Testing the Feasibility of Intervening to Optimize Chiropractic Care for Adults With Neck Pain Disorders

NCT02483091 | Completed Phase 1 DMC

• 1 other identifier: G241013 R.E Strauss X-C 218563
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neck Pain

Keywords

Knowledge translation; Clinical practice guidelines; Multimodal care; Brief Action Planning; Feasibility outcomes

Outcome Measures

Primary Outcomes (1)

• Feasibility outcome (composite outcome measure)

  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

Secondary Outcomes (1)

• Scores on measures of behavioural constructs (composite outcome measure)

  6 months

Other Outcomes (3)

• Pain

  3 months (before and at the end of treatment)

• Disability

  3 months (before and at the end of treatment)

• Satisfaction with care

  3 months (end of treatment) and 3 months of follow-up

Study Arms (2)

Multifaceted KT intervention

EXPERIMENTAL

Webinars, online vignettes and e-module, copy of guideline recommendations

Behavioral: Multifaceted KT intervention

Control

NO INTERVENTION

Printed copy of guideline recommendations

Interventions

Multifaceted KT intervention BEHAVIORAL

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.

Multifaceted KT intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• Previous neck surgery;
• Presence of Red flags;
• Pregnancy; and
• Chiropractic care received in the preceding 3 months for a complaint of neck pain

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

McGill University

Montreal, Quebec, H3G 1Y5, Canada

Location

Related Publications (5)

• 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.

  PMID: 25880218 BACKGROUND

• 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.

  PMID: 23433271 BACKGROUND

• 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.

  PMID: 23159157 BACKGROUND

• 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.

  PMID: 31346409 DERIVED

• 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.

  PMID: 27965852 DERIVED

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• André E Bussières, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 26, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

CA (1)