This clinical trial develops and studies whether using a new remote patient monitoring (RPM) program \[Smart Health Integration for Early Life-saving Detection (SHIELD)\] in cancer practices helps manage infectious complications among cancer patients who are initiating systemic therapy. Infectious complications are among the most common, costly, and clinically consequential side effects experienced by patients receiving cancer-directed therapy and can lead to increased emergency department evaluations, reduced quality of life, and death. National guidelines support using management strategies within cancer practices for selected patients with infectious complications; however, implementation remains limited by the need for reliable monitoring programs while the patient is at home. The SHIELD program combines remote electronic patient-reported outcome symptom assessments with continuous temperature monitoring (CTM). Patients complete electronic patient-reported outcome symptom assessments on a mobile application and wear a CTM device. Patient responses and CTM data are integrated into the electronic health record, which can create alerts. Cancer practice clinical assistants and nurses review the alerts and create care escalation pathways to the clinical care team or emergency department if needed. The application can also deliver patient education and guidance for self-management of low-grade symptoms. Using the SHIELD program in cancer practices may be an effective way to help manage infectious complications among cancer patients who are initiating systemic therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
470
Smart Health Integration for Early Life-saving Detection (SHIELD) program used as an electronic patient-reported outcomes (ePRO) and continuous temperature monitoring (CTM)-integrated remote patient monitoring (RPM) care delivery model
Participants will wear the TempShield device by AION an FDA-approved, medical grade continuous temperature monitoring (CTM) wearable sensor
Patients complete questionnaires and study surveys
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Reach - screening eligibility
Screening eligibility rates will be assessed by the percentage of eligible patients screened for study participation.
Time frame: Baseline
Reach - enrollment rates
Enrollment rates will be assessed by the percentage of screened patients who enroll in the study.
Time frame: Baseline
Reach - representativeness of enrollment
Representativeness of enrollment will be assessed by comparison of urban-rural residence / Rural-Urban Commuting Area (RUCA) codes recorded for participants
Time frame: Baseline
Acceptability - PRISM PCSI Staff Survey
The Practical Robust Implementation and Sustainability (PRISM) Contextual Survey Instrument (PCSI) staff survey consists of one question ascertaining the staff role and 29 questions related to perspectives, sustainability, and organizational characteristics of implementing the SHIELD remote patient monitoring program. Questions are answered on a 5-point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree). Results will be analyzed and reported descriptively.
Time frame: Baseline
Usability - Remote Patient Monitoring (RPM) Patient/Caregiver Survey
The Remote Patient Monitoring (RPM) survey consists of 17 questions answered on a 5-point scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) and two open-ended questions related to what impressed and what disappointed about the RPM program. Results will be analyzed and reported descriptively.
Time frame: 90 days
Enrollment fidelity
Assessed by staff-reported reasons for screening not being completed. Results will be analyzed and reported descriptively.
Time frame: Baseline
Intervention fidelity
Assessed by documentation of intervention delivery - delivered as intended or reasons recorded for adaptation of intervention. Results will be analyzed and reported descriptively.
Time frame: 90 days
Feasibility - treatment adherence
Assessed by the percent overall of electronic patient-reported outcome (ePRO) assessments completed.
Time frame: 90 days
Feasibility - symptoms recorded
Assessed by the percent overall of complete symptom data transmitted
Time frame: 90 days
Penetration - enrollment
Assessed by the proportion of sites and individual work units who enroll patients
Time frame: Baseline
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