Improving Communication About Serious Illness

Study Overview
=================
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.

Official Title
-----------------
Health System Intervention to Improve Communication About End-of-Life Care for Vulnerable Patients

Conditions
-----------------
Critical Illness, Chronic Disease, Terminal Care, Palliative Care, Communication, Advance Care Planning, Neoplasm Metastasis, Lung Neoplasms, Pulmonary Disease, Chronic Obstructive, Heart Failure, End Stage Liver Disease, Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Behavioral: Communication Feedback Form for Patients with Serious Illness


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feedback Group<br>Subjects will complete surveys and assessments and will be given the Communication Feedback Form for Patients with Serious Illness to use prior to and during a target outpatient visit. | Behavioral: Communication Feedback Form for Patients with Serious Illness<br>* 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.<br>* Other names: Audit and Feedback;|
| No Intervention: Comparison/Usual Care Group<br>Subjects will only complete surveys and assessments. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | 2 weeks after target visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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? | 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 | Target visit | 
| Goal-Concordant Care | Binary variable indicating whether patient's reported focus of current treatment was concordant with treatment preference | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6-month period following the target visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, Palliative Care, End-of-Life Issues, Patient/Clinician Communication, Patient/Family Communication, Concordance, Treatment Preferences, Depressive Symptoms, Talking with Your Doctor, Coping with Serious Illness, Outpatient Collaboration