Feasibility of Delivering a Supportive Oncology Care at Home Intervention for Hospitalized Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Rates of study enrollment
研究概览
简要总结
This study is evaluating if a program that involves remote monitoring and home-based care may improve the post-discharge care of recently hospitalized patients with advanced cancer.
The Supportive Oncology Care at Home intervention consists of three key components:
- Remote patient monitoring (e.g. patient-reported symptoms, home-monitored vital signs and body weight);
- A Medically Home care model for symptom assessment, evaluation, and management (e.g. triggers for phone calls and visits to patients' homes to address and manage any concerning issues identified);
- Structured communication with the oncology team to ensure continuity of care.
详细描述
This is a single-arm pilot study of recently hospitalized patients with advanced cancer to assess the the feasibility of delivering a remote monitoring and home-based program, Supportive Oncology Care at Home, the acceptability and satisfaction with the Supportive Oncology Care at Home program, and changes in the quality of life and symptoms of patients who receive the Supportive Oncology Care at Home program.
Oncologists at the MGH Cancer Center developed the Supportive Oncology Care program to address the symptoms and frequent hospital visits that patients face as a result of their cancer and the treatment they receive.
The research study procedures include:
- Remote monitoring of symptoms, vital signs, and body weight
- Questionnaires asking about demographic information (e.g. gender, ethnicity, income) and participant experience with cancer (e.g. your quality of life, your symptoms)
- Interviews to assess participant impressions of the program
- Caregiver Interviews, Questionnaires and Surveys to assess caregiver impressions of the program and caregiver perceptions of participant symptoms while in the program
- Clinician Interviews and Questionnaires to assess impressions of the program
- Data collection from participant medical record.
Patients will take part in the program for two weeks following hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patient Eligibility
- •Age 18 or older
- •Diagnosed with advanced cancer (defined as receiving treatment with palliative intent per chemotherapy order entry treatment intent designation and/or trial consent forms OR based on documentation in the oncology clinic notes for those not receiving chemotherapy)
- •Admitted with an unplanned or non-elective hospitalization at Massachusetts General Hospital (MGH)
- •Not requiring ICU-level care during their hospitalization
- •Receiving care at the MGH Cancer Center
- •Ability to read and respond to question in English
- •Residing within 50 miles of MGH.
- •Caregiver Eligibility
- •Relative or friend of eligible patient
- •Verbally fluent in English
- •Age 18 or older
- •Clinician Eligibility
- •-- Outpatient oncology physicians and advanced practice clinicians who care for patients that receive the Supportive Oncology Care at Home intervention
排除标准
- •Patient Exclusion
- •Are admitted to the intensive care unit
- •Have a high oxygen requirement (FIO2 > 0.40)
- •Experience active angina or cardiac arrythmias
- •Have a planned inpatient surgical or interventional procedure
- •Have uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written informed consent
- •Are deemed ineligible for home-based care based on the inpatient oncology clinician assessment
- •Are planning to be discharged to hospice or to any location other than their home
- •Caregiver Exclusion -- Caregivers who are unwilling or unable to participate in the study.
- •Clinician Exclusion
- •-- Clinicians who are unwilling or unable to participate in the study.
研究组 & 干预措施
Supportive Oncology Care at Home
Participants will receive the Supportive Oncology Care at Home program for 14 days following their discharge from the hospital.
The Supportive Oncology Care at Home intervention consists of three key components:
- Daily monitoring of patient-reported symptoms, vital signs, and body weight.
- Medically Home care based on algorithmic changes in patients' daily symptoms, vital signs, and body weight.
- Structured communication with the oncology team regarding care delivered to ensure continuity of care.
干预措施: Supportive Oncology Care at Home (Other)
结局指标
主要结局
Rates of study enrollment
时间窗: 2 years
Proportion of patients who agree to participate in the study and sign informed consent.
Rates of completion of daily symptom assessment
时间窗: 2 years
Proportion of daily patient-reported symptom assessments completed throughout the study period.
次要结局
- Rates of completion of daily vital signs(2 years)
- Rates of completion of daily body weight(2 years)
- Number of home visits required(Baseline to 2 weeks post-enrollment)
- Duration of home visits(Baseline to 2 weeks post-enrollment)
- Issues addressed during home visits(Baseline to 2 weeks post-enrollment)
- Interventions delivered during home visits(Baseline to 2 weeks post-enrollment)
- Number of phone calls required(Baseline to 2 weeks post-enrollment)
- Duration of phone calls(Baseline to 2 weeks post-enrollment)
- Number of emails required(Baseline to 2 weeks post-enrollment)
- Patient acceptability(1 year)
- Family caregiver acceptability(1 year)
- Clinician acceptability(1 year)
- Change in symptoms burden longitudinally throughout the study(Baseline to 2 weeks post-enrollment)
- Change in psychological distress score longitudinally throughout the study(Baseline to 2 weeks post-enrollment)
- Change in quality of life score longitudinally throughout the study(Baseline to 2 weeks post-enrollment)
- Change in care satisfaction score longitudinally throughout the study(Baseline to 2 weeks post-enrollment)
- Number of emergency department visits(Baseline up to one month post-enrollment)
- Rates of emergency department visits(1 year)
- Number of urgent visits(Baseline up to one month post-enrollment)
- Rates of urgent visits(1 year)
- Number of hospital readmissions(Baseline up to one month post-enrollment)
- Rates of hospital readmissions(1 year)
- Length of hospital readmissions(Baseline up to one month post-enrollment)
- Days outside of hospital(Baseline to 2 weeks post-enrollment)
- Hospitalization length of stay(Baseline to 2 weeks post-enrollment)
- Change in caregivers reports of patients' symptom burden longitudinally throughout the study(Baseline to 2 weeks post-enrollment)
- Concordance between caregiver and patient reports of patient symptom burden(Baseline to 2 weeks post-enrollment)
研究者
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital