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CancerNCT04232709

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

A study testing Shared electronic patient record in people with Cancer, run by Women's College Hospital at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Cancer
What is being tested?
Shared electronic patient record
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteCanada
Study dates
1 Feb 2018to 9 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

Other trials in Canada

About this study

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.

Read the 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.

Conditions
Cancer
Being tested
Shared electronic patient record
Keywords
systemic therapy, chemotherapy, targeted therapy, immunotherapy, after-hours telemedicine, shared electronic patient record, symptom management, oncology
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shared electronic patient recordOther

    Also called MedChart

    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

Study groups in NCT04232709
Study groupRoleWhat they receive
After-hours careNo interventionPatients 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.
After-hours care w/personal health infoExperimentalPatients 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.
Receives: Other: Shared electronic patient record

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients willing to be randomized

    The proportion of patients willing to be randomized

    Measured: 9.5 Months

  2. Proportion of enrolled patients lost to follow up

    The proportion of enrolled patients lost to follow up in each randomized group

    Measured: 9.5 Months

  3. Number of attempted questionnaires relative to number of questionnaires that should have been completed

    The number of completed questionnaires for both patient participants and healthcare provider participants in relation to the total number of times a questionnaire should have been completed

    Measured: 9.5 Months

  4. Number of completed questionnaires relative to number of questionnaires that should have been completed

    The number of attempted questionnaires for both patient participants and healthcare provider participants in relation to the total number of times a questionnaire should have been completed

    Measured: 9.5 Months

  5. Percent of total emergency department (ED) visits reported that occurred at Southlake

    Comparison of total self-reported ED visits to total ED visits recorded in institutional records

    Measured: 9.5 Months

  6. Time to complete questionnaire battery

    Estimation of time required for patients to complete the questionnaires at each timepoint

    Measured: 9.5 Months

  7. Completion rate for satisfaction survey

    Percent of callers for whom Bayshore's satisfaction survey results were obtained

    Measured: 9.5 Months

Secondary outcomes (13)
  1. Self-reported health service utilization

    Total number of encounters with the health system for any concern, including cancer-related symptom management.

    Measured: 3 Months

  2. Hospital-reported health service utilization: Emergency Department Visits

    The total number of emergency department visits

    Measured: 3 Months

  3. Hospital-reported health service utilization: Outcomes of ED Visits

    The outcomes of the emergency department visits

    Measured: 3 Months

  4. Hospital-reported health service utilization: Length of Hospital Stay

    The total length of stay for any admission to the hospital

    Measured: 3 Months

  5. Edmonton Symptom Assessment System-revised (ESAS-r) Scale

    Self-reported measurement of the severity of nine common symptoms of cancer, at the time of questionnaire completion

    Measured: 3 Months

  6. Functional Assessment of Cancer Therapy - General (FACT-G) Scale

    Patient-reported assessment of health-related quality of life, over the past week, for patients undergoing cancer therapy

    Measured: 3 Months

  7. Prompt Access to Care (PAC) Scale

    Measurement of a cancer patient's perception of their ability to reach or see an oncology professional, as required, at various times of the day and on different days of the week

    Measured: 3 Months

  8. Continuity of Care (CoC) Scale

    Measurement of a cancer patient's perception of continuity of care across all healthcare professionals in the cancer care continuum

    Measured: 3 Months

  9. Prevented health service utilization

    Frequency of reports of a health service that a patient would have accessed if they did not have access to the after-hours service

    Measured: 3 Months

  10. Efficiency of after-hours service advice

    Proportion of calls that were handled by telephone advice alone, that is, those calls that were not followed by any unplanned referrals or visits to other healthcare professional within 2 weeks of the after-hours service encounter

    Measured: 3 Months

  11. Patient confidence

    Patients' level of confidence in the advice they received through the after-hours service

    Measured: 3 Months

  12. Perceived reliability of the after-hours service encounter

    Patients' perceived reliability of the after-hours service encounter which will be measured as agreement with a statement regarding the similarity of the encounter to an in-person visit

    Measured: 3 Months

  13. Provider confidence (measured using a modified version of the C-scale)

    Assessment of a nurse's confidence in relation to various aspects of the triage encounter

    Measured: 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start1 Feb 2018
  3. Primary completion9 May 2019
  4. Study completion9 May 2019

Why it stopped: Due to unforeseen circumstances, the funder decided to discontinue all funding.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04232709
Sponsor's protocol ID
WCHCCH-001
Status last verified
Jan 2020
First submitted
4 Mar 2019
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23290526
  • Cancer Care Ontario. (2014). Quality Person-Centred Systemic Treatment in Ontario, 2014-2019 (pp. 1-46). Toronto, ON: Cancer Care Ontario.

  • 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/

  • 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.

    PubMed 12537920
  • 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.

    PubMed 16810138
  • 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.

    PubMed 23675348
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Shared electronic patient record in people with Cancer, run by Women's College Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to unforeseen circumstances, the funder decided to discontinue all funding.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients willing to be randomized (time frame: 9.5 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04232709, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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