Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain
2019年3月21日 更新者：Jordan Miller, PT, PhD、Queen's University
Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial
This is a pilot cluster randomized controlled trial to determine the feasibility of a cluster randomized trial to evaluate the individual and health system impact of implementing a new physiotherapist-led primary care model for back pain in Canada.
研究概览
详细说明
This study aims to determine the feasibility of conducting a cluster randomized trial in primary care settings in Ontario to evaluate the individual health outcomes and health system impact of implementing a new physiotherapist-led primary care model for people with back pain.
The primary purpose of this pilot study is to determine the feasibility including recruitment and retention of primary care teams (sites) and patient participants, carrying out the assessment procedures, and implementing the physiotherapist-led primary care intervention including training the physiotherapist to adopt this role.
研究类型
介入性
注册 (实际的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Kingston、Ontario、加拿大、K7L 3N6
- Queen's University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adults (18 years and over) with back pain of any duration
- Seeking primary care for back pain at a participating site
- Primary care visit may be a first or repeat visit
Exclusion Criteria:
- Patients who do not consent to participation
- Patients who report being unable to understand, read, and write English
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：物理治疗师主导的背痛初级保健模式
由 PT 主导的背痛初级保健模型将涉及在初级保健团队中加入 PT，在第一时间接触背痛患者，而患者无需支付任何费用。
该模型中的患者可以选择看 PT 或家庭医生。
他们将被鼓励与 PT 预约，除非就诊的主要原因是药物更新，或者患者有其他健康问题需要在同一次就诊时得到医生的关注。
PT 主导的初级保健干预将有 4 个关键组成部分：1) 初步评估和筛查； 2) 初次就诊时进行简短的个体化干预； 3) 健康服务导航； 4) 为需求未得到满足的人提供额外的 PT 护理。
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有源比较器：Usual care
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
This usually includes a visit to a primary care physician, who would perform a history and physical examination, provide LBP education, and prescribe medications and/or refer based on their assessment findings and patient preferences.
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The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recruitment of primary care teams
大体时间：Baseline
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Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate
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Baseline
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Recruitment of patient participants
大体时间：Baseline to 14 weeks
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Recruitment rate (participants/week) or total number of participants recruited in 14 weeks
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Baseline to 14 weeks
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Assessment completion
大体时间：Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
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Percentage of all assessment items completed by participants completing each assessment
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Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
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Retention of patient participants
大体时间：Retention of participants at 6-week, 12-week, 6, 9, and 12-month follow-up assessments. The primary timeline for this outcome is 12-month follow-up.
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Attrition rate
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Retention of participants at 6-week, 12-week, 6, 9, and 12-month follow-up assessments. The primary timeline for this outcome is 12-month follow-up.
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Physiotherapist confidence in carrying out the interventions
大体时间：Baseline
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The PT will rate his/her confidence in each component of the intervention after the training on a scale from 0-10 with higher scores indicating greater confidence in carrying out that component of the intervention.
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Baseline
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Treatment fidelity
大体时间：6-week follow-up
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Treatment fidelity will be measured by consistency with the intervention described in the protocol measured through an intervention checklist completed by the physiotherapist and an audit of the EMR notes.
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6-week follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Self-reported disability
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using the Roland Morris Disability Questionnaire (0 to 24 with higher scores indicating greater disability)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Self-reported pain intensity
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity (measured at rest, during walking, and during a lifting task)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Health Related Quality of Life
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Global rating of change
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using an 11-point scale (-5 to +5 with negative scores indicating a worsening of physical functioning related to back pain and positive scores indicating an improvement of physical functioning related to back pain)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Satisfaction with health care
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using an 11-point scale(-5 to +5 with negative scores indicating a dissatisfaction with health care received and positive scores indicating satisfaction with health care received)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Catastrophic Thinking
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Depressive symptoms
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using the 9-item Patient Health Questionnaire (PHQ-9) (0 to 27 with greater scores indicating increased depressive symptoms)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Adverse events
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using an adverse events questionnaire that asks 1) if the patient has experienced any adverse events as a result of the treatments received (yes/no); 2) how long the event lasted (hours or days); 3) how severe the adverse event was (0-10 scale); 4) what adverse events were experienced.
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Health care accessibility
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Percentage of patients receiving care within 48 hours.
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Health care accessibility
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care.
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Health care utilization
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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All health care visits (aggregated and dis-aggregated) including: primary care visits, emergency department visits, hospitalizations, surgeries, consultations with other health care providers, diagnostic imaging, medications, and other care received by the patient
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Costs (piloted for a cost utility analysis in a future trial)
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Includes all health care costs plus societal costs using a human capital approach for loss of productivity
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Medications prescribed
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Measured as a process outcome
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Diagnostic imaging ordered
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Measured as a process outcome
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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referrals to other health care providers made
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Measured as a process outcome
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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notes made by primary care provider to employers or insurers
大体时间：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Measured as a process outcome
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jordan Miller, PhD、Queen's University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年9月20日
初级完成 (实际的)
2019年1月15日
研究完成 (实际的)
2019年1月15日
研究注册日期
首次提交
2017年10月16日
首先提交符合 QC 标准的
2017年10月24日
首次发布 (实际的)
2017年10月25日
研究记录更新
最后更新发布 (实际的)
2019年3月25日
上次提交的符合 QC 标准的更新
2019年3月21日
最后验证
2019年3月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
There is no plan to share individual participant data from this pilot study.
This data will be used to inform the protocol for a fully powered cluster randomized trial.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
背疼的临床试验
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Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)完全的