Advance Care Planning, Chronic Disease, Communication, Critical Illness, End Stage Liver Disease, Heart Failure, Kidney Failure, Chronic, Lung Neoplasms, Neoplasm Metastasis, Palliative Care, Pulmonary Disease, Chronic Obstructive, Terminal Care
Conditions
Keywords
Palliative Care, End-of-Life Issues, Patient/Clinician Communication, Patient/Family Communication, Concordance, Treatment Preferences, Anxiety, Depressive Symptoms, Talking with Your Doctor, Coping with Serious Illness, Outpatient Collaboration
Brief summary
The purpose of this study is to improve care delivered to patients with serious illness by enhancing communication among patients, families, and clinicians in the outpatient setting. We are testing a new way to help patients share their preferences for talking about end-of-life care with their clinicians and families. To do this we created a simple, short feedback form. The form is designed to help clinicians understand what patients would like to talk about. The goal of this research study is to show that using a feedback form is possible and can be helpful for patients and their families.
Detailed description
Four decades of research on end-of-life care indicate that people who are dying often spend their final days with a significant burden of pain and other symptoms and receive care they would not choose. Patient-clinician communication about end-of-life care is an important focus for improving care for three reasons: 1) when it occurs, it is associated with improved quality of life, reduced anxiety, and fewer intensive life-sustaining therapies at the end of life; 2) physicians frequently do not have discussions about end-of-life care with their patients even though most patients desire these discussions; and 3) our preliminary studies suggest that a simple intervention based on each patient's informational needs and preferences can increase the occurrence and quality of patient-clinician communication about end-of-life care. By tailoring patient-clinician discussions to the individual patient, patients will be able to make care decisions that are best for them and clinicians will be able to provide patients with the care patients' desire. Our long-term goal is to ensure that patients receive the end-of-life care they desire through improved patient-clinician communication. If effective, this health-system intervention will improve: 1) the occurrence and quality of patient-centered communication about end-of-life care for patients with chronic life-limiting illness and their families; 2) the agreement between patients' wishes for care and care received; and 3) the burden of symptoms of anxiety and depression experienced by patients and families. We propose a randomized trial of a feedback form, called a Jumpstart form, provided to patients, family members and clinicians, specifying the individual patient's communication needs and preferences concerning end-of- life care. The trial will be tested with clinicians (n=120) who provide primary or specialty care to eligible patients at clinics of two large healthcare systems. Eligible patients (up to 6 per clinician, goal n=500) will include those with chronic, life-limiting illness. Family members of patients and interdisciplinary team members of primary clinicians may participate. Primary clinicians will be randomized to the intervention or usual care. The intervention's effectiveness will be compared with usual care using validated self-report questionnaires that will be collected longitudinally (baseline/enrollment, within 2 weeks of the target visit, 3 months, 6 months) from patients and families. Analyses include statistical approaches that take into account that there will be more than one patient for each physician and that data are collected at multiple time points. Outcomes of this study include patient assessments of: 1) frequency and quality of patient/clinician communication; 2) agreement between care patients desire and care patients receive; and 3) symptoms of anxiety and depression. We will also use qualitative data to accomplish the following goals: 1) to explore subjects' experiences with the study's activities; 2) to understand barriers to participation; and 3) to explore patient and family experiences with the intervention. To obtain these goals, we will contact a total of 30-40 participants, selected from all subject groups, to participate in one-on-one semi-structured interviews during which they will be asked to share their experiences as a study participant and their perspectives on study activities.
Interventions
BEHAVIORALCommunication Feedback Form for Patients with Serious Illness
The intervention, based on self-efficacy theory, identifies patients' preferences for communication about end-of-life care (EOLC) and barriers and facilitators to this communication, and collates these data into a feedback form. The feedback forms are tailored to each recipient (clinician, patient, family) to support the communication tasks which that recipient will address. Feedback forms are sent to participants prior to the target clinic visit. The primary clinician's form suggests referral to palliative care if there are potentially unmet palliative-care communication needs. All forms include tips to help the recipient respond to communication preferences appropriately.
Sponsors
Patient-Centered Outcomes Research Institute
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible primary clinicians will include all clinicians who provide ongoing primary or specialty care to eligible patient populations. This will include primary care physicians (family medicine and internal medicine), oncologists, pulmonologists, cardiologists, gastroenterologists, nephrologists, neurologists, hepatologists, and geriatricians. Primary clinicians may also include nurse practitioners and physician assistants playing a primary role with eligible patients. A primary role denotes any clinician for whom having a discussion about end-of-life care with eligible patients would be indicated * Eligible interprofessional team members will include nurses, social workers and other clinicians who are part of an enrolled primary clinician's clinic team. * Eligible patients will be those under the care of a participating clinician who are 18 years of age or older, have had 2 or more visits with the primary clinician in the last 18 months, and meet diagnostic criteria. Diagnostic criteria include: 1) metastatic cancer or inoperable lung cancer; 2) chronic obstructive pulmonary disease with FEV1 values \<35% predicted or oxygen dependence or restrictive lung disease with a TLC \< 50% predicted; 3) New York Heart Association Class III or IV heart failure; 4) Child's Class C cirrhosis or MELD score of \>17; 5) dialysis-dependent renal failure and either diabetes or a serum albumin of \< 2.5; or, 6) older than 75 years with at least one life-limiting chronic illness or older than 90 years. Additional criteria include: PAH w. 6MWD \<250m, restrictive lung disease (IPF, ILD) w/ TLC \<50%, and cystic fibrosis with FEV1 \< 30%. Eligible patients will also be English-speaking and have no significant dementia or cognitive impairment that would limit his/her ability to complete questionnaires. * Eligible family members will be identified by the patient, with the criterion that the patient would want the family member involved in medical decision-making for the patient if he/she was not able. For the purpose of this study, family member is not confined to legal next-of-kin or immediate family member. Any family member, friend, or caregiver is eligible who is English-speaking and has no dementia or delirium limiting his/her ability to complete questionnaires.
Exclusion criteria
* Reasons for exclusion for all subject groups include: legal or risk management concerns; and physical or mental limitations preventing ability to complete research activities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Discussion About Goals of Care at Target Visit | 2 weeks after target visit | Patient's response to question, Did you discuss with this doctor the kind of medical care you would want if you were too sick to speak for yourself? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Discussion About Goals of Care at Target Visit | Target visit | Electronic Health Record (EHR) documentation of discussion about advance care planning, prognosis, treatment preference, hospice, palliative care, or Physician Orders for Life-Sustaining Treatment (POLST) at target visit |
| Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline | 2 weeks after target visit | Patient's response to question, Did you discuss with this doctor the kind of medical care you would want if you were too sick to speak for yourself? |
| Goal-Concordant Care | 3 months after target visit | Binary variable indicating whether patient's reported focus of current treatment was concordant with treatment preference |
| Goal-Concordant Care Among Patients With Stable Treatment Preference | 3 months after target visit | Binary variable indicating whether patient's reported focus of current treatment was concordant with treatment preference |
| Quality of Communication (QOC): Four-Indicator Latent Construct | 2 weeks from target visit | Quality of Communication: patient ratings of clinician on seven aspects of end-of-life communication, each aspect having a pseudo-continuous response range of 0 ('clinician didn't do this') to 11 ('the very best I could imagine'). Measured with QOC items 1, 2, 5, & 6 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable; Higher value indicates better outcome (i.e., higher quality communication) Unit of measurement: scores on a scale |
| Quality of Communication (QOC): Individual QOC Items | 2 weeks from target visit | Quality of Communication: patient ratings of clinician on seven aspects of end-of-life communication, each aspect having a pseudo-continuous response range of 0 ('clinician didn't do this') to 11 ('the very best I could imagine'). Individual QOC Items. Theoretical range: 0-11 Actual range: 0-11 Higher value indicates better outcome (i.e., higher quality communication) Unit of measurement: units on a scale |
| Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct | 3 months after target visit | Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with PHQ items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale |
| Patient Health Questionnaire (PHQ-8): Eight-Item Scale | 3 months after target visit | Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Eight-Item Scale: Sum of responses for the eight symptoms (weighted by 8/7 if only 7 items answered). Theoretical range: 0-24 Actual range: 0-24 Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale |
| Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct | 3 months after target visit | Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with GAD items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale |
| Palliative Care Consultation and/or Referral - All Patients | 3-month period following the target visit | EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay. |
| Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit | 3-month period following the target visit | EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion. |
| Generalized Anxiety Disorder (GAD-7): Seven-Item Scale | 3 months after target visit | Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Seven-Item Scale: Sum of responses for the seven symptoms (weighted by 7/6 if only 6 items answered). (Strong floor effect.) Theoretical range: 0-21 Actual range: 0-21 Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale |
| Avoidance of Life-Sustaining Therapies, All Patients | 6-month period following the target visit | Review of EHR documentation to assess use of three indicators of life-sustaining therapies (LST): admission to an ICU, receipt of CPR, and receipt of mechanical ventilation |
| Avoidance of Life-Sustaining Therapies, Patients With Comfort Care Preference | 6-month period following the target visit | Review of EHR documentation to assess use of three indicators of life-sustaining therapies (LST): admission to an ICU, receipt of CPR, and receipt of mechanical ventilation for patients preferring comfort (quality of life over extending life) at the end-of-life |
| Palliative Care Consultation, Inpatient Stay - All Patients | 3-month period following the target visit | EHR documentation of palliative care consultation during an inpatient stay for all patients with target visit and chart abstraction. |
| Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit | 3-month period following the target visit | EHR documentation of palliative care consultation during an inpatient stay for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion. |
| Palliative Care Referral, Outpatient Visit - All Patients | 3-month period following the target visit | EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit. |
| Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit | 3-month period following the target visit | EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care) | 3 months after target visit | Binary variable indicating whether patient's current preference was for life-extension or comfort care |
| Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care) | 3 months after target visit | Binary variable indicating whether patient's treatment preference was stable between target visit (or baseline, if no 2-week questionnaire was returned) and 3 months. |
Countries
United States
Participant flow
Recruitment details
CLINICIANS and INTERPROFESSIONAL (IP) TEAM recruited from Feb 2014 to Nov 2015. PATIENTS and FAMILY recruited from Mar 2014 to Jun 2016. Potential subjects received introductory letters and phone calls to assess interest and eligibility. INTERVIEWEES were selected via purposive sampling from those who completed the intervention activities.
Pre-assignment details
635 CLINICIANS assessed for eligibility; 503 excluded; 132 enrolled. Unit of randomization was clinician. 11 IP TEAM members identified; 4 enrolled. 1113 PATIENTS assessed for eligibility; 576 excluded; 537 enrolled. 142 FAMILY identified; 23 excluded; 119 enrolled. Subjects were enrolled if they completed a baseline survey prior to target visit.
Participants by arm
| Arm | Count |
|---|---|
| Clinician Intervention Received Jumpstart feedback forms and education | 65 |
| Clinician Control Received/Provided usual care, surveys only | 67 |
| IP Team Intervention Received Jumpstart feedback forms and education | 2 |
| IP Team Control Received/Provided usual care, surveys only | 2 |
| Patient Intervention Received Jumpstart feedback forms and education | 249 |
| Patient Control Received usual care, surveys only | 288 |
| Family Member Intervention Received Jumpstart feedback forms and education | 58 |
| Family Member Control Received usual care, surveys only | 61 |
| Interviewees Key informants: Clinicians, Patients and Family Members. These subjects did not complete baseline measures. | 0 |
| Total | 792 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Became Ineligible | 4 | 0 | 0 | 0 | 13 | 10 | 13 | 6 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 21 | 32 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 8 | 9 | 1 | 4 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 | 0 | 17 | 16 | 1 | 4 | 0 |
Baseline characteristics
| Characteristic | Clinician Intervention | Clinician Control | IP Team Intervention | IP Team Control | Patient Intervention | Patient Control | Family Member Intervention | Family Member Control | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 189 Participants | 212 Participants | 30 Participants | 34 Participants | 467 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants | 65 Participants | 2 Participants | 2 Participants | 60 Participants | 76 Participants | 28 Participants | 27 Participants | 325 Participants |
| Age, Continuous | 46.9 years STANDARD_DEVIATION 8.64 | 47.2 years STANDARD_DEVIATION 10.48 | 41.0 years STANDARD_DEVIATION 2.83 | 59.0 years STANDARD_DEVIATION 5.66 | 73.6 years STANDARD_DEVIATION 11.37 | 73.3 years STANDARD_DEVIATION 13.71 | 65.4 years STANDARD_DEVIATION 13.32 | 65.3 years STANDARD_DEVIATION 13.96 | 67.7 years STANDARD_DEVIATION 15.73 |
| Barriers I don't know what kind of care I would want | — | — | — | — | 101 Participants | 114 Participants | — | — | 215 Participants |
| Barriers I don't like to talk about getting very sick | — | — | — | — | 69 Participants | 79 Participants | — | — | 148 Participants |
| Barriers I'd rather concentrate on staying alive | — | — | — | — | 145 Participants | 169 Participants | — | — | 314 Participants |
| Barriers I feel that talking about death can bring it close | — | — | — | — | 29 Participants | 37 Participants | — | — | 66 Participants |
| Barriers I have a living will, so I don't need to talk | — | — | — | — | 51 Participants | 73 Participants | — | — | 124 Participants |
| Barriers I have not felt sick enough | — | — | — | — | 132 Participants | 146 Participants | — | — | 278 Participants |
| Barriers I'm not ready to talk about care I would want | — | — | — | — | 55 Participants | 55 Participants | — | — | 110 Participants |
| Barriers I'm not sure which doctor would be caring for me | — | — | — | — | 126 Participants | 136 Participants | — | — | 262 Participants |
| Barriers My doctor never seems to have the time | — | — | — | — | 18 Participants | 25 Participants | — | — | 43 Participants |
| Barriers My ideas about the kind of care I want change | — | — | — | — | 107 Participants | 110 Participants | — | — | 217 Participants |
| Choosing Care Extending life | — | — | — | — | 46 Participants | 43 Participants | 12 Participants | 11 Participants | 112 Participants |
| Choosing Care I don't know/Not sure | — | — | — | — | 54 Participants | 69 Participants | 14 Participants | 10 Participants | 147 Participants |
| Choosing Care Quality of life (relieving pain and discomfort) | — | — | — | — | 149 Participants | 174 Participants | 32 Participants | 38 Participants | 393 Participants |
| Clinician's Specialty Cardiology | 14 Participants | 3 Participants | — | — | — | — | — | — | 17 Participants |
| Clinician's Specialty Family Medicine | 14 Participants | 17 Participants | — | — | — | — | — | — | 31 Participants |
| Clinician's Specialty Gastroenterology | 3 Participants | 1 Participants | — | — | — | — | — | — | 4 Participants |
| Clinician's Specialty Geriatrics | 2 Participants | 1 Participants | — | — | — | — | — | — | 3 Participants |
| Clinician's Specialty Internal Medicine | 18 Participants | 18 Participants | — | — | — | — | — | — | 36 Participants |
| Clinician's Specialty Nephrology | 3 Participants | 4 Participants | — | — | — | — | — | — | 7 Participants |
| Clinician's Specialty Oncology | 8 Participants | 18 Participants | — | — | — | — | — | — | 26 Participants |
| Clinician's Specialty Pulmonology | 3 Participants | 5 Participants | — | — | — | — | — | — | 8 Participants |
| Clinician Type Nurse Practicioner | 5 Participants | 5 Participants | — | — | — | — | — | — | 10 Participants |
| Clinician Type Physician | 60 Participants | 62 Participants | — | — | — | — | — | — | 122 Participants |
| Competence [Communication & End-of-Life (EOL) Care] | 3.8 units on a scale STANDARD_DEVIATION 0.55 | 3.5 units on a scale STANDARD_DEVIATION 0.57 | — | — | — | — | — | — | 3.8 units on a scale STANDARD_DEVIATION 0.56 |
| Facilitators I have been very sick | — | — | — | — | 130 Participants | 145 Participants | — | — | 275 Participants |
| Facilitators I have had family or friends who have died | — | — | — | — | 161 Participants | 200 Participants | — | — | 361 Participants |
| Facilitators I worry about the quality of my life in the future | — | — | — | — | 132 Participants | 151 Participants | — | — | 283 Participants |
| Facilitators I worry that I could be a burden | — | — | — | — | 171 Participants | 190 Participants | — | — | 361 Participants |
| Focus of Care Extending life | — | — | — | — | 84 Participants | 113 Participants | 19 Participants | 20 Participants | 236 Participants |
| Focus of Care I don't know/Not sure | — | — | — | — | 76 Participants | 81 Participants | 18 Participants | 15 Participants | 190 Participants |
| Focus of Care Quality of life (relieving pain and discomfort) | — | — | — | — | 84 Participants | 90 Participants | 20 Participants | 24 Participants | 218 Participants |
| Generalized Anxiety Disorder (GAD-7): Seven-Item Scale | — | — | — | — | 2 scores on a scale | 1 scores on a scale | — | — | 2 scores on a scale |
| Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct | — | — | — | — | 0.179 scores on a scale STANDARD_DEVIATION 0.901 | 0.000 scores on a scale STANDARD_DEVIATION 0.899 | — | — | 0.082 scores on a scale STANDARD_DEVIATION 0.903 |
| Patient Average Monthly Income | — | — | — | — | 5 units on a scale | 5 units on a scale | — | — | 5 units on a scale |
| Patient Education Level | — | — | — | — | 3 units on a scale | 3 units on a scale | — | — | 3 units on a scale |
| Patient Health Questionnaire (PHQ-8): Eight-Item Scale | — | — | — | — | 5.859 scores on a scale STANDARD_DEVIATION 4.796 | 5.152 scores on a scale STANDARD_DEVIATION 4.744 | — | — | 5.478 scores on a scale STANDARD_DEVIATION 4.777 |
| Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct | — | — | — | — | 0.327 scores on a scale STANDARD_DEVIATION 0.706 | 0.000 scores on a scale STANDARD_DEVIATION 0.743 | — | — | 0.146 scores on a scale STANDARD_DEVIATION 0.743 |
| Patient Self-Assessed Health Status | — | — | — | — | 2 units on a scale | 2 units on a scale | — | — | 2 units on a scale |
| Preference Regarding Future Discussion with Clinician No objection to future discussion stated | — | — | — | — | 197 Participants | 212 Participants | — | — | 409 Participants |
| Preference Regarding Future Discussion with Clinician Objected to future discussion | — | — | — | — | 52 Participants | 76 Participants | — | — | 128 Participants |
| Quality of Communication (QOC): Four-Indicator Latent Construct | — | — | — | — | -0.695 scores on a scale STANDARD_DEVIATION 7.089 | 0.000 scores on a scale STANDARD_DEVIATION 6.332 | — | — | -0.329 scores on a scale STANDARD_DEVIATION 6.698 |
| Quality of Communication (QOC): Individual QOC Items Ask about important things in life | — | — | — | — | 5 units on a scale | 8 units on a scale | — | — | 6 units on a scale |
| Quality of Communication (QOC): Individual QOC Items Ask about spiritual or religious beliefs | — | — | — | — | 0 units on a scale | 0 units on a scale | — | — | 0 units on a scale |
| Quality of Communication (QOC): Individual QOC Items Discuss details about getting sicker | — | — | — | — | 7 units on a scale | 8 units on a scale | — | — | 7 units on a scale |
| Quality of Communication (QOC): Individual QOC Items Discuss feelings about getting sicker | — | — | — | — | 5.5 units on a scale | 8 units on a scale | — | — | 6 units on a scale |
| Quality of Communication (QOC): Individual QOC Items Discuss prognosis | — | — | — | — | 0 units on a scale | 0 units on a scale | — | — | 0 units on a scale |
| Quality of Communication (QOC): Individual QOC Items Discuss what dying might be like | — | — | — | — | 0 units on a scale | 0 units on a scale | — | — | 0 units on a scale |
| Quality of Communication (QOC): Individual QOC Items Involve in EOL treatment decisions | — | — | — | — | 0 units on a scale | 0 units on a scale | — | — | 0 units on a scale |
| Race/Ethnicity, Customized Minority Race/Ethnicity | 16 Participants | 16 Participants | 0 Participants | 0 Participants | 43 Participants | 69 Participants | 9 Participants | 8 Participants | 161 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 49 Participants | 51 Participants | 2 Participants | 2 Participants | 206 Participants | 219 Participants | 49 Participants | 51 Participants | 629 Participants |
| Sex: Female, Male Female | 37 Participants | 34 Participants | 2 Participants | 2 Participants | 124 Participants | 132 Participants | 46 Participants | 43 Participants | 420 Participants |
| Sex: Female, Male Male | 28 Participants | 33 Participants | 0 Participants | 0 Participants | 125 Participants | 156 Participants | 12 Participants | 18 Participants | 372 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 | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 65 | 0 / 67 | 0 / 2 | 0 / 2 | 0 / 249 | 2 / 288 | 0 / 58 | 0 / 61 | 0 / 25 |
| serious Total, serious adverse events | 0 / 65 | 0 / 67 | 0 / 2 | 0 / 2 | 0 / 249 | 0 / 288 | 0 / 58 | 0 / 61 | 0 / 25 |
Outcome results
Primary
Occurrence of Discussion About Goals of Care at Target Visit
Patient's response to question, Did you discuss with this doctor the kind of medical care you would want if you were too sick to speak for yourself?
Time frame: 2 weeks after target visit
Population: Patients completing 2-week questionnaires. Not all patients provided data at this time point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Occurrence of Discussion About Goals of Care at Target Visit | Yes | 137 Participants |
| Patient Intervention | Occurrence of Discussion About Goals of Care at Target Visit | No or Don't Know | 47 Participants |
| Patient Intervention | Occurrence of Discussion About Goals of Care at Target Visit | No response | 0 Participants |
| Patient Control | Occurrence of Discussion About Goals of Care at Target Visit | Yes | 66 Participants |
| Patient Control | Occurrence of Discussion About Goals of Care at Target Visit | No or Don't Know | 145 Participants |
| Patient Control | Occurrence of Discussion About Goals of Care at Target Visit | No response | 4 Participants |
p-value: <0.00195% CI: [0.844, 1.446]Clustered probit regression
Secondary
Avoidance of Life-Sustaining Therapies, All Patients
Review of EHR documentation to assess use of three indicators of life-sustaining therapies (LST): admission to an ICU, receipt of CPR, and receipt of mechanical ventilation
Time frame: 6-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Avoidance of Life-Sustaining Therapies, All Patients | Received LST | 18 Participants |
| Patient Intervention | Avoidance of Life-Sustaining Therapies, All Patients | Avoided LST | 209 Participants |
| Patient Control | Avoidance of Life-Sustaining Therapies, All Patients | Received LST | 14 Participants |
| Patient Control | Avoidance of Life-Sustaining Therapies, All Patients | Avoided LST | 251 Participants |
p-value: 0.41895% CI: [-0.923, 0.482]clustered probit regression
Secondary
Avoidance of Life-Sustaining Therapies, Patients With Comfort Care Preference
Review of EHR documentation to assess use of three indicators of life-sustaining therapies (LST): admission to an ICU, receipt of CPR, and receipt of mechanical ventilation for patients preferring comfort (quality of life over extending life) at the end-of-life
Time frame: 6-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Avoidance of Life-Sustaining Therapies, Patients With Comfort Care Preference | Received LST | 7 Participants |
| Patient Intervention | Avoidance of Life-Sustaining Therapies, Patients With Comfort Care Preference | Avoided LST | 102 Participants |
| Patient Control | Avoidance of Life-Sustaining Therapies, Patients With Comfort Care Preference | Received LST | 10 Participants |
| Patient Control | Avoidance of Life-Sustaining Therapies, Patients With Comfort Care Preference | Avoided LST | 102 Participants |
p-value: 0.56895% CI: [-0.613, 0.962]clustered probit regression
Secondary
Generalized Anxiety Disorder (GAD-7): Seven-Item Scale
Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Seven-Item Scale: Sum of responses for the seven symptoms (weighted by 7/6 if only 6 items answered). (Strong floor effect.) Theoretical range: 0-21 Actual range: 0-21 Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale
Time frame: 3 months after target visit
Population: Survey items asked of patients at 3-months. Some intervention and control patients did not provide valid responses on 6+ items.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient Intervention | Generalized Anxiety Disorder (GAD-7): Seven-Item Scale | 2 scores on a scale |
| Patient Control | Generalized Anxiety Disorder (GAD-7): Seven-Item Scale | 2 scores on a scale |
Comparison: Symptoms of anxiety: Standard GAD-7 composite scorep-value: 0.93595% CI: [-0.946, 1.028]Clustered Tobit regression
Secondary
Generalized Anxiety Disorder (GAD-7): Seven-Item Scale
Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Seven-Item Scale: Sum of responses for the seven symptoms (weighted by 7/6 if only 6 items answered). (Strong floor effect.) Theoretical range: 0-21 Actual range: 0-21 Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale
Time frame: 6 months after target visit
Population: Survey items asked of patients at 6-months. Some intervention and control patients did not provide valid responses on 6+ items.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient Intervention | Generalized Anxiety Disorder (GAD-7): Seven-Item Scale | 1 scores on a scale |
| Patient Control | Generalized Anxiety Disorder (GAD-7): Seven-Item Scale | 1 scores on a scale |
p-value: 0.85295% CI: [-1.204, 0.995]Clustered Tobit regression
Secondary
Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct
Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with GAD items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale
Time frame: 3 months after target visit
Population: Both survey items answered by patients at baseline, 3-months \& 6-months: 127 valid intervention responses; 150 valid control responses.~Continuous measure with control group mean fixed at zero at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Intervention | Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct | 0.281 scores on a scale | Standard Deviation 0.788 |
| Patient Control | Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct | 0.217 scores on a scale | Standard Deviation 0.807 |
Comparison: Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over timep-value: 0.73495% CI: [-0.232, 0.163]Clustered probit regression
Secondary
Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct
Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with GAD items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale
Time frame: 6 months after target visit
Population: Both survey items answered by patients at baseline, 3-months \& 6-months: 127 valid intervention responses; 150 valid control responses.~Continuous measure with control group mean fixed at zero at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Intervention | Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct | 0.297 scores on a scale | Standard Deviation 0.847 |
| Patient Control | Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct | 0.209 scores on a scale | Standard Deviation 0.935 |
Comparison: Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over timep-value: 0.68995% CI: [-0.247, 0.163]Clustered probit regression
Secondary
Goal-Concordant Care
Binary variable indicating whether patient's reported focus of current treatment was concordant with treatment preference
Time frame: 3 months after target visit
Population: Survey items asked of patients at 3-months. Not all patients provided data at this time point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Goal-Concordant Care | Discordant | 74 Participants |
| Patient Intervention | Goal-Concordant Care | Concordant | 93 Participants |
| Patient Intervention | Goal-Concordant Care | Unknown (no resp to preference &/or current care) | 9 Participants |
| Patient Control | Goal-Concordant Care | Discordant | 116 Participants |
| Patient Control | Goal-Concordant Care | Concordant | 84 Participants |
| Patient Control | Goal-Concordant Care | Unknown (no resp to preference &/or current care) | 11 Participants |
Comparison: Occurrence of goal-concordant carep-value: 0.07395% CI: [-0.031, 0.699]Clustered probit regression
Secondary
Goal-Concordant Care Among Patients With Stable Treatment Preference
Binary variable indicating whether patient's reported focus of current treatment was concordant with treatment preference
Time frame: 3 months after target visit
Population: Survey items asked of patients at 3-months. Not all patients provided data at this time point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Goal-Concordant Care Among Patients With Stable Treatment Preference | Discordant | 27 Participants |
| Patient Intervention | Goal-Concordant Care Among Patients With Stable Treatment Preference | Concordant | 74 Participants |
