the latent variable would indicate greater competence. We will evaluate this mediator cross-sectionally. |
| Perceived Competence Scale (PCS), 1 Month - Family | Assessed on 1-month questionnaires | The Perceived Competence Scale (PCS) is a 4-item questionnaire assessing participants' feelings of competence. Items can be worded differently for different target behaviors. Responses range from Not at all true (1) to Very True (7); higher score on the latent variable would indicate greater competence. We will evaluate this mediator cross-sectionally. |
Countries
United States
Participant flow
Recruitment details
Patients and family were screened and recruited from April 2019 to March 2023. Potential subjects received introductory calls from the research coordinator to assess interest and eligibility. Enrollees completed baseline surveys and were randomized. Patients and family were approached for interviews between March 2020 and December 2022. Clinicians and administrators were recruited between January 2021 and January 2023.
Pre-assignment details
2823 patients and family were assessed for eligibility. 1806 were excluded; main reasons included: family or legal next of kin unavailable, and patient status improved/transferred from ICU. 568 declined participation; main reason given was the family member feeling overwhelmed. 505 family subjects were enrolled, representing 449 enrolled patients.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care/CONTROL: Patient Received Usual Care and/or Attention Control; patient subjects did not complete surveys | 224 |
| Facilitator-Based INTERVENTION: Patient Received 3-Month Communication Facilitator Intervention; patient subjects did not complete surveys | 225 |
| Usual Care/CONTROL: Family Received Usual Care and/or Attention Control; family member subjects completed follow-up outcome surveys at 1-3-6 months after randomization | 241 |
| Facilitator-Based INTERVENTION: Family Received 3-Month Communication Facilitator Intervention; family member subjects completed follow-up outcome surveys at 1-3-6 months after randomization | 264 |
| Clinician & Administrator Interviewees Subjects participated in qualitative interviews designed to evaluate the intervention | 23 |
| Total | 977 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 40 | 28 | 0 |
Baseline characteristics
| Characteristic | Usual Care/CONTROL: Patient | Total | Clinician & Administrator Interviewees | Facilitator-Based INTERVENTION: Family | Usual Care/CONTROL: Family | Facilitator-Based INTERVENTION: Patient |
|---|---|---|---|---|---|---|
| Age, Continuous | 58 years | 55 years | 39.5 years | 55 years | 53 years | 57 years |
| Age, Customized <= 18 years | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >= 65 years | 77 Participants | 274 Participants | 1 Participants | 63 Participants | 54 Participants | 79 Participants |
| Age, Customized Between 18 and 65 years | 146 Participants | 683 Participants | 15 Participants | 197 Participants | 179 Participants | 146 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 19 Participants | 7 Participants | 4 Participants | 8 Participants | 0 Participants |
| Anxiety Symptoms, Family (HADS-A) | — | 10.4 scores on a scale STANDARD_DEVIATION 4.7 | — | 10.5 scores on a scale STANDARD_DEVIATION 4.7 | 10.4 scores on a scale STANDARD_DEVIATION 4.8 | — |
| APACHE II Score, Patients | 25 APACHE II Severity of Disease Score | 25 APACHE II Severity of Disease Score | — | — | — | 24 APACHE II Severity of Disease Score |
| Depression Symptoms, Family (HADS-D) | — | 7.2 scores on a scale STANDARD_DEVIATION 4.4 | — | 7.2 scores on a scale STANDARD_DEVIATION 4.2 | 7.2 scores on a scale STANDARD_DEVIATION 4.6 | — |
| Diagnoses, Patients Acute-ARDS (acute respiratory distress syndrome) | 45 Participants | 101 Participants | 0 Participants | 0 Participants | 0 Participants | 56 Participants |
| Diagnoses, Patients Acute-ICU Admission with COVID-19 | 28 Participants | 56 Participants | 0 Participants | 0 Participants | 0 Participants | 28 Participants |
| Diagnoses, Patients Acute-New spinal cord injury (SCI) with Quadriplegia | 3 Participants | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Diagnoses, Patients Acute-On ECMO/ECLS (extracorporeal life support) | 5 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Diagnoses, Patients Acute-Respiratory Failure | 177 Participants | 351 Participants | 0 Participants | 0 Participants | 0 Participants | 174 Participants |
| Diagnoses, Patients Acute-TBI (traumatic brain injury) | 27 Participants | 67 Participants | 0 Participants | 0 Participants | 0 Participants | 40 Participants |
| Diagnoses, Patients Acute-Vascular/non-TBI (non-traumatic brain injury) | 73 Participants | 138 Participants | 0 Participants | 0 Participants | 0 Participants | 65 Participants |
| Diagnoses, Patients Chronic-CAD (coronary artery disease) | 38 Participants | 72 Participants | 0 Participants | 0 Participants | 0 Participants | 34 Participants |
| Diagnoses, Patients Chronic-Cancer | 25 Participants | 45 Participants | 0 Participants | 0 Participants | 0 Participants | 20 Participants |
| Diagnoses, Patients Chronic-CHF (congestive heart failure) | 55 Participants | 108 Participants | 0 Participants | 0 Participants | 0 Participants | 53 Participants |
