Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000434493
Ethics application status
Approved
Date submitted
31/03/2016
Date registered
5/04/2016
Date last updated
5/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Practice-based Investigation and Study of Attendees at Chiropractic Offices
Scientific title
A Practice-based Investigation and Study of Attendees at Chiropractic Offices in Western Australia (PIStAChiO): a sequential mixed methods, external pilot study
Secondary ID [1] 288891 0
None
Universal Trial Number (UTN)
U1111-1181-4369
Trial acronym
PIStAChiO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chiropractic health care seeking
 298228 0
Condition category
Condition code
Alternative and Complementary Medicine 298361 298361 0 0
Other alternative and complementary medicine
Public Health 298362 298362 0 0
Health service research
Musculoskeletal 298363 298363 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study was designed as a sequential, explanatory, mixed-methods, cross-sectional, practice-based, external pilot study of patients seeking chiropractic services in Western Australia. A select non-random sample of independent private chiropractic practices was recruited and between July-September 2014 consecutive adult patients self-presenting to these practices for the first time were invited to participate. Patient participants were assessed on a single occasion only at the time of first presentation to chiropractor within the study period. Data for analysis were collected using a computer-based online questionnaire; including various patient demographic data and human quality of life measures (HQoL’s; SF-12 and PIQ-R). Both qualitative and quantitative responses were collected from the practice practitioners and support staff and a descriptive analysis which characterised the sample practices and chiropractors is provided.
Intervention code [1] 294351 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297833 0
Critique of pilot study

Acceptability and feasibility of carrying out the study for chiropractors and chiropractic office staff, assessed using a Likert Scale and open-ended (qualitative) questionnaire designed for this study. Thus the primary purpose of this external pilot study was to provide a critique of the research design and methods and collect data from a selected sample of chiropractic practices, with a view to offer recommendations related to the design, feasibility and implementation (including sample size calculations) for a definitive study, and provide insights into the possible outcomes of such a study.
Timepoint [1] 297833 0
12 weeks
Data collected on a single occasion from each (new) patient participant presenting to a chiropractor over the 12 week study period.
Data collected via an online portal on a single occassion at the end of the study for each practice staff participant (practitioner & office support staff) using likert scale and open ended (qualitative) questionnaire.
Primary outcome [2] 297863 0
Recruitment of Practices

Recruitment assessed by recording number of practices who consent and participate out of all practitioners invited.
Timepoint [2] 297863 0
4 weeks recruitment of practices.
Mid-May - Mid-June 2014
Primary outcome [3] 297864 0
Recruitment and Enrollment of Patients

Recruitment rate assessed by recording number of patients who consent out of all patients presenting to a participating chiropractic office within the study period.
Timepoint [3] 297864 0
12 weeks. Data collected on a single occasion from each participant presenting to a chiropractor over the 12 week study period.
Secondary outcome [1] 322476 0
Demographics
1. What is your gender?
2. What is your age?
3. What language do you mainly speak at home?
4. Do you identify as an Aboriginal or Torres- Strait Islander person?
Timepoint [1] 322476 0
12 weeks. Data collected on a single occasion from each participant presenting to a chiropractor over the 12 week study period.
Secondary outcome [2] 322477 0
Occupation
Which of the following best describes your current occupation?
Architecture and Engineering
Arts, Design, Entertainment, Sports, and Media
Business and Financial Operations
Cleaning and Maintenance
Community and Social Service
Computer and Mathematical
Construction
Education, Training, and Library
Farming, Fishing, and Forestry
Food Preparation and Serving Related
Other (please specify)
Timepoint [2] 322477 0
12 Weeks.
Data collected on a single occasion from each participant presenting to a chiropractor over the 12 week study period.
Secondary outcome [3] 322478 0
Payment
Which best describes the source of payment for your visit?
Department of Veterans’ Affairs (DVA)
Insurance Commission (ICWA) or Transport Accident Commission
Medicare
Patient paid 100% [No insurance]
Patient paid partial [Co-payment]
Private health insurance
No charge
Workers Compensation
Other (please specify)
Timepoint [3] 322478 0
12 Weeks. Data collected on a single occasion from each participant presenting to a chiropractor over the 12 week study period.
Secondary outcome [4] 322479 0
Source
How did you find out about this clinic?
Word of mouth (personal referral)
Referral from a medical practitioner
Referral from another health practitioner
Referral from another source (eg; Lawyer)
Friends or family
Print advertisement
Internet
Social Media
Signage
Other (please specify)
Timepoint [4] 322479 0
12 Weeks. Data collected on a single occasion from each participant presenting to a chiropractor over the 12 week study period.
Secondary outcome [5] 322480 0
Presenting Complaint(s)
Which of the following best describes the MAIN reason you have consulted this chiropractor?
Low Back problem
Mid Back (between the shoulders) problem
Neck problem
Muscle problem
Health maintenance or preventive care
Back syndrome with radiating pain
Musculoskeletal symptom or complaint
Headache
Sprain or strain of joint
Shoulder problem
Nerve-related problem
General symptom or complaint
Bursitis, tendinitis or synovitis
Kyphosis and scoliosis
Foot or toe symptom or complaint
Ankle problem
Osteoarthrosis, other (not spine)
Hip symptom or complaint
Leg or thigh symptom or complaint
Musculoskeletal injury
Depression
Other (please specify)

Which of the following are reasons OTHER than the main reason you have consulted this
chiropractor? (same options as above)
Timepoint [5] 322480 0
12 Weeks. Data collected on a single occasion from each participant presenting to a chiropractor over the 12 week study period.
Secondary outcome [6] 322481 0
Co-morbidities
Have you been diagnosed by a medical practitioner (doctor) with any other health conditions before you have consulted this chiropractor?
Cardiovascular problem
Cancer
Diabetes
Respiratory problem
Neurological disorder
Depression or mental illness
Other (please specify)
Timepoint [6] 322481 0
12 weeks. Data collected on a single occasion from each participant presenting to a chiropractor over the 12 week study period.
Secondary outcome [7] 322482 0
Prior Chiropractic Use
Have you been to a chiropractor before this one?
Timepoint [7] 322482 0
12 weeks. Data collected on a single occasion from each participant presenting to a chiropractor over the 12 week study period.
Secondary outcome [8] 322483 0
Health Status
Human Quality of Life Measures
1. SF-12 HQoL
2. PIQ-6
Timepoint [8] 322483 0
12 weeks. Data collected on a single occasion from each participant presenting to a chiropractor over the 12 week study period.
Secondary outcome [9] 322498 0
Lifestyle
Do you smoke?
In a typical week how many alcoholic drinks would you consume?
Timepoint [9] 322498 0
12 Weeks
Data collected on a single occasion from each participant presenting to a chiropractor over the 12 week study period.
Secondary outcome [10] 322499 0
Medication and Supplement Use
Medication and nutritional supplements
Please indicate how many different types you take per day
Prescription medication
Over the counter medications
Nutritional supplements
Timepoint [10] 322499 0
12 Weeks
Data collected on a single occasion from each participant presenting to a chiropractor over the 12 week study period.
Secondary outcome [11] 322500 0
Previous Health Seeking
Have you consulted any other health practitioners for the main complaint you are seeing the chiropractor today?
Medical Practitioner
Physiotherapist
Osteopath
Massage Therapist
Occupational Therapist
Acupuncturist
Other (please specify)
Timepoint [11] 322500 0
12 Weeks
Data collected on a single occasion from each participant presenting to a chiropractor over the 12 week study period.

Eligibility
Key inclusion criteria
Adults (18yrs and over) presenting to chiropractors in Western Australia Jul-Sep 2014
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not applicable

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Odds ratios calculated to estimate the odds of a secondary complaint for various combinations of main complaints, from univariate logistic regression models.

Sample estimation
Arriving at an estimation of the practice sample size was difficult to determine. The default position was to have as many practices involved as possible from as many regions as possible. However, this was tempered by a pragmatic recognition of the likelihood of practice drop-out and the assumed lesser number of practices in rural and remote geographical settings.
Target sample size for the pilot study was thus determined by team consensus on 'best fit', logistics, available resources and time, and calculations. Each chiropractic practice was estimated to average at least 6 new self-presenting adult patients per week. With a potential ~35% of patients declining to participate or not completing the survey, it was estimated that approximately ~320 patients could be recruited into the study during the 12 week study period across at least 7 practices. The estimated rate of those declining to participate was based on; (1) the invitation was face to face, (2) low chance of participation fatigue (prior invitation), (3) the issue was salient to the participants and (4) low demands in terms of participation. Since there is no issue of ‘finding’ participants to recruit, this estimate was considered somewhat conservative. Calculations to determine priori sample size estimation using G*Power software indicated a total sample of 320 would be sufficient to achieve a study power of >80% (assumed effect size 0.2, a=0.05 assumed df=5; www.gpower.hhu.de).