| Patient Intervention | Goal-Concordant Care Among Patients With Stable Treatment Preference | Unknown (no resp to preference &/or current care) | 3 Participants |
| Patient Control | Goal-Concordant Care Among Patients With Stable Treatment Preference | Discordant | 43 Participants |
| Patient Control | Goal-Concordant Care Among Patients With Stable Treatment Preference | Concordant | 57 Participants |
| Patient Control | Goal-Concordant Care Among Patients With Stable Treatment Preference | Unknown (no resp to preference &/or current care) | 3 Participants |
p-value: 0.01795% CI: [0.085, 0.877]Clustered probit regression
Secondary
Occurrence of Discussion About Goals of Care at Target Visit
Electronic Health Record (EHR) documentation of discussion about advance care planning, prognosis, treatment preference, hospice, palliative care, or Physician Orders for Life-Sustaining Treatment (POLST) at target visit
Time frame: Target visit
Population: Target visit abstracted from patient electronic health record (EHR); not all data were available for this time point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Occurrence of Discussion About Goals of Care at Target Visit | Discussion documented | 140 Participants |
| Patient Intervention | Occurrence of Discussion About Goals of Care at Target Visit | Discussion not documented | 87 Participants |
| Patient Control | Occurrence of Discussion About Goals of Care at Target Visit | Discussion documented | 45 Participants |
| Patient Control | Occurrence of Discussion About Goals of Care at Target Visit | Discussion not documented | 220 Participants |
p-value: <0.00195% CI: [0.92, 1.583]Clustered probit regression
Secondary
Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline
Electronic Health Record (EHR) documentation of discussion about advance care planning, prognosis, treatment preference, hospice, palliative care, or Physician Orders for Life-Sustaining Treatment (POLST) at target visit
Time frame: Target visit
Population: Patient EHR abstracted for target visit and had no objection at baseline.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline | Discussion documented | 114 Participants |
| Patient Intervention | Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline | Discussion not documented | 66 Participants |
| Patient Control | Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline | Discussion documented | 34 Participants |
| Patient Control | Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline | Discussion not documented | 165 Participants |
Secondary
Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline
Patient's response to question, Did you discuss with this doctor the kind of medical care you would want if you were too sick to speak for yourself?
Time frame: 2 weeks after target visit
Population: Patients who completed 2-week questionnaires and reported no objection at baseline.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline | Yes | 112 Participants |
| Patient Intervention | Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline | No or Don't know | 31 Participants |
| Patient Intervention | Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline | No response | 0 Participants |
| Patient Control | Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline | Yes | 44 Participants |
| Patient Control | Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline | No or Don't know | 116 Participants |
| Patient Control | Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline | No response | 4 Participants |
p-value: <0.00195% CI: [1.046, 1.715]Clustered probit regression
Secondary
Palliative Care Consultation and/or Referral - All Patients
EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay.
Time frame: 6-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Palliative Care Consultation and/or Referral - All Patients | No | 206 Participants |
| Patient Intervention | Palliative Care Consultation and/or Referral - All Patients | Yes | 21 Participants |
| Patient Control | Palliative Care Consultation and/or Referral - All Patients | No | 240 Participants |
| Patient Control | Palliative Care Consultation and/or Referral - All Patients | Yes | 25 Participants |
p-value: 0.95595% CI: [-0.474, 0.454]clustered probit regression
Secondary
Palliative Care Consultation and/or Referral - All Patients
EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay.
Time frame: 3-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Palliative Care Consultation and/or Referral - All Patients | No | 212 Participants |
| Patient Intervention | Palliative Care Consultation and/or Referral - All Patients | Yes | 15 Participants |
| Patient Control | Palliative Care Consultation and/or Referral - All Patients | No | 247 Participants |
| Patient Control | Palliative Care Consultation and/or Referral - All Patients | Yes | 18 Participants |
p-value: 0.9495% CI: [-0.489, 0.461]clustered probit regression
Secondary
Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit
EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion.
Time frame: 6-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit | No | 87 Participants |
| Patient Intervention | Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit | Yes | 6 Participants |
| Patient Control | Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit | No | 106 Participants |
| Patient Control | Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit | Yes | 13 Participants |
p-value: 0.30395% CI: [-1.005, 0.431]clustered probit regression
Secondary
Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit
EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion.
Time frame: 3-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit | No | 83 Participants |
| Patient Intervention | Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit | Yes | 4 Participants |
| Patient Control | Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit | No | 102 Participants |
| Patient Control | Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit | Yes | 8 Participants |
p-value: 0.4795% CI: [-1.044, 0.587]clustered probit regression
Secondary
Palliative Care Consultation, Inpatient Stay - All Patients
EHR documentation of palliative care consultation during an inpatient stay for all patients with target visit and chart abstraction.
Time frame: 3-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Palliative Care Consultation, Inpatient Stay - All Patients | Yes | 6 Participants |
| Patient Intervention | Palliative Care Consultation, Inpatient Stay - All Patients | No | 221 Participants |
| Patient Control | Palliative Care Consultation, Inpatient Stay - All Patients | No | 260 Participants |
| Patient Control | Palliative Care Consultation, Inpatient Stay - All Patients | Yes | 5 Participants |
p-value: 0.59295% CI: [-0.534, 0.815]clustered probit regression
Secondary
Palliative Care Consultation, Inpatient Stay - All Patients
EHR documentation of palliative care consultation during an inpatient stay for all patients with target visit and chart abstraction.
Time frame: 6-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Palliative Care Consultation, Inpatient Stay - All Patients | No | 218 Participants |
| Patient Intervention | Palliative Care Consultation, Inpatient Stay - All Patients | Yes | 9 Participants |
| Patient Control | Palliative Care Consultation, Inpatient Stay - All Patients | No | 257 Participants |
| Patient Control | Palliative Care Consultation, Inpatient Stay - All Patients | Yes | 8 Participants |
p-value: 0.64495% CI: [-0.56, 0.805]clustered probit regression
Secondary
Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit
EHR documentation of palliative care consultation during an inpatient stay for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion.
Time frame: 6-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit | No | 91 Participants |
| Patient Intervention | Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit | Yes | 2 Participants |
| Patient Control | Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit | No | 114 Participants |
| Patient Control | Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit | Yes | 5 Participants |
p-value: 0.90895% CI: [-3.833, 3.503]clustered probit regression
Secondary
Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit
EHR documentation of palliative care consultation during an inpatient stay for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion.
Time frame: 3-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit | No | 86 Participants |
| Patient Intervention | Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit | Yes | 1 Participants |
| Patient Control | Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit | No | 102 Participants |
| Patient Control | Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit | Yes | 8 Participants |
p-value: 0.70595% CI: [-1.398, 1.04]clustered probit regression
Secondary
Palliative Care Referral, Outpatient Visit - All Patients
EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit.
Time frame: 3-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Palliative Care Referral, Outpatient Visit - All Patients | No | 217 Participants |
| Patient Intervention | Palliative Care Referral, Outpatient Visit - All Patients | Yes | 10 Participants |
| Patient Control | Palliative Care Referral, Outpatient Visit - All Patients | No | 250 Participants |
| Patient Control | Palliative Care Referral, Outpatient Visit - All Patients | Yes | 15 Participants |
p-value: 0.55295% CI: [-0.646, 0.403]clustered probit regression
Secondary
Palliative Care Referral, Outpatient Visit - All Patients
EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit.
Time frame: 6-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Palliative Care Referral, Outpatient Visit - All Patients | No | 213 Participants |
| Patient Intervention | Palliative Care Referral, Outpatient Visit - All Patients | Yes | 14 Participants |
| Patient Control | Palliative Care Referral, Outpatient Visit - All Patients | No | 244 Participants |
| Patient Control | Palliative Care Referral, Outpatient Visit - All Patients | Yes | 21 Participants |
p-value: 0.50195% CI: [-0.63, 0.369]clustered probit regression
Secondary
Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit
EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion.
Time frame: 3-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit | No | 84 Participants |
| Patient Intervention | Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit | Yes | 3 Participants |
| Patient Control | Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit | No | 103 Participants |
| Patient Control | Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit | Yes | 7 Participants |
p-value: 0.37295% CI: [-1.139, 0.553]clustered probit regression
Secondary
Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit
EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion.
Time frame: 6-month period following the target visit
Population: Patients who had a target visit and a chart reviewed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit | No | 89 Participants |
| Patient Intervention | Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit | Yes | 4 Participants |
| Patient Control | Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit | No | 108 Participants |
| Patient Control | Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit | Yes | 11 Participants |
p-value: 0.19295% CI: [-1.16, 0.38]clustered probit regression
Secondary
Patient Health Questionnaire (PHQ-8): Eight-Item Scale
Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Eight-Item Scale: Sum of responses for the eight symptoms (weighted by 8/7 if only 7 items answered). Theoretical range: 0-24 Actual range: 0-24 Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale
Time frame: 3 months after target visit
Population: Survey items asked of patients at baseline. Some intervention and control patients did not provide valid responses on 7+ items.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Intervention | Patient Health Questionnaire (PHQ-8): Eight-Item Scale | 5.879 scores on a scale | Standard Deviation 4.776 |
| Patient Control | Patient Health Questionnaire (PHQ-8): Eight-Item Scale | 4.908 scores on a scale | Standard Deviation 4.634 |
Comparison: Symptoms of depression: standard PHQ-8 composite score.p-value: 0.53695% CI: [-0.571, 1.097]Clustered robust linear regression
Secondary
Patient Health Questionnaire (PHQ-8): Eight-Item Scale
Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Eight-Item Scale: Sum of responses for the eight symptoms (weighted by 8/7 if only 7 items answered). Theoretical range: 0-24 Actual range: 0-24 Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale
Time frame: 6 months after target visit
Population: Survey items asked of patients at 6-months. Some intervention and control patients did not provide valid responses on 7+ items.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Intervention | Patient Health Questionnaire (PHQ-8): Eight-Item Scale | 5.853 scores on a scale | Standard Deviation 5.339 |
| Patient Control | Patient Health Questionnaire (PHQ-8): Eight-Item Scale | 4.850 scores on a scale | Standard Deviation 4.41 |
Comparison: Symptoms of depression: Standard PHQ-8 composite scorep-value: 0.34395% CI: [-0.476, 1.368]Clustered robust linear regression
Secondary
Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct
Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with PHQ items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale
Time frame: 6 months after target visit
Population: Both survey items answered by patients at baseline, 3-months \& 6-months: 117 valid intervention responses; 145 valid control responses.~Continuous measure with control group mean fixed at zero at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Intervention | Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct | 0.399 scores on a scale | Standard Deviation 0.873 |
| Patient Control | Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct | 0.244 scores on a scale | Standard Deviation 0.737 |
Comparison: Symptoms of depression: Two-indicator latent variable with measurement invariance imposed between groups and over timep-value: 0.10695% CI: [-0.044, 0.461]Clustered probit regression
Secondary
Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct
Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with PHQ items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale
Time frame: 3 months after target visit
Population: Both survey items answered by patients at baseline, 3-months \& 6-months: 117 valid intervention responses; 145 valid control responses.~Continuous measure with control group mean fixed at zero.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Intervention | Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct | 0.255 scores on a scale | Standard Deviation 0.804 |
| Patient Control | Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct | 0.199 scores on a scale | Standard Deviation 0.722 |
Comparison: Symptoms of depression - Two-indicator latent variable with measurement invariance imposed between groups and over time.p-value: 0.36995% CI: [-0.327, 0.122]Clustered probit regression
Secondary
Quality of Communication (QOC): Four-Indicator Latent Construct
Quality of Communication: patient ratings of clinician on seven aspects of end-of-life communication, each aspect having a pseudo-continuous response range of 0 ('clinician didn't do this') to 11 ('the very best I could imagine'). Measured with QOC items 1, 2, 5, & 6 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable; Higher value indicates better outcome (i.e., higher quality communication) Unit of measurement: scores on a scale
Time frame: 2 weeks from target visit
Population: All 4 items asked of patients at baseline \& 2 weeks. Not all patients provided data at these time points.~Continuous measure with control group mean fixed at zero at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Intervention | Quality of Communication (QOC): Four-Indicator Latent Construct | 4.585 scores on a scale | Standard Deviation 4.208 |
| Patient Control | Quality of Communication (QOC): Four-Indicator Latent Construct | 2.128 scores on a scale | Standard Deviation 5.57 |
p-value: 0.0195% CI: [0.476, 3.569]Clustered probit regression
Secondary
Quality of Communication (QOC): Individual QOC Items
Quality of Communication: patient ratings of clinician on seven aspects of end-of-life communication, each aspect having a pseudo-continuous response range of 0 ('clinician didn't do this') to 11 ('the very best I could imagine'). Individual QOC Items. Theoretical range: 0-11 Actual range: 0-11 Higher value indicates better outcome (i.e., higher quality communication) Unit of measurement: units on a scale
Time frame: 2 weeks from target visit
Population: Survey items asked of patients at 2-weeks. Not all patients provided data at this time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patient Intervention | Quality of Communication (QOC): Individual QOC Items | Ask about important things in life | 9 units on a scale |
| Patient Intervention | Quality of Communication (QOC): Individual QOC Items | Ask about spiritual or religion beliefs | 0 units on a scale |
| Patient Intervention | Quality of Communication (QOC): Individual QOC Items | Discuss feelings about getting sicker | 10 units on a scale |
| Patient Intervention | Quality of Communication (QOC): Individual QOC Items | Discuss details about getting sicker | 9 units on a scale |
| Patient Intervention | Quality of Communication (QOC): Individual QOC Items | Discuss prognosis | 0 units on a scale |
| Patient Intervention | Quality of Communication (QOC): Individual QOC Items | Discuss what dying might be like | 0 units on a scale |
| Patient Intervention | Quality of Communication (QOC): Individual QOC Items | Involve in EOL treatment decisions | 9 units on a scale |
| Patient Control | Quality of Communication (QOC): Individual QOC Items | Ask about spiritual or religion beliefs | 0 units on a scale |
| Patient Control | Quality of Communication (QOC): Individual QOC Items | Discuss prognosis | 0 units on a scale |
| Patient Control | Quality of Communication (QOC): Individual QOC Items | Ask about important things in life | 8 units on a scale |
| Patient Control | Quality of Communication (QOC): Individual QOC Items | Involve in EOL treatment decisions | 0 units on a scale |
| Patient Control | Quality of Communication (QOC): Individual QOC Items | Discuss feelings about getting sicker | 8 units on a scale |
| Patient Control | Quality of Communication (QOC): Individual QOC Items | Discuss what dying might be like | 0 units on a scale |
| Patient Control | Quality of Communication (QOC): Individual QOC Items | Discuss details about getting sicker | 8 units on a scale |
Comparison: Patient rating of clinician's quality of communication about patient's feelings about getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect.p-value: 0.00195% CI: [0.939, 3.479]Clustered Tobit regression
Comparison: Patient rating of clinician's quality of communication about details of getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect.p-value: 0.12295% CI: [-0.33, 2.804]Clustered Tobit regression
Comparison: Patient rating of clinician's quality of communication about how long the patient might have to live.~Variable with range 0-11, defined as censored from below because of strong floor effect.p-value: 0.09895% CI: [-0.426, 5.083]Clustered Tobit regression
Comparison: Patient rating of clinician's quality of communication about what dying might be like.~Variable with range 0-11, defined as censored from below because of strong floor effect.p-value: 0.35295% CI: [-1.742, 4.887]Clustered Tobit regression
Comparison: Patient rating of clinician's quality of communication about patient's involvement in end-of-life treatment decisions.~Variable with range 0-11, defined as censored from below because of strong floor effect.p-value: <0.00195% CI: [2.06, 7.19]Clustered Tobit regression
Comparison: Patient rating of clinician's quality of communication about things in life that are important to the patient.~Variable with range 0-11, defined as censored from below because of strong floor effect.p-value: 0.00295% CI: [0.898, 3.909]Clustered Tobit regression
Comparison: Patient rating of clinician's quality of communication about patient's religious/spiritual beliefs.~Variable with range 0-11, defined as censored from below because of strong floor effect.p-value: 0.07595% CI: [-0.25, 5.159]Clustered Tobit regression
Other Pre-specified
Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care)
Binary variable indicating whether patient's treatment preference was stable between target visit (or baseline, if no 2-week questionnaire was returned) and 3 months.
Time frame: 3 months after target visit
Population: Patients completing 3-month questionnaires.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care) | Stable | 104 Participants |
| Patient Intervention | Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care) | Not stable | 12 Participants |
| Patient Intervention | Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care) | Unknown (pref not stated at one or both time pts) | 60 Participants |
| Patient Control | Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care) | Stable | 103 Participants |
| Patient Control | Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care) | Not stable | 13 Participants |
| Patient Control | Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care) | Unknown (pref not stated at one or both time pts) | 95 Participants |
Other Pre-specified
Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care)
Binary variable indicating whether patient's current preference was for life-extension or comfort care
Time frame: 3 months after target visit
Population: Patients completing 3-month questionnaires.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Intervention | Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care) | Unsure | 34 Participants |
| Patient Intervention | Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care) | Comfort | 104 Participants |
| Patient Intervention | Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care) | No response | 5 Participants |
| Patient Intervention | Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care) | Life extension | 33 Participants |
| Patient Control | Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care) | No response | 7 Participants |
| Patient Control | Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care) | Comfort | 121 Participants |
| Patient Control | Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care) | Unsure | 52 Participants |
| Patient Control | Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care) | Life extension | 31 Participants |