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Serious Illness Communication Project

Primary Purpose

End of Life Care, Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End of Life Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Trained Clinicians

Non-trained Clinicians

Non-volunteer Clinicians

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Enhanced goal-consistent care
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
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.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2012
Last Updated
January 17, 2019
Sponsor
Dana-Farber Cancer Institute
Collaborators
Partners HealthCare, Charina Endowment Fund, Margaret T. Morris Foundation, Harvard School of Public Health (HSPH), Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01786811
Brief Title
Serious Illness Communication Project
Official Title
Serious Illness Communication Project
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Partners HealthCare, Charina Endowment Fund, Margaret T. Morris Foundation, Harvard School of Public Health (HSPH), Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End of Life Care, Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
994 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trained Clinicians
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-trained Clinicians
Arm Type
No Intervention
Arm Description
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.
Arm Title
Non-volunteer Clinicians
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Training
Intervention Description
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 Outcome Measure Information:
Title
Enhanced goal-consistent care
Description
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.
Time Frame
up to 2 years
Title
PEACE
Description
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.
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachelle Bernacki, MD, MS
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Atul Gawande, MD, MPH
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Block, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32363775
Citation
Paladino J, Koritsanszky L, Nisotel L, Neville BA, Miller K, Sanders J, Benjamin E, Fromme E, Block S, Bernacki R. Patient and clinician experience of a serious illness conversation guide in oncology: A descriptive analysis. Cancer Med. 2020 Jul;9(13):4550-4560. doi: 10.1002/cam4.3102. Epub 2020 May 4.
Results Reference
derived
PubMed Identifier
30870563
Citation
Bernacki R, Paladino J, Neville BA, Hutchings M, Kavanagh J, Geerse OP, Lakin J, Sanders JJ, Miller K, Lipsitz S, Gawande AA, Block SD. Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2019 Jun 1;179(6):751-759. doi: 10.1001/jamainternmed.2019.0077.
Results Reference
derived
PubMed Identifier
30870556
Citation
Paladino J, Bernacki R, Neville BA, Kavanagh J, Miranda SP, Palmor M, Lakin J, Desai M, Lamas D, Sanders JJ, Gass J, Henrich N, Lipsitz S, Fromme E, Gawande AA, Block SD. Evaluating an Intervention to Improve Communication Between Oncology Clinicians and Patients With Life-Limiting Cancer: A Cluster Randomized Clinical Trial of the Serious Illness Care Program. JAMA Oncol. 2019 Jun 1;5(6):801-809. doi: 10.1001/jamaoncol.2019.0292.
Results Reference
derived
PubMed Identifier
26443662
Citation
Bernacki R, Hutchings M, Vick J, Smith G, Paladino J, Lipsitz S, Gawande AA, Block SD. Development of the Serious Illness Care Program: a randomised controlled trial of a palliative care communication intervention. BMJ Open. 2015 Oct 6;5(10):e009032. doi: 10.1136/bmjopen-2015-009032.
Results Reference
derived

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Serious Illness Communication Project

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