Determining the Impact of a New Physiotherapist-Led Primary Care Model for Hip and Knee Pain - A Pilot Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Participant Recruitment Rate
研究概览
简要总结
This is a pilot cluster randomized controlled trial to to evaluate the individual and health system impacts of implementing a new physiotherapist-led primary care model for hip and knee pain in Canada.
详细描述
Arthritis is one of the leading causes of pain, disability, and reduced quality of life in patients. Arthritis currently affects one in five Canadians (six million), which is expected to rise to nine million people by 2040. Osteoarthritis (OA) is the most common forms of arthritis, with hip and knee being two of the most common locations.
For most people, the first point of contact for their pain is their primary care provider. Due to the rise in patients seeking support at the primary care level, the shortage of primary care providers, and the high burden on these providers, patients often do not receive timely access to the care they require. A promising strategy is to have an integrated model of care where a physiotherapist (PT) is the first point of contact within interprofessional primary care teams. PTs can provide a comprehensive and efficient management strategy for patients presenting to their primary care provider with hip and knee pain complaints.
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 hip and knee pain.
The primary objectives of this pilot study are:
- Determine the feasibility of participant recruitment, assessment procedures, and retention.
- Determine the feasibility of implementing a new PT led primary care model for hip and knee pain.
- Explore the perspectives of patient participants and HCPs related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value and impact on clinic processes and patient participant outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 patient participants 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Adults >= 19 years who ask to book a primary care visits where the primary reason is for hip or knee pain of any duration.
排除标准
- •Cannot understand, read, and write English
- •Known cancer causing hip or knee pain
研究组 & 干预措施
Physiotherapist-led primary care model for hip and knee pain
The index intervention will incorporate a PT within the primary care team and make them available at the first point of contact for people with hip or knee pain. There will be 4 key components of this intervention: 1) Initial assessment and screening; 2) Brief individualized intervention at first visit; 3) Health services navigation; 4) Providing additional PT care for people with an unmet need (e.g., no insurance coverage for PT).
干预措施: Physiotherapist-led primary care model for hip and knee pain (Other)
Usual physician-led primary care model for hip and knee pain
Participants will be seen by a primary care physician or a nurse practitioner, depending on the current practice at the clinic. Participants in both groups will be permitted to seek additional care outside of the primary care clinic.
干预措施: Usual physician-led primary care model for hip and knee pain (Other)
结局指标
主要结局
Participant Recruitment Rate
时间窗: 20 weeks
A full trial will be feasible if the investigators are able to recruit 1.5 participants per week per site over 20 weeks
Assessment Procedures
时间窗: 12 months
The investigators consider ≥80% of all assessment items completed and a mean time for completion of ≤60 minutes acceptable.
Retention
时间窗: 12 months
The investigators consider an attrition rate of ≤20% at 12-month follow-up successful. ≤35% attrition will be considered partially successful; however, additional retention strategies would be required for the full trial based on evidence that ≥20% attrition threatens trial validity
PT Treatment Fidelity
时间窗: 20 weeks
Treatment fidelity will be measured through an audit of a PT fidelity checklist and electronic medical record (EMR) to determine the consistency of the care provided. An acceptable level of fidelity will be considered ≥80% for each intervention component.
次要结局
- Satisfaction with Health Care(3, 6, 9, and 12 months follow-up)
- Health-Care Utilization Survey - Walk-In Clinic Visits(12 months)
- Health-Care Utilization Survey - Inpatient Hospital Stays(12 months)
- Process Outcome - Exercises Prescribed(12 months)
- Process Outcome - Education Provided(12 months)
- Assistance Needed(12 months)
- Extra Expenses(12 months)
- Self-Reported Pain Intensity(Baseline and 3, 6, 9, and 12 months follow-up)
- Health-Related Quality of Life(Baseline and 3, 6, 9, and 12 months follow-up)
- Pain Self Efficacy(Baseline and 3, 6, 9, and 12 months follow-up)
- Adverse Events(3, 6, 9, and 12 months follow-up)
- Global Rating of Change(3, 6, 9, and 12 months follow-up)
- Catastrophic Thinking(Baseline and 3, 6, 9, and 12 months follow-up)
- Fear of Movement(Baseline and 3, 6, 9, and 12 months follow-up)
- Health Care Accessibility(Baseline)
- Process Outcome - Primary Care Visits(12 months)
- Health-Care Utilization Survey - Specialist Visits(12 months)
- Health-Care Utilization Survey - Diagnostic Imaging(12 months)
- Process Outcome - Referrals to other health care providers (HCPs)(12 months)
- Self-Report Time Lost(12 months)
- Cost Outcomes(12 months)
- Process Outcome - Notes to Employers or Insurers(12 months)
- Self-Reported Functioning(Baseline and 3, 6, 9, and 12 months follow-up)
- Depression Subscale(Baseline and 3, 6, 9, and 12 months follow-up)
- Health-Care Utilization - Consultations in Electronic Medical Record (EMR)(12 months)
- Health-Care Utilization Survey - Visits to health professionals(12 months)
- Health-Care Utilization Survey - Medications(12 months)
- Health-Care Utilization Survey - Surgeries, Procedures, Injections(12 months)
- Process Outcome - Medications Prescibed(12 months)
- Process Outcome - Diagnostic Imaging Ordered(12 months)
- Health-Care Utilization Survey - Emergency Department Visits(12 months)
研究者
Jordan Miller, PT, PhD
Assistant Professor, School of Rehabilitation Therapy, Queen's University
Queen's University