| Diagnoses, Patients Chronic-COPD (chronic obstructive pulmonary disease) | 33 Participants | 59 Participants | 0 Participants | 0 Participants | 0 Participants | 26 Participants |
| Diagnoses, Patients Chronic-Dementia | 8 Participants | 23 Participants | 0 Participants | 0 Participants | 0 Participants | 15 Participants |
| Diagnoses, Patients Chronic-Diabetes | 17 Participants | 39 Participants | 0 Participants | 0 Participants | 0 Participants | 22 Participants |
| Diagnoses, Patients Chronic-Had 3+ Diagnoses | 69 Participants | 131 Participants | 0 Participants | 0 Participants | 0 Participants | 62 Participants |
| Diagnoses, Patients Chronic-Liver Disease | 25 Participants | 44 Participants | 0 Participants | 0 Participants | 0 Participants | 19 Participants |
| Diagnoses, Patients Chronic-PVD (peripheral vascular disease) | 26 Participants | 38 Participants | 0 Participants | 0 Participants | 0 Participants | 12 Participants |
| Diagnoses, Patients Chronic-Renal Failure | 39 Participants | 71 Participants | 0 Participants | 0 Participants | 0 Participants | 32 Participants |
| Education Level, Family 4-year college degree | — | 107 Participants | — | 52 Participants | 55 Participants | — |
| Education Level, Family 8th grade or less | — | 1 Participants | — | 0 Participants | 1 Participants | — |
| Education Level, Family Graduate degree | — | 82 Participants | — | 45 Participants | 37 Participants | — |
| Education Level, Family High school diploma/GED | — | 58 Participants | — | 29 Participants | 29 Participants | — |
| Education Level, Family Some graduate school | — | 20 Participants | — | 11 Participants | 9 Participants | — |
| Education Level, Family Some high school | — | 13 Participants | — | 6 Participants | 7 Participants | — |
| Education Level, Family Trade school or some college | — | 224 Participants | — | 121 Participants | 103 Participants | — |
| Employment Status, Family Disabled | — | 32 Participants | — | 12 Participants | 20 Participants | — |
| Employment Status, Family Full-time | — | 238 Participants | — | 133 Participants | 105 Participants | — |
| Employment Status, Family Other | — | 32 Participants | — | 17 Participants | 15 Participants | — |
| Employment Status, Family Part-time | — | 50 Participants | — | 23 Participants | 27 Participants | — |
| Employment Status, Family Retired | — | 106 Participants | — | 56 Participants | 50 Participants | — |
| Employment Status, Family Unemployed | — | 38 Participants | — | 18 Participants | 20 Participants | — |
| Employment Status, Family Unknown, not reported | — | 9 Participants | — | 5 Participants | 4 Participants | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 75 Participants | 0 Participants | 23 Participants | 21 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 199 Participants | 861 Participants | 23 Participants | 234 Participants | 215 Participants | 190 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 41 Participants | 0 Participants | 7 Participants | 5 Participants | 17 Participants |
| Financial Situation, Family Difficulty paying bills no matter what | — | 35 Participants | — | 14 Participants | 21 Participants | — |
| Financial Situation, Family Enough money as a result of cutting back | — | 81 Participants | — | 44 Participants | 37 Participants | — |
| Financial Situation, Family Enough money for special things | — | 226 Participants | — | 119 Participants | 107 Participants | — |
| Financial Situation, Family Enough money to pay bills but little for extra things | — | 152 Participants | — | 81 Participants | 71 Participants | — |
| Financial Situation, Family Unknown, not reported | — | 11 Participants | — | 6 Participants | 5 Participants | — |
| Goal-Concordant Care, Family Assessment | — | 259 Participants | — | 136 Participants | 123 Participants | — |
| Health Status, Family Excellent | — | 57 Participants | — | 26 Participants | 31 Participants | — |
| Health Status, Family Fair | — | 62 Participants | — | 35 Participants | 27 Participants | — |
| Health Status, Family Good | — | 174 Participants | — | 91 Participants | 83 Participants | — |
| Health Status, Family Poor | — | 10 Participants | — | 4 Participants | 6 Participants | — |
| Health Status, Family Unknown, not reported | — | 2 Participants | — | 1 Participants | 1 Participants | — |
| Health Status, Family Very Good | — | 200 Participants | — | 107 Participants | 93 Participants | — |
| Hospital Site Community Hospital | 12 Participants | 54 Participants | 0 Participants | 15 Participants | 13 Participants | 14 Participants |
| Hospital Site County Hospital | 167 Participants | 719 Participants | 8 Participants | 198 Participants | 181 Participants | 165 Participants |
| Hospital Site More than One Hospital Location | 0 Participants | 4 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hospital Site University Hospital | 45 Participants | 200 Participants | 11 Participants | 51 Participants | 47 Participants | 46 Participants |
| Perceived Competence, FAMILY I am able to get the care for my family member that he/she wants. | — | 6 units on a scale | — | 6 units on a scale | 6 units on a scale | — |
