Heart Failure Clinical Trial
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.
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.
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