Clinical trial NCT05629065: Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)
Official title: Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Gastrointestinal Cancer
Gynecologic Cancer
Thoracic Cancer
Genitourinary Cancer
Keywords: Breast Cancer
Gastrointestinal Cancer
Gynecologic Cancer
Thoracic Cancer
Genitourinary Cancer
Serious Illness Communication
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 4 arm randomized clinical trial
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of patients with an SIC at 60 days for arm 1 (patient +clinician nudge) vs arm 2 (no nudge).
timeFrame: up to 60 days after reaching the poor prognosis node
Secondary outcomes:
measure: Proportion of patients with an SIC at 60 days, comparison of all 4 study arms
timeFrame: up to 60 days after reaching the poor prognosis node
measure: Time from SIC to death among decedents
timeFrame: randomization up to 1 year
measure: Receipt of chemotherapy in last 14 days of life
timeFrame: randomization up to 1 year
measure: ED visits in the last 30 days of life
timeFrame: randomization up to 1 year
measure: Hospitalization in last 30 days of life
timeFrame: randomization up to 1 year
measure: Median length of hospitalization
timeFrame: randomization up to 1 year
measure: ICU utilization in last 30 days of life
timeFrame: randomization up to 1 year
measure: Death in an acute care facility
timeFrame: randomization up to 1 year
measure: Death in the ICU
timeFrame: randomization up to 1 year
measure: Hospice enrollment at death
timeFrame: randomization up to 1 year
measure: Enrolled < 4 days in hospice at death
timeFrame: randomization up to 1 year
measure: Patient preferences
timeFrame: Up to 60 days after randomization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christopher Manz, MD
role: PRINCIPAL_INVESTIGATOR
References: