Breast Cancer, Gastrointestinal Cancer, Genitourinary Cancer, Gynecologic Cancer, Thoracic Cancer
Conditions
Keywords
Breast Cancer, Gastrointestinal Cancer, Gynecologic Cancer, Thoracic Cancer, Genitourinary Cancer, Serious Illness Communication
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.
Interventions
OTHERClinician Nudge Email
-Clinician nudge email encouraging discussion to initiate discussion on SIC at next visit
OTHERPatient 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.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Intervention model description
4 arm randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Median length of hospitalization | randomization up to 1 year | Median length of last hospitalization, in days among decedents |
| 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 |
| 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 |
| ICU utilization in last 30 days of life | randomization up to 1 year | ICU hospitalization in the last 30 days of life, among decedents |
Countries
United States
Outcome results
None listed