Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Recruitment of primary care teams
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Due to the nature of the new model of care and comparison, it is not possible to blind the patients or health care providers. Since the primary outcomes are self-reported outcome measures, the assessor is also not blind to the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who do not consent to participation
- •Patients who report being unable to understand, read, and write English
研究组 & 干预措施
Physiotherapist-led primary care model for back pain
The PT-led primary care model for back pain will involve incorporating a PT within the primary care team at the first point of contact for people with back pain at no cost to the patient. Patients in this model will be given the choice of seeing the PT or family doctor. They will be encouraged to book with the PT except when the primary reason for visit is for medication renewals or when the patient has additional health concerns that need attention from their physician in the same visit. There will be 4 key components of the PT led primary care intervention: 1) Initial assessment and screening; 2) Brief individualized intervention at the first visit; 3) Health services navigation; 4) Providing additional PT care for people with an unmet need.
干预措施: Physiotherapist-led primary care model for back pain (Behavioral)
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.
干预措施: Usual care (Other)
结局指标
主要结局
Recruitment of primary care teams
时间窗: Baseline
Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate
Recruitment of patient participants
时间窗: Baseline to 14 weeks
Recruitment rate (participants/week) or total number of participants recruited in 14 weeks
Assessment completion
时间窗: Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
Percentage of all assessment items completed by participants completing each assessment
Retention of patient participants
时间窗: 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.
Attrition rate
Physiotherapist confidence in carrying out the interventions
时间窗: Baseline
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.
Treatment fidelity
时间窗: 6-week follow-up
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.
次要结局
- Self-reported disability(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Self-reported pain intensity(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Health Related Quality of Life(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Global rating of change(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Satisfaction with health care(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Catastrophic Thinking(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Adverse events(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Health care utilization(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Depressive symptoms(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Costs (piloted for a cost utility analysis in a future trial)(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Medications prescribed(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Diagnostic imaging ordered(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- referrals to other health care providers made(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- notes made by primary care provider to employers or insurers(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Health care accessibility(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
研究者
Jordan Miller, PT, PhD
Assistant Professor, School of Rehabilitation Therapy
Queen's University