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

NCT04232709 | Terminated

• 1 other identifier: WCHCCH-001
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

systemic therapy; chemotherapy; targeted therapy; immunotherapy; after-hours telemedicine; shared electronic patient record; symptom management; oncology

Outcome Measures

Primary Outcomes (7)

• Proportion of patients willing to be randomized

  The proportion of patients willing to be randomized

  9.5 Months

• Proportion of enrolled patients lost to follow up

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

  9.5 Months

• 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

• 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

• 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

• Time to complete questionnaire battery

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

  9.5 Months

• Completion rate for satisfaction survey

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

  9.5 Months

Secondary Outcomes (13)

• Self-reported health service utilization

  3 Months

• Hospital-reported health service utilization: Emergency Department Visits

  3 Months

• Hospital-reported health service utilization: Outcomes of ED Visits

  3 Months

• Hospital-reported health service utilization: Length of Hospital Stay

  3 Months

• Edmonton Symptom Assessment System-revised (ESAS-r) Scale

  3 Months

Study Arms (2)

After-hours care

NO INTERVENTION

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.

After-hours care w/personal health info

EXPERIMENTAL

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.

Other: Shared electronic patient record

Interventions

Shared electronic patient record 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

Also known as: MedChart

After-hours care w/personal health info

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead
• Southlake Regional Health Centre: collaborator

Study Sites (1)

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

Related 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.

  PMID: 23290526 BACKGROUND

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

  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/

  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.

  PMID: 12537920 BACKGROUND

• 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.

  PMID: 16810138 BACKGROUND

• 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.

  PMID: 23675348 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sacha Bhatia, MD, FRCPC, MBA

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

• Peter Anglin, MD, FRCPC, MBA

  Southlake Regional Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: January 18, 2020
• Study Start: February 1, 2018
• Primary Completion: May 9, 2019
• Study Completion: May 9, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)