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The purpose of this study is to increase serious illness conversations (SICs) about patients goals and preferences regarding their healthcare between patients with cancer and their oncology clinicians and improved care provided near the end of life.
The objective of this study is to implement an intervention in a pragmatic randomized controlled trial that uses cancer treatment pathways data to identify patients appropriate for serious illness conversations (SICs) and applies "nudges" to patients and their oncology clinicians to increase SICs and improve end of life (EOL) outcomes.
Identified participants and clinicians will be randomized into 1 or 4 groups.
The expected enrollment is approximately 800 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Both patient and clinician receive a nudge | Experimental |
|
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| Neither the patient nor clinician receive a nudge | No Intervention | Standard Care | |
| Patient receives a nudge but not the clinician | Experimental | -Patient nudge consists of a letter and SHARE questionnaire |
|
| Clinician receives a nudge but not the patient | Experimental | -Clinician "nudge" email encouraging discussion to initiate discussion on SIC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinician Nudge Email | Other | -Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with an SIC at 60 days for arm 1 (patient +clinician nudge) vs arm 2 (no nudge). | The numerator includes patients with any SIC documentation extracted from the Advanced Care Planning module between the date of the poor prognosis node and 60 days. The denominator is all patients randomized to the applicable study arm. | up to 60 days after reaching the poor prognosis node |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with an SIC at 60 days, comparison of all 4 study arms | Same as the primary outcome | up to 60 days after reaching the poor prognosis node |
| Time from SIC to death among decedents |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Manz, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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4 arm randomized clinical trial
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| Patient Nudge Letter and Share questionaire | Other | Involves patient nudge consists of a letter and SHARE questionnaire - patient nudge is a letter and a SHARE questionnaire encourages the participant to complete the SHARE questionnaire, which asks questions about the participants goals and preferences around cancer care, and discuss the questionnaire with their oncology clinician at the next visit. |
|
Time from SIC to death among decedents
| randomization up to 1 year |
| Receipt of chemotherapy in last 14 days of life | Whether or not the patient received chemotherapy in the last 14 days of life, among decedents | randomization up to 1 year |
| ED visits in the last 30 days of life | Number of ED visits in the last 30 days of life, among decedents | randomization up to 1 year |
| Hospitalization in last 30 days of life | Hospitalization in the last 30 days of life, among decedents | randomization up to 1 year |
| Median length of hospitalization | Median length of last hospitalization, in days among decedents | randomization up to 1 year |
| ICU utilization in last 30 days of life | ICU hospitalization in the last 30 days of life, among decedents | randomization up to 1 year |
| Death in an acute care facility | Presence or absence of death in an acute care facility like a hospital or emergency room | randomization up to 1 year |
| Death in the ICU | Whether or not death occurred in an ICU | randomization up to 1 year |
| Hospice enrollment at death | Whether or not the patient was enrolled in hospice on the day of death | randomization up to 1 year |
| Enrolled < 4 days in hospice at death | Whether or not the patient was enrolled in hospice for less than 4 days on the day of death | randomization up to 1 year |
| Patient preferences | Patient responses on SHARE questionnaire | Up to 60 days after randomization |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D014565 | Urogenital Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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