A Stratified Approach for Managing Patients With Low Back Pain in Primary Care (SPLIT Program): A Before-and-After Study.

PURPOSE: To determine the effects of stratified primary care for low back pain (SPLIT program) in decreasing back-related disability for patients with low back pain (LBP) in primary care. METHODS: We conducted a before-and-after study. We compared health-related outcomes for 2 sequential, independent cohorts of patients with LBP recruited at 7 primary care units in Portugal. The first prospective cohort study characterized usual care (UC) and collected data from February to September 2018. The second was performed when the SPLIT program was implemented and collected data from November 2018 to October 2021. Between cohorts, physical therapists were trained in the implementation of the SPLIT program, which used the STarT Back Screening Tool to categorize patients for matched treatment. We compared back-related disability (Roland-Morris Disability Questionnaire, 0-24 points), pain (Numeric Pain Rating Scale, 0-10 points), perceived effect of treatment (Global Perceived Effect Scale, -5 to +5 points), and health-related quality of life (EuroQoL 5 dimensions 3 levels index, 0-1 points). RESULTS: We enrolled a total of 447 patients: 115 in the UC cohort (mostly treated with pharmacologic treatment) and 332 in the SPLIT cohort (all referred for a physical therapy intervention program). Over the study period of 6 months, patients in the SPLIT program showed significantly greater improvements in back-related disability (ß, -2.94; 95% CI, -3.63 to -2.24; P ≤ .001), pain (ß, -0.88; 95% CI, -1.18 to -0.57; P ≤ .001), perceived effect of treatment (ß, 1.40; 95% CI, 0.97 to 1.82; P ≤ .001), and health-related quality of life (ß, 0.11; 95% CI, 0.08 to 0.14; P ≤ .001) compared with UC. CONCLUSIONS: Patients in the SPLIT program for LBP showed greater benefits regarding health-related outcomes than those receiving UC.

Comparison of health-care utilization, costs and health-related quality of life across the subgroups defined by the Keele STarT MSK Tool.

OBJECTIVES: The aim of this study was to describe and compare health economic outcomes [health-care utilization and costs, work outcomes, and health-related quality of life (EQ-5D-5L)] in patients classified into different levels-of-risk subgroups by the Keele STarT MSK Tool. METHODS: Data on health-care utilization, costs and EQ-5D-5L were collected from a health-care perspective within a primary care prospective observational cohort study. Patients presenting with one (or more) of the five most common musculoskeletal pain presentations were included: back, neck, shoulder, knee or multi-site pain. Participants at low, medium and high risk of persistent disabling pain were compared in relation to mean health-care utilization and costs, health-related quality of life, and employment status. Regression analysis was used to estimate costs. RESULTS: Over 6 months, the mean (s.d.) total health-care (National Health Service and private) costs associated with the low, medium, and high-risk subgroups were £132.92 (167.88), £279.32 (462.98) and £476.07 (716.44), respectively. Mean health-related quality of life over the 6-month period was lower and more people changed their employment status in the high-risk subgroup compared with the medium- and low-risk subgroups. CONCLUSIONS: This study demonstrates that subgroups of people with different levels of risk for poor musculoskeletal pain outcomes also have different levels of health-care utilization, health-care costs, health-related quality of life, and work outcomes. The findings show that the STarT MSK Tool not only identifies those at risk of a poorer outcome, but also those who will have more health-care visits and incur higher costs.

Physiotherapists' perspectives of barriers and facilitators to effective community provision after hip fracture: a qualitative study in England.

