Clinical trial NCT01786811: Serious Illness Communication Project
Official title: Serious Illness Communication Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End of Life Care
Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Partners HealthCare
name: Charina Endowment Fund
name: Margaret T. Morris Foundation
name: Harvard School of Public Health (HSPH)
name: Brigham and Women's Hospital
First posted: 2013-02-08
Enrollment: 994
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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:

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

Primary outcomes:
measure: Enhanced goal-consistent care
timeFrame: up to 2 years
measure: PEACE
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Rachelle Bernacki, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Atul Gawande, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Susan Block, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.