Serious Illness Communication Project

The purpose of the study is to evaluate the impact of implementing a "Serious Illness Conversation Guide" to guide patient/family-clinician discussions and planning about end-of-life care decisions. The goal of the intervention is to improve achievement of patient care priorities and peacefulness at the end of life for patients with serious and life-threatening illness and their families. We hypothesize that patients whose physician is trained to use and adheres to the elements of the Serious Illness Conversation Guide will demonstrate enhanced consistency between documented key priorities and care received, and will experience greater peace in the final month of life; similarly, their families will experience higher satisfaction with care.

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Key information

Conditions

End of Life Care Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

The subjects of this study will be the clinicians (physicians and nurse practitioners) conducting the SICG conversations, their patient with high-risk cancers, and a friend or family member of the patient.

Clinician Inclusion Criteria:

Dana-Farber Cancer Institute medical oncology clinician
Care for patients with selected high-risk cancers

Clinician Exclusion Criteria:

DFCI Gynecology-Oncology specialist
Seeing patients only in the Phase I clinical trial disease center

Patient Inclusion Criteria

Over 18 years of age
English speaker
Patient at Dana-Farber Cancer Institute, including satellite sites at Milford Regional Medical Center and South Shore Hospital
Diagnosis of one of the following high mortality or advanced cancers: breast, gastric, intestinal, esophageal, pancreatic, biliary, colorectal, hepatocellular, head and neck, renal, bladder, prostate, acute myeloid lymphoma (AML), acute lymphoblastic lymphoma (ALL), lymphoma, melanoma, glioblastoma multiforme (GBM), sarcoma, and lung.
Ability to provide consent

Patient Exclusion Criteria

Diagnosis of advanced obstetric-gynecological cancer
Cognitive impairment

Family Member Inclusion Criteria

Over 18 years of age
English speaker
Friend or family member of study patient (Health care proxy, or close friend or family member who is involved in helping the patient think about decisions related to their health care)
Ability to provide consent

Treatment and study plan

Training

Behavioral

Initial Training: The training program for clinicians randomized into the intervention arm will be 2.5 hours. The project will be introduced and the Serious Illness Conversation Guide shared. The training session will include a brief didactic session on "Challenges in discussing advance care planning/values and goals" followed by practice using the SICG.
Coaching and Feedback: We will also provide individual coaching for clinicians. Clinicians will be able to contact the study doctor to request coaching/debriefing on a challenging case; one of the investigators will respond within 24-48 hours for urgent or distressing cases (up to 72 hours on weekends). In-the-moment coaching will be by telephone or in person.

Primary outcomes

Enhanced goal-consistent care

Time frame: up to 2 years

Patients whose physician is trained to use and adheres to the SICG will receive care that is more consistent with their key life priorities during the last week and the last 3 months of life than patients whose physician is not trained to use the SICG. Goal consistent care will be measured by comparing goals identified by the patient during the final 3 months and final week of life, to care received by the patient, which will be measured by chart review and family report. For each priority/goal listed by the patient as important, we will give a score from 0 to 3 to quantify the extent to which that goal was achieved by the patient. Higher overall score will show more goal-consistent care.
PEACE

Time frame: up to 2 years

Patients whose physician is trained to use and adheres to the SICG will be more likely to report being at peace in the final 3 months of life than patients whose physician is not trained to use the SICG. Being at peace will be measured by the PEACE scale, a 13-item validated questionnaire in cancer patients.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

Brigham and Women's Hospital
Charina Endowment Fund
Harvard School of Public Health (HSPH)
Margaret T. Morris Foundation
Partners HealthCare

Registry information

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Feb 8, 2013
Registry last updated: Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed