Health TAPESTRY Ontario: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 599
- 试验地点
- 2
- 主要终点
- Change in Physical activity
研究概览
简要总结
The Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) is a community-based program led by primary care teams, that creates connections between trained community volunteers, interprofessional health care teams, novel technology and community engagement through improved system navigation. The overall vision is to help people stay healthier for longer in the places where they live.
详细描述
The Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) involves recording a person's life and health goals, screening for health risks and needs, and then initiating a plan that supports achievement of those goals and address risks and needs. It includes four parts:
- Trained volunteers connect with clients (patients) in their home to gather health and social information and discuss and record life and health goals
- Interprofessional health care teams provide health care services to the client and focuses on a plan to support them on meeting their health goals
- Technology is used to collect and share information
- Community engagement connects clients with resources and supports in the community
Initial findings from Implementation Phase I: 6-month unblinded delayed intervention pragmatic randomized controlled trial that took place in Hamilton, ON (HiREB File #14-726, Clinical Trials.gov NCT02283723) showed significant differences between the intervention and control group. Specifically, at 6-months the it was found:
- a reduction in the intervention group versus control group in self-reported time sitting
- an increase in minutes walking in the intervention group versus the control group
- an increase in number of primary care visits in the intervention group versus the control group
- a reduction in odds of people experiencing 1 or more hospitalizations in the intervention group versus the control group
Understanding the feasibility of implementing Health TAPESTRY in other primary care sites is important to evaluate its potential as an approach. Replication of these initial findings are critical in terms of empirical support for the approach as well as spread and scalability in the wider primary health care system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 70 years of age or older
- •Rostered to a participating family physician
- •Participant
排除标准
- •They are expected to die within 12 months
- •They live in a long-term care facility
- •They (or their caregiver) are unable to speak and understand English
- •They have other conditions or circumstances that means the patient is unable to engage with the volunteers or complete the TAP-App (e.g., severe dementia)
- •They are out of the country for more than 6 months or otherwise unavailable for the intervention and assessments
- •Participated in Health TAPESTRY phase I implementation (for Hamilton site)
- •Site Inclusion Criteria:
- •A Health TAPESTRY site must have the commitment and capacity to implement and sustain the full Health TAPESTRY Program (all four parts). As such, the following success factors are essential:
- •A strong Lead Organization with a clearly identified Health TAPESTRY Practice Model Champion from primary care;
- •Visible and influential primary care partner in governance and implementation;
- •Team-based use of an electronic system for documentation;
- •Primary care team available to provide core of implementation;
- •Available Information Technology capacity and commitment to integrate with TAP-App (minimum HL7 document transfer capability) and kindred PHR within 6-9 months of program start date;
- •Volunteer infrastructure that can recruit, train, sustain, and coordinate/schedule volunteers, and ensure volunteers have access to the digital health tools needed to fulfill role;
- •Existing partnerships with local community services;
- •Capacity for local program management either through existing staff or with the addition of new staff;
- •Available in-kind resources that can support participation in the Health TAPESTRY Program (e.g., clinician and staff engagement, community engagement, patient engagement, etc.); and
- •Commitment to evaluation including, but not limited to, collecting and sharing data from electronic documentation system (based on consent).
- •Site Exclusion Criteria:
- •No functional primary care team linkage to support individual patient or client assessments
- •Focused assessment on a single condition or disease
结局指标
主要结局
Change in Physical activity
时间窗: Change in physical activity from baseline measurement to 6 months
Physical activity will be measured by the Short version of the International Physical Activity Questionnaire. Respondents indicate how many days in the past seven days and for how many minutes they have engaged in vigorous and moderate intensity activity and walking activity. Scores are calculated by multiplying the days by the number of minutes on one day, by the metabolic equivalent of task (8.0,4.0 and 3.3 for vigorous, moderate, walking activity respectively). Minimum score is of the scale is zero, with higher scores representing higher levels of physical activity.
Change in Hospitalizations
时间窗: Change of number of hospitalizations from baseline to 6 months
Number of hospitalizations in the past 6 months.
次要结局
- Primary care visits(Baseline, 6 months)
- Falls(Baseline, 6 months)
- Emergency department and urgent care visits(Baseline, 6 months)
- Treatment burden(Baseline, 6 months)
- Quality of life(Baseline, 6 months)
- Negative effects (unmet expectations)(Baseline, 6 months)
- Hours sitting(Baseline, 6 months)
- Patient enablement(Baseline, 6 months)
- Disease burden(Baseline, 6 months)
- Negative effects (effects of labeling)(6 months)
- Negative effects (serious adverse events)(6 months)
- Reason for hospitalization(Baseline, 6 months)
- Medications(Baseline, 6 months)