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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
817
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.
Valley Medical Center
Renton, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Northwest Hospital and Medical Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
UW Neighborhood Clinics
Seattle, Washington, United States
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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