Improving Communication About Serious Illness (ICSI)
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|ClinicalTrials.gov Identifier: NCT01933789|
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : January 10, 2017
|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|
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|
|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|
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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
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 ClinicalTrials.gov 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|
|Principal Investigator:||J. Randall Curtis, MD, MPH||University of Washington|