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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facilitator-Based Intervention | Experimental | The 'Facilitator-Based Intervention' includes patient and family member subjects. |
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| Usual Care | No Intervention | The 'Usual Care' arm includes patient and family member subjects. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facilitator-Based Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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), | 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 | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth A Engelberg, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Medicine - Harborview Medical Center | Seattle | Washington | 98104 | United States | ||
| University of Washington Medical Center - Northwest |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care/CONTROL: Patient | Received Usual Care and/or Attention Control; patient subjects did not complete surveys |
| FG001 | Facilitator-Based INTERVENTION: Patient | Received 3-Month Communication Facilitator Intervention; patient subjects did not complete surveys |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2024 |
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| 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 |
| 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). | 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 |
| 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). | 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 |
| 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). | 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 |
| 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). | 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 |
| 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) | 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 |
| 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. | within 30 days after discharge from the index hospitalization |
| 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. | 30 days after randomization |
| 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. | 91 days after randomization |
| 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. | 183 days after randomization |
| 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. | 30 days after randomization |
| 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. | 91 days after randomization |
| 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. | 183 days after randomization |
| 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. | Randomization to discharge from index hospitalization, up to 183 days |
| 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. | Randomization to 30 days after randomization |
| Assessed on 1-month questionnaires |
| 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. | Assessed on 3-month questionnaires |
| 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. | Assessed on 6-month questionnaires |
| 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. | Assessed on 3-month questionnaires |
| 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 |
| 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 |
| Seattle |
| Washington |
| 98133 |
| United States |
| University of Washington Medical Center - Montlake | Seattle | Washington | 98195 | United States |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | Clinician & Administrator Interviewees | Subjects participated in qualitative interviews designed to evaluate the intervention |
| Completed Survey at 1-Month |
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| Completed Survey at 3-Months |
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| Completed Survey at 6-Months |
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| Completed Qualitative Interview |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care/CONTROL: Patient | Received Usual Care and/or Attention Control; patient subjects did not complete surveys |
| BG001 | Facilitator-Based INTERVENTION: Patient | Received 3-Month Communication Facilitator Intervention; patient subjects did not complete surveys |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Clinician & Administrator Interviewees | Subjects participated in qualitative interviews designed to evaluate the intervention |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Hospital Site | Count of Participants | Participants |
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| Diagnoses, Patients | Collected from EHR. Eligibility diagnoses during the ICU stay; categorized as Chronic Condition (e.g. Dartmouth Atlas) or Acute Conditions. Counts are not mutually exclusive and participants may have more than one categorical diagnosis. | Measure Analysis Population Description: These data were not collected for family members ("Usual Care/CONTROL: Family" & "Facilitator-Based INTERVENTION: Family" or "Clinician & Administrator Interviewees" subjects. Patients can have more than one condition so the number will not sum to the number of participants analyzed. | Count of Participants | Participants |
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| APACHE II Score, Patients | Acute Physiology and Chronic Health Evaluation (APACHE II) Severity of Disease Score collected within 24-48 hours of ICU admission (where available).APACHE II gives an integer score from 0 to 71 that computed using several physiological measurements and age; higher scores correspond to more severe disease. | These data were not collected for family members or clinician/administrator interview subjects. | Median | Inter-Quartile Range | APACHE II Severity of Disease Score |
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| Type of Insurance, Patients | These data were not collected for family members or clinician/administrator interview subjects. | Count of Participants | Participants |
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| Relationship, Family | Relationship of participating family member to the patient, self-report via survey item. | These data only apply to family member subjects. | Count of Participants | Participants |
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| Education Level, Family | Highest completed education level of participating family member, self-report via survey item. | These data were only collected from family member subjects. | Count of Participants | Participants |
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| Employment Status, Family | Employment status of participating family member, self-report via survey item. | These data were only collected from family member subjects. | Count of Participants | Participants |
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| Financial Situation, Family | Financial situation of participating family member, self-report via survey item. | These data were only collected from family member subjects. | Count of Participants | Participants |
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| Health Status, Family | Health status of participating family member, self-report via Short Form Health Survey (SF-1) item. | These data were only collected from family member subjects. | Count of Participants | Participants |
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| Depression Symptoms, Family (HADS-D) | Family member symptoms of depression and anxiety assessed with Hospital Anxiety and Depression Scale (HADS); reliable and valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress; 7 items evaluate anxiety and 7 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, with higher scores indicating greater symptoms of psychological distress. | These measures were only collected from family subjects. Two respondents missing data. | Mean | Standard Deviation | scores on a scale |
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| Anxiety Symptoms, Family (HADS-A) | Family member symptoms of depression and anxiety assessed with Hospital Anxiety and Depression Scale (HADS); reliable and valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress; 7 items evaluate anxiety and 7 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, with higher scores indicating greater symptoms of psychological distress. | These measures were only collected from family subjects. Two respondents missing data. | Mean | Standard Deviation | scores on a scale |
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| Quality of Family Experience - Relationship with Healthcare Providers | Family member measure of experience of patients with serious illness; QUAL-E (Fam) is a validated instrument to measure of quality of life at the end of life; four domains are measured, including, relationship with healthcare providers (4 items), completion (3 items), and preparation (4 items). These data report on the "Relationship with Healthcare Providers" subscale domain items: told what to expect, involved in decision-making, kept informed, and concerns responded to. Ratings are on a scale of 1-5, with higher score indicating 'better relationship'. | These measures were only collected from family subjects. Eight respondents are missing data. | Mean | Standard Deviation | scores on a scale |
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| Quality of Family Experience - Sense of Completion | Family member measure of experience of patients with serious illness; QUAL-E (Fam) is a validated instrument to measure of quality of life at the end of life; four domains are measured, including, relationship with healthcare providers (4 items), completion (3 items), and preparation (4 items). These data report on the "Sense of Completion" subscale domain items: able to make a positive difference, able to have meaningful interaction, and able to say important things to patient. Ratings are on a scale of 1-5, with higher score indicating 'better sense of completion'. | These measures were only collected from family subjects. Ten respondents are missing data. | Mean | Standard Deviation | scores on a scale |
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| Quality of Family Experience - Preparation Issues | Family member measure of experience of patients with serious illness; QUAL-E (Fam) is a validated instrument to measure of quality of life at the end of life; four domains are measured, including, relationship with healthcare providers (4 items), completion (3 items), and preparation (4 items) These data report on the "Preparation" subscale domain items: feeling financial strain, feeling emotionally prepared for future, feeling at peace, feeling at peace patient's care. Ratings are on a scale of 1-5, with higher score indicating 'better preparation'. | These measures were only collected from family subjects. Two respondents are missing data. | Mean | Standard Deviation | scores on a scale |
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| Goal-Concordant Care, Family Assessment | Family report on concordance between the care patients want and the care they are receiving; measured with two 'forced choice' items: 1) patient preference (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?); and 2) perception of current treatment using the same two options. If the answers on the two items matched, they were considered "concordant". | These measures were only collected from family subjects. Twelve respondents are missing data. | Count of Participants | Participants |
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| Perceived Competence, 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. | This measure was only collected from family subjects. | Median | Inter-Quartile Range | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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), | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| 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) | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale, mean value of 4 items | 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 |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale, mean value of 3 items | 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 |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale, sum of items | 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 |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| 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) | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale (0,1) | within 30 days after discharge from the index hospitalization |
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| 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. | Patients who were randomized before index hospitalization discharge. | Posted | Mean | Standard Deviation | days | 30 days after randomization |
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| 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. | Patients who were randomized before index hospitalization discharge. | Posted | Mean | Standard Deviation | days | 91 days after randomization |
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| 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. | Patients who were randomized before index hospitalization discharge. | Posted | Mean | Standard Deviation | days | 183 days after randomization |
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| 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. | Patients who were randomized before index hospitalization discharge. | Posted | Mean | Standard Deviation | days | 30 days after randomization |
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| 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. | Patients who were randomized before index hospitalization discharge. | Posted | Mean | Standard Deviation | days | 91 days after randomization |
