Serious Illness Communication Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Dana-Farber Cancer Institute
Sponsor:
Collaborators:
Partners HealthCare
Charina Endowment Fund
Margaret T. Morris Foundation
Harvard School of Public Health
Information provided by (Responsible Party):
Rachelle Bernacki, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01786811
First received: August 7, 2012
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

The purpose of the study is to evaluate the impact of implementing a "Serious Illness Communication Checklist" 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 Communication Checklist 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 Intervention
End of Life Care
Behavioral: Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Serious Illness Communication Project

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Enhanced goal-consistent care [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1002
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trained Clinicians Behavioral: Training
  1. Initial Training: The initial training program for clinicians randomized into the intervention arm will be 2.5 hours. The project will be introduced and the Serious Illness Communication Checklist shared. The training session will include a brief didactic session on "Challenges in discussing advance care planning/values and goals" and practice using the SICC.
  2. Ongoing Coaching: Ongoing group coaching will be available from project directors for routine and difficult patient encounters.
  3. "Real-Time" Feedback: We will also provide "in the moment" individual coaching for clinicians. Clinicians will be able to contact an email inbox 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: Not trained Clinicians
No Intervention: Non-volunteer Clinicians

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

Clinician Inclusion Criteria:

  1. Dana-Farber Cancer Center clinician
  2. Care for patients with selected high-risk cancers (breast oncology, gastrointestinal oncology, head and neck oncology, genitourinary oncology, hematologic malignancies, melanoma, neuro-oncology, sarcoma, and thoracic oncology) or patients in Phase I Clinical Trials

Clinician Exclusion Criteria:

1. DFCI Gynecology-Oncology specialist

Patient Inclusion Criteria

  1. Over 18 years of age
  2. English speaker
  3. Patient at Dana-Farber Cancer Institute
  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), melanoma, glioblastoma multiforme (GBM), sarcoma, and lung; or enrollment in a Phase I clinical trial.
  5. Ability to provide consent

Patient Exclusion Criteria

1. Diagnosis of advanced obstetric-gynecological cancer

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786811

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Mathilde Sabourin, MPH    617-632-6055    mathilde_sabourin@dfci.harvard.edu   
Contact: Judith Vick, BA    617-632-6055    judith_vick@dfci.harvard.edu   
Sponsors and Collaborators
Dana-Farber Cancer Institute
Partners HealthCare
Charina Endowment Fund
Margaret T. Morris Foundation
Harvard School of Public Health
Investigators
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

No publications provided

Responsible Party: Rachelle Bernacki, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01786811     History of Changes
Other Study ID Numbers: 12-027
Study First Received: August 7, 2012
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 20, 2014