My Team of Care (MyTOC) Trial: a Pilot Randomized Controlled Trial of an Online Communication Tool (Loop) for Collaborative Care in Complex Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Trial feasibility measured with number of patients recruited for study who have consented and participate for the duration of the study.
研究概览
简要总结
This project will pilot and test a new online communication tool, Loop, developed within a research framework with participatory and user-centred design. This pilot trial focuses on advanced cancer as an example of complex care. Cancer care involves many healthcare providers, spanning hospital to home. There is no organized way for them to communicate. Loop is a practical tool for ongoing collaboration in the patient's actual team of care that engages patients. The study will answer the questions: does Loop improve communication efficiency, engage patients and family physicians, and show early benefits in quality and health care costs?
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Stage IV cancer, or Patients with stage III cancer and poor prognosis as determined by a physician (>3 months but <2 years)
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
- •Each patient must have at least two healthcare providers, including an attending oncologist or palliative care physician
- •Patient and, if applicable, family caregiver must be ≥18 years of age
- •Literacy and language capacity and competency to provide informed consent
- •Patient or caregiver must have access to a computer and the internet
排除标准
- •Patients without the capacity to participate in use of the online tool, and do not have a caregiver who can engage in use of the tool on their behalf
- •Participants without the capacity to participate in evaluation of outcome measures, including, but not limited to, online and paper-based multiple-choice questions, checklists, and visual analogue scales, and do not have a family caregiver who can complete outcome measures
- •A potential candidate for or currently receiving hormone therapy for breast or prostate cancer
- •Patients with a prognosis of <3 months as determined by attending physician
- •Patients with impaired mental status as previously assessed by a physician or judged by research staff using the Bedside Confusion Scale
- •It has been determined that the patient is participating in another study precluding them from taking part in this study, as determined by an agreed-upon algorithm, tracked and managed by study coordinators
研究组 & 干预措施
Intervention Group
The randomization is at the level of attending healthcare professional who identifies patients for recruitment. For each participant in the intervention arm, a secure space (called a Patient Loop) is created in the online clinical communication system. A Patient Loop can be accessed by the patient, their caregiver, and the healthcare providers who have permission to do so through an algorithm of invitation, authentication and careful partitioning. In each Patient Loop, team members can post messages that can be read and responded to by the entire team. Each Patient Loop consists of a patient, their caregiver and at least two healthcare professionals.
干预措施: Loop (Other)
Control Group
Participants receive usual care.
结局指标
主要结局
Trial feasibility measured with number of patients recruited for study who have consented and participate for the duration of the study.
时间窗: 1 year
次要结局
- Trial feasibility measured with number of healthcare providers recruited for study who have consented and participate for the duration of the study.(1 year)
- Trial feasibility measured with number of family caregivers recruited for study who have consented and participate for the duration of the study.(1 year)
- Palliative Care Outcomes Scale(3 months)
- Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale(3 months)
- Ambulatory and Home Care Record(3 months)
- The proportion of eligible participants who are invited to participate(1 year)
- Instrument completion rate for the Palliative Care Outcomes Scale(1 year)
- Item response rate for the Edmonton Symptom Assessment Scale(1 year)
- Number of family physicians who participate per study group(1 year)
- Eastern Cooperative Oncology Group score(3 months)
- The proportion of invited participants who consent to participate(1 year)
- The mean duration of participation of all study participants(1 year)
- Instrument completion rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale(1 year)
- Item response rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale(1 year)
- Edmonton Symptom Assessment Scale(3 months)
- Item response rate for the Palliative Care Outcomes Scale(1 year)
- Instrument completion rate for the Ambulatory and Home Care Record(1 year)
- Item response rate for the Ambulatory and Home Care Record(1 year)
- Instrument completion rate for the Edmonton Symptom Assessment Scale(1 year)