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

Primary Purpose

Neck Pain

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Multifaceted KT intervention
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Neck Pain focused on measuring Knowledge translation, Clinical practice guidelines, Multimodal care, Brief Action Planning, Feasibility outcomes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McGill University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multifaceted KT intervention

Control

Arm Description

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

Printed copy of guideline recommendations

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Scores on measures of behavioural constructs (composite outcome measure)
For chiropractors: Scores on measures of behavioural constructs (levels of knowledge and self-efficacy) for recommended multimodal care.

Full Information

First Posted
June 17, 2015
Last Updated
September 12, 2016
Sponsor
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT02483091
Brief Title
Testing the Feasibility of Intervening to Optimize Chiropractic Care for Adults With Neck Pain Disorders
Official Title
Chiropractors Can Do: Testing the Feasibility of Intervening to Optimize Chiropractic Care for Adults With Neck Pain Disorders: A Pilot Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Knowledge translation, Clinical practice guidelines, Multimodal care, Brief Action Planning, Feasibility outcomes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifaceted KT intervention
Arm Type
Experimental
Arm Description
Webinars, online vignettes and e-module, copy of guideline recommendations
Arm Title
Control
Arm Type
No Intervention
Arm Description
Printed copy of guideline recommendations
Intervention Type
Behavioral
Intervention Name(s)
Multifaceted KT intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility outcome (composite outcome measure)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Scores on measures of behavioural constructs (composite outcome measure)
Description
For chiropractors: Scores on measures of behavioural constructs (levels of knowledge and self-efficacy) for recommended multimodal care.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Pain
Description
Self-rated level of pain on an 11 points continuous Visual Analogue Scale (VAS)
Time Frame
3 months (before and at the end of treatment)
Title
Disability
Description
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
Time Frame
3 months (before and at the end of treatment)
Title
Satisfaction with care
Description
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)
Time Frame
3 months (end of treatment) and 3 months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André E Bussières, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1Y5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25880218
Citation
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.
Results Reference
background
PubMed Identifier
23433271
Citation
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.
Results Reference
background
PubMed Identifier
23159157
Citation
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.
Results Reference
background
PubMed Identifier
31346409
Citation
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.
Results Reference
derived
PubMed Identifier
27965852
Citation
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.
Results Reference
derived

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

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