Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04232709
Study type Interventional
Source Women's College Hospital
Contact
Status Terminated
Phase N/A
Start date February 1, 2018
Completion date May 9, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients