Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)
- Conditions
- Breast CancerGenitourinary CancerThoracic CancerGastrointestinal CancerGynecologic Cancer
- Interventions
- Other: Clinician Nudge EmailOther: Patient Nudge Letter and Share questionaire
- Registration Number
- NCT05629065
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief Summary
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.
- Detailed Description
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.
* Nudge to patient and clinician
* Nudge to patient only
* Nudge to clinician only
* No nudge.
The expected enrollment is approximately 800 participants.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Patients who are aged 18 years or older, reach one of the poor prognosis nodes identified and have an upcoming appointment at one of the following Dana Farber Cancer Institute oncology clinics (including Longwood and Chestnut Hill locations)
- Breast Oncology Clinic
- Gastrointestinal Oncology Clinic
- Genitourinary Oncology Clinic
- Gynecologic Oncology Clinic
- Thoracic Oncology Clinic
- Patients with an SIC documented in the Advance Care Planning module of the electronic health record in the 6 months prior to reaching a poor prognosis node
- Patients who have previously been randomized in this trial (e.g., the patient is encountering a poor-prognosis node for the second time during the trial period)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Both patient and clinician receive a nudge Patient Nudge Letter and Share questionaire * Patient nudge consists of a letter and SHARE questionnaire * Clinician "nudge" email encouraging discussion to initiate discussion on SIC Patient receives a nudge but not the clinician Patient Nudge Letter and Share questionaire -Patient nudge consists of a letter and SHARE questionnaire Clinician receives a nudge but not the patient Clinician Nudge Email -Clinician "nudge" email encouraging discussion to initiate discussion on SIC Both patient and clinician receive a nudge Clinician Nudge Email * Patient nudge consists of a letter and SHARE questionnaire * Clinician "nudge" email encouraging discussion to initiate discussion on SIC
- Primary Outcome Measures
Name Time Method Proportion of patients with an SIC at 60 days for arm 1 (patient +clinician nudge) vs arm 2 (no nudge). up to 60 days after reaching the poor prognosis node 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.
- Secondary Outcome Measures
Name Time Method ICU utilization in last 30 days of life randomization up to 1 year ICU hospitalization in the last 30 days of life, among decedents
Enrolled < 4 days in hospice at death randomization up to 1 year Whether or not the patient was enrolled in hospice for less than 4 days on the day of death
Median length of hospitalization randomization up to 1 year Median length of last hospitalization, in days among decedents
Death in the ICU randomization up to 1 year Whether or not death occurred in an ICU
Hospitalization in last 30 days of life randomization up to 1 year Hospitalization in the last 30 days of life, among decedents
Death in an acute care facility randomization up to 1 year Presence or absence of death in an acute care facility like a hospital or emergency room
Hospice enrollment at death randomization up to 1 year Whether or not the patient was enrolled in hospice on the day of death
Proportion of patients with an SIC at 60 days, comparison of all 4 study arms up to 60 days after reaching the poor prognosis node Same as the primary outcome
Time from SIC to death among decedents randomization up to 1 year Time from SIC to death among decedents
ED visits in the last 30 days of life randomization up to 1 year Number of ED visits in the last 30 days of life, among decedents
Receipt of chemotherapy in last 14 days of life randomization up to 1 year Whether or not the patient received chemotherapy in the last 14 days of life, among decedents
Patient preferences Up to 60 days after randomization Patient responses on SHARE questionnaire
Trial Locations
- Locations (1)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States