Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Key Implementation Factors |
Qualitative interviews after individual participation has concluded. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context. |
3 months after randomization |
|
Primary |
EHR documentation of Goals of Care discussions |
The primary outcome is the proportion of patients who have a goals-of-care discussion that has been documented in the EHR in the period between randomization and 30 days following randomization. The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. |
Assessed for the period between randomization and 30 days following randomization |
|
Secondary |
Intensity of care/ICU use: ICU admissions |
Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR. |
Assessed for the period between randomization and 30 days following randomization |
|
Secondary |
Intensity of care/ICU use: ICU length of stay |
Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days alive and out of the ICU within 30 days from randomization will be collected from the EHR. Number of ICU days from randomization to hospital discharge or death will also be collected from the EHR. |
Assessed for the period between randomization and 30 days following randomization |
|
Secondary |
Intensity of care/Hospital use: Hospital length of stay |
Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days alive and out of the hospital within 30 days from randomization will be collected from the EHR. Number of hospital days from randomization to hospital discharge or death will also be collected from the EHR. |
Assessed for the period between randomization and 30 days following randomization |
|
Secondary |
Intensity of care: Hospital Readmissions 30 days |
Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization collected from the EHR. |
Assessed for the period between randomization and 30 days following randomization |
|
Secondary |
Intensity of care: ICU Readmissions 30 days |
Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR. |
Assessed for the period between randomization and 30 days following randomization |
|
Secondary |
Intensity of care: Healthcare costs |
Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed. |
Between randomization and 30 days after randomization |
|
Secondary |
Intensity of care: Healthcare utilization |
Subjects will complete a short healthcare utilization survey at the time of the 2nd follow-up questionnaire in which they will self-report the number of visits to emergency departments, hospitals and/or outpatient clinics during the study period. |
Between randomization and 30 days after randomization |
|
Secondary |
All-cause mortality at 1 year (safety outcome) |
From Washington State death certificates. |
1 year after randomization |
|
Secondary |
Patient or surrogate/family-reported discussion of goals |
Subjects will self-report (yes or no) if they had a discussion of goals of care ("the kind of medical care you/your loved one would want") during the index hospitalization. This outcome will be presented as a proportion: the number of subjects reporting a goals-of-care discussion over the number of patients in each study arm. |
3 days and 4 weeks after randomization |
|
Secondary |
Quality of Communication (QOC) |
Quality of goals-of-care communication is assessed with the end-of-life communication scale (QOC_eol) of the Quality of Communication (QOC) survey. The QOC_eol subscale is based on 4 to 7 items, with item scores ranging from 0 (worst) to 10 (best). |
3 days after randomization |
|
Secondary |
SUPPORT questions |
Concordance between the care patients want and the care they are receiving will be measured with two questions from the SUPPORT study. The first defines patients' preferences: "If you [patient] had to make a choice at this time, would you prefer a course of treatment focused on extending life as much as possible, even if it means having more pain and discomfort, or would you want a plan of care focused on relieving pain and discomfort as much as possible, even if that means not living as long?" The second question assesses perceptions of current treatment using the same two options. The outcome is a dichotomous variable of whether the preference matches the report of care received. |
3 days and 4 weeks after randomization |
|
Secondary |
Anxiety and depression (HADS) |
Symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a reliable, valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety and seven evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. |
4 weeks after randomization |
|
Secondary |
EuroQol 5 Dimensions 5 Level (EQ-5D-5L) |
The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. |
4 weeks after randomization |
|
Secondary |
SF1 |
We will use the SF1 as a measure of self-reported overall health status. |
3 days and 4 weeks after randomization |
|
Secondary |
CollaboRATE |
The CollaboRATE is patient-reported measure of shared decision making. |
3 days after randomization |
|
Secondary |
Patient reported discussion of life-sustaining treatments |
We are using the following question to probe patient-reported discussions of life-sustaining treatments with their doctors: "Have you ever thought about what kinds of life-sustaining treatments you would want, or not want, if you got a lot sicker? Yes/no" |
3 days and 4 weeks after randomization |
|
Secondary |
Goal concordance |
Concordance between the care patients want and the care they are receiving will be measured by an investigator-developed question: "Do you think that your current medical care is in line with your goals?" |
3 days and 4 weeks after randomization |
|