Hospital at Home at EOL in Heme Malignancies

Hematologic Malignancy Clinical Trial

Official title:

Hospital-at-Home Care Model to Optimize End-of-Life (EOL) Care for Patients With Hematologic Malignancies: A Pilot Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04690205
• Other study ID #: 20-468
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 26, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is evaluating an intervention, which the investigators call "Optimize End of Life (EOL) Care at Home," that entails remote patient monitoring and home-based supportive care for patients with advanced hematologic malignancies.

Description:

This research study is a single arm pilot feasibility study, which is the first-time investigators are examining this care at home intervention in patients with advanced hematologic malignancies. The research study procedures include screening for eligibility, questionnaires, remote patient monitoring (e.g. patient-reported symptoms, home monitored vital signs) and hospital care at home (e.g. providing maximal supportive care to to address and manage patients' symptoms) and structured communications oncology clinicians to optimize end of life care for patients with advanced hematologic malignancies. Participants will include 3 groups: 1) Enrolled patients with advanced hematologic malignancies receiving the end of life (EOL) care at home intervention; 2) caregivers of these patients; and 3) oncology clinicians caring for these patients. Participants will be in this research study for approximately six months after consent. It is expected that about 30 patients, 30 caregivers, and 15 oncology clinicians will take part in this research study. Medically Home company is supporting this research study by providing funding.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18 or older
• diagnosed with relapsed or refractory hematologic malignancy
• must be receiving treatment with non-curative intent or supportive care alone based on the intent of chemotherapy as reported in order entry or Electronic Health Record
• deemed eligible to receive EOL care at home based on the primary oncologist's assessment
• Able to communicate and respond to questionnaires in English or with the assistance of an interpreter.
• residing within 50 miles of MGH. Of note, patients requiring supportive transfusions in the oncology clinic will still be eligible to participate.

Exclusion Criteria:

• Those with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written informed consent as determined by the primary oncologist.

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

Other:
• End of Life (EOL) Care at at Home
Remote monitoring and home-based care designed for patients with advanced hematologic malignancies

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Medically Home

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment Rate	The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 60% (95% confidence interval +/- 18%) of eligible patients are enrolled in the study.	6 months
Primary	Retention Rate	The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 80% of enrolled participants will complete a minimum of 60% of their daily assessments (i.e. patient-reported symptoms)	6 months
Secondary	Acceptability of the intervention	Qualitative acceptability ratings from patients, caregivers, and oncology clinicians defined by perceptions of usefulness, effectiveness, and relevance of the intervention obtained via interviews regarding acceptability from patients, family caregivers, and oncology clinicians.	6 months
Secondary	Patient Quality of Life (Functional Assessment of Cancer Therapy-General - Fact-G)	Change in quality of life as measured by the FACT-G throughout the study. FACT-G score ranges from 0 to 108 points with higher score indicating better quality of life	up to 6 months
Secondary	Caregiver Quality of Life (CareGiver Oncology QOL)	Change in caregiver quality of life as measured by the CarGOQOL throughout the study. Caregiver Oncology QOL questionnaire ranges from 0 to 100 points with higher scores indicating better caregiver quality of life	6 months
Secondary	Patient Symptom Burden (using the Edmonton Symptom Assessment Scale-revise)	Change in patient symptom burden measured with Edmonton Symptom Assessment System-revised (ESAS-r). Scores range from 0-100 with higher scores indicate worse symptom burden.	up to 6 months
Secondary	Caregiver Burden	Caregiving burden will be assessed using the Caregiver Reaction Assessment (CRA) caregiving burden. The CRA score ranges from 24-120, with higher score indicating higher caregiving burden	up to 6 months
Secondary	Health Care Utilization	Electronic Health Records (EHR) will be used to assess patient health care utilization including hospitalizations, chemotherapy use, and emergency department visits at the end of life.	6 months
Secondary	Patient psychological distress (using the Hospital Anxiety and Depression Scale (HADS))	The Hospital Anxiety and Depression Scale (HADS) will be used to assess patient psychological distress. The HADS score ranges from 0-21 with higher score indicating more psychological distress.	Up to 6 months
Secondary	Caregiver psychological distress (using the Hospital Anxiety and Depression Scale (HADS))	The Hospital Anxiety and Depression Scale (HADS) will be used to caregiver psychological distress. The HADS score range from 0-21 with higher scores indicating worse psychological distress	Up to 6 months
Secondary	Caregiver Satisfaction with patient's end of life (EOL) care using the FAMCARE	Nine items from the FAMCARE will be used to assess caregivers' satisfaction with the quality of medical services provided to them and the patient at the end of life. FAMCARE provides rating of quality of death on a scale of 0-10, with higher scores indicating best possible death. FAMCARE also provides a total score ranges 0-24, with higher score indicating better satisfaction with EOL care	Up to 6 months