Improving Communication About Serious Illness (ICSI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01933789
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : January 10, 2017
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
J. Randall Curtis, University of Washington

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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Communication Feedback Form for Patients with Serious Illness Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 792 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Health System Intervention to Improve Communication About End-of-Life Care for Vulnerable Patients
Study Start Date : September 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hospice Care

Arm Intervention/treatment
Experimental: Feedback Group
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
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.
Other Name: "Audit and Feedback"

No Intervention: Comparison/Usual Care Group
Subjects will only complete surveys and assessments.

Primary Outcome Measures :
  1. Occurrence of Communication [ Time Frame: 2 weeks [primary timepoint]; 3 months and 6 months after target visit [additional timepoints] ]
    Dichotomous item evaluating occurrence of communication for patients who indicate a desire to talk with their clinician about end-of-life care via patient report.

Secondary Outcome Measures :
  1. Quality of Communication about End-of-Life Scale (QOC_eol) [ Time Frame: 2 weeks [primary timepoint]; 3 months and 6 months after target visit [additional timepoints] ]
    The QOC_eol subscale is based on seven items, with scores potentially ranging from 0 (worst) to 10 (best).

  2. Care Concordance [ Time Frame: 3 months after target visit ]
    Concordance between the care patients report they want at baseline and the care they report having received at the 3 month assessment will be measured with two questions from SUPPORT. The first question defines patient preferences for either extending life or ensuring comfort. The second question assesses patients' perceptions of current treatment. The outcome will be a dichotomous variable measuring whether patient's preferences match their report of the care received.

  3. Referral to Palliative Care Services [ Time Frame: within 6-month study period ]
    Referral to palliative care services for patients who potentially have unmet palliative care communication needs (as determined from the baseline patient questionnaire) will be assessed using the electronic health record (EHR). The outcome measure will be a binary variable which indicates whether the patient received a referral for palliative care consultation services.

  4. Provision of Life-Sustaining Therapies [ Time Frame: within 6-month study period ]
    We will review the EHR to assess use of three indicators of life-sustaining therapies: admission to an ICU, receipt of CPR, and receipt of mechanical ventilation. These analyses will include a consideration of patients' preferences for care.

  5. Generalized Anxiety Disorder (GAD-7) [ Time Frame: 3 months after target visit [primary timepoint]; 6 months after target visit [additional timepoint] ]
    Symptoms of anxiety among patients and family members will be assessed using this 7-item questionnaire.

  6. Patient Health Questionnaire (PHQ-8) [ Time Frame: 3 months after target visit [primary timepoint]; 6 months after target visit [additional timepoint] ]
    Symptoms of depression among patients and family members will be assessed using this 8-item questionnaire that is appropriate for primary care and general populations. It provides a marker of the diagnosis of depression as well as an index of depression severity.

Other Outcome Measures:
  1. Group Differences [ Time Frame: after target visit; 2 weeks, 3 months, and 6 months ]
    We will assess for differential effects of the intervention in key patient subgroups, including groups defined by patient race/ethnicity and specific chronic illnesses (cancer, lung disease, liver disease, heart disease).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eligible primary clinicians will include all clinicians who provide ongoing primary or specialty care to eligible patient populations. This will include primary care physicians (family medicine and internal medicine), oncologists, pulmonologists, cardiologists, gastroenterologists, nephrologists, neurologists, hepatologists, and geriatricians. Primary clinicians may also include nurse practitioners and physician assistants playing a "primary role" with eligible patients. A "primary role" denotes any clinician for whom having a discussion about end-of-life care with eligible patients would be indicated
  • Eligible interprofessional team members will include nurses, social workers and other clinicians who are part of an enrolled primary clinician's clinic team.
  • Eligible patients will be those under the care of a participating clinician who are 18 years of age or older, have had 2 or more visits with the primary clinician in the last 18 months, and meet diagnostic criteria. Diagnostic criteria include: 1) metastatic cancer or inoperable lung cancer; 2) chronic obstructive pulmonary disease with FEV1 values <35% predicted or oxygen dependence or restrictive lung disease with a TLC < 50% predicted; 3) New York Heart Association Class III or IV heart failure; 4) Child's Class C cirrhosis or MELD score of >17; 5) dialysis-dependent renal failure and either diabetes or a serum albumin of < 2.5; or, 6) older than 75 years with at least one life-limiting chronic illness or older than 90 years. Additional criteria include: PAH w. 6MWD <250m, restrictive lung disease (IPF, ILD) w/ TLC <50%, and cystic fibrosis with FEV1 < 30%. Eligible patients will also be English-speaking and have no significant dementia or cognitive impairment that would limit his/her ability to complete questionnaires.
  • Eligible family members will be identified by the patient, with the criterion that the patient would want the family member involved in medical decision-making for the patient if he/she was not able. For the purpose of this study, "family member" is not confined to legal next-of-kin or immediate family member. Any family member, friend, or caregiver is eligible who is English-speaking and has no dementia or delirium limiting his/her ability to complete questionnaires.

Exclusion Criteria:

  • Reasons for exclusion for all subject groups include: legal or risk management concerns; and physical or mental limitations preventing ability to complete research activities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01933789

United States, Washington
Valley Medical Center
Renton, Washington, United States, 98058
Harborview Medical Center
Seattle, Washington, United States, 98104
Swedish Medical Center
Seattle, Washington, United States, 98122
Northwest Hospital and Medical Center
Seattle, Washington, United States, 98133
University of Washington Medical Center
Seattle, Washington, United States, 98195
UW Neighborhood Clinics
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Patient-Centered Outcomes Research Institute
Principal Investigator: J. Randall Curtis, MD, MPH University of Washington

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: J. Randall Curtis, Study Principal Investigator, University of Washington Identifier: NCT01933789     History of Changes
Other Study ID Numbers: 44023-E/A
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by J. Randall Curtis, University of Washington:
Palliative Care
End-of-Life Issues
Patient/Clinician Communication
Patient/Family Communication
Treatment Preferences
Depressive Symptoms
Talking with Your Doctor
Coping with Serious Illness
Outpatient Collaboration

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Liver Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Critical Illness
Renal Insufficiency
Lung Neoplasms
Neoplasm Metastasis
Kidney Failure, Chronic
End Stage Liver Disease
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Digestive System Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Kidney Diseases
Urologic Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplastic Processes
Renal Insufficiency, Chronic
Liver Failure
Hepatic Insufficiency