Serious Illness Communication Project
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Serious Illness Communication Project|
- 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 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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01786811
|Contact: Mathilde M Hutchings, MPHfirstname.lastname@example.org|
|Contact: Joanna Paladino, MDemail@example.com|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Mathilde Hutchings, MPH 617-632-6055 firstname.lastname@example.org|
|Principal Investigator:||Rachelle Bernacki, MD, MS||Dana-Farber Cancer Institute|
|Principal Investigator:||Atul Gawande, MD, MPH||Harvard T. H. Chan School of Public Health|
|Principal Investigator:||Susan Block, MD||Dana-Farber Cancer Institute|