Testing the Feasibility of Intervening to Optimize Chiropractic Care for Adults With Neck Pain Disorders
Condition: Neck Pain
MeSH terms: Neck Pain; Somatoform Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Multifaceted KT intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Knowledge translation; Clinical practice guidelines; Multimodal care; Brief Action Planning; Feasibility outcomes