Background
Low back pain (LBP) is the leading cause of years lived with disability worldwide [
1], imposing an enormous burden on individuals and high societal costs [
2]. Over the last 25 to 30 years, the level of disability associated with LBP has risen by more than 50% [
2]. Most international guidelines for the management of persistent (equal to or greater than 3 months) or recurrent (repeat episodes) LBP recommend that patients self-manage their condition. First-line patient recommendations include reassurance and education about the nature of their condition, staying at work (or returning as soon as possible), and advising to remain physically active, and/or exercise [
3,
4].
Guideline recommendations are not routinely implemented, leading to treatment variability, wasted resources and potential harm [
5]. A recent review of evidence-based guideline adherence for musculoskeletal conditions found up to 81% of physical therapists provided care of unknown value, i.e., treatments not mentioned in guidelines [
6]. Further, 43% of physical therapists provided low-value care, i.e., treatments that guidelines do not endorse or recommend against [
6]. This non-adherence appears to be increasing [
7]. Apart from physical therapists, little is known with respect to other health care providers, i.e., chiropractic care aligning with guideline recommendations [
8].
To improve the implementation of guidelines into practice for the management of persistent and recurrent LBP, GLA:D® Back (Good Life with osteoArthritis in Denmark) was developed. GLA:D® Back aims to translate guideline recommendations into a practitioner-delivered program to promote evidence-based self-management support [
9]. The GLA:D® Back program is presently offered and taught to the members of the chiropractic and physiotherapy professions; and comprises two patient education sessions, plus 16 structured and individualised supervised group exercise therapy sessions [
9]. The GLA:D® Back program is based on the successful implementation of clinical practice guideline recommendations for the hip and knee—GLA:D®, with good results for reduced pain, improved function, reduced analgesic intake and reduced sick leave for people with osteoarthritis [
10]. GLA:D® Back was developed to adopt a similar approach for those with persistent or recurrent LBP to empower and benefit patients through effective self-management strategies based on their personal goals and capacities [
9]. GLA:D® Back has been implemented and evaluated in Denmark [
11‐
15], and more recently, in the Canadian healthcare settings [
16]. While the Danish and Canadian programs were deemed practical in their respective settings, using similar feasibility items, both faced similar challenges with adoption, e.g., logistical factors such as setting up the program and patient recruitment. To date, it is not known whether it is feasible to implement this program for LBP in Australia. Despite likely cultural, professional, and legislative differences existing, we hypothesise our results, using similar feasibility criteria, would be comparable to those described in the Danish and Canadian pilot programs [
16,
17].
The primary aim of this project was to investigate the feasibility and acceptability of implementing the GLA:D® Back program in Australia. We aimed to evaluate: (1) the ability to recruit chiropractors and physiotherapists to undergo GLA:D® Back training; (2) the ability to recruit and retain patients into the GLA:D® Back program; (3) the ability to directly observe program fidelity; and (4) barriers and facilitators for GLA:D® Back implementation for clinicians and patients. We also collected secondary data pertaining to: (5) clinician confidence, attitudes, and behaviour; and (6) patient self-reported outcomes related to pain, disability, and clinical performance tests.
Methods
Ethics
This study was approved by Macquarie University Ethics Board (Project ID 5655): 52019565510186.
Study participants—clinicians
Chiropractors and physiotherapists were invited to participate from a convenience sample, formed from our clinical networks, assisted by the President of Sports Chiropractic Australia and one of the GLA:D® hip and knee Australia program leads, who both identified clinicians and clinics who had shown interest in, or had enquired about, GLA:D® Back. These clinicians were approached and invited via email and/or phone call by the GLA:D® Back Australia research team to participate in this feasibility study.
Australian Health Practitioner Regulation Agency registered clinicians were eligible to participate if they provided treatment in a primary care setting for people with persistent or recurrent LBP. Clinicians were also required to have access to adequate floor space to conduct patient education groups and group exercise classes, and access to a computer connected to the Internet to enter data into the Research electronic data capture (REDCap) database system [
18,
19].
GLA:D® Back implementation strategy: clinician training
The Australian GLA:D® Back training course was delivered by the developers of the original program in Denmark [
9] and local investigators, including the GLA:D® Knee and Hip Australia program lead and prominent Australian LBP primary care researchers. The training ran over 2 days and comprised lectures and practical workshops to educate and motivate clinicians to deliver the program for people with persistent or recurrent LBP [
11].
Clinicians were initially exposed to contemporary evidence regarding the burden of LBP to develop or enhance their ability to deliver patient education. Key messages relating to central education themes from the patient education material were introduced (Additional file
1: Appendix Table S1) [
9], with clinicians role-playing the delivery of these key messages as part of the education content. Clinicians were taught to facilitate individualised goals, using the Specific, Measurable, Attainable, Realistic and Timed (S.M.A.R.T) approach [
20]. GLA:D® Back supervised exercises were also introduced during the training workshop, which blends strength, endurance, and flexibility approaches, divided into four levels of difficulty, and is accompanied by an exercise booklet.
Clinicians were also introduced and given access to a project specific REDCap registry to assist with data collection for patient characteristics and outcomes. The platform also contained essential GLA:D® Back materials, comprising a slide show to be used for patient education, exercises to support patients’ reflections, and posters with key patient education messages. Implementation was further supported through a private group messaging App for ongoing, informal clinician feedback. Clinicians had access to the research team to express concerns or ask questions. Additionally, an online 1-h booster session was conducted 3 months after initial training to refresh the clinicians’ knowledge of the GLA:D® Back course material and to encourage patient recruitment.
Study participants—patients
Adults (18 years or older) reporting persistent or recurrent LBP were eligible to participate in the GLA:D® Back program. Patients currently under care at the clinic could participate in GLA:D® Back and if deemed relevant, continue other therapy, or care concurrently. The study was limited to participants with adequate English comprehension to complete the study questionnaires. Exclusion criteria included: first episode of acute LBP (less than 3 months duration); nerve root involvement/clear neurologic signs; suspected serious pathology; spinal trauma (e.g., fracture); pregnancy; conditions that require a specialist consultation or could be aggravated or worsened if treated by the interventions in this study. Patients with planned spinal surgery or other major surgery within the study period were excluded, as were patients currently participating in a supervised exercise or rehabilitation program.
Clinicians were directed to approach, screen, and recruit patients who they considered would benefit from improved self-management skills for recurrent or persistent LBP. Interested patients provided their email addresses and received study information and an online form in REDcap by which to provide consent. Patients who were interested in participating were required to sign informed consent at the clinic prior to commencing the program. Recruited patients completed outcome measures for the clinical registry at baseline, 8 weeks and 3 months follow up.
GLA:D® Back intervention
Eligible patients performed four clinical performance tests, supervised by their clinician: the standing forward bending test [
21], trunk flexor endurance test [
22,
23], back extensor endurance test [
22‐
24], and 30 s chair stand test (Additional file
2: Appendix Table S2) [
25]. S.M.A.R.T. goals were also discussed and established as was the exercise program with the initial level of difficulty determined. As the GLA:D® Back intervention was developed around cognitive behavioural theory [
9], patients commenced the program with education classes in the clinic over 2 1-h sessions. Key education themes were introduced to help patients understand recurrent and persistent LBP in a non-threatening way. This was followed by the supervised exercise program, which comprised 16, 1-h, individualised exercise sessions in a patient group setting bi-weekly over an 8-week period. Clinicians guided and encouraged patients to focus on: (i) exploring variation of movements; (ii) feeling key muscles during the exercises; and (iii) motivation and confidence building [
9]. Clinicians conducted a final patient assessment and interview, revisiting personalised goals and clinical performance tests. Further details of the GLA:D® Back training and intervention has been described and published previously [
9].
Feasibility outcomes
Assessing feasibility of implementation were based on the following 4 domains.
Addressing aim 1: clinician recruitment
We aimed to recruit 10-to-20 interested clinicians for the GLA:D® Back course within 2 weeks of contacting them. Of those recruited, we defined feasibility success if 50% of clinicians delivered the program.
Addressing aim 2: patient recruitment, retention, and data collection
Clinicians aimed to recruit as many eligible patients as possible within a 3-month period. Additionally, we planned to record patient retention rates over the course of the program offered within each clinic and assess the feasibility of collecting patient outcomes at baseline, 8 weeks, and 3 months from the GLA:D® Back program commencement. Recruiting a minimum of 60 patients, with ≥ 80% retention rate (i.e., completing the program) would meet our criterion for feasibility success.
Addressing aim 3: observation of delivery of the program
We aimed to observe and document elements of fidelity, i.e., adherence related to delivery of the program, including patient attendance, absences, and cancellations, as well as observing session length, evidence of individualised coaching and group discussions. We planned to observe and document the presence of materials used, such as visibility of the patient training manual, GLA:D® Back key messages poster, PowerPoint slides and clinician use of reflection exercises. Items of the fidelity checklist can be found at Additional file
3: Appendix Table S3.
Addressing aim 4: barriers and facilitators
We aimed to explore barriers and facilitators for GLA:D® Back implementation through qualitative interviews with both clinician and patient participants. Interview questions were informed by the Theoretical Domains Framework (TDF) [
26], to identify factors influencing healthcare provider behaviour. Three researchers (MF, AY, JW) conducted one-to-one semi structured interviews online (Zoom) or via telephone, which were audiotaped and transcribed.
One clinician from each participating clinic who delivered GLA:D® Back will interviewed with questions focussed on perspectives regarding the content of the clinical intervention and program implementation and feasibility. Patients who both completed and dropped out of the program were interviewed and asked to reflect on their experiences and what they gained by participating in the GLA:D® Back program. In developing the patient interview questions, a consumer who had experience with LBP from Musculoskeletal Australia (
www.msk.org.au) was invited to comment on the questions related to the patient’s LBP experience.
Secondary aims 5 and 6: clinician and patient self-reported outcomes
Clinician outcome measures were collected 1 week before, immediately after, and 3 months post-course to evaluate the potential change in the Practitioner Confidence Scale [
27], along with biomedical and behavioural treatment orientation within the practitioner attitudes and beliefs scale [
28,
29]. Patients received a link to the REDCap system on the day of the baseline consultation and 3 months later, which included the following outcomes: Arthritis Self-Efficacy Scale [
30], Oswestry Disability Index = ODI [
31], Numeric Pain Rating Scale [
32], the Fear-Avoidance Behaviour Questionnaire—FABQ [
33], the STarT Back Screening Tool [
34], the Brief Illness Perception Questionnaire—B-IPQ [
35], the SF-36 quality of life questionnaire [
36] and self-assessed physical fitness [
37]. Details of all outcome measures and interpretation scales are shown in Additional file
2: Appendix Table S2.
Analysis
Quantitative data were presented descriptively, including: (1) clinician recruitment rates; (2) patient recruitment, retention and follow up rates; and (3) directly observing the GLA:D® Back program. Qualitative data analysis occurred via codes generated and grouped into themes using thematic analysis from the qualitative semi-structured interviews [
38].
Researchers (MF, AY and JW) conducted a qualitative analysis of each interview transcript by individually reading line by line to capture an overall impression of the data. Data codes, supported by Nvivo software (QSR International Pty Ltd, Melbourne, Australia), were collated into a broader level of potential themes. Subsequent ensuing themes were discussed until a consensus was reached by researchers (MF, AY, JW). Themes related to barriers and facilitators were then mapped to the relevant domains from the TDF [
26]. Direct quotations from the main themes are presented.
For clinician outcomes, group median change scores were calculated on the Practitioner Confidence, and Practitioner Attitudes and Beliefs Scales at baseline, post training and 3- month follow-up. Patient outcomes in terms of pain, disability, fear avoidance behaviour, prognosis, brief illness perception, quality of life and physical fitness were also described as median change scores from baseline to 3 months. As this was a feasibility study, no inferential analyses were performed.
Discussion
Our findings suggest that the implementation of GLA:D® Back appears feasible in Australian physiotherapy and/or chiropractic private practice settings. The program was acceptable to the small sample of invited clinicians with potential improvement in outcomes by the small sample of participating patients. However, the COVID-19 pandemic impacted patient recruitment, follow-up rates and data collection. Strategies to address these need to be put into practice to scale up GLA:D® Back implementation.
We recruited 20 enthusiastic and motivated clinicians, including physiotherapists who had previously implemented GLA:D® hip and knee. However, only 11 of the 20 clinicians (55%) adopted the GLA:D® Back program. This met our pre-determined success criteria (50%), and is in line with the GLA:D® Back 2019 Danish Annual Report of clinicians conducting the program (54%) [
40]. However it was lower than the Canadian GLA:D® Back program, with 71% of their clinicians delivering the program [
16]. While clinicians from both the Australian, Danish and Canadian programs experienced similar barriers implementing the program, it is highly likely the COVID-19 pandemic further impacted some of our clinician’s capacity to offer GLA:D® Back. Importantly, clinicians who did not deliver GLA:D® Back in Australia expressed the intention to deliver the program in the future if given the opportunity.
We successfully recruited 57 patients, just short of our minimum criterion of 60. However, retention was impacted by a 33% dropout rate, thus not meeting our predefined criterion of ≤ 20% of dropouts. This contrasted with the Canadian program, which reported a 12% drop out rate [
16]. The COVID-19 outbreak was largely responsible for dropouts in our study, accounting for almost 50% of our patient dropouts. Other contributing factors were barriers to patient recruitment, i.e., programs were suspended or paused for patient safety or abandoned due to business restrictions imposed by the Federal Government. A transition to online delivery (via Zoom) was offered and generally well accepted by most patients. Amendments to the original face-to-face program were few, with clinical performance tests observed online, and patient education continuously reiterated, with clinicians providing patient feedback virtually. Some patients declined virtual delivery finding the transition either too difficult or were not interested in this format.
Of our 57 participants, 35 of 38 (92%) who remained in the program took part in more than 80% of the GLA:D® Back program sessions available, suggesting good program adherence. This is comparable to the Canadian program, where 84% of their participants attended both education sessions and 74% attended the majority (if not all) 16-session within the program [
16].
The patient attrition rate impacted completeness of patient-reported items, with 67% of patients completing the 3-month follow-up survey. This rate was identical to the Canadian program [
16], but short of the 88% response rate for GLA:D® Back participants in Denmark [
17]. As a pragmatic implementation study, a response to every question was not mandatory, hence, we do not have the entire patient population responding to some questions, including the SF-36 and sick leave follow-up data. Future studies will need to investigate if non-response introduces bias, while concurrently seeking ways to improve follow-up rates and responses to clinical outcomes. This could include altering the patient reminder system (adding phone text reminder messages and phone calls to standardised emails) and/or building better rapport (i.e., checking up) with participants.
We did not observe the key education messages poster during all four clinic fidelity observations, despite one or more key messages from these posters delivered during the classes by the clinician. The GLA:D® Back key messages poster is recommended for the education sessions and integrated into the exercise sessions [
9]. Posters may have been visible in another session not observed or were not visible from the Zoom screen sharing. Further, some exercises were either not performed or were modified by clinicians, who accommodated patients by adapting to their injury history and/or observed comorbidity. Future GLA:D® Back offerings may consider further regression of exercises within the level of difficulty currently offered.
Facilitators and barriers of the GLA:D® Back program
Most clinicians were confident, motivated, and freely volunteered for the course. GLA:D® Back implementation was smooth, particularly for those who previously implemented systems associated with the GLA:D® hip and knee program, i.e., had dedicated floor space and established referral networks. Clinicians observed several patient benefits, including clinical performance test improvements at follow-up, new knowledge gained and learning to move ‘more freely’. Patients felt more confident handling their back problems despite the ongoing presence of pain and future flare ups, underscoring one of the desired effects of the GLA:D® Back program. These apparent patient beliefs observed quantitatively via the FABQ and behavioural changes observed by clinicians should be further investigated for maintenance over the longer-term. Patients also felt reassured, with clinicians nurturing a safe environment, promoting a friendly, competitive atmosphere in a group setting [
41]. As such, group exercises should be further encouraged, in light of group-based and individual physiotherapy exercise programmes being found to be equally effective for musculoskeletal conditions [
42].
