Cancer Clinical Trial
Official title:
Evaluating the CAREchart@Home™ Program for Enhancing After-hours Care of Cancer Patients in Ontario: A Pilot Randomized Controlled Trial
The objective of the current project is to pilot the evaluation of the health and economic
benefits of having online access to health information in the context of providing
telemedicine support for oncology patients receiving outpatient systemic therapy in Ontario.
This pilot study will determine the feasibility of conducting a full-scale randomized
controlled trial that could definitively determine whether the addition of access to
patients' health information in the after-hours telemedicine program reduces emergency
department use, affect patients' experience of care, or improve patient-reported health.
The study will be conducted at, and with patients from, the Stronach Regional Cancer Centre
(SRCC) at Southlake. Eligible patients will be adults (at least 18 years of age) with a
confirmed cancer diagnosis, and initiating or continuing treatment with systemic therapy at
the SRCC. Prospective patients will be randomized across two arms. Recruitment will take
place during a 6.5-month recruitment period and followed up for a period of 3 months.
Advances in systemic therapy (including oral or intravenously injected anti-cancer drugs)
have led to the improvement in overall survival for many cancers and more than half of
patients diagnosed with cancer will receive some form of systemic therapy. Unfortunately,
Cancer Care Ontario (CCO) data indicates that up to 50% of patients will experience
treatment-related side effects resulting in a visit to the emergency department (ED) or
admission to hospital within 4 weeks of receiving chemotherapy - the most common form of
systemic therapy. Despite differences in international healthcare systems, it is useful to
note that one US-based study found that approximately 25% of total ED costs during cancer
treatment could be potentially preventable, presenting a significant opportunity to lower
health system costs related to cancer care.
While most systemic therapy is delivered in cancer clinics which operate during business
hours, data shows that a significant portion of unplanned ED visits and hospital admissions
occur after-hours, that is, on evenings and weekends. One of the strategic priorities of
CCO's 2014-2019 Systemic Treatment Provincial Plan was to reduce ED utilization through
enhanced management of toxicity due to treatment with one avenue being the provision of
symptom management services through alternate models of care, especially during after-hour
time periods.
In July 2016, Bayshore Healthcare Ltd. introduced a program to provide after-hours symptom
management support for oncology patients receiving systemic therapy. The program runs Monday
to Friday 6:00pm - 8:30am, and Saturday 8:30am to Monday 8:30am, including statutory holidays
and involves highly trained oncology nursing staff answering telephone calls from patients
related to symptom management. In two separate partnerships in 2016, Southlake Regional
Health Centre partnered with Bayshore HealthCare Ltd. to pilot the after-hours telephone
symptom management program and also initiated a concurrent, but completely separate pilot
with MedChart Inc. to offer Southlake patients (and their circle of care) online access to
medical records, primarily outside the cancer program. MedChart's technology is a
cloud-based, online Consumer Moderated Health Information Exchange (CME) network that
connects to healthcare providers and provides access to health records in any format.
While at least one study has reported a reduction in ED visits, over four years, after the
introduction of telephone support with physician access to medical records, the causal
pathway connecting the provision of the medical records with reduced ED visits and health
system costs is largely unexplored. As such, it is unclear whether there are outcomes, other
than ED utilization, that may also be scientifically interesting and/or more feasible to
capture. Furthermore, there are no recent studies that prospectively compared the provision
of after-hours services with and without medical records.
The objective of the current project is to pilot the evaluation of the health and economic
benefits of having online access to health information in the context of providing
telemedicine support for oncology patients receiving outpatient systemic therapy in Ontario.
This pilot study will determine the feasibility of conducting a full-scale randomized
controlled trial (RCT) that could definitively determine whether the addition of access to
patients' health information in the after-hours telemedicine program reduces emergency
department use, affects patients' experience of care, or improves patient-reported health.
The evaluation will focus on the shared electronic patient record (provided by MedChart) in
the context of Bayshore's after-hours telemedicine program (CAREchart@home).
This will be a single-centre, non-blinded, two-arm pilot RCT. Once recruited, patients will
be randomized to one of two study arms: (1) the control arm, which constitutes usual care -
access to after-hours telemedicine (AH); and (2) the intervention arm - access to after-hours
telemedicine with some cancer-related personal health information (AH-PHI), i.e.
CAREchart@home™. Recruitment will take place during a 6.5-month recruitment time period and
all patients will be followed up for a period of 3 months during which patients will complete
a series of questionnaires and data from institutional records will be compiled.
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