Clinical trial NCT01933789: Improving Communication About Serious Illness
Official title: Health System Intervention to Improve Communication About End-of-Life Care for Vulnerable Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2013-09-02
Enrollment: 817
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Occurrence of Discussion About Goals of Care at Target Visit
timeFrame: 2 weeks after target visit
Secondary outcomes:
measure: Occurrence of Discussion About Goals of Care at Target Visit
timeFrame: Target visit
measure: Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline
timeFrame: 2 weeks after target visit
measure: Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline
timeFrame: Target visit
measure: Goal-Concordant Care
timeFrame: 3 months after target visit
measure: Goal-Concordant Care Among Patients With Stable Treatment Preference
timeFrame: 3 months after target visit
measure: Quality of Communication (QOC): Four-Indicator Latent Construct
timeFrame: 2 weeks from target visit
measure: Quality of Communication (QOC): Individual QOC Items
timeFrame: 2 weeks from target visit
measure: Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct
timeFrame: 3 months after target visit
measure: Patient Health Questionnaire (PHQ-8): Eight-Item Scale
timeFrame: 3 months after target visit
measure: Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct
timeFrame: 6 months after target visit
measure: Patient Health Questionnaire (PHQ-8): Eight-Item Scale
timeFrame: 6 months after target visit
measure: Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct
timeFrame: 3 months after target visit
measure: Generalized Anxiety Disorder (GAD-7): Seven-Item Scale
timeFrame: 3 months after target visit
measure: Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct
timeFrame: 6 months after target visit
measure: Generalized Anxiety Disorder (GAD-7): Seven-Item Scale
timeFrame: 6 months after target visit
measure: Avoidance of Life-Sustaining Therapies, All Patients
timeFrame: 6-month period following the target visit
measure: Avoidance of Life-Sustaining Therapies, Patients With Comfort Care Preference
timeFrame: 6-month period following the target visit
measure: Palliative Care Consultation, Inpatient Stay - All Patients
timeFrame: 3-month period following the target visit
measure: Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit
timeFrame: 3-month period following the target visit
measure: Palliative Care Consultation, Inpatient Stay - All Patients
timeFrame: 6-month period following the target visit
measure: Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit
timeFrame: 6-month period following the target visit
measure: Palliative Care Referral, Outpatient Visit - All Patients
timeFrame: 3-month period following the target visit
measure: Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit
timeFrame: 3-month period following the target visit
measure: Palliative Care Referral, Outpatient Visit - All Patients
timeFrame: 6-month period following the target visit
measure: Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit
timeFrame: 6-month period following the target visit
measure: Palliative Care Consultation and/or Referral - All Patients
timeFrame: 3-month period following the target visit
measure: Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit
timeFrame: 3-month period following the target visit
measure: Palliative Care Consultation and/or Referral - All Patients
timeFrame: 6-month period following the target visit
measure: Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit
timeFrame: 6-month period following the target visit
Other outcomes:
measure: Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care)
timeFrame: 3 months after target visit
measure: Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care)
timeFrame: 3 months after target visit
Locations:
city: Renton
country: United States
facility: Valley Medical Center
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: Northwest Hospital and Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Seattle
country: United States
facility: UW Neighborhood Clinics
state: Washington
Study officials:
affiliation: University of Washington
name: J. Randall Curtis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Knauft 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.
citation: Curtis 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.
citation: Curtis 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.
citation: Engelberg 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.
citation: Curtis 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.
citation: Coats 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.
citation: Curtis 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.
citation: Fakhri 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.