Some clinicians encountered difficulties implementing the GLA:D® program, including patient recruitment challenges. This underscores the importance of skilled staff and other resources dedicated to patient recruitment (i.e., implementing marketing strategies and assisting program set up). Clinicians undertaking such roles were likely discouraged to implement the program, being drawn away from their established clinical responsibilities. Greater support provided by the GLA:D® Back team (beyond the training course) may facilitate greater widespread adoption of GLA:D® Back among clinicians.
Virtual platforms were not adopted by all patient in our GLA:D® Back study, with some favouring the initial face-to-face approach of the program. Emerging evidence [
43], indicates that telehealth can provide improvements in exercise adherence [
44]; however, patient barriers like age, education level and computer literacy can all hinder virtual uptake [
45]. Future research should look to overcome telehealth barriers, in light of a recent survey showing that virtual participation facilitated the clinicians’ role as coaches [
46], consistent with the GLA:D® back self-management approach.
(Secondary) clinical and patient outcomes
Clinicians’ overall evaluation of the course was positive, reflected by successful adoption of the program. Clinician treatment orientation (beliefs and attitudes) favoured a more biomedical orientation at 3 months follow up, contrasting the GLA:D® Back studies in Denmark [
17], Canada [
16], and the overall GLA:D® Back objectives. It may be that our clinicians held initial strong biomedical beliefs [
47,
48], reflective of their training [
49], or being perceived as not meeting patient treatment expectations [
50]. Almost 60% of patients reported experiencing LBP for more than 1 year, therefore they were appropriately recruited for the GLA:D® Back program. Improvements in fear avoidance suggests the program’s education and exercise modules may be addressing this component. Positive changes were noted for the clinical performance tests, which are in line with patient improvements in the Canadian [
16] and Danish programs [
40]. Patient illness beliefs (B-IPQ) did not meaningfully change over time and may likely altered over a longer time duration or not at all. While results from our outcomes are underpowered, they show promise, with trends like those reported in previous GLA:D® Back programs [
16,
17,
40].
Study strengths and limitations
A key limitation of our study implementation was the impact of the COVID-19 pandemic. As a feasibility study, only preliminary short-term evaluation of clinician and patient outcomes took place, hence the maintenance of long-term outcomes is unknown. We also conveniently sampled and recruited clinicians we felt would be interested in and likely adopt the program. Although evidence and guidelines support the approach and intervention taken with GLA:D® Back, no clinical trial has evaluated efficacy of the program compared to usual care. The small sample in our feasibility study signifies a need to evaluate implementation with a larger sample of clinicians and patients prior to a national roll out of the program. Implementation of our study was limited by the in-person training of clinicians, i.e., limited by cost and location, and there is a need to train local trainers to deliver the program. The feasibility of online training was also not assessed. Further, inclusion of other stakeholders in qualitative research is needed, including potential referrers (e.g., general practitioners), and funders (e.g., private health insurers). We only assessed some aspects of fidelity, with future fidelity assessments targeting focused behavioural change techniques and clinician communication styles. While our secondary aims were pertaining to patient outcomes, it should be noted that improvement trends in these outcomes cannot be taken as evidence for effectiveness. Our feasibility study in Australia builds on the original English implementation of the GLA:D® Back program in Canada [
16], therefore encouraging implementation in other English-speaking countries.
Conclusion
Implementation of the GLA:D® Back program in Australia appears feasible. The program was acceptable to the small sample of invited chiropractors and physiotherapists and with potential improvement in patient outcomes. However, the COVID-19 pandemic impacted patient recruitment, retention, and data collection. To scale up GLA:D® Back implementation in private and public settings, further work is warranted to address associated barriers, and to leverage facilitators. Also, clinical benefits of the program when compared to current models of care needs to be determined.
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