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| 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. | Patients who were randomized before index hospitalization discharge. | Posted | Mean | Standard Deviation | days | 183 days after randomization |
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| 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. | Patients who were randomized before index hospitalization discharge. | Posted | Mean | Standard Deviation | USDollar (inflation-adjusted total cost) | Randomization to discharge from index hospitalization, up to 183 days |
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| 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. | Patients who were randomized before index hospitalization discharge. | Posted | Mean | Standard Deviation | USDollar (inflation-adjusted total cost) | Randomization to 30 days after randomization |
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| 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. | 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). | Posted | Median | Inter-Quartile Range | score on a scale | Assessed on 1-month questionnaires |
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| 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. | 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). | Posted | Median | Inter-Quartile Range | score on a scale | Assessed on 3-month questionnaires |
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| 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. | 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). | Posted | Median | Inter-Quartile Range | score on a scale | Assessed on 6-month questionnaires |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Assessed on 3-month questionnaires |
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| 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. | Not Posted | 6-months after randomization | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | 6-months after randomization | Participants |
Enrollment/Randomization though 6-month study duration
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care/CONTROL: Patient | Received Usual Care and/or Attention Control; patient subjects did not complete surveys | 111 | 224 | 0 | 224 | 0 | 224 |
| EG001 | Facilitator-Based INTERVENTION: Patient | Received 3-Month Communication Facilitator Intervention; patient subjects did not complete surveys | 94 | 225 | 0 | 225 | 0 | 225 |
| EG002 | 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 | 0 | 241 | 0 | 241 | 0 | 241 |
| EG003 | 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 | 0 | 264 | 0 | 264 | 0 | 264 |
| EG004 | Clinician & Administrator Interviewees | Subjects participated in qualitative interviews designed to evaluate the intervention | 0 | 23 | 0 | 23 | 0 | 23 |
Not provided
Not provided
This study took place in one region of the US and may not generalize to other regions. There may be selection bias among those family members and patients who were willing to participate.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ruth Engelberg | University of Washington | 206-744-9523 | rengel@uw.edu |
| Oct 24, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D009362 | Neoplasm Metastasis |
| D008175 | Lung Neoplasms |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006333 | Heart Failure |
| D008103 | Liver Cirrhosis |
| D007676 | Kidney Failure, Chronic |
| D009102 | Multiple Organ Failure |
| D008171 | Lung Diseases |
| D002561 | Cerebrovascular Disorders |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012769 | Shock |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
Not provided
Not provided
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| Between 18 and 65 years |
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| >= 65 years |
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| Unknown or Not Reported |
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| Male |
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| Unknown or Not Reported |
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| Chronic-COPD (chronic obstructive pulmonary disease) |
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| Chronic-CAD (coronary artery disease) |
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| Chronic-CHF (congestive heart failure) |
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| Chronic-PVD (peripheral vascular disease) |
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| Chronic-Liver Disease |
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| Chronic-Diabetes |
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| Chronic-Renal Failure |
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| Chronic-Dementia |
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| Chronic-Had 3+ Diagnoses |
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| Acute-ARDS (acute respiratory distress syndrome) |
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| Acute-On ECMO/ECLS (extracorporeal life support) |
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| Acute-TBI (traumatic brain injury) |
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| Acute-Vascular/non-TBI (non-traumatic brain injury) |
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| Acute-Respiratory Failure |
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| Acute-New spinal cord injury (SCI) with Quadriplegia |
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| Acute-ICU Admission with COVID-19 |
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| I am capable of getting the care for my family member that he/she wants. |
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| I am able to get the care for my family member that he/she wants. |
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| I feel able to meet the challenge of getting the care for my family member that he/she wants. |
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| at 3-months |
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| at 6-months |
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| Superiority |
| Mixed Models Analysis | Average Intervention effect with time interaction (control-intervention) | 0.510 | Superiority |
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Received 3-Month Communication Facilitator Intervention; family member subjects completed follow-up outcome surveys at 1-3-6 months after randomization |
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Received 3-Month Communication Facilitator Intervention; family member subjects completed follow-up outcome surveys at 1-3-6 months after randomization |
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Received 3-Month Communication Facilitator Intervention; family member subjects completed follow-up outcome surveys at 1-3-6 months after randomization |
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| OG001 | 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 |
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