PURPOSE: to investigate physiotherapists' perspectives of effective community provision following hip fracture. METHODS: qualitative semi-structured interviews were conducted with 17 community physiotherapists across England. Thematic analysis drawing on the Theoretical Domains Framework identified barriers and facilitators to implementation of effective provision. Interviews were complemented by process mapping community provision in one London borough, to identify points of care where suggested interventions are in place and/or could be implemented. RESULTS: four themes were identified: ineffective coordination of care systems, ineffective patient stratification, insufficient staff recruitment and retention approaches and inhibitory fear avoidance behaviours. To enhance care coordination, participants suggested improving access to social services and occupational therapists, maximising multidisciplinary communication through online notation, extended physiotherapy roles, orthopaedic-specific roles and seven-day working. Participants advised the importance of stratifying patients on receipt of referrals, at assessment and into appropriately matched interventions. To mitigate insufficient staff recruitment and retention, participants proposed return-to-practice streams, apprenticeship schemes, university engagement, combined acute-community rotations and improving job description advertisements. To reduce effects of fear avoidance behaviour on rehabilitation, participants proposed the use of patient-specific goals, patient and carer education, staff education in psychological strategies or community psychologist access. Process mapping of one London borough identified points of care where suggested interventions to overcome barriers were in place and/or could be implemented. CONCLUSION: physiotherapists propose that effective provision of community physiotherapy following hip fracture could be improved by refining care coordination, utilising stratification techniques, employing enhanced recruitment and retainment strategies and addressing fear avoidance behaviours.

A multidimensional approach for differentiating the clinical needs of young people presenting for primary mental health care.

OBJECTIVES: There is an ongoing necessity to match clinical interventions with the multidimensional needs of young people. A key step toward better service planning and the design of optimal models of care is to use multidimensional assessment to understand the clinical needs of those presenting to primary mental health care. METHODS: 1284 people aged 12-25 years presenting to primary youth mental health services completed an online assessment at service entry. Latent class analysis was conducted for seven scales assessing anxiety, depression, psychosis, mania, functioning (indexed by Work and Social Adjustment Scale), and suicidality. RESULTS: A three-class solution was identified as the optimal solution. Class 1 (n = 305, 23.75%), an early illness stage group, had low and mixed symptomatology with limited functional impairment, class 2 (n = 353, 27.49%) was made up of older persons with established depression and functional impairment, and class 3 (n = 626, 48.75%) had very high and complex needs, with functional impairment, suicidality, and at-risk mental states (psychosis or mania). Additional differentiating characteristics included psychological distress, circadian disturbances, social support, mental health history, eating disorder behaviours, and symptoms of post-traumatic stress disorder. CONCLUSIONS: A large proportion of help-seeking young people present with symptoms and functional impairment that may exceed the levels of care available from basic primary care or brief intervention services. These subgroups highlight the importance of multidimensional assessments to determine appropriate service pathways and care options.

Development and feasibility of stratified primary care physiotherapy integrated with eHealth in patients with neck and/or shoulder complaints: results of a mixed methods study.

BACKGROUND: Providing individualized care based on the context and preferences of the patient is important. Knowledge on both prognostic risk stratification and blended eHealth care in musculoskeletal conditions is increasing and seems promising. Stratification can be used to match patients to the most optimal content and intensity of treatment as well as mode of treatment delivery (i.e. face-to-face or blended with eHealth). However, research on the integration of stratified and blended eHealth care with corresponding matched treatment options for patients with neck and/or shoulder complaints is lacking. METHODS: This study was a mixed methods study comprising the development of matched treatment options, followed by an evaluation of the feasibility of the developed Stratified Blended Physiotherapy approach. In the first phase, three focus groups with physiotherapists and physiotherapy experts were conducted. The second phase investigated the feasibility (i.e. satisfaction, usability and experiences) of the Stratified Blended Physiotherapy approach for both physiotherapists and patients in a multicenter single-arm convergent parallel mixed methods feasibility study. RESULTS: In the first phase, matched treatment options were developed for six patient subgroups. Recommendations for content and intensity of physiotherapy were matched to the patient's risk of persistent disabling pain (using the Keele STarT MSK Tool: low/medium/high risk). In addition, selection of mode of treatment delivery was matched to the patient's suitability for blended care (using the Dutch Blended Physiotherapy Checklist: yes/no). A paper-based workbook and e-Exercise app modules were developed as two different mode of treatment delivery options, to support physiotherapists. Feasibility