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Serious Illness Communication Project

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ClinicalTrials.gov Identifier: NCT01786811
Recruitment Status : Completed
First Posted : February 8, 2013
Last Update Posted : January 21, 2019
Sponsor:
Collaborators:
Partners HealthCare
Charina Endowment Fund
Margaret T. Morris Foundation
Harvard School of Public Health
Brigham and Women's Hospital
Information provided by (Responsible Party):
Rachelle Bernacki, Dana-Farber Cancer Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End of Life Care Cancer Behavioral: Training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 994 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Serious Illness Communication Project
Actual Study Start Date : June 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Trained Clinicians
Clinicians randomized into this group will receive training in using the Serious Illness Conversation Guide with their patients. Patients of these clinicians will also be in the intervention arm.
 Behavioral: Training
  1. 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.
  2. 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.
No Intervention: Non-trained Clinicians
Clinicians randomized into this group will not receive training in using the Serious Illness Conversation Guide with their patients. They will provide usual care. Patients of these clinicians will also be in the control arm.
No Intervention: Non-volunteer Clinicians
These clinicians do not agree to participate in the study. They will continue to provide usual care. Their patients will be invited to participate and be followed.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

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

Clinician Exclusion Criteria:

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

Patient Inclusion Criteria

  1. Over 18 years of age
  2. English speaker
  3. Patient at Dana-Farber Cancer Institute, including satellite sites at Milford Regional Medical Center and South Shore Hospital
  4. 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.
  5. Ability to provide consent

Patient Exclusion Criteria

  1. Diagnosis of advanced obstetric-gynecological cancer
  2. Cognitive impairment

Family Member Inclusion Criteria

  1. Over 18 years of age
  2. English speaker
  3. 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)
  4. Ability to provide consent
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01786811


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Partners HealthCare
Charina Endowment Fund
Margaret T. Morris Foundation
Harvard School of Public Health
Brigham and Women's Hospital
Investigators
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Principal Investigator: Rachelle Bernacki, MD, MS Dana-Farber Cancer Institute
Principal Investigator: Atul Gawande, MD, MPH Harvard School of Public Health
Principal Investigator: Susan Block, MD Dana-Farber Cancer Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rachelle Bernacki, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01786811     History of Changes
Other Study ID Numbers: 12-027
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019