Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Proportion of patients with an SIC at 60 days for arm 1 (patient +clinician nudge) vs arm 2 (no nudge).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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
干预措施: Clinician Nudge Email (Other)
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
干预措施: Patient Nudge Letter and Share questionaire (Other)
Neither the patient nor clinician receive a nudge
Standard Care
Patient receives a nudge but not the clinician
-Patient nudge consists of a letter and SHARE questionnaire
干预措施: Patient Nudge Letter and Share questionaire (Other)
Clinician receives a nudge but not the patient
-Clinician "nudge" email encouraging discussion to initiate discussion on SIC
干预措施: Clinician Nudge Email (Other)
结局指标
主要结局
Proportion of patients with an SIC at 60 days for arm 1 (patient +clinician nudge) vs arm 2 (no nudge).
时间窗: 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.
次要结局
- Enrolled < 4 days in hospice at death(randomization up to 1 year)
- Median length of hospitalization(randomization up to 1 year)
- Death in the ICU(randomization up to 1 year)
- Hospitalization in last 30 days of life(randomization up to 1 year)
- Death in an acute care facility(randomization up to 1 year)
- Hospice enrollment at death(randomization up to 1 year)
- 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)
- Time from SIC to death among decedents(randomization up to 1 year)
- ED visits in the last 30 days of life(randomization up to 1 year)
- Receipt of chemotherapy in last 14 days of life(randomization up to 1 year)
- ICU utilization in last 30 days of life(randomization up to 1 year)
- Patient preferences(Up to 60 days after randomization)
研究者
Christopher Manz, MD
Principal Investigator
Dana-Farber Cancer Institute