Effectiveness of a coordinated support system linking public hospitals to a health coaching service compared with usual care at discharge for patients with chronic low back pain: protocol for a randomised controlled trial.

BACKGROUND: Although many people with chronic low back pain (LBP) improve following conservative treatment, one in five will experience worsening symptoms after discharge from treatment and seek health care again. The current LBP clinical care pathway in many health services lacks a well-integrated, systematic approach to support patients to remain physically active and self-manage their symptoms following discharge from treatment. Health coaching can support people to improve physical activity levels and may potentially reduce health care utilisation for LBP. The primary aim of this study is to evaluate the effect of introducing a coordinated support system (linking hospital outpatient physiotherapy services to a public health coaching service) at discharge from LBP treatment, on the future use of hospital, medical, and health services for LBP, compared with usual care provided at discharge. METHODS: Three hundred and seventy-four adults with chronic non-specific LBP will be recruited from the outpatient physiotherapy departments of public hospitals in New South Wales, Australia. Participants will be individually randomised to a support system (n = 187) or usual care group (n = 187). All participants will receive usual care provided at discharge from treatment. Participants allocated to the support system will also receive up to 10 telephone-based health coaching sessions, delivered by the Get Healthy Service®, over a 6-month period. Health coaches will monitor and support participants to improve physical activity levels and achieve personal health-related goals. The primary outcome is the total number of encounters with hospital, medical, and health services for LBP, at 12 months from baseline. A within-trial economic evaluation will quantify the incremental costs and benefits of the support system from a health system perspective, to support reimbursement decision making. DISCUSSION: This study will establish the effect of a coordinated support system, introduced at discharge from treatment, on the future use of hospital, medical, and health services for LBP and various health outcomes. CONCLUSION: Innovative community-driven solutions to support people with chronic LBP after discharge from treatment are urgently needed. Study findings will help inform health care policy and clinical practice in Australia. TRIAL REGISTRATION: Prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12620000889954 ) on 10/09/2020.

TANGO: Development of Consumer Information Leaflets to Support TAperiNG of Opioids in Older Adults with Low Back Pain and Hip and Knee Osteoarthritis.

INTRODUCTION: Globally, the rate of opioid prescription is high for chronic musculoskeletal conditions despite guidelines recommending against their use as their adverse effects outweigh their modest benefit. Deprescribing opioids is a complex process that can be hindered by multiple prescriber- and patient-related barriers. These include fear of the process of, or outcomes from, weaning medications, or a lack of ongoing support. Thus, involving patients, their carers, and healthcare professionals (HCPs) in the development of consumer materials that can educate and provide support for patients and HCPs over the deprescribing process is critical to ensure that the resources have high readability, usability, and acceptability to the population of interest. OBJECTIVE: This study aimed to (1) develop two educational consumer leaflets to support opioid tapering in older people with low back pain (LBP) and hip or knee osteoarthritis (HoKOA), and (2) evaluate the perceived usability, acceptability, and credibility of the consumer leaflets from the perspective of consumers and HCPs. DESIGN: This was an observational survey involving a consumer review panel and an HCP review panel. PARTICIPANTS: 30 consumers (and/or their carers) and 20 HCPs were included in the study. Consumers were people older than 65 years of age who were currently experiencing LBP or HoKOA, and with no HCP background. Carers were people who provided unpaid care, support, or assistance to an individual meeting the inclusion criteria for consumers. HCPs included physiotherapists (n = 9), pharmacists (n = 7), an orthopaedic surgeon (n = 1), a rheumatologist (n = 1), nurse practitioner (n = 1) and a general practitioner (n = 1), all with at least three years of clinical experience and who reported working closely with this target patient population within the last 12 months. METHODS: Prototypes of two educational consumer leaflets (a brochure and a personal plan) were developed by a team of LBP, OA, and geriatric pharmacotherapy researchers and clinicians. The leaflet prototypes were evaluated by two separate chronological review panels involving (1) consumers and/or their carers, and (2) HCPs. Data collection for both panels occurred via an online survey. Outcomes were the perceived usability, acceptability, and credibility of the consumer leaflets. Feedback received from the consumer panel was used to refine the leaflets, before circulating the leaflets for further review by the HCP panel. Additional feedback from the HCP review panel was then used to refine the final versions of the consumer leaflets. RESULTS: Both consumers and HCPs perceived the leaflets and personal plan to be usable, acceptable, and credible. Consumers rated the brochure against several categories, which scored between 53 and 97% positive responses. Similarly, the overall feedback provided by HCPs was 85-100% positive. The modified System Usability Scale scores obtained from HCPs was 55-95% positive, indicating excellent usability. Feedback for the personal plan from both HCPs and consumers was largely positive, with consumers providing the highest positive ratings (80-93%). While feedback for HCPs was also high, we did identify that prescribers were hesitant to provide the plan to patients frequently (no positive responses). CONCLUSIONS: This study led to the development of a leaflet and personal plan to support the reduction of opioid use in older people with LBP or HoKOA. The development of the consumer leaflets incorporated feedback provided by HCPs and consumers to maximise clinical effectiveness and future intervention implementation.

Opioids are medications that are often used to treat severe or chronic pain. However, they can have serious adverse effects and are not usually recommended for long-term use. This study aimed to create educational materials for patients with chronic low back pain or hip or knee osteoarthritis who are taking opioids and to evaluate the materials' perceived usability, acceptability, and credibility from the perspective of both healthcare professionals (HCPs) and patients. The materials included a brochure and a personal plan and were developed by a team of researchers and clinicians. Both materials were evaluated by HCPs and patients in separate review panels. The brochure and personal plan were found to be usable, acceptable, and credible by both groups. The materials were created to support patients in reducing their opioid use and were refined based on feedback from both HCPs and patients. The materials may be useful in supporting the complex process of tapering off opioids, which can be hindered by various barriers related to both patients and HCPs.

The impact of aggregate positive lifestyle behaviors on low back pain resilience and care seeking.

BACKGROUND CONTEXT: Low back pain (LBP) is a global issue, and the high associated costs are mainly attributed to a small proportion of people with LBP who seek care. Importantly, the impact of aggregate positive lifestyle behaviors on LBP resilience and care seeking is not known. PURPOSE: This study aimed to evaluate the relationship between positive lifestyle behaviors and LBP resilience. STUDY DESIGN: This study was a prospective longitudinal cohort study. PATIENT SAMPLE: Data was collected as part of the AUstralian Twin BACK Study (AUTBACK). Participants who reported a lifetime previous history of LBP at baseline were included in this analysis (n = 340). OUTCOME MEASURES: The outcomes of interest were the number of weeks without activity limiting LBP and total number of days of healthcare usage, health practitioner care, self-management care, and medication intake. METHODS: A lifestyle behavior score was built using variables of body mass index (BMI), physical activity, smoking status, and sleep quality. Negative binomial regression analyses were used to assess the relationship between the positive lifestyle behavior score and the count outcomes of number of weeks without activity limiting LBP and number of days participants used care. RESULTS: After adjusting for covariates, no association was found between participants' positive lifestyle behavior score and their number of weeks without activity limiting LBP (IRR: 1.02, 95% CI 1.00-1.05). There was a statistically significant relationship between higher positive lifestyle behavior scores and fewer number of days of participants' total healthcare usage (IRR:0.69, 95% CI 0.56-0.84), healthcare practitioner visits (IRR:0.62, 95% CI 0.45-0.84), use of self-management strategies (IRR:0.74, 95% CI 0.60-0.91), and use of pain medication (IRR:0.55, 95% CI 0.44-0.68). CONCLUSION: People who adopt optimal lifestyle behaviors, such as engaging in adequate physical activity, achieving optimal quality sleep, maintaining an ideal BMI, and not smoking, may not experience less time suffering from activity limiting LBP, but are less likely to use healthcare and pain medication for their LBP.

Developing resilient clinical trials: Lessons learned from rolling out the Get Back to Healthy trial during a pandemic.

BACKGROUND: The COVID-19 pandemic has caused wide-spread disruptions to the conduct of randomised controlled trials (RCTs), particularly those involving public health services. Using the Get Back to Healthy trial as an example, this study aimed to contextualise the challenges imposed by the COVID-19 pandemic on implementation of RCTs involving public health services in Australia, summarise the effect of common and novel contingency strategies employed to mitigate these challenges, and describe key lessons learned. METHODS: The main challenges, the effect of contingency strategies employed, and key lessons learned were summarised descriptively. RESULTS: The main COVID-19-related challenge has been slow recruitment due to the suspension of clinical services for the trial target population. This challenge has been addressed through carefully considered adjustments to trial design (i.e., expanding the trial eligibility criteria), which has markedly improved trial recruitment rates. Other challenges have included the rapid transition to remote consent and data collection methods, increased complexity of monitoring participant safety, and future statistical challenges with disentangling the impact of the COVID-19 pandemic from treatment effects. The key lessons learned are: (i) adaptations to trial design may be necessary during a pandemic; (ii) offering remote methods may encourage trial participation from all age groups during a pandemic; (iii) enhanced monitoring of safety is critical during a pandemic; (iv) statistical challenges are likely to occur and should be considered when interpreting trial results. CONCLUSION: Key lessons learned may be useful for informing the conduct of resilient RCTs, particularly those involving public health services, in the present and future.