Evaluating the CAREchart@Home™ Program for Enhancing After-hours Cancer Care

NCT ID: NCT04232709

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-05-09

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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After-hours care

Patients in the after-hours care (AH) group will receive the usual (telemedicine) care. That is, they will have the option to call the after-hours centre and receive help from the oncology nurses using the COSTaRS practice guides to manage their after-hours symptoms.

Group Type NO_INTERVENTION

No interventions assigned to this group

After-hours care w/personal health info

Patients in the after-hours care with personal health information (AH-PHI) group will also receive the usual (telemedicine) care. However, if they call the telemedicine service, the oncology nurses will have access to some of their personal health information from the cancer centre (i.e., a shared electronic patient record) via the MedChart platform.

Group Type EXPERIMENTAL

Shared electronic patient record

Intervention Type OTHER

MedChart allows access to a shared electronic patient record that contains selected information related to a patient's cancer treatment. If a patient contacts the after-hours telemedicine service, the oncology nurse will have access to this shared record

Interventions

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Shared electronic patient record

MedChart allows access to a shared electronic patient record that contains selected information related to a patient's cancer treatment. If a patient contacts the after-hours telemedicine service, the oncology nurse will have access to this shared record

Intervention Type OTHER

Other Intervention Names

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MedChart

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southlake Regional Health Centre

OTHER

Sponsor Role collaborator

Women's College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sacha Bhatia, MD, FRCPC, MBA

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Peter Anglin, MD, FRCPC, MBA

Role: PRINCIPAL_INVESTIGATOR

Southlake Regional Health Centre

Locations

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Southlake Regional Health Centre

Newmarket, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 23290526 (View on PubMed)

Cancer Care Ontario. (2014). Quality Person-Centred Systemic Treatment in Ontario, 2014-2019 (pp. 1-46). Toronto, ON: Cancer Care Ontario.

Reference Type BACKGROUND

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/

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 12537920 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16810138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23675348 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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WCHCCH-001

Identifier Type: -

Identifier Source: org_study_id

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