Home Hospital for Lymphoma
Study Details
Study Description
Brief Summary
The goal of this research is to evaluate an intervention, which the investigators call "Home Hospital for Lymphoma," that involves remote patient monitoring and home-based supportive care for patients hospitalized with lymphoma at Massachusetts General Hospital.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This research study is a single arm pilot Feasibility Study, which is the first-time investigators are examining this hospital at home intervention for patients with lymphoma.
The research study procedures include screening for eligibility, questionnaires, remote patient monitoring (e.g. patient-reported symptoms and home monitored vital signs) and home-based supportive care (e.g. visits to patients' homes to address and manage any concerning issues identified), and interviews of participants, caregivers, and clinicians asking their perceptions of the Home Hospital for Lymphoma program.
Participants will include 3 groups:
Enrolled participants receiving the hospital at home intervention, caregivers of participants, and clinicians.
Participants will be in the research study for about six months after consent. It is expected that up to 38 participants will take part in this research study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Home Hospital for Lymphoma The Home Hospital for Lymphoma intervention entails the following: patient-reported symptoms and vital signs with appropriate triggers for phone calls and home visits, and regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care. |
Other: Home Hospital for Lymphoma
Remote monitoring and home-based care designed for hospitalized patients with lymphoma
|
Outcome Measures
Primary Outcome Measures
- enrollment rate [1 year]
The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study
- retention rate [1 year]
The primary endpoint is feasibility. The proposed intervention will be deemed feasible if those enrolled patients complete at least 60% of daily patient-reported symptom assessment.
Secondary Outcome Measures
- Acceptability of the intervention [1 year]
Qualitative acceptability ratings from patients, caregivers, and clinicians obtained via exit individual interviews regarding acceptability (i.e. usefulness, effectiveness, and relevance of the intervention) from patients, family caregivers, and clinicians. The intervention will be deemed acceptable if ≥ 60% of patients, family caregivers, and clinicians report that the intervention was helpful.
- Rates of completion of daily vital signs [1 year]
Proportion of participants that complete daily reporting of vital signs during their home hospital admission.
- Rates of Adverse Events [1 year]
The rates of Adverse Events and Serious Adverse Events that are judged by the treating lymphoma clinician to be at least possibly related to the study intervention.
Other Outcome Measures
- Symptom burden (Edmonton Symptom Assessment System-revised - ESAS-r) [1 year]
Change in participants' symptom burden as measured by the ESAS-r throughout the study. The ESAS-r ranges 0-10 for each symptom with higher scores indicating worse symptom burden.
- Psychological distress (Hospital Anxiety and Depression Scale - HADS) [1 year]
Change in psychological distress as measured by the HADS, with subscale ranges from 0-21 with higher scores indicating worse psychological distress.
- Quality of life (Functional Assessment of Cancer Therapy-General - FACT-G) [1 year]
Change in quality of life as measured by the FACT-G throughout the study, with range of 0-108 and higher scores indicating better quality of life.
- Length of home hospital admission [1 year]
Number of days the participant receives home hospital care through the home hospital program.
- Number of home visits [1 year]
Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to participants at their home.
- Number of phone calls [1 year]
Number of phone calls required per participants as well as the average duration of these calls.
- Number of urgent visits [1 year]
The number of urgent visits to clinic per participant and the proportion of participants who have an urgent visit to clinic.
- Number of emergency department (ED) visits The number of imaging tests ordered during home hospital admission [1 year]
The number of emergency department (ED) visits per participant and the proportion of participants who have an ED visit.
- Number of hospital readmissions [1 year]
The number of hospital readmissions in 30 days per participant and the proportion of participants who have a hospital readmission within 30 days.
- Number of imaging studies [1 year]
The number of imaging studies obtained per participant during the Home Hospital admission.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 or older
-
Receiving their lymphoma care with curative intent at MGH (treatment intent based upon chemotherapy order in the electronic medical record)
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Hemodynamically stable during the first 24 hours of hospital admission at MGH
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Residing within the designated geographic area for MGH Home Hospital Service (an approximately 10-mile radius from MGH)
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Able to communicate and respond to questionnaires in English
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Lives with a family member or a friend who supports the patient at home
-
Deemed eligible for supportive oncology care at home based on the MGH Home Hospital clinician evaluation
Exclusion Criteria:
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Those admitted to the intensive care unit
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Have high oxygen requirement (FIO2 > 0.4)
-
Experience active angina or cardiac arrythmias
-
Have a planned inpatient surgical or interventional procedure
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Have uncontrolled psychiatric illness or impaired cognition that prohibits complying with the study procedures
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Have uncontrolled pain requiring intravenous pain medications
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Those deemed ineligible based on the Home Hospital Service clinician evaluation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-613