Early Point-of-Service SBDOH Screening in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Rates of SBDOH screen completion prior to initial surgical consult
研究概览
简要总结
The overarching goal of this project is to optimize the collection of social and behavioral determinants of health (SBDOH) for patients with a pathological diagnosis of breast cancer at Penn Medicine. The investigators will measure rates of SBDOH data collection by modality and rates of referral to and uptake of social support services, time to evaluation, staff time, acceptability, patient-centered communication, medical mistrust, and clinician acceptability.
详细描述
The investigators will conduct a patient-level, pragmatic opt-out trial to test implementation of a comprehensive, tech-enabled platform for administration of a validated SBDOH screening tool in contrast to the current practice of unstructured social history collection at this institution.
For internally referred patients, study coordinators - who are functioning as patient navigators - will facilitate a warm handoff from radiology to the New Patient Office as well as study introduction and enrollment. If patients do not wish to have a warm handoff call with a new-patient coordinator (NPC) in the NPO who will schedule the patient's consult with a surgeon and/or oncologist, or if patients are diagnosed external to Penn Medicine, the patient coordinator will follow up directly with the patient to facilitate communication and enrollment within 24 hours of diagnosis.
All patients who do not opt out will be part of the analytic cohort and randomized to one of three screening assessment tools:
- Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HSRN);
- Health Leads Social Needs Screening Toolkit (Health Leads);
- National Comprehensive Cancer Network (NCCN) Distress Thermometer + Problem List (NCCN DT+PL).
. The initial request for completion will be administered via the institutional EHR's Epic-based patient portal. Patients will have 48 hours to respond and will receive 2 reminders via a MyPennMedicine message (MPM), through which a patient can also indicate a desire to opt-out if they wish.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •Based on available EHR data, patients will be eligible for Activities 1 and 2 if they:
- •Are referred to one of the following locations for surgical consult following a new diagnosis of operable (Stage 0-III) breast cancer: the Hospital of the University of Pennsylvania (HUP), Penn Presbyterian Medical Center (PPMC), Pennsylvania Hospital (PAH), and Penn Medicine Radnor
- •Are female
- •Are 18 years of age or older, and
- •Are able to read and speak English or Spanish
- •Clinicians and clinical leaders will be eligible for participation in Activity 2 if they:
- •Presently work as a clinician or clinical leader in breast surgery or oncology
- •Access PennChart as an aspect of their clinical duties
- •Are 18 years of age or older
- •Are able to read and speak English or Spanish
排除标准
- •Based on available EHR data, patients will be ineligible if they:
- •Are listed as not wanting to be contacted or solicited for research;
- •Have known metastatic disease at time of enrollment; and/or
- •Do not otherwise meet all of the enrollment criteria
- •Clinicians and clinical leaders will be ineligible for participation in Activity 2 if they:
- •Are not presently engaged in clinical duties or
- •Do not otherwise meet all of the enrollment criteria
- •This study will not exclude men or nonbinary people who may be diagnosed with breast cancer, but investigators anticipate the sample size for these characteristics will be too small to support meaningful analysis.
研究组 & 干预措施
The Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)
Patients will be randomized to receive one of three social needs screening instruments. The AHC-HRSN is a 10-item tool developed by the Centers for Medicare and Medicaid Services to assess patient needs in 5 core domains, including housing instability, food insecurity, transportation problems, utility help needs, and interpersonal safety, with eight supplemental domains to collect information about financial strain, employment, family and community support, education, physical activity, substance abuse, mental health, and disabilities. The AHC-HRSN tool is designed to help physicians identify unmet needs and refer affected patients to appropriate community services.
干预措施: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening (Other)
Health Leads Social Screening Tool
Patients will be randomized to receive one of three social needs screening instruments. Health Leads is an 8-item survey with yes/no responses, which screens for food insecurity, utility needs, housing instability, childcare, financial resource strain, transportation challenges, education, and social isolation.
干预措施: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening (Other)
National Comprehensive Care Network (NCCN) Distress Thermometer and Problem List (DT + PL)
Patients will be randomized to receive one of three social needs screening instruments. The NCCN Distress thermometer is a single-item tool designed to measure patients' current level of distress. Patients are asked to rate their distress using a 10-point Likert scale, where 0=no distress and 10=extreme distress. The Problem List (PL) helps physicians identify the sources of patients' distress and direct patients to appropriate support services. The NCCN DT+PL is a widely used, validated tool for evaluating distress in patients diagnosed with or receiving treatment for cancer.
干预措施: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening (Other)
Chatbot
Patients who do not respond to the survey within 48 hours of being first administered via MyPennMedicine will be sent the same survey via one of two modality arms. The chatbot is a bidirectional text-based conversational agent administered via WaytoHealth. Patients will again have 48 hours to respond via chatbot.
干预措施: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening (Other)
Interactive Voice Response (IVR) System
Patients who do not respond to the survey within 48 hours of being first administered via MyPennMedicine will be sent the same survey via one of two modality arms. The interactive voice response (IVR) system is administered via phone through WaytoHealth. Patients will be called over the phone and will receive the screening tool through IVR. Patients will again have 48 hours to respond via IVR.
干预措施: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening (Other)
结局指标
主要结局
Rates of SBDOH screen completion prior to initial surgical consult
时间窗: 1 year
Rates of SBDOH screen completion prior to initial surgical consult will be first compared by instrument (Accountable Health Communities Health-Related Social Needs Screening Tool \[AHC-HRSN\], Health Leads Social Needs Screening Toolkit \[Health Leads\], National Comprehensive Cancer Network Distress Thermometer and Problem List \[NCCN DT + PL\]). Only the NCCN DT employs a 10-point Likert scale, where 0 = no distress and 10 = extreme distress. Among patients who do not respond to initial screening administration and who then receive the screening via either chatbot or IVR, rates of SBDOH screen completion will be compared by modality.
次要结局
- Identify factors associated with rates of post-diagnosis, pre-consultation SBDOH screen completion(6 months)
- Time from biopsy to initial surgical consult(1 years)
研究者
Oluwadamilola Fayanju, MD, MA, MPHS, FACS
Principal Investigator
Abramson Cancer Center at Penn Medicine