| Perceived Competence, FAMILY I am capable of getting the care for my family member that he/she wants. | — | 6 units on a scale | — | 6 units on a scale | 6 units on a scale | — |
| Perceived Competence, FAMILY I feel able to meet the challenge of getting the care for my family member that he/she wants. | — | 6 units on a scale | — | 6 units on a scale | 6 units on a scale | — |
| Perceived Competence, FAMILY I feel confident in my ability to get the care for my family member that he/she wants. | — | 6 units on a scale | — | 6 units on a scale | 6 units on a scale | — |
| Quality of Family Experience - Preparation Issues | — | 13.4 scores on a scale STANDARD_DEVIATION 3.2 | — | 13.3 scores on a scale STANDARD_DEVIATION 3.3 | 13.5 scores on a scale STANDARD_DEVIATION 3 | — |
| Quality of Family Experience - Relationship with Healthcare Providers | — | 4.03 scores on a scale STANDARD_DEVIATION 0.85 | — | 4.02 scores on a scale STANDARD_DEVIATION 0.89 | 4.03 scores on a scale STANDARD_DEVIATION 0.81 | — |
| Quality of Family Experience - Sense of Completion | — | 3.35 scores on a scale STANDARD_DEVIATION 1.27 | — | 3.32 scores on a scale STANDARD_DEVIATION 1.27 | 3.38 scores on a scale STANDARD_DEVIATION 1.28 | — |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 27 Participants | 0 Participants | 7 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 26 Participants | 2 Participants | 7 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 45 Participants | 0 Participants | 16 Participants | 7 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 57 Participants | 2 Participants | 24 Participants | 22 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 11 Participants | 0 Participants | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 31 Participants | 0 Participants | 3 Participants | 4 Participants | 15 Participants |
| Race (NIH/OMB) White | 186 Participants | 780 Participants | 19 Participants | 205 Participants | 190 Participants | 180 Participants |
| Region of Enrollment United States | 224 participants | 977 participants | 23 participants | 264 participants | 241 participants | 225 participants |
| Relationship, Family Child | — | 133 Participants | — | 71 Participants | 62 Participants | — |
| Relationship, Family Friend | — | 8 Participants | — | 3 Participants | 5 Participants | — |
| Relationship, Family Other relationship | — | 6 Participants | — | 4 Participants | 2 Participants | — |
| Relationship, Family Other relative | — | 18 Participants | — | 8 Participants | 10 Participants | — |
| Relationship, Family Parent | — | 108 Participants | — | 58 Participants | 50 Participants | — |
| Relationship, Family Sibling | — | 64 Participants | — | 32 Participants | 32 Participants | — |
| Relationship, Family Spouse/Partner | — | 168 Participants | — | 88 Participants | 80 Participants | — |
| Sex/Gender, Customized Female | 78 Participants | 556 Participants | 18 Participants | 183 Participants | 175 Participants | 102 Participants |
| Sex/Gender, Customized Male | 146 Participants | 420 Participants | 5 Participants | 81 Participants | 65 Participants | 123 Participants |
| Sex/Gender, Customized Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Type of Insurance, Patients Medicare | 138 Participants | 288 Participants | — | — | — | 150 Participants |
| Type of Insurance, Patients Military | 8 Participants | 15 Participants | — | — | — | 7 Participants |
| Type of Insurance, Patients Other | 6 Participants | 12 Participants | — | — | — | 6 Participants |
| Type of Insurance, Patients Private/commercial | 71 Participants | 132 Participants | — | — | — | 61 Participants |
| Type of Insurance, Patients Unknown | 1 Participants | 2 Participants | — | — | — | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 111 / 224 | 94 / 225 | 0 / 241 | 0 / 264 | 0 / 23 |
| other Total, other adverse events | 0 / 224 | 0 / 225 | 0 / 241 | 0 / 264 | 0 / 23 |
| serious Total, serious adverse events | 0 / 224 | 0 / 225 | 0 / 241 | 0 / 264 | 0 / 23 |
Outcome results
Primary
Depression Symptoms, Family (HADS-D)
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),
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
Population: Family members with answers to at least half (4 of 7) of the HADS depression items at baseline and also with answers to at least half of the HADS depression items at one or more of the three follow-up points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care/CONTROL: Family | Depression Symptoms, Family (HADS-D) | at 1-month | 6.4 score on a scale | Standard Deviation 4.4 |
| Usual Care/CONTROL: Family | Depression Symptoms, Family (HADS-D) | at 3-months | 6.3 score on a scale | Standard Deviation 4.3 |
| Usual Care/CONTROL: Family | Depression Symptoms, Family (HADS-D) | at 6-months | 5.9 score on a scale | Standard Deviation 4.1 |
| Facilitator-Based INTERVENTION: Family | Depression Symptoms, Family (HADS-D) | at 1-month | 6.5 score on a scale | Standard Deviation 4.3 |
| Facilitator-Based INTERVENTION: Family | Depression Symptoms, Family (HADS-D) | at 3-months | 5.9 score on a scale | Standard Deviation 4.1 |
| Facilitator-Based INTERVENTION: Family | Depression Symptoms, Family (HADS-D) | at 6-months | 5.9 score on a scale | Standard Deviation 4.5 |
Comparison: Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)p-value: 0.68895% CI: [-0.505, 0.764]Mixed Models Analysis
p-value: 0.51Mixed Models Analysis
Secondary
Anxiety Symptoms, Family (HADS-A)
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 anxiety, weighted for the number of items with valid responses. The sum could range from 0 to 21, with higher values indicating greater anxiety (i.e., worse outcome)
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
Population: Family members with answers to at least half (4 of 7) of the HADS anxiety items at baseline and also with answers to at least half of the HADS anxiety items at one or more of the three follow-up points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care/CONTROL: Family | Anxiety Symptoms, Family (HADS-A) | at 1-month | 8.2 score on a scale | Standard Deviation 4.5 |
| Usual Care/CONTROL: Family | Anxiety Symptoms, Family (HADS-A) | at 3-months | 8.4 score on a scale | Standard Deviation 4.8 |
| Usual Care/CONTROL: Family | Anxiety Symptoms, Family (HADS-A) | at 6-months | 8.1 score on a scale | Standard Deviation 4.8 |
| Facilitator-Based INTERVENTION: Family | Anxiety Symptoms, Family (HADS-A) | at 1-month | 8.4 score on a scale | Standard Deviation 4.3 |
| Facilitator-Based INTERVENTION: Family | Anxiety Symptoms, Family (HADS-A) | at 3-months | 8.2 score on a scale | Standard Deviation 4.4 |
| Facilitator-Based INTERVENTION: Family | Anxiety Symptoms, Family (HADS-A) | at 6-months | 7.9 score on a scale | Standard Deviation 4.6 |
Comparison: Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)p-value: 0.65895% CI: [-0.491, 0.777]Mixed Models Analysis
p-value: 0.268Mixed Models Analysis
Secondary
Goal-Concordant Care, Family Assessment
Concordance between the care patients want and the care they receive is measured with two questions from the SUPPORT study. The first defines preference (care focused on extending life even with more pain and discomfort vs. care focused on relieving pain and discomfort even with not living as long.) The second assesses perception of current treatment using the same options. The outcome is a dichotomous variable of whether preference matches care received. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was coded 1 if the respondent's perception of the focus of care the patient received (comfort vs. life extension) matched their perception of the patient's preferred focus of care; and 0 if the perceived focus of care received did not match the perceived patient's care preference. If the response to either item was don't know, the outcome was coded 0. The higher value indicated goal-concordant care (the better outcome).
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
Population: Family members who - at baseline - provided valid responses to both component items or who said don't know to either item; and who also at one or more of the follow-up points - provided valid responses to both component items or who said don't know to either item.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care/CONTROL: Family | Goal-Concordant Care, Family Assessment | at 1-month | 0.57 score on a scale | Standard Deviation 0.497 |
| Usual Care/CONTROL: Family | Goal-Concordant Care, Family Assessment | at 3-months | 0.57 score on a scale | Standard Deviation 0.497 |
| Usual Care/CONTROL: Family | Goal-Concordant Care, Family Assessment | at 6-months | 0.59 score on a scale | Standard Deviation 0.495 |
| Facilitator-Based INTERVENTION: Family | Goal-Concordant Care, Family Assessment | at 1-month | 0.63 score on a scale | Standard Deviation 0.484 |
| Facilitator-Based INTERVENTION: Family | Goal-Concordant Care, Family Assessment | at 3-months | 0.65 score on a scale | Standard Deviation 0.479 |
| Facilitator-Based INTERVENTION: Family | Goal-Concordant Care, Family Assessment | at 6-months | 0.64 score on a scale | Standard Deviation 0.481 |
Comparison: Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)p-value: 0.05395% CI: [-0.791, 0.005]Mixed Models Analysis
p-value: 0.039Mixed Models Analysis
Secondary
Healthcare Costs, 30 Days - Patient
Total hospitalization costs for the 30-day period beginning with the date of randomization, adjusted to their value in December 2023 based on the Consumer Price Index for Medical Care. Values ranged from $1,631.73 to $585,386.34, with higher values indicating worse outcomes; missing if the patient was randomized after index hospitalization discharge.
Time frame: Randomization to 30 days after randomization
Population: Patients who were randomized before index hospitalization discharge.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care/CONTROL: Family | Healthcare Costs, 30 Days - Patient | 103,731.28 USDollar (inflation-adjusted total cost) |
| Facilitator-Based INTERVENTION: Family | Healthcare Costs, 30 Days - Patient | 99,087.38 USDollar (inflation-adjusted total cost) |
Comparison: Superior outcome for Group2 (Patient-Intervention)p-value: 0.59995% CI: [-0.000003, 0.0000053]other type of regression
Secondary
Healthcare Costs, Discharge - Patient
Total hospitalization costs from date of randomization to index hospitalization discharge. Costs ranged from $1,631.73 to $1,299,781.53, with higher value indicating a worse outcome; missing if the patient was randomized after discharge from the index hospitalization.
Time frame: Randomization to discharge from index hospitalization, up to 183 days
Population: Patients who were randomized before index hospitalization discharge.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care/CONTROL: Family | Healthcare Costs, Discharge - Patient | 124,358.13 USDollar (inflation-adjusted total cost) |
| Facilitator-Based INTERVENTION: Family | Healthcare Costs, Discharge - Patient | 129,058.54 USDollar (inflation-adjusted total cost) |
Comparison: Superior outcome for Group2 (Patient-Intervention)p-value: 0.7195% CI: [-0.0000057, 0.0000039]other type of regression
Secondary
Healthcare Utilization: Hospital Free Days, 183 Days - Patient
Number of full days on which the patient was alive and not in the hospital between the randomization date and 182 days after the randomization date. Values could range from 0 to 183, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Time frame: 183 days after randomization
Population: Patients who were randomized before index hospitalization discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care/CONTROL: Family | Healthcare Utilization: Hospital Free Days, 183 Days - Patient | 93.66 days | Standard Deviation 74.03 |
| Facilitator-Based INTERVENTION: Family | Healthcare Utilization: Hospital Free Days, 183 Days - Patient | 98.13 days | Standard Deviation 72.55 |
Comparison: Superior outcome for Group2 (Patient-Intervention)p-value: 0.53395% CI: [-9.367, 18.097]Regression, Linear
Secondary
Healthcare Utilization: Hospital Free Days, 30 Days - Patient
Number of full days on which the patient was alive and not in the hospital between the randomization date and 29 days after the randomization date. Values could range from 0 to 30, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Time frame: 30 days after randomization
Population: Patients who were randomized before index hospitalization discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care/CONTROL: Family | Healthcare Utilization: Hospital Free Days, 30 Days - Patient | 5.65 days | Standard Deviation 8.45 |
| Facilitator-Based INTERVENTION: Family | Healthcare Utilization: Hospital Free Days, 30 Days - Patient | 6.78 days | Standard Deviation 8.74 |
Comparison: Superior outcome for Group2 (Patient-Intervention)p-value: 0.18395% CI: [-0.511, 2.666]Regression, Linear
Secondary
Healthcare Utilization: Hospital Free Days, 91 Days - Patient
Number of full days on which the patient was alive and not in the hospital between the randomization date and 90 days after the randomization date. Values could range from 0 to 91, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Time frame: 91 days after randomization
Population: Patients who were randomized before index hospitalization discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care/CONTROL: Family | Healthcare Utilization: Hospital Free Days, 91 Days - Patient | 39.63 days | Standard Deviation 32.95 |
| Facilitator-Based INTERVENTION: Family | Healthcare Utilization: Hospital Free Days, 91 Days - Patient | 41.43 days | Standard Deviation 33.29 |
Comparison: Superior outcome for Group2 (Patient-Intervention)p-value: 0.59395% CI: [-4.518, 7.892]Regression, Linear
Secondary
Healthcare Utilization: Hospital Readmission - Patient
Documentation in the patient's electronic health record of hospital readmission within 30 days after discharge from the index hospitalization: 0=no readmission, 1=one or more readmissions; missing if index hospitalization still ongoing at the end of the 183-day follow-up period, patient death during index hospitalization, or randomization occurred after index hospitalization discharge. Valid outcomes could be either 0 or 1, with higher value indicating a worse outcome.
Time frame: within 30 days after discharge from the index hospitalization
Population: Patients whose index hospitalization had ended before the end of the 183-day follow-up period, who did not die during the index hospitalization, and who were randomized before index hospitalization discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care/CONTROL: Family | Healthcare Utilization: Hospital Readmission - Patient | 0.10 score on a scale (0,1) | Standard Deviation 0.31 |
| Facilitator-Based INTERVENTION: Family | Healthcare Utilization: Hospital Readmission - Patient | 0.19 score on a scale (0,1) | Standard Deviation 0.39 |
Comparison: Superior outcome for Group2 (Patient-Intervention)p-value: 0.02995% CI: [0.009, 0.169]Regression, Linear
Secondary
Healthcare Utilization: ICU Free Days, 183 Days - Patient
Number of full days on which the patient was alive and not in an ICU between the randomization date and 182 days after the randomization date. Values could range from 0 to 183, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Time frame: 183 days after randomization
Population: Patients who were randomized before index hospitalization discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care/CONTROL: Family | Healthcare Utilization: ICU Free Days, 183 Days - Patient | 113.96 days | Standard Deviation 80.66 |
| Facilitator-Based INTERVENTION: Family | Healthcare Utilization: ICU Free Days, 183 Days - Patient | 122.15 days | Standard Deviation 76.32 |
Comparison: Superior outcome for Group2 (Patient-Intervention)p-value: 0.27395% CI: [-6.479, 22.868]Regression, Linear
Secondary
Healthcare Utilization: ICU Free Days, 30 Days - Patient
Number of full days on which the patient was alive and not in an ICU between the randomization date and 29 days after the randomization date. Values could range from 0 to 30, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Time frame: 30 days after randomization
Population: Patients who were randomized before index hospitalization discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care/CONTROL: Family | Healthcare Utilization: ICU Free Days, 30 Days - Patient | 18.54 days | Standard Deviation 11.9 |
| Facilitator-Based INTERVENTION: Family | Healthcare Utilization: ICU Free Days, 30 Days - Patient | 19.62 days | Standard Deviation 10.59 |
Comparison: Superior outcome for Group2 (Patient-Intervention)p-value: 0.31895% CI: [-1.032, 3.173]Regression, Linear
Secondary
Healthcare Utilization: ICU Free Days, 91 Days - Patient
Number of full days on which the patient was alive and not in an ICU between the randomization date and 90 days after the randomization date. Values could range from 0 to 91, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Time frame: 91 days after randomization
Population: Patients who were randomized before index hospitalization discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care/CONTROL: Family | Healthcare Utilization: ICU Free Days, 91 Days - Patient | 58.20 days | Standard Deviation 38.2 |
