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

Background Neck pain in adults is common and a leading cause of physical disability. Recently, a guideline was developed for the management of non-specific neck pain (NSNP) with an aim to improve the quality of the delivery of chiropractic care. One key guideline recommendation is to undertake multimodal care for patients with NSNP. The aim of this pilot study is to determine the feasibility of implementing a multifaceted knowledge translation intervention by promoting the use of multimodal care by chiropractors managing patients with NSNP. Methods/design The design is a cluster-randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be approached to participate in the study. Thirty consenting chiropractors will be randomized to receive either a theory-based educational intervention in the experimental group or simply a printed copy of the guideline in the control group. Each chiropractor will recruit five neck pain patients (a total of 150 patients) into the study. Development of the multifaceted intervention was informed by the results of a related qualitative study based on the Theoretical Domains Framework and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning, and a printed copy of the practice guideline. Primary feasibility outcomes for both chiropractors and patients include rates of (1) recruitment, (2) retention, and (3) adherence to the intervention. 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 3 months. Secondary outcomes include scores of behavioural constructs (level of knowledge and self-efficacy) for recommended multimodal care. Clinical outcomes include pain intensity and neck pain-specific disability. Analyses from this study will focus on generating point estimates and corresponding 95 % confidence intervals for parameters of a priori interest (recruitment, retention, adherence, pain intensity, Neck Disability Index). Discussion Results of this study will inform the design of a larger cluster-randomized controlled trial aimed at evaluating the effectiveness of the theory-based tailored intervention and increasing the use of multimodal care by chiropractors managing patients with NSNP. Trial registration https://clinicaltrials.gov/, NCT02483091 Electronic supplementary material The online version of this article (doi:10.1186/s40814-016-0076-9) contains supplementary material, which is available to authorized users.


Introduction:
You are being asked to participate in this research project because as a licensed chiropractor you regularly manage patients with neck pain. Please read this 'Information Sheet and Consent Form' carefully and ask as many questions as you like before deciding whether to participate in this research study. You can discuss this decision with your colleagues.
Participation in this study is voluntary.You arefree torefuse to participate or to withdraw your consent to participate at any time.Refusing to participate will involve no penalty or loss of benefits. There is no penalty for withdrawing and all your collected data will be destroyed.

Background, Purpose and Design of the Study:
Current evidence suggests a multimodal approach including manual therapy, advice about self-management, and physical activity including exercise is an effective treatment strategy for acute and chronic neck pain. However, research shows that the transfer of evidence into practice is unpredictable and can be a slow and haphazard process. The purpose of this pilot project is to determine the feasibility of implementing a knowledge translation intervention designed to improve the management of non-specific neck pain. We plan to build on the results of this feasibility study by formally evaluating the strategies to integrate evidencebased multimodal care approach into clinical practice for individuals with nonspecific neck pain and methods for bringing new research findings into practice. Also, this study will help us determine the best way to measure the effects of treatment. The study design is a feasibility study of chiropractors who will receive a KT intervention. We anticipate 40 licensed chiropractors to take part in the study.

Study Procedures:
If you agree to take part in this study, you will be randomly assigned to receive either the KT intervention plus a copy of the clinical practice guidelines neck pain management for the intervention group, or the clinical practice guideline alone for the control group. The randomization is 1:1. You will be asked to complete a demographic questionnaire that consists of your name, age, gender, chiropractic school attended, area of practice, number of patients you treat daily and techniques used. It should be completed after signing the consent form.
Practitioners randomized to the intervention group will be asked to watch three webinars on the neck pain guideline, each of a length of 50-60 minutes, a learning module on selfmanagement of 22 minutes in length, and two clinical vignettes, each taking about 15-20 minutes to complete. These activities can be complete at your own pace preferably within the same week. You will be asked to implement the KT strategies you have learned on patients with acute or chronic neck pain you have recruited for the study. We anticipate that only about 45minutes are needed to complete the study forms for each recruited patient.

Possible Side Effects and/or Risks:
There are no known risks to chiropractors and patients.

Benefits of the Study:
Your participation in this research may allow the researchers to gain in depth understanding of how best to transfer new knowledge strategies to chiropractors. This in turn may be of benefit to future patients.

Confidentiality:
No identifying information will be reported in any publications, reports or presentations. Confidentiality of the data will be protected by assigning each participant such as yourself a unique identification number replacing the name and the registration number of care providers and using that number on all data about participation. The data will be use to evaluate the feasibility to implement the KT intervention within chiropractic practice. All paper records will be stored in a locked office. Only the principal investigator of the studywill access your data. All electronic records will be stored at the administrative Services Building of McGill University and protected by a user password. The study data retention is for 7 years after which time the data will be destroyed.

Compensation:
If you agree to participate in the study, you will be entered into a draw to win one of four $250 gift certificates from Amazon as a token of appreciation. Please note if you were randomized to the usual care group, the webinars and online module may be watched at any time after the completion of the study by registering on CE Connect system on the Canadian Memorial Chiropractic College (CMCC) website.Most provincial chiropractic regulatory boards have pre-approved the KT intervention for four hours of Continuing Education (CE). Certificates of completion are produced once the KT intervention is completed and all quizzes have been successfully answered. Certificates must be submitted to your regulatory board so you are eligible to receive the CE credit hours. Please note that recognition of CE activities can vary from one province to another. Please communicate with the Registrar in your province if you have questions about the process.

Questions about the Study:
A. If you have any questions or concerns, please contact Dr. André Bussières at andre.bussieres@mcgill.ca. or by phone: (514)