Clinical and Economic Effectiveness of a Single Session Compared to Multiple Sessions of Education and Exercise for Older Adults With Spinal Pain in an Advanced Practice Physiotherapy Model of Care: Protocol for a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory (BPI) Short form, Pain severity scale (change from baseline)
研究概览
简要总结
Objectives: To assess the effectiveness and cost-effectiveness of a single session compared to multiple sessions of education and exercise for older adults with spinal pain treated conservatively in an advanced practice physiotherapy (APP) model of care.
Methods and Analysis: In this pragmatic randomized controlled trial, 152 adults (≥ 18 years old) with neck or back pain initially referred for a consultation in neurosurgery, but treated conservatively, will be recruited through the APP neurosurgery CareAxis program in the Montreal region (Quebec, Canada). In the CareAxis program, older patients with spinal pain are triaged by an advance practice physiotherapist and are offered conservative care and only potential surgical candidates are referred to a neurosurgeon. Participants will be randomized into one of two arms: 1- a single session or 2- multiple sessions (6 sessions over 12 weeks) of education and exercise with the advance practice physiotherapist. The primary outcome measure will be the Brief Pain Inventory (pain severity and interference subscales). Secondary measures will include self-reported disability (the Neck Disability Index or Oswestry Disability Index), The Pain Catastrophizing Scale, satisfaction with care (VSQ-9 and MedRisk questionnaires), and health-related quality of life (EQ-5D-5L). Participants healthcare resources use, and related costs will be measured. Outcomes will be collected at baseline and at 6, 12 and 26 weeks after enrollment. Intention-to-treat analyses will be performed, and repeated mixed-model ANOVA will assess differences between treatment arms. Cost-utility analyses will be conducted from the perspective of the health care system.
Ethics and dissemination: Ethics approval has been obtained from the Comité d'éthique de la recherche du CIUSS de l'Est-de-l'Île-de-Montréal (FWA00001935 and IRB00002087). Results of this study will be presented to different stakeholders, published in peer-reviewed journals and presented at international conferences.
详细描述
OBJECTIVES
The aim of this pragmatic randomized controlled trial is to evaluate at 6, 12 and 24 weeks, the clinical effectiveness in terms of patient-centered outcomes and the cost-effectiveness of a single session compared to multiple sessions of education and exercise for older adults with spinal pain treated conservatively in an APP neurosurgery model of care.
METHODS
Study Design This study is a pragmatic randomized controlled trial with cost-effectiveness analyses. This trial will use a pragmatic approach within an existing APP model of care in neurosurgery. Therefore, the rehabilitation intervention in both treatment arms will be offered as they are provided in their current clinical reality (see Figure 1 for flowchart).
Setting and Participants This pragmatic randomized controlled trial will be performed within the CareAxis neurosurgery APP model of care. In 2019, CareAxis, a non-profit organization, developed and implemented an APP model of care for older patients with spinal pain referred to neurosurgery in the province of Quebec (Canada). The model was developed in partnership with the Montreal Neurological Institute and Hospital, Montreal, Quebec, Canada. The aim of this model is to reduce wait time to consult a neurosurgeon, more efficiently triage surgical candidates, and improve conservative and rehabilitation care for patients referred to the program. The current model of care involves a group of trained APPTs, who assess and triage potential surgical candidates, recommend medical care (medication or injection), provide education, and prescribe a self-management exercise program. This is systematically offered to all patients in a one-hour session. Only patients deemed surgical candidates are then referred to see the neurosurgeon. The program is funded through health charities and is offered at no costs to older adults with a referral from a family physician.
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
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults consulting for a neck or back condition;
- •aged 65 years old or older;
- •referred for a consultation in neurosurgery to the CareAxis group, either directly by family physicians or from the Centre de répartition des demandes de service de Montréal and
- •not considered as a potential surgical candidate based on the initial APPT assessment.
排除标准
- •1. Considered as a potential surgical candidate based on the initial advanced practice physiotherapist assessment.
研究组 & 干预措施
Single session APP arm
Participants in this group will received one session with the advanced practice physiotherapist.
干预措施: Single session of education and exercise provided by an advanced practice physiotherapist. (Other)
Multiple sessions APP arm
Participants in this group will received 6 sessions (in 12 weeks) with the advanced practice physiotherapist.
干预措施: Multiple session of education and exercise provided by an advanced practice physiotherapist. (Other)
结局指标
主要结局
Brief Pain Inventory (BPI) Short form, Pain severity scale (change from baseline)
时间窗: Change from baseline to 26 weeks
The BPI pain severity scale is a self-administered questionnaire which includes 4 items where the patient is asked to rate their pain intensity (wort, least, general and current). The final score ranges from 0 to 10 (0=no pain; 10=pain as bad as you can imagine).
Brief Pain Inventory (BPI) Short form, Pain interference scale (change from baseline)
时间窗: Change from baseline to 26 weeks
The BPI pain interference scale is a self-administered questionnaire which includes 7 items where the patient is asked to rate their perceived impact of pain on various functional activities. The final score ranges from 0 to 10 (0=pain does not interfere; 10=pain completely interferes).
Brief Pain Inventory (BPI) Short form, Pain interference scale (change from baseline)
时间窗: Change from baseline to 6 weeks
The BPI pain interference scale is a self-administered questionnaire which includes 7 items where the patient is asked to rate their perceived impact of pain on various functional activities. The finale score ranges from 0 to 10 (0=pain does not interfere; 10=pain completely interferes).
Brief Pain Inventory (BPI) Short form, Pain interference scale (change from baseline)
时间窗: Change from baseline to 12 weeks
The BPI pain interference scale is a self-administered questionnaire which includes 7 items where the patient is asked to rate their perceived impact of pain on various functional activities. The final score ranges from 0 to 10 (0=pain does not interfere; 10=pain completely interferes).
Brief Pain Inventory (BPI) Short form, Pain severity scale (change from baseline)
时间窗: Change from baseline to 6 weeks
The BPI pain severity scale is a self-administered questionnaire which includes 4 items where the patient is asked to rate their pain intensity (wort, least, general and current). The final score ranges from 0 to 10 (0=no pain; 10=pain as bad as you can imagine).
Brief Pain Inventory (BPI) Short form, Pain severity scale (change from baseline)
时间窗: Change from baseline to 12 weeks
The BPI pain severity scale is a self-administered questionnaire which includes 4 items where the patient is asked to rate their pain intensity (wort, least, general and current). The final score ranges from 0 to 10 (0=no pain; 10=pain as bad as you can imagine).
次要结局
- Oswestry Disability Index (ODI) (change from baseline)(Change from baseline to 26 weeks)
- Neck Disability Index (NDI) (change from baseline)(Change from baseline to 26 weeks)
- Modified 9-item visit-specific satisfaction questionnaire (VSQ-9)(Baseline)
- Pain Catastrophizing Scale (PCS) (change from baseline)(Change from baseline to 26 weeks)
- MedRisk(12 weeks)
- EQ-5D-5L (change from baseline)(Change from baseline to 26 weeks)
- Adverse events(up to 26 weeks)
- EQ-VAS (change from baseline)(Change from baseline to 26 weeks)
- Health care resources(up to 26 weeks)
- Neck Disability Index (NDI) (change from baseline)(Change from baseline to 6 weeks)
- Neck Disability Index (NDI) (change from baseline)(Change from baseline to 12 weeks)
- Oswestry Disability Index (ODI) (change from baseline)(Change from baseline to 6 weeks)
- Oswestry Disability Index (ODI) (change from baseline)(Change from baseline to 12 weeks)
- Pain Catastrophizing Scale (PCS) (change from baseline)(Change from baseline to 6 weeks)
- Pain Catastrophizing Scale (PCS) (change from baseline)(Change from baseline to 12 weeks)
- EQ-5D-5L (change from baseline)(Change from baseline to 6 weeks)
- EQ-5D-5L (change from baseline)(Change from baseline to 12 weeks)
- EQ-VAS (change from baseline)(Change from baseline to 6 weeks)
- EQ-VAS (change from baseline)(Change from baseline to 12 weeks)