Supportive Oncology Care at Home Post-Discharge

N/AActive Not RecruitingNCT04637035

Massachusetts General Hospital110 enrolled

Overview

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: 1. Remote patient monitoring (e.g. patient-reported symptoms, home-monitored vital signs and body weight); 2. 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); 3. Structured communication with the oncology team to ensure continuity of care.

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. It is expected that between 75 and 110 people will enroll, including up to 30 patients, up to 30 caregivers, and up to 15 clinicians. Medically Home Group, Inc. is supporting this research study by providing funding for this research study.

Study Type

INTERVENTIONAL

Allocation

Purpose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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 Exclusion Criteria: 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.

Outcomes

Primary Outcomes

Rates of study enrollment

Proportion of patients who agree to participate in the study and sign informed consent.

Time frame: 2 years

Rates of completion of daily symptom assessment

Proportion of daily patient-reported symptom assessments completed throughout the study period.

Time frame: 2 years

Secondary Outcomes

Rates of completion of daily vital signs

Proportion of daily vital signs completed throughout the study period.

Time frame: 2 years

Rates of completion of daily body weight

Proportion of daily reporting body weights completed throughout the study period.

Time frame: 2 years

Number of home visits required

Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to patients at their home.

Time frame: Baseline to 2 weeks post-enrollment

Duration of home visits

Average duration of home visits required during the study period.

Time frame: Baseline to 2 weeks post-enrollment

Issues addressed during home visits

Issues addressed during home visit throughout the study period.

Time frame: Baseline to 2 weeks post-enrollment

Interventions delivered during home visits

Interventions delivered to patients at their home throughout the study period.

Time frame: Baseline to 2 weeks post-enrollment

Number of phone calls required

Number of phone calls required per patient.

Time frame: Baseline to 2 weeks post-enrollment

Duration of phone calls

Average duration of phone calls required for patients.

Time frame: Baseline to 2 weeks post-enrollment

Number of emails required

Number of emails from Medically Home to the primary oncology team.

Time frame: Baseline to 2 weeks post-enrollment

Patient acceptability

Qualitative interview acceptability ratings from patients regarding usefulness, effectiveness, and relevance of the study.

Time frame: 1 year

Family caregiver acceptability

Qualitative interview acceptability ratings from caregivers regarding usefulness, effectiveness, and relevance of the study.

Time frame: 1 year

Clinician acceptability

Qualitative interview acceptability ratings from clinicians regarding usefulness, effectiveness, and relevance of the study.

Time frame: 1 year

Change in symptoms burden longitudinally throughout the study

Change in symptom burden (assessed using Edmonton Symptom Assessment System-revised \[ESAS-r\], range 0-10 for each symptom with higher score indicating worse symptom burden) throughout the study.

Time frame: Baseline to 2 weeks post-enrollment

Change in psychological distress score longitudinally throughout the study

Change in psychological distress (assessed using Hospital Anxiety and Depression Scale \[HADS\], range 0-21 for scores of anxiety and depression with higher score indicating worse anxiety or depression) throughout the study.

Time frame: Baseline to 2 weeks post-enrollment

Change in quality of life score longitudinally throughout the study

Change in quality of life (assessed using Functional Assessment of Cancer Therapy-General \[FACT-G\] questionnaire, assessing physical, functional, emotional, and social well-being during the prior seven days, with total score ranging from 0-108 with higher scores indicating better quality of life) throughout the study.

Time frame: Baseline to 2 weeks post-enrollment

Change in care satisfaction score longitudinally throughout the study

Change in patient care satisfaction (assessed using the 16-item FAMCARE questionnaire \[FAMCARE-P\], range of 16-80 with higher score indicating higher care satisfaction) throughout the study.

Time frame: Baseline to 2 weeks post-enrollment

Number of emergency department visits

The number of emergency department \[ED\] visits per patient.

Time frame: Baseline up to one month post-enrollment

Rates of emergency department visits

Proportion of patients needing an emergency department \[ED\] visit.

Time frame: 1 year

Number of urgent visits

The number of urgent visits to clinic per patient.

Time frame: Baseline up to one month post-enrollment

Rates of urgent visits

Proportion of patients needing an urgent visit to clinic.

Time frame: 1 year

Number of hospital readmissions

The number of hospital readmissions per patient.

Time frame: Baseline up to one month post-enrollment

Rates of hospital readmissions

Proportion of patients needing hospital readmission.

Time frame: 1 year

Length of hospital readmissions

The length of stay (LOS) per each hospital readmission for patients who are readmitted.

Time frame: Baseline up to one month post-enrollment

Days outside of hospital

The proportion of days patients spent outside the hospital during the study period.

Time frame: Baseline to 2 weeks post-enrollment

Hospitalization length of stay

The index hospitalization length of stay (LOS).

Time frame: Baseline to 2 weeks post-enrollment

Change in caregivers reports of patients' symptom burden longitudinally throughout the study

Change in symptom burden (assessed using Edmonton Symptom Assessment System-revised \[ESAS-r\], range 0-10 for each symptom with higher score indicating worse symptom burden) throughout the study.

Time frame: Baseline to 2 weeks post-enrollment

Concordance between caregiver and patient reports of patient symptom burden

Difference in symptom burden (assessed using Edmonton Symptom Assessment System-revised \[ESAS-r\], range 0-10 for each symptom with higher score indicating worse symptom burden) between patients and caregivers throughout the study.

Time frame: Baseline to 2 weeks post-enrollment

Supportive Oncology Care at Home Post-Discharge

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes