Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)

Conditions
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Breast Cancer, Gastrointestinal Cancer, Gynecologic Cancer, Thoracic Cancer, Genitourinary Cancer

Intervention / Treatment
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* Other: Clinician Nudge Email
* Other: Patient Nudge Letter and Share questionaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 4 arm randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Both patient and clinician receive a nudge<br>Patient nudge consists of a letter and SHARE questionnaire Clinician nudge email encouraging discussion to initiate discussion on SIC | Other: Clinician Nudge Email<br>* -Clinician nudge email encouraging discussion to initiate discussion on SIC at next visit<br>Other: Patient Nudge Letter and Share questionaire<br>* 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.<br>|
| No Intervention: Neither the patient nor clinician receive a nudge<br>Standard Care | |
| Experimental: Patient receives a nudge but not the clinician<br>-Patient nudge consists of a letter and SHARE questionnaire | Other: Patient Nudge Letter and Share questionaire<br>* 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.<br>|
| Experimental: Clinician receives a nudge but not the patient<br>-Clinician nudge email encouraging discussion to initiate discussion on SIC | Other: Clinician Nudge Email<br>* -Clinician nudge email encouraging discussion to initiate discussion on SIC at next visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Gastrointestinal Cancer, Gynecologic Cancer, Thoracic Cancer, Genitourinary Cancer, Serious Illness Communication