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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04232709
• Other study ID #: WCHCCH-001
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: May 9, 2019

Study information

• Verified date: January 2020
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: May 9, 2019
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	Southlake Regional Health Centre	Newmarket	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Women's College Hospital	Southlake Regional Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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. — View Citation

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. — View 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. — View 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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients willing to be randomized	The proportion of patients willing to be randomized	9.5 Months
Primary	Proportion of enrolled patients lost to follow up	The proportion of enrolled patients lost to follow up in each randomized group	9.5 Months
Primary	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	9.5 Months
Primary	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	9.5 Months
Primary	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	9.5 Months
Primary	Time to complete questionnaire battery	Estimation of time required for patients to complete the questionnaires at each timepoint	9.5 Months
Primary	Completion rate for satisfaction survey	Percent of callers for whom Bayshore's satisfaction survey results were obtained	9.5 Months
Secondary	Self-reported health service utilization	Total number of encounters with the health system for any concern, including cancer-related symptom management.	3 Months
Secondary	Hospital-reported health service utilization: Emergency Department Visits	The total number of emergency department visits	3 Months
Secondary	Hospital-reported health service utilization: Outcomes of ED Visits	The outcomes of the emergency department visits	3 Months
Secondary	Hospital-reported health service utilization: Length of Hospital Stay	The total length of stay for any admission to the hospital	3 Months
Secondary	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	3 Months
Secondary	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	3 Months
Secondary	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	3 Months
Secondary	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	3 Months
Secondary	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	3 Months
Secondary	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	3 Months
Secondary	Patient confidence	Patients' level of confidence in the advice they received through the after-hours service	3 Months
Secondary	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	3 Months
Secondary	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	3 Months