Ref: Amorin-Woods et al.; BJMMR, 5(4): 539-556, 2015; Article no.BJMMR.2015.059

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2014
Date of last participant enrolment
Anticipated
Actual
30/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
Final
325
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 293245 0
University
Name [1] 293245 0
The University of Western Australia
Country [1] 293245 0
Australia
Funding source category [2] 293266 0
Commercial sector/Industry
Name [2] 293266 0
Chiropractors Association of Australia (WA Branch)
Country [2] 293266 0
Australia
Primary sponsor type
University
Name
The University of WA
Address
35 Stirling Hwy, CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 292047 0
Commercial sector/Industry
Name [1] 292047 0
Chiropractors Association of Australia (WA Branch)
Address [1] 292047 0
Suite 29, 18 Stirling Hwy, NEDLANDS WA 6009
Country [1] 292047 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294723 0
Human Research Ethics Committee of The University of Western Australia
Ethics committee address [1] 294723 0
35 Stirling Hwy, CRAWLEY WA 6009
Ethics committee country [1] 294723 0
Australia
Date submitted for ethics approval [1] 294723 0
19/03/2014
Approval date [1] 294723 0
15/05/2014
Ethics approval number [1] 294723 0
RA/4/1/6713

Summary
Brief summary
The emerging focus in healthcare is to have care services delivered using strategies that are cost-efficient and evidence-based, while engaging with the broadest applicable workforce. Therein is the opportunity for the chiropractic profession to play an expanding role within the context of a multi-disciplinary care, particularly in the area of musculoskeletal/spinal health. Practice-based data collection would offer insight into the nature of chiropractic practice and contribute to resolving the conundrum of chiropractic’s role in contemporary healthcare, latterly informing care service policy. However, there is little formal data available about chiropractic practice to inform us about the nature and role of chiropractic within the context of a modern multidisciplinary healthcare context in Australia, particularly at a local and regional level. This purpose of this prospective, mixed-methods, cross-sectional, external pilot study was to provide a critique of the research design and collect data from a selected sample of chiropractic practices, with a view to offer recommendations related to the design, feasibility and implementation of a future confirmatory study. A narrative critique of the research methods of this pilot study is offered, covering: (a) practice and patient recruitment, (b) enrollment of patients, (c) data collection methods, (d) acceptability of the study methods, (e) sample size calculations, and (f) design critique. The result of this critique provides a sensible sample size estimate and recommendations as to the design and implementation of a future confirmatory study. Furthermore, we believe that a confirmatory study is not only feasible, but indeed necessary, with a view to offer meaningful insight into chiropractic practice in Western Australia.
Trial website
Not applicable
Trial related presentations / publications
Australian Research Centre for Complementary and Integrative Medicine
(ARCCIM) University of Technology Sydney September 2014
https://www.uts.edu.au/research-and-teaching/our-research/arccim/events/seminar-practice-based-investigation-and-study
Seminar: Practice-based Investigation and Study of Attendees at Chiropractic Offices (PIStAChiO) Dr Lyndon Amorin-Woods will discuss “Practice-based Investigation and Study of Attendees at Chiropractic Offices PIStAChiO): describing the characteristics of patients presenting to Chiropractors in Western Australia – a prospective, cross-sectional, practice-based pilot study.”

Amorin-Woods, L. G., Nedkoff, L., Parkin-Smith, G. F., & Fisher, C. (2015 -(01-10 February)). The Design of A Practice-based Study of Attendees at Chiropractic Offices in Western Australia. Br J Med Med Res, 5(4), 539-556.
doi: 10.9734/BJMMR/2014/13083
http://www.sciencedomain.org/abstract.php?iid=663&id=12&aid=6198
Public notes

Contacts
Principal investigator
Name 64822 0
Dr Lyndon Amorin-Woods
Address 64822 0
Murdoch University School of Health Professions
90 South St
MURDOCH WA 6150
Country 64822 0
Australia
Phone 64822 0
+61 8 93601267
Fax 64822 0
Email 64822 0
[email protected]
Contact person for public queries
Name 64823 0
Dr Lyndon Amorin-Woods
Address 64823 0
Murdoch University School of Health Professions
90 South St
MURDOCH WA 6150
Country 64823 0
Australia
Phone 64823 0
+61893601267
Fax 64823 0
Email 64823 0
[email protected]
Contact person for scientific queries
Name 64824 0
Dr Lyndon Amorin-Woods
Address 64824 0
Murdoch University School of Health Professions
90 South St
MURDOCH WA 6150
Country 64824 0
Australia
Phone 64824 0
+61893601267
Fax 64824 0
Email 64824 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCritique of a practice-based pilot study in chiropractic practices in Western Australia.2016https://dx.doi.org/10.1186/s12998-016-0117-8
EmbaseOutcomes of a pilot study in chiropractic practices in Western Australia.2016https://dx.doi.org/10.1186/s12998-016-0116-9
N.B. These documents automatically identified may not have been verified by the study sponsor.