Trial record 1 of 27 for:    Open Studies | Terminal Care
Previous Study | Return to List | Next Study

Improving Communication About Serious Illness (ICSI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Washington
Sponsor:
Collaborator:
Patient Centered Outcome Research Institute
Information provided by (Responsible Party):
J. Randall Curtis, University of Washington
ClinicalTrials.gov Identifier:
NCT01933789
First received: August 28, 2013
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Health System Intervention to Improve Communication About End-of-Life Care for Vulnerable Patients

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Occurrence of Communication [ Time Frame: 2 weeks [primary timepoint]; 3 months and 6 months after target visit [additional timepoints] ] [ Designated as safety issue: No ]
    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:
  • 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] ] [ Designated as safety issue: No ]
    The QOC_eol subscale is based on seven items, with scores potentially ranging from 0 (worst) to 10 (best).

  • Care Concordance [ Time Frame: 3 months after target visit ] [ Designated as safety issue: No ]
    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 the preference matches the patient's report of the care received.

  • Referral to Palliative Care Services [ Time Frame: 3 months after target visit ] [ Designated as safety issue: No ]
    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.

  • Provision of Life-Sustaining Therapies [ Time Frame: 3 months and 6 months after target visit ] [ Designated as safety issue: No ]
    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.

  • Generalized Anxiety Disorder (GAD-7) [ Time Frame: 3 months after target visit [primary timepoint]; 6 months after target visit [additional timepoint] ] [ Designated as safety issue: No ]
    Symptoms of anxiety among patients and family members will be assessed using this 7-item questionnaire.

  • Patient Health Questionnaire (PHQ-8) [ Time Frame: 3 months after target visit [primary timepoint]; 6 months after target visit [additional timepoint] ] [ Designated as safety issue: No ]
    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:
  • Group Differences [ Time Frame: after target visit; 2 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 1728
Study Start Date: September 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 to support the communication tasks which that recipient will be positioned to address. Feedback forms are sent to participants prior to the target clinic visit and placed into the EHR. The primary clinician's form will suggest referral to palliative care if there are "potentially unmet palliative-care communication needs." In addition, primary clinicians will also receive patient-specific prognostic estimates based on available data to facilitate communication about prognosis. 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.

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" 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 a large healthcare system. Eligible patients (6 per clinician, n=720) 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, 2 weeks following 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 more than 3 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 >20; 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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933789

Contacts
Contact: J. Randall Curtis, MD, MPH 206-744-3356 jrc@uw.edu
Contact: Ruth A. Engelberg, PhD 206-744-9523 rengel@uw.edu

Locations
United States, Washington
Valley Medical Center Recruiting
Renton, Washington, United States, 98058
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Northwest Hospital and Medical Center Recruiting
Seattle, Washington, United States, 98133
UW Neighborhood Clinics Recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Patient Centered Outcome Research Institute
Investigators
Principal Investigator: J. Randall Curtis, MD, MPH University of Washington
  More Information

Additional Information:
Publications:
Responsible Party: J. Randall Curtis, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01933789     History of Changes
Other Study ID Numbers: 44023-G
Study First Received: August 28, 2013
Last Updated: December 20, 2013
Health Authority: United States: Patient Centered Outcomes Research Institute

Keywords provided by University of Washington:
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

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

ClinicalTrials.gov processed this record on August 26, 2014