Testing the Feasibility of Intervening to Optimize Chiropractic Care for Adults With Neck Pain Disorders
Chiropractors Can Do: Testing the Feasibility of Intervening to Optimize Chiropractic Care for Adults With Neck Pain Disorders: A Pilot Cluster Randomized Controlled Trial
To assess the feasibility of conducting a larger cluster randomized controlled trial to facilitate the effectiveness of a complex Knowledge Translation (KT) intervention, i.e. implementation of multimodal care, into chiropractic clinical practice, designed to improve the management of patients with Non-Specific Neck Pain (NSNP) disorders.
To evaluate feasibility, the investigators will ascertain how well participating chiropractors and patients adhere to the study protocol and will solicit feedback from them about the overall usefulness of the content and format of the KT intervention. This study will determine planning for the main study and also the outcomes to be used as a primary outcome.
研究概览
详细说明
The aim of this pilot study project is to determine the feasibility of implementing a multifaceted KT intervention to promote the use of multimodal care by chiropractors managing patients with NSNP.
Design: Cluster randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be randomized to receive either a theory-based tailored KT intervention in the experimental group or simply a printed copy of the guideline in the control group.
Study population and sample size: 30 chiropractors will be recruited from a random, nationally representative sample of 200 chiropractors. Each chiropractor will recruit five neck pain patients for a total of 150 patients.
The design of the KT intervention was informed by the results of a related qualitative study (Theoretical Domains Framework interviews) and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning (BAP) and a printed copy of the practice guideline (Bussières et al., 2015).
Primary feasibility outcomes for both chiropractors and patients include rates of: 1) recruitment, 2) study retention, and 3) adherence to the intervention (Tickle-Degnen, 2013). A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations e.g., exercise and self-care prescriptions, at study onset and at three months follow-up.
Secondary outcomes include whether or not the chiropractor's recommended multimodal care, scores on measures of behavioural constructs e.g., self-efficacy, knowledge.
Primary clinical outcomes for patients includes measures of pain intensity and neck pain-specific disability.
Analyses from this pilot study will focus on generating point estimates and corresponding 95% confidence intervals for parameters of a priori interest (e.g., recruitment, retention, adherence, pain intensity, neck disability index).
Discussion: The main strength of this study includes its use of a representative sample and randomized controlled design. The results of this study will inform the design of a larger cluster randomized controlled trial aimed at confirming the effectiveness and increasing the use of multimodal care by chiropractors managing patients with NSNP.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Quebec
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Montreal、Quebec、加拿大、H3G 1Y5
- McGill University
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Chiropractors
Inclusion criteria:
- Registered with their professional licensing boards and in private practice in the Canada;
- Graduated at least one year ago;
- Provide chiropractic treatment to a minimum of two adults (age 18-65) with neck pain per week;
- Speak English or French; and
- Have access to Internet.
Exclusion criteria:
- Chiropractors will be excluded if they have already attended the webinar series or the self-management learning module. Prior webinar and learning module participants will have needed to register beforehand, which therefore provides the mechanism for confirming study ineligibility.
Patients
Inclusion criteria:
- Attend a consenting chiropractor for non-specific neck pain of any duration;
- Aged between 18 and 65, with a primary complaint of acute (<3 months) or chronic (>3 months) neck pain presenting as a new condition for treatment at the participating clinic;
- Fluency in English or French to a level where they can read and understand the study information sheet, complete the consent form, and respond to the telephone-administered questionnaire. This will be assessed by the staff member of each chiropractor's team at the time of screening; and
- Provide written informed consent.
Exclusion criteria:
- Previous neck surgery;
- Presence of Red flags;
- Pregnancy; and
- Chiropractic care received in the preceding 3 months for a complaint of neck pain
学习计划
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Multifaceted KT intervention
Webinars, online vignettes and e-module, copy of guideline recommendations
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The intervention consists of three webinars followed by the quiz, two online case scenario and a video on BAP model plus a printed copy of Clinical Practice Guideline (CPGs) on NSNP. After completing these modules and learning the key strategies, each chiropractor will recruit five neck pain patients and implement the strategies on their patients to measure the clinical outcomes for a follow-up of three months. The control group will receive only a printed copy of CPGs. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations at study onset and at three months. |
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无干预：Control
Printed copy of guideline recommendations
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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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Feasibility outcome (composite outcome measure)
大体时间：6 months
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The main outcome of interest is feasibility that includes recruitment, retention, adherence to the study protocol and effectiveness potential. Recruitment rate include: 1) eligibility rate (number of eligible chiropractors and patients divided by invited chiropractors or patients) and 2) participation rate (number agreeing to participate divided by eligible chiropractors or patients). Retention rate: Number of chiropractors and patients who completed all outcome measures at baseline and at 3 month follow-up plus rate of completion of questionnaires by chiropractors (measures of behavioural constructs) and patients (clinical outcomes). For chiropractors, rate of adherence includes attendance of all 3 webinars, associated quizzes, 2 clinical vignettes and the self-management learning module; For patients, rate of adherence includes follow-up visits, prescribed home exercise and physical activity. |
6 months
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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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Scores on measures of behavioural constructs (composite outcome measure)
大体时间：6 months
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For chiropractors: Scores on measures of behavioural constructs (levels of knowledge and self-efficacy) for recommended multimodal care.
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6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain
大体时间：3 months (before and at the end of treatment)
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Self-rated level of pain on an 11 points continuous Visual Analogue Scale (VAS)
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3 months (before and at the end of treatment)
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Disability
大体时间：3 months (before and at the end of treatment)
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Self-rated disability due to neck pain measured on the Neck Disability Index (NDI).
Scale range and subscales:10 items in total, each item is scored from 0-5 ("0" = no disability and "5" = full disability) for a total of 50
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3 months (before and at the end of treatment)
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Satisfaction with care
大体时间：3 months (end of treatment) and 3 months of follow-up
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Self-rated satisfaction with care measured on the Short Form Patient Satisfaction Questionnaire (PSQ-18).
Scale range and subscales:10 items in total, each item is scored from 1-5 ("1" = strongly agree and "5" = strongly disagree)
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3 months (end of treatment) and 3 months of follow-up
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合作者和调查者
调查人员
- 首席研究员：André E Bussières, PhD、McGill University
出版物和有用的链接
一般刊物
- Bussieres AE, Al Zoubi F, Quon JA, Ahmed S, Thomas A, Stuber K, Sajko S, French S; Members of Canadian Chiropractic Guideline Initiative. Fast tracking the design of theory-based KT interventions through a consensus process. Implement Sci. 2015 Feb 11;10:18. doi: 10.1186/s13012-015-0213-5.
- Tickle-Degnen L. Nuts and bolts of conducting feasibility studies. Am J Occup Ther. 2013 Mar-Apr;67(2):171-6. doi: 10.5014/ajot.2013.006270.
- Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available.
- Dhopte P, French SD, Quon JA, Owens H, Bussieres A; Canadian Chiropractic Guideline Initiative. Guideline implementation in the Canadian chiropractic setting: a pilot cluster randomized controlled trial and parallel study. Chiropr Man Therap. 2019 Jul 17;27:31. doi: 10.1186/s12998-019-0253-z. eCollection 2019.
- Dhopte P, Ahmed S, Mayo N, French S, Quon JA, Bussieres A. Testing the feasibility of a knowledge translation intervention designed to improve chiropractic care for adults with neck pain disorders: study protocol for a pilot cluster-randomized controlled trial. Pilot Feasibility Stud. 2016 Jul 20;2:33. doi: 10.1186/s40814-016-0076-9. eCollection 2016.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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- G241013 R.E Strauss X-C 218563
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