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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 22, 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

Tracking Information
First Submitted Date  ICMJE August 7, 2012
First Posted Date  ICMJE February 8, 2013
Last Update Posted Date January 22, 2019
Actual Study Start Date  ICMJE June 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
  • Enhanced goal-consistent care [ Time Frame: up to 2 years ]
    Patients whose physician is trained to use and adheres to the SICC 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 SICC. Goal consistent care will be measured by comparing patient identified goals to chart review and family report.
  • PEACE [ Time Frame: up to 2 years ]
    Patients whose physician is trained to use and adheres to the SICC 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 SICC. Being at peace will be measured by the PEACE scale, a 13-item validated questionnaire in cancer patients.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serious Illness Communication Project
Official Title  ICMJE Serious Illness Communication Project
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • End of Life Care
  • Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Training
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2016)
994
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2013)
1002
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01786811
Other Study ID Numbers  ICMJE 12-027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rachelle Bernacki, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Partners HealthCare
  • Charina Endowment Fund
  • Margaret T. Morris Foundation
  • Harvard School of Public Health
  • Brigham and Women's Hospital
Investigators  ICMJE
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
PRS Account Dana-Farber Cancer Institute
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP