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Trial registered on ANZCTR


Registration number
ACTRN12616000896471
Ethics application status
Approved
Date submitted
4/07/2016
Date registered
7/07/2016
Date last updated
7/05/2019
Date data sharing statement initially provided
7/05/2019
Date results information initially provided
7/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot implementation of the Fear Reduction Exercised Early (FREE) approach to low back pain
Scientific title
The Fear Reduction Exercised Early (FREE) approach to acute low back pain in general practice: a pilot implementation study
Secondary ID [1] 289591 0
Nil
Universal Trial Number (UTN)
U1111-1183-4351
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 299359 0
Condition category
Condition code
Musculoskeletal 299347 299347 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Fear Reduction Exercised Early (FREE) approach to acute low back pain (LBP). The FREE approach aims to assist GPs to identify and address attitudes and beliefs which may be barriers to recovery from acute LBP, explain back pain to their patients, and to provide patients with a framework which enables patients to resume normal employment and activities of daily living.

General practitioner (GP) participants will be instructed in the FREE approach through an initial four-hour workshop facilitated by an experienced physiotherapist. The workshop will be supported by a booklet, a website, and a module within the practice's electronic patient management system. GPs will then practise using the approach for approximately one-month with any patients who present with acute low back pain. GPs will then attend a one-hour refresher workshop facilitated by a physiotherapist. The refresher workshop will discuss experiences of using the approach and address any barriers identified . GPs will also be provided with a novel information booklet to provide to their patients. This booklet outlines current best practice for acute LBP, supports recommendations from the GP booklet, and addresses commonly held beliefs. It encourages an active approach to managing LBP. The approachwill also be supported by a website. GPs will have access to the website throughout the study and on an ongoing basis following the study. GPs will be able to continue using the FREE approach following the four-month study period in each practice. GPs will be able to personalise the care they provide to any individual patient based on their own clinical reasoning.

A purposive sample of approximately twelve patients who consult GPs who have completed FREE training with a primary complaint of acute low back pain will be interviewed as part of this study.
Intervention code [1] 295197 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298815 0
GP beliefs about back pain measured with the Back Pain Attitudes Questionnaire (Back-PAQ)
Timepoint [1] 298815 0
4 months after initial training workshop (also measured at 4 weeks - following the refresher training session)
Primary outcome [2] 298816 0
Attitudes to pain and impairment measured with the Health Care Providers Pain and Impairment Relationship Scale (HC-PAIRS)
Timepoint [2] 298816 0
4 months after initial training workshop (also measured at 4 weeks - following the refresher training session)
Secondary outcome [1] 325294 0
GP Implementation acceptability through items drawn from the Modified Acceptability Of Intervention (AIM) Post-Intervention Survey
Timepoint [1] 325294 0
4 months after initial training workshop
Secondary outcome [2] 325295 0
Penetration within the primary study general practice population measured by counting the number of GPs who complete FREE training out of a total population of 131 GPs. Please note that this analysis will also draw on data from the parallel RCT involving 60 GPs from within the primary general practice population (through which these 60 GPs will receive FREE training).
Timepoint [2] 325295 0
Study termination (estimated July 2018)
Secondary outcome [3] 325296 0
Routinely collected insurance data will be used to measure the number of patient LBP claims initiated by GPs involved in the implementation study in the twelve months before they receive training, and the twelve months following their refresher training session.

Timepoint [3] 325296 0
Twelve months following the final practice refresher training session (estimated July 2019)
Secondary outcome [4] 325297 0
Qualitative interviews will be conducted by a research fellow experienced in qualitative research to explore implementation constructs in more depth with purposive samples of both GPs and their patients. These interviews will be semi-structured and audio-recorded. An interview guide with open-ended questions will allow flexibility to discuss issues as these arise. It is anticipated that each interview will last approximately 30 minutes. Additional participants will be interviewed until saturation of major themes is achieved.
Timepoint [4] 325297 0
Throughout the implementation period. It is anticipated that approximately twelve interviews will be required with GP participants and interviews with patient participants to achieve data saturation
Secondary outcome [5] 325298 0
GP evaluation of workshop using a purpose developed questionnaire with likert scale and free text response options
Timepoint [5] 325298 0
Immediately after the training workshop
Secondary outcome [6] 325299 0
GP evaluation of training using Eight quantitative items selected from the thirteen item Training/Practice Acceptability/Feasibility/Appropriateness Scale scored on a 5-point likert scale and three qualitative items with free text responses
Timepoint [6] 325299 0
After the refresher training session (4 weeks post initial training workshop)
Secondary outcome [7] 325409 0
GP reported implementation adoption measured with items drawn from the Adoption of Information Technology Innovation scale and items adapted from the Level of Use instrument
Timepoint [7] 325409 0
4 months after initial training workshop
Secondary outcome [8] 325410 0
GP reported implementation appropriateness measured with items drawn from the Parenting Strategies Questionnaire and the Scott Innovation Scale – Behavioural intention subscale
Timepoint [8] 325410 0
4 months after initial training workshop
Secondary outcome [9] 325411 0
GP reported implementation feasibility measured through a purpose developed item and items from the feasibility subscale of the Training/Practice Acceptability/Feasibility/Appropriateness Scale
Timepoint [9] 325411 0
4 months after initial training workshop
Secondary outcome [10] 325412 0
Penetration within all practices which receive training will be measured by counting the number of GPs who complete FREE training out of the number of GPs who practice at these sites
Timepoint [10] 325412 0
Study termination (estimated July 2018)
Secondary outcome [11] 325413 0
Routinely collected insurance data will be used to measure the cost of patient claims (and components of these costs) for LBP claims initiated by GPs involved in the implementation study in the twelve months before they receive training, and the twelve months following their refresher training session.
Timepoint [11] 325413 0
Twelve months following the final practice refresher training session (estimated July 2019)
Secondary outcome [12] 325414 0
Routinely collected insurance data will be used to measure the rates of earnings compensation for LBP claims initiated by GPs involved in the implementation study in the twelve months before they receive training, and the twelve months following their refresher training session.
Timepoint [12] 325414 0
Twelve months following the final practice refresher training session (estimated July 2019)
Secondary outcome [13] 325415 0
Routinely collected insurance data will be used to measure the rates of patient referral for additional health care for LBP claims initiated by GPs involved in the implementation study in the twelve months before they receive training, and the twelve months following their refresher training session.
Timepoint [13] 325415 0
Twelve months following the final practice refresher training session (estimated July 2019)
Secondary outcome [14] 325416 0
Routinely collected insurance data will also be used to assess the proportion of patient with LBP claims initiated by GPs involved in the implementation study in the twelve months before they receive training, and the twelve months following their refresher training session. who file another LBP claim in the 12 months and 24 months following their initial claim.
Timepoint [14] 325416 0
12 and 24 months following the final practice refresher training session (24 month time point estimated to be achieved at July 2020)

Eligibility
Key inclusion criteria
GP participants will be eligible for the study if they meet the following criteria:
1) New Zealand registered GP
2) Working within the Hutt Valley, Wairarapa, Wellington, or Kapiti regions
3) Have agreed to attend the FREE approach training sessions

Patient participants will be eligible for the study if they meet the following criteria:
1) Attended a GP who has been interviewed as part of the FREE implementation study with a primary complaint of LBP which had been present for less than 6 weeks
2) Over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
GP participants will not be eligible for the study if they:
1) Have participated in pilot testing
2) Have been participants in a parallel RCT (60/134 GPs in the Hutt Valley)
3) Do not attend the initial FREE training workshop

Patient participants will not be eligible for the study if they:
1) Are unable to communicate in English
2) Have not been exposed to the FREE approach (assessed via Medtech consultation notes and/or patient inquiry related to FREE resources)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Sample size:
One hundred and forty GPs will be invited to participate in the implementation study. This will give good precision for the primary outcome (Back-PAQ measure – no formal power calculated as the study aim is to estimate changes in beliefs, rather than hypothesis testing per se) and also on the penetration measure (coverage of all Hutt Valley GPs undertaking training).

GP self-reported outcomes:
The mean and standard deviation of the Back-PAQ and HC-PAIRS scores will be calculated pre- and post-intervention. The change score along with its 95% confidence interval will be calculated to estimate the magnitude of any change, using a paired t-test to identify any statistically significant change, with alpha set at 0.05.

Quantitative workshop evaluation data will be analysed with descriptive statistics.

Implementation outcomes:
Implementation measures are single time-point evaluations, so will be reported using descriptive statistics (frequencies, medians and interquartile range).

Penetration will be calculated by dividing the number of GPs who complete FREE training by the total population of GPs in the study region and practices..

Cost-benefit:
The impact of implementation on ACC insurance costs will be calculated for each GP trained in the FREE approach in the Hutt Valley. Data related to ACC insurance claims for the twelve months preceding FREE training will be compared with data for the twelve months following completion of FREE training. These comparisons will be analysed with paired t-tests. Statistical significance will be judged with an alpha of 0.01 to account for multiple comparisons.

Net Benefit will be calculated by subtracting the net cost of implementation from the monetary benefit (adjusted pre-post change in the total cost of claims) on a per-GP basis and a per-10,000 population basis given a range of assumptions regarding GPs/10,000 people aged >18yrs. The net cost of implementation will comprise the initial training and implementation costs.

Qualitative interviews:
Qualitative interviews will be analysed using Thematic Analysis. Recruitment will continue until theme saturation is achieved. Approximately 12 GPs and 12 patients will be interviewed.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7999 0
New Zealand
State/province [1] 7999 0
Lower North Island

Funding & Sponsors
Funding source category [1] 293980 0
Other
Name [1] 293980 0
Accident Compensation Corporation
Address [1] 293980 0
Justice Centre
19 Aitken Street
PO Box 242
Wellington 6140
Country [1] 293980 0
New Zealand
Primary sponsor type
Individual
Name
Dr Ben Darlow
Address
Department of Primary Health Care and General Practice
University of Otago, Wellington
23 Mein Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 292796 0
None
Name [1] 292796 0
Address [1] 292796 0
Country [1] 292796 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295398 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 295398 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 295398 0
New Zealand
Date submitted for ethics approval [1] 295398 0
09/06/2016
Approval date [1] 295398 0
27/06/2016
Ethics approval number [1] 295398 0
16/CEN/77

Summary
Brief summary
This study will evaluate the implementation of a new approach to managing acute low back pain. It will train 140 GPs in the approach and investigate if the training changes their knowledge and beliefs about back pain. It will also look at GPs' views of how the new approach was implemented and explore patients' experiences of the approach.
Trial website
http://www.otago.ac.nz/backpainstudy
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67118 0
Dr Ben Darlow
Address 67118 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
23 Mein Street
Newtown
Wellington 6021
Country 67118 0
New Zealand
Phone 67118 0
+6449186051
Fax 67118 0
+6443855539
Email 67118 0
ben.darlow@otago.ac.nz
Contact person for public queries
Name 67119 0
Dr Ben Darlow
Address 67119 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
23 Mein Street
Newtown
Wellington 6021
Country 67119 0
New Zealand
Phone 67119 0
+6449186051
Fax 67119 0
+6443855539
Email 67119 0
ben.darlow@otago.ac.nz
Contact person for scientific queries
Name 67120 0
Dr Ben Darlow
Address 67120 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
23 Mein Street
Newtown
Wellington 6021
Country 67120 0
New Zealand
Phone 67120 0
+6449186051
Fax 67120 0
+6443855539
Email 67120 0
ben.darlow@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant quantitative data and data dictionaries. Qualitative interview data will not be shared.
When will data be available (start and end dates)?
Data will be available following acceptance for publication (anticipated to be available from the first quarter of 2020). There is no pre-determined end date.
Available to whom?
Researchers who provide a methodologically sound proposal and evidence of ethical approval.
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Direct email to the Prinicpal Investigatior (ben.darlow@otago.ac.nz) and following completion of a data access agreement.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 2019 0
Study protocol
Citation [1] 2019 0
Link [1] 2019 0
Email [1] 2019 0
Other [1] 2019 0
This will also be provided on request
Attachment [1] 2019 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary