Homebound Care Utilizing Telemedicine in Reducing Hospital Readmission in Patients with Plasma Cell Tumor Undergoing Stem Cell Transplant
This clinical trial studies how well homebound care utilizing virtual care visits and remote data transmission (telemedicine) works in reducing hospital readmission in patients with plasma cell tumors undergoing a stem cell transplant. Homebound care may help to increase patient satisfaction and decrease the risk of infections associated with stem cell transplants.
Inclusion Criteria
- Diagnosis of plasma cell dyscrasia
- Treatment plan including autologous HSCT
- 18-80 years of age
- Appropriate homebound setting as defined by one of the following: * Lodging at Memorial Sloan-Kettering (MSK) residence * Staying at home or a "home equivalent" in any one of the zip codes; home equivalent is defined as a residence which may or may not be the primary residence of the patient * "Home equivalent" must pass the "Home Environment Screening Tool" for homebound stem cell transplantation (not required for other MSK recognized lodging facility)
- Adequate caregiver support as defined by: * During the safety/feasibility run-in: Single or multiple informal caregivers willing and able to provide 24 hour a day, seven day a week supervision of the transplant recipient in their home or "home-like" environment * Beyond the safety/feasibility run-in: Single or multiple informal caregivers willing and able to provide care from 6pm to 8am, seven days a week to supervise the transplant recipient in their home or “home-like” environment * Caregiver willing and able to fulfill the basic stem cell transplant caregiver education requirements as determined by caregiver and healthcare team, including social worker
- Have wireless fidelity (Wi-Fi) connection
- Appropriate third party payer coverage for "Homebound Stem Cell Transplant Program"
- Both patient and caregiver willing to give and sign informed consent
Exclusion Criteria
- Patients with a documented active infection prior to starting their preparative regimen; this includes grade 3 or higher viral, bacterial, or fungal infection
- Uncontrolled arrhythmias
- Active or uncontrolled pulmonary disease
- Karnofsky performance scale (KPS) score < 80
- Sorror co-morbidity index > 4 except in patients with history of resected cancers
- Creatinine clearance (calculated or measured) of < 50 cc/minute
- Inability of patient or caregiver to speak or read English
- Inadequate housing arrangements
- Inadequate caregiver arrangements
Additional locations may be listed on ClinicalTrials.gov for NCT02671448.
Locations matching your search criteria
United States
New York
New York
PRIMARY OBJECTIVES:
I. To investigate the feasibility of home bound stem cell transplantation in patients with a diagnosis of multiple myeloma undergoing autologous hematopoietic stem cell transplantation (HSCT) by assessing readmission rate within 21 days of HSCT. (Initial Pilot Trial)
II. To investigate the safety of using telemedicine to provide caregiver respite while patients with plasma cell disorders undergo homebound stem cell transplantation by assessing readmission rate within 21 days of HSCT. (Second Cohort)
SECONDARY OBJECTIVES:
I. To assess overall frequency of infections and grades 3-4-5 non-hematologic toxicities.
II. To assess the quality of life of the patient and the caregiver using patient reported outcomes (PROs) and caregiver reported outcomes instruments.
III. To assess changes in stool microbiota in patients undergoing homebound HSCT.
IV. To determine the hours of respite attained by the caregiver.
V. To determine out of pocket costs incurred by the caregiver as well as the total costs of the program.
VI. To assess the satisfaction of the patient and the caregiver with the homebound care experience using a survey questionnaire.
VII. To describe the patient and caregiver experience in 'real time' through the use of video diaries and one-on-one focused interviews. (Initial Pilot Trial)
OUTLINE:
INITIAL PILOT TRIAL (COMPLETE): Patients receive homebound care starting on day 1, including a visit in the morning hours from a HSCT nurse practitioner (NP) or physician's assistant (PA), a visit by a registered nurse (RN) in the afternoon hours, and visual communication with an attending physician through the use of teleconsult equipment for 3 months after HSCT.
SECOND COHORT: Patients receive protocol-specific care starting on day 0. Patients receive a teleconsult visit from an advanced practice provider (APP) on days 1 through engraftment (day 10). Patient receives an in-home RN visit on days 3, 5 and through engraftment (day 10). Depending on the APP visit, patients may also receive an in-home RN visit on days 1, 2, and 4. Patients use the Withings blood pressure monitor, thermometer, weight scale, Nonin pulse oximeter, and Fitbit from day 0 to engraftment.
After completion of study, patients and caregivers are followed up for 30 days and 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorHeather J Landau
- Primary ID15-022
- Secondary IDsNCI-2016-01703
- ClinicalTrials.gov IDNCT02671448