| Facilitator-Based INTERVENTION: Family | Healthcare Utilization: ICU Free Days, 91 Days - Patient | 62.32 days | Standard Deviation 35.32 |
Comparison: Superior outcome for Group2 (Patient-Intervention)p-value: 0.24195% CI: [-2.773, 11.007]Regression, Linear
Secondary
Impact of Event, Family Assessment (IES-6)
The Impact of Event Scale-6 (IES-6), derived from the IES-R, uses six 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). For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of 6 items measuring the traumatic impact of events, weighted for the number of items with valid responses. The sum could range from 0 to 24, with higher values indicating greater traumatic impact (i.e., worse outcome)
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
Population: Family members with answers to at least half (3 of 6) of the IES items at one or more of the three follow-up points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care/CONTROL: Family | Impact of Event, Family Assessment (IES-6) | at 1-month | 11 score on a scale | Standard Deviation 6 |
| Usual Care/CONTROL: Family | Impact of Event, Family Assessment (IES-6) | at 3-months | 9 score on a scale | Standard Deviation 6 |
| Usual Care/CONTROL: Family | Impact of Event, Family Assessment (IES-6) | at 6-months | 9 score on a scale | Standard Deviation 6 |
| Facilitator-Based INTERVENTION: Family | Impact of Event, Family Assessment (IES-6) | at 1-month | 9.4 score on a scale | Standard Deviation 5.9 |
| Facilitator-Based INTERVENTION: Family | Impact of Event, Family Assessment (IES-6) | at 3-months | 8.9 score on a scale | Standard Deviation 6.4 |
| Facilitator-Based INTERVENTION: Family | Impact of Event, Family Assessment (IES-6) | at 6-months | 8.1 score on a scale | Standard Deviation 6 |
Comparison: Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)p-value: 0.23995% CI: [-0.425, 1.7]Mixed Models Analysis
p-value: 0.17Mixed Models Analysis
Secondary
Quality of Family Experience - Preparation Issues (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, 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. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of valid responses to QUAL-E (Fam) items #12, 13, 14, and 15, weighted for the number of items with valid responses. The sum could range from 4 to 20, with higher values indicating greater preparation (i.e., better outcome).
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
Population: Family members with answers to at least half (2 of 4) of QUAL-E (Fam) items #12, 13, 14, and 15 at baseline and also with answers to at least half of those items at one or more of the three follow-up points; higher score indicates higher preparation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care/CONTROL: Family | Quality of Family Experience - Preparation Issues (QUAL-E Fam) | at 1-month | 13.5 score on a scale, sum of items | Standard Deviation 3.2 |
| Usual Care/CONTROL: Family | Quality of Family Experience - Preparation Issues (QUAL-E Fam) | at 3-months | 13.3 score on a scale, sum of items | Standard Deviation 3.2 |
| Usual Care/CONTROL: Family | Quality of Family Experience - Preparation Issues (QUAL-E Fam) | at 6-months | 13.6 score on a scale, sum of items | Standard Deviation 3.4 |
| Facilitator-Based INTERVENTION: Family | Quality of Family Experience - Preparation Issues (QUAL-E Fam) | at 1-month | 13.9 score on a scale, sum of items | Standard Deviation 3.2 |
| Facilitator-Based INTERVENTION: Family | Quality of Family Experience - Preparation Issues (QUAL-E Fam) | at 3-months | 14.0 score on a scale, sum of items | Standard Deviation 3.2 |
| Facilitator-Based INTERVENTION: Family | Quality of Family Experience - Preparation Issues (QUAL-E Fam) | at 6-months | 14.0 score on a scale, sum of items | Standard Deviation 3.2 |
Comparison: Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)p-value: 0.0695% CI: [-0.919, 0.02]Mixed Models Analysis
p-value: 0.701Mixed Models Analysis
Secondary
Quality of Family Experience - Relationship With Healthcare Providers (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, 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. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the mean of the valid responses to QUAL-E (Fam) items #5, 6, 7, and 8. The mean could range from 1 to 5, with higher values indicating higher quality of relationship (i.e., better outcome).
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
Population: Family members with answers to at least half (2 of 4) of QUAL-E (Fam) items #5, 6, 7, and 8 at baseline and also with answers to at least half of those items at one or more of the three follow-up points; higher score indicates higher quality of relationship.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care/CONTROL: Family | Quality of Family Experience - Relationship With Healthcare Providers (QUAL-E Fam) | at 1-month | 3.94 score on a scale, mean value of 4 items | Standard Deviation 0.85 |
| Usual Care/CONTROL: Family | Quality of Family Experience - Relationship With Healthcare Providers (QUAL-E Fam) | at 3-months | 3.51 score on a scale, mean value of 4 items | Standard Deviation 1.16 |
| Usual Care/CONTROL: Family | Quality of Family Experience - Relationship With Healthcare Providers (QUAL-E Fam) | at 6-months | 3.54 score on a scale, mean value of 4 items | Standard Deviation 1.13 |
| Facilitator-Based INTERVENTION: Family | Quality of Family Experience - Relationship With Healthcare Providers (QUAL-E Fam) | at 1-month | 4.10 score on a scale, mean value of 4 items | Standard Deviation 0.77 |
| Facilitator-Based INTERVENTION: Family | Quality of Family Experience - Relationship With Healthcare Providers (QUAL-E Fam) | at 3-months | 3.87 score on a scale, mean value of 4 items | Standard Deviation 0.97 |
| Facilitator-Based INTERVENTION: Family | Quality of Family Experience - Relationship With Healthcare Providers (QUAL-E Fam) | at 6-months | 3.64 score on a scale, mean value of 4 items | Standard Deviation 1.11 |
Comparison: Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)p-value: 0.0195% CI: [-0.353, -0.048]Mixed Models Analysis
p-value: 0.175Mixed Models Analysis
Secondary
Quality of Family Experience - Sense of Completion (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, 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. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the mean of the valid responses to QUAL-E (Fam) items #9, 10, and 11. The mean could range from 1 to 5, with higher values indicating higher sense of completion (i.e., better outcome).
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
Population: Family members with answers to at least half (2 of 3) of QUAL-E (Fam) items #9, 10, and 11 at baseline and also with answers to at least half of those items at one or more of the three follow-up points; higher score indicates higher sense of completion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care/CONTROL: Family | Quality of Family Experience - Sense of Completion (QUAL-E Fam) | at 1-month | 3.68 score on a scale, mean value of 3 items | Standard Deviation 1.16 |
| Usual Care/CONTROL: Family | Quality of Family Experience - Sense of Completion (QUAL-E Fam) | at 3-months | 3.98 score on a scale, mean value of 3 items | Standard Deviation 0.98 |
| Usual Care/CONTROL: Family | Quality of Family Experience - Sense of Completion (QUAL-E Fam) | at 6-months | 4.05 score on a scale, mean value of 3 items | Standard Deviation 0.93 |
| Facilitator-Based INTERVENTION: Family | Quality of Family Experience - Sense of Completion (QUAL-E Fam) | at 1-month | 3.75 score on a scale, mean value of 3 items | Standard Deviation 1.02 |
| Facilitator-Based INTERVENTION: Family | Quality of Family Experience - Sense of Completion (QUAL-E Fam) | at 3-months | 3.94 score on a scale, mean value of 3 items | Standard Deviation 1.03 |
| Facilitator-Based INTERVENTION: Family | Quality of Family Experience - Sense of Completion (QUAL-E Fam) | at 6-months | 4.01 score on a scale, mean value of 3 items | Standard Deviation 1 |
Comparison: Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)p-value: 0.81795% CI: [-0.203, 0.16]Mixed Models Analysis
p-value: 0.949Mixed Models Analysis
Other Pre-specified
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.
Time frame: 6-months after randomization
Other Pre-specified
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.
Time frame: 6-months after randomization
Other Pre-specified
Measure of Acceptability of Intervention - Family in the Intervention Group
The Acceptability of Intervention Measure (AIM) is a 4 item measure with proven reliability, validity and responsiveness to change. It is designed to assess participants' perception of the intervention in which they participated as agreeable (meets my approval), palatable (appealing to me) or satisfactory (like it, welcome it). Response options include completely disagree, disagree, neither agree nor disagree, agree and completely agree. These items were asked of the intervention participants at the conclusion of the 3-month intervention phase.
Time frame: Assessed on 3-month questionnaires
Population: These questionnaire items were only asked of the family subjects in the intervention arm. Reporting valid responses on the 3-month questionnaire distributed at the end of the intervention period.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Facilitator-Based INTERVENTION: Family | Measure of Acceptability of Intervention - Family in the Intervention Group | The facilitator intervention meets my approval. | 5 score on a scale |
| Facilitator-Based INTERVENTION: Family | Measure of Acceptability of Intervention - Family in the Intervention Group | The facilitator intervention is appealing to me. | 5 score on a scale |
| Facilitator-Based INTERVENTION: Family | Measure of Acceptability of Intervention - Family in the Intervention Group | I like the facilitator intervention. | 5 score on a scale |
| Facilitator-Based INTERVENTION: Family | Measure of Acceptability of Intervention - Family in the Intervention Group | I welcome the facilitator intervention. | 5 score on a scale |
Other Pre-specified
Perceived Competence Scale (PCS), 1 Month - Family
The Perceived Competence Scale (PCS) is a 4-item questionnaire assessing participants' feelings of competence. Items can be worded differently for different target behaviors. Responses range from Not at all true (1) to Very True (7); higher score on the latent variable would indicate greater competence. We will evaluate this mediator cross-sectionally.
Time frame: Assessed on 1-month questionnaires
Population: Perceived Competence Scale, 4 items collected by self-report via survey item at each assessment point. These data were only collected from family member subjects. Unit of Measure is self-assessed competence (1 \[not at all true\] through 3 \[somewhat true\] to 7 \[very true\]). PCS was not asked in after-death questionnaires. Number analyzed only reflects valid responses (not skipped or missing).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Care/CONTROL: Family | Perceived Competence Scale (PCS), 1 Month - Family | I feel confident in my ability to get the care for my family member that he/she wants. | 5 score on a scale |
| Usual Care/CONTROL: Family | Perceived Competence Scale (PCS), 1 Month - Family | I am capable of getting the care for my family member that he/she wants. | 5 score on a scale |
| Usual Care/CONTROL: Family | Perceived Competence Scale (PCS), 1 Month - Family | I am able to get the care for my family member that he/she wants. | 5 score on a scale |
| Usual Care/CONTROL: Family | Perceived Competence Scale (PCS), 1 Month - Family | I feel able to meet the challenge of getting the care for my family member that he/she wants. | 5 score on a scale |
| Facilitator-Based INTERVENTION: Family | Perceived Competence Scale (PCS), 1 Month - Family | I feel able to meet the challenge of getting the care for my family member that he/she wants. | 5 score on a scale |
| Facilitator-Based INTERVENTION: Family | Perceived Competence Scale (PCS), 1 Month - Family | I feel confident in my ability to get the care for my family member that he/she wants. | 6 score on a scale |
| Facilitator-Based INTERVENTION: Family | Perceived Competence Scale (PCS), 1 Month - Family | I am able to get the care for my family member that he/she wants. | 5 score on a scale |
| Facilitator-Based INTERVENTION: Family | Perceived Competence Scale (PCS), 1 Month - Family | I am capable of getting the care for my family member that he/she wants. | 6 score on a scale |
Other Pre-specified
Perceived Competence Scale (PCS), 3 Months - Family
The Perceived Competence Scale (PCS) is a 4-item questionnaire assessing participants' feelings of competence. Items can be worded differently for different target behaviors. Responses range from Not at all true (1) to Very True (7); higher score on the latent variable would indicate greater competence. We will evaluate this mediator cross-sectionally.
Time frame: Assessed on 3-month questionnaires
Population: Perceived Competence Scale, 4 items collected by self-report via survey item at each assessment point. These data were only collected from family member subjects. Unit of Measure is self-assessed competence (1 \[not at all true\] through 3 \[somewhat true\] to 7 \[very true\]). PCS was not asked in after-death questionnaires. Number analyzed only reflects valid responses (not skipped or missing).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Care/CONTROL: Family | Perceived Competence Scale (PCS), 3 Months - Family | I feel confident in my ability to get the care for my family member that he/she wants. | 5 score on a scale |
| Usual Care/CONTROL: Family | Perceived Competence Scale (PCS), 3 Months - Family | I am capable of getting the care for my family member that he/she wants. | 5 score on a scale |
| Usual Care/CONTROL: Family | Perceived Competence Scale (PCS), 3 Months - Family | I feel able to meet the challenge of getting the care for my family member that he/she wants. | 5 score on a scale |
| Usual Care/CONTROL: Family | Perceived Competence Scale (PCS), 3 Months - Family | I am able to get the care for my family member that he/she wants. | 5 score on a scale |
| Facilitator-Based INTERVENTION: Family | Perceived Competence Scale (PCS), 3 Months - Family | I am able to get the care for my family member that he/she wants. | 6 score on a scale |
| Facilitator-Based INTERVENTION: Family | Perceived Competence Scale (PCS), 3 Months - Family | I feel confident in my ability to get the care for my family member that he/she wants. | 6 score on a scale |
| Facilitator-Based INTERVENTION: Family | Perceived Competence Scale (PCS), 3 Months - Family | I feel able to meet the challenge of getting the care for my family member that he/she wants. | 6 score on a scale |
| Facilitator-Based INTERVENTION: Family | Perceived Competence Scale (PCS), 3 Months - Family | I am capable of getting the care for my family member that he/she wants. | 6 score on a scale |
Other Pre-specified
Perceived Competence Scale (PCS), 6 Months - Family
The Perceived Competence Scale (PCS) is a 4-item questionnaire assessing participants' feelings of competence. Items can be worded differently for different target behaviors. Responses range from Not at all true (1) to Very True (7); higher score on the latent variable would indicate greater competence. We will evaluate this mediator cross-sectionally.
Time frame: Assessed on 6-month questionnaires
Population: Perceived Competence Scale, 4 items collected by self-report via survey item at each assessment point. These data were only collected from family member subjects. Unit of Measure is self-assessed competence (1 \[not at all true\] through 3 \[somewhat true\] to 7 \[very true\]). PCS was not asked in after-death questionnaires. Number analyzed only reflects valid responses (not skipped or missing).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Care/CONTROL: Family | Perceived Competence Scale (PCS), 6 Months - Family | I feel confident in my ability to get the care for my family member that he/she wants. | 6 score on a scale |
| Usual Care/CONTROL: Family | Perceived Competence Scale (PCS), 6 Months - Family | I am capable of getting the care for my family member that he/she wants. | 6 score on a scale |
| Usual Care/CONTROL: Family | Perceived Competence Scale (PCS), 6 Months - Family | I am able to get the care for my family member that he/she wants. | 5 score on a scale |
| Usual Care/CONTROL: Family | Perceived Competence Scale (PCS), 6 Months - Family | I feel able to meet the challenge of getting the care for my family member that he/she wants. | 5 score on a scale |
| Facilitator-Based INTERVENTION: Family | Perceived Competence Scale (PCS), 6 Months - Family | I feel able to meet the challenge of getting the care for my family member that he/she wants. | 5 score on a scale |
| Facilitator-Based INTERVENTION: Family | Perceived Competence Scale (PCS), 6 Months - Family | I feel confident in my ability to get the care for my family member that he/she wants. | 6 score on a scale |
| Facilitator-Based INTERVENTION: Family | Perceived Competence Scale (PCS), 6 Months - Family | I am able to get the care for my family member that he/she wants. | 5 score on a scale |
| Facilitator-Based INTERVENTION: Family | Perceived Competence Scale (PCS), 6 Months - Family | I am capable of getting the care for my family member that he/she wants. | 6 score on a scale |