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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05629065

Collaborator

(none)

800

Enrollment

Location

Arms

37.1

Anticipated Duration (Months)

21.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Gastrointestinal Cancer Gynecologic Cancer Thoracic Cancer Genitourinary Cancer	Other: Clinician Nudge Email Other: Patient Nudge Letter and Share questionaire	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

4 arm randomized clinical trial4 arm randomized clinical trial

Masking:

Single (Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 28, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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
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
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
Hospitalization in last 30 days of life [randomization up to 1 year]
Hospitalization in the last 30 days of life, among decedents
Median length of hospitalization [randomization up to 1 year]
Median length of last hospitalization, in days among decedents
ICU utilization in last 30 days of life [randomization up to 1 year]
ICU 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
Death in the ICU [randomization up to 1 year]
Whether or not death occurred in an ICU
Hospice enrollment at death [randomization up to 1 year]
Whether or not the patient was enrolled in hospice on the day of death
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
Patient preferences [Up to 60 days after randomization]
Patient responses on SHARE questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)