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
|Condition or disease||Intervention/treatment||Phase|
|End of Life Care Cancer||Behavioral: Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||994 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Serious Illness Communication Project|
|Actual Study Start Date :||June 2012|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786811
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Rachelle Bernacki, MD, MS||Dana-Farber Cancer Institute|
|Principal Investigator:||Atul Gawande, MD, MPH||Harvard School of Public Health (HSPH)|
|Principal Investigator:||Susan Block, MD||Dana-Farber Cancer Institute|