Critical IllnessICSINCT01933789
Improving Communication About Serious Illness
A study testing Communication Feedback Form for Patients with Serious Illness in people with Critical Illness and Chronic Disease, run by University of Washington at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Chronic Disease, Terminal Care
- What is being tested?
- Communication Feedback Form for Patients with Serious Illness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 817 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Reasons for exclusion for all subject groups include: legal or risk management concerns; and physical or mental limitations preventing ability to complete research activities.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Valley Medical Center
Renton, Washington, 98058
Harborview Medical Center
Seattle, Washington, 98104
Swedish Medical Center
Seattle, Washington, 98122
Northwest Hospital and Medical Center
Seattle, Washington, 98133
University of Washington Medical Center
Seattle, Washington, 98195
UW Neighborhood Clinics
Seattle, Washington, 98195
About this study
Official title: Health System Intervention to Improve Communication About End-of-Life Care for Vulnerable Patients
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.
Read the 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.
- Conditions
- Critical Illness, Chronic Disease, Terminal Care, Palliative Care, Communication, Advance Care Planning
- Being tested
- Communication Feedback Form for Patients with Serious Illness
- 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
- Medical subject headings
- Critical Illness, Chronic Disease, Communication, Neoplasm Metastasis, Lung Neoplasms, Pulmonary Disease, Chronic Obstructive, Heart Failure, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication Feedback Form for Patients with Serious IllnessBehavioural
Also called "Audit and Feedback"
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.
| Study group | Role | What they receive |
|---|---|---|
| Feedback Group | Experimental | 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. Receives: Behavioral: Communication Feedback Form for Patients with Serious Illness |
| Comparison/Usual Care Group | No intervention | Subjects will only complete surveys and assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: 2 weeks after target visit
Secondary outcomes (29)
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
Measured: 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?"
Measured: 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
Measured: Target visit
Goal-Concordant Care
Binary variable indicating whether patient's reported focus of current treatment was concordant with treatment preference
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-month period following the target visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 817 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, J. Randall Curtis, University of Washington
- Investigators
- J. Randall Curtis, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933789
- Sponsor's protocol ID
- 44023
- Acronym
- ICSI
- Status last verified
- Mar 2019
- First submitted
- 28 Aug 2013
- Last updated
- 20 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Au DH, Udris EM, Engelberg RA, Diehr PH, Bryson CL, Reinke LF, Curtis JR. A randomized trial to improve communication about end-of-life care among patients with COPD. Chest. 2012 Mar;141(3):726-735. doi: 10.1378/chest.11-0362. Epub 2011 Sep 22.
PubMed 21940765Knauft E, Nielsen EL, Engelberg RA, Patrick DL, Curtis JR. Barriers and facilitators to end-of-life care communication for patients with COPD. Chest. 2005 Jun;127(6):2188-96. doi: 10.1378/chest.127.6.2188.
PubMed 15947336Curtis JR, Patrick DL. Barriers to communication about end-of-life care in AIDS patients. J Gen Intern Med. 1997 Dec;12(12):736-41. doi: 10.1046/j.1525-1497.1997.07158.x.
PubMed 9436892Curtis JR, Engelberg RA, Nielsen EL, Au DH, Patrick DL. Patient-physician communication about end-of-life care for patients with severe COPD. Eur Respir J. 2004 Aug;24(2):200-5. doi: 10.1183/09031936.04.00010104.
PubMed 15332385Engelberg R, Downey L, Curtis JR. Psychometric characteristics of a quality of communication questionnaire assessing communication about end-of-life care. J Palliat Med. 2006 Oct;9(5):1086-98. doi: 10.1089/jpm.2006.9.1086.
PubMed 17040146Curtis JR, Wenrich MD, Carline JD, Shannon SE, Ambrozy DM, Ramsey PG. Patients' perspectives on physician skill in end-of-life care: differences between patients with COPD, cancer, and AIDS. Chest. 2002 Jul;122(1):356-62. doi: 10.1378/chest.122.1.356.
PubMed 12114382Coats H, Downey L, Sharma RK, Curtis JR, Engelberg RA. Quality of Communication and Trust in Patients With Serious Illness: An Exploratory Study of the Relationships of Race/Ethnicity, Socioeconomic Status, and Religiosity. J Pain Symptom Manage. 2018 Oct;56(4):530-540.e6. doi: 10.1016/j.jpainsymman.2018.07.005. Epub 2018 Jul 17.
PubMed 30025937Curtis JR, Downey L, Back AL, Nielsen EL, Paul S, Lahdya AZ, Treece PD, Armstrong P, Peck R, Engelberg RA. Effect of a Patient and Clinician Communication-Priming Intervention on Patient-Reported Goals-of-Care Discussions Between Patients With Serious Illness and Clinicians: A Randomized Clinical Trial. JAMA Intern Med. 2018 Jul 1;178(7):930-940. doi: 10.1001/jamainternmed.2018.2317.
PubMed 29802770Fakhri S, Engelberg RA, Downey L, Nielsen EL, Paul S, Lahdya AZ, Treece PD, Curtis JR. Factors Affecting Patients' Preferences for and Actual Discussions About End-of-Life Care. J Pain Symptom Manage. 2016 Sep;52(3):386-94. doi: 10.1016/j.jpainsymman.2016.03.012. Epub 2016 Jun 3.
PubMed 27265813
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health System Intervention to Improve Communication About End-of-Life Care for Vulnerable Patients
- ClinicalTrials.gov ID
- NCT01933789
- Acronym / sponsor ID
- ICSI / 44023
- Conditions
- Critical Illness, Chronic Disease, Terminal Care, Palliative Care, Communication, Advance Care Planning
- Keywords
- Palliative Care, End-of-Life Issues, Patient/Clinician Communication, Patient/Family Communication, Concordance, Treatment Preferences, Anxiety, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Posted 11 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback Group | Experimental | Behavioral: Communication Feedback Form for Patients with Serious IllnessSubjects 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. |
| Comparison/Usual Care Group | No intervention | –Subjects will only complete surveys and assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Reasons for exclusion for all subject groups include: legal or risk management concerns; and physical or mental limitations preventing ability to complete research activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication Feedback Form for Patients with Serious IllnessAlso: "Audit and Feedback"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. | Behavioural | Feedback Group |
Primary outcome
Occurrence of Discussion About Goals of Care at Target Visit
Time frame: 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?"
29 secondary outcomes
Occurrence of Discussion About Goals of Care 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
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
Time frame: Target visit
Goal-Concordant Care
Time frame: 3 months after target visit
Goal-Concordant Care Among Patients With Stable Treatment Preference
Time frame: 3 months after target visit
Quality of Communication (QOC): Four-Indicator Latent Construct
Time frame: 2 weeks from target visit
Quality of Communication (QOC): Individual QOC Items
Time frame: 2 weeks from target visit
Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct
Time frame: 3 months after target visit
Patient Health Questionnaire (PHQ-8): Eight-Item Scale
Time frame: 3 months after target visit
Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct
Time frame: 6 months after target visit
Patient Health Questionnaire (PHQ-8): Eight-Item Scale
Time frame: 6 months after target visit
Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct
Time frame: 3 months after target visit
Generalized Anxiety Disorder (GAD-7): Seven-Item Scale
Time frame: 3 months after target visit
Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct
Time frame: 6 months after target visit
Generalized Anxiety Disorder (GAD-7): Seven-Item Scale
Time frame: 6 months after target visit
Avoidance of Life-Sustaining Therapies, All Patients
Time frame: 6-month period following the target visit
Avoidance of Life-Sustaining Therapies, Patients With Comfort Care Preference
Time frame: 6-month period following the target visit
Palliative Care Consultation, Inpatient Stay - All Patients
Time frame: 3-month period following the target visit
Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit
Time frame: 3-month period following the target visit
Palliative Care Consultation, Inpatient Stay - All Patients
Time frame: 6-month period following the target visit
Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit
Time frame: 6-month period following the target visit
Palliative Care Referral, Outpatient Visit - All Patients
Time frame: 3-month period following the target visit
Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit
Time frame: 3-month period following the target visit
Palliative Care Referral, Outpatient Visit - All Patients
Time frame: 6-month period following the target visit
Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit
Time frame: 6-month period following the target visit
Palliative Care Consultation and/or Referral - All Patients
Time frame: 3-month period following the target visit
Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit
Time frame: 3-month period following the target visit
Palliative Care Consultation and/or Referral - All Patients
Time frame: 6-month period following the target visit
Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit
Time frame: 6-month period following the target visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21940765Au DH, Udris EM, Engelberg RA, Diehr PH, Bryson CL, Reinke LF, Curtis JR. A randomized trial to improve communication about end-of-life care among patients with COPD. Chest. 2012 Mar;141(3):726-735. doi: 10.1378/chest.11-0362. Epub 2011 Sep 22.
