跳至主要内容
临床试验/NCT04232709
NCT04232709终止不适用

Evaluating the CAREchart@Home™ Program for Enhancing After-hours Care of Cancer Patients in Ontario: A Pilot Randomized Controlled Trial

Women's College Hospital2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
105
试验地点
2
主要终点
Time to complete questionnaire battery

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Time to complete questionnaire battery

时间窗: 9.5 Months

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

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

时间窗: 9.5 Months

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

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

时间窗: 9.5 Months

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

Completion rate for satisfaction survey

时间窗: 9.5 Months

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

Proportion of patients willing to be randomized

时间窗: 9.5 Months

The proportion of patients willing to be randomized

Proportion of enrolled patients lost to follow up

时间窗: 9.5 Months

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

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

时间窗: 9.5 Months

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

次要结局

  • Hospital-reported health service utilization: Outcomes of ED Visits(3 Months)
  • Hospital-reported health service utilization: Length of Hospital Stay(3 Months)
  • Prompt Access to Care (PAC) Scale(3 Months)
  • Edmonton Symptom Assessment System-revised (ESAS-r) Scale(3 Months)
  • Functional Assessment of Cancer Therapy - General (FACT-G) Scale(3 Months)
  • Self-reported health service utilization(3 Months)
  • Hospital-reported health service utilization: Emergency Department Visits(3 Months)
  • Patient confidence(3 Months)
  • Continuity of Care (CoC) Scale(3 Months)
  • Prevented health service utilization(3 Months)
  • Efficiency of after-hours service advice(3 Months)
  • Perceived reliability of the after-hours service encounter(3 Months)
  • Provider confidence (measured using a modified version of the C-scale)(3 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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