Clinical trial NCT04232709: Evaluating the CAREchart@Home™ Program for Enhancing After-hours Cancer Care
Official title: Evaluating the CAREchart@Home™ Program for Enhancing After-hours Care of Cancer Patients in Ontario: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Keywords: systemic therapy
chemotherapy
targeted therapy
immunotherapy
after-hours telemedicine
shared electronic patient record
symptom management
oncology
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Southlake Regional Health Centre
First posted: 2020-01-18
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Confirmed cancer diagnosis (all cancers, all stages)
* Initiating or continuing treatment with systemic therapy (oral or injected/IV; excluding hormonal therapy for breast or prostate cancer) at Stronach Regional Cancer Centre at Southlake

Exclusion Criteria:

* Being treated with radiation
* Unable to read or understand spoken English (Required for completing the questionnaires)
* Unable to utilize the after-hours services due to cognitive impairment

Primary outcomes:
measure: Proportion of patients willing to be randomized
timeFrame: 9.5 Months
measure: Proportion of enrolled patients lost to follow up
timeFrame: 9.5 Months
measure: Number of attempted questionnaires relative to number of questionnaires that should have been completed
timeFrame: 9.5 Months
measure: Number of completed questionnaires relative to number of questionnaires that should have been completed
timeFrame: 9.5 Months
measure: Percent of total emergency department (ED) visits reported that occurred at Southlake
timeFrame: 9.5 Months
measure: Time to complete questionnaire battery
timeFrame: 9.5 Months
measure: Completion rate for satisfaction survey
timeFrame: 9.5 Months
Secondary outcomes:
measure: Self-reported health service utilization
timeFrame: 3 Months
measure: Hospital-reported health service utilization: Emergency Department Visits
timeFrame: 3 Months
measure: Hospital-reported health service utilization: Outcomes of ED Visits
timeFrame: 3 Months
measure: Hospital-reported health service utilization: Length of Hospital Stay
timeFrame: 3 Months
measure: Edmonton Symptom Assessment System-revised (ESAS-r) Scale
timeFrame: 3 Months
measure: Functional Assessment of Cancer Therapy - General (FACT-G) Scale
timeFrame: 3 Months
measure: Prompt Access to Care (PAC) Scale
timeFrame: 3 Months
measure: Continuity of Care (CoC) Scale
timeFrame: 3 Months
measure: Prevented health service utilization
timeFrame: 3 Months
measure: Efficiency of after-hours service advice
timeFrame: 3 Months
measure: Patient confidence
timeFrame: 3 Months
measure: Perceived reliability of the after-hours service encounter
timeFrame: 3 Months
measure: Provider confidence (measured using a modified version of the C-scale)
timeFrame: 3 Months
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Sacha Bhatia, MD, FRCPC, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Southlake Regional Health Centre
name: Peter Anglin, MD, FRCPC, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barbera L, Atzema C, Sutradhar R, Seow H, Howell D, Husain A, Sussman J, Earle C, Liu Y, Dudgeon D. Do patient-reported symptoms predict emergency department visits in cancer patients? A population-based analysis. Ann Emerg Med. 2013 Apr;61(4):427-437.e5. doi: 10.1016/j.annemergmed.2012.10.010. Epub 2013 Jan 4.
citation: Cancer Care Ontario. (2014). Quality Person-Centred Systemic Treatment in Ontario, 2014-2019 (pp. 1-46). Toronto, ON: Cancer Care Ontario.
citation: Cancer Quality Council of Ontario. (2016, October). Cancer Safety Quality Index: Unplanned Hospital Visits During Chemotherapy. Retrieved March 23, 2018, from http://www.csqi.on.ca/by_patient_journey/treatment/unplanned_hospital_visits_during_chemotherapy/
citation: Ferrer-Roca O, Subirana R. A four-year study of telephone support for oncology patients using a non-supervised call centre. J Telemed Telecare. 2002;8(6):331-6. doi: 10.1258/135763302320939211.
citation: Kurtz ME, Kurtz JC, Given CW, Given B. Effects of a symptom control intervention on utilization of health care services among cancer patients. Med Sci Monit. 2006 Jul;12(7):CR319-24. Epub 2006 Jun 28.
citation: Palumbo MO, Kavan P, Miller WH Jr, Panasci L, Assouline S, Johnson N, Cohen V, Patenaude F, Pollak M, Jagoe RT, Batist G. Systemic cancer therapy: achievements and challenges that lie ahead. Front Pharmacol. 2013 May 7;4:57. doi: 10.3389/fphar.2013.00057. eCollection 2013.
citation: Panattoni, L., Fedorenko, C. R., Kreizenbeck, K. L., Greenlee, S., Walker, J. R., Greenwood-Hickman, M. A., et al. (2017). Costs of potentially preventable emergency department use during cancer treatment: A regional study [Abstract]. Journal of Clinical Oncology / 2017 ASCO Annual Meeting, 35(8_suppl), Abst 6505. http://doi.org/10.1200/JCO.2017.35.8_suppl.2