- Background: PubMed 15947336Knauft E, Nielsen EL, Engelberg RA, Patrick DL, Curtis JR. Barriers and facilitators to end-of-life care communication for patients with COPD. Chest. 2005 Jun;127(6):2188-96. doi: 10.1378/chest.127.6.2188.
- Background: PubMed 9436892Curtis JR, Patrick DL. Barriers to communication about end-of-life care in AIDS patients. J Gen Intern Med. 1997 Dec;12(12):736-41. doi: 10.1046/j.1525-1497.1997.07158.x.
- Background: PubMed 15332385Curtis JR, Engelberg RA, Nielsen EL, Au DH, Patrick DL. Patient-physician communication about end-of-life care for patients with severe COPD. Eur Respir J. 2004 Aug;24(2):200-5. doi: 10.1183/09031936.04.00010104.
- Background: PubMed 17040146Engelberg R, Downey L, Curtis JR. Psychometric characteristics of a quality of communication questionnaire assessing communication about end-of-life care. J Palliat Med. 2006 Oct;9(5):1086-98. doi: 10.1089/jpm.2006.9.1086.
- Background: PubMed 12114382Curtis JR, Wenrich MD, Carline JD, Shannon SE, Ambrozy DM, Ramsey PG. Patients' perspectives on physician skill in end-of-life care: differences between patients with COPD, cancer, and AIDS. Chest. 2002 Jul;122(1):356-62. doi: 10.1378/chest.122.1.356.
- Derived from this study: PubMed 30025937Coats H, Downey L, Sharma RK, Curtis JR, Engelberg RA. Quality of Communication and Trust in Patients With Serious Illness: An Exploratory Study of the Relationships of Race/Ethnicity, Socioeconomic Status, and Religiosity. J Pain Symptom Manage. 2018 Oct;56(4):530-540.e6. doi: 10.1016/j.jpainsymman.2018.07.005. Epub 2018 Jul 17.
- Derived from this study: PubMed 29802770Curtis JR, Downey L, Back AL, Nielsen EL, Paul S, Lahdya AZ, Treece PD, Armstrong P, Peck R, Engelberg RA. Effect of a Patient and Clinician Communication-Priming Intervention on Patient-Reported Goals-of-Care Discussions Between Patients With Serious Illness and Clinicians: A Randomized Clinical Trial. JAMA Intern Med. 2018 Jul 1;178(7):930-940. doi: 10.1001/jamainternmed.2018.2317.
- Derived from this study: PubMed 27265813Fakhri S, Engelberg RA, Downey L, Nielsen EL, Paul S, Lahdya AZ, Treece PD, Curtis JR. Factors Affecting Patients' Preferences for and Actual Discussions About End-of-Life Care. J Pain Symptom Manage. 2016 Sep;52(3):386-94. doi: 10.1016/j.jpainsymman.2016.03.012. Epub 2016 Jun 3.
- Click here for more information about this study. PCORI Project Summary: Health System Intervention to Improve Communication about End-of-Life Care for Vulnerable PatientsLink provided by the sponsor.
- The End-of-Life Care Research Program at the UW School of MedicineLink provided by the sponsor.
- The Palliative Care Center of Excellence at the University of WashingtonLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Randall Curtis, MD, MPH principal investigator
University of Washington
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Feedback Form for Patients with Serious Illness in people with Critical Illness and Chronic Disease, run by University of Washington at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Discussion About Goals of Care at Target Visit (time frame: 2 weeks after target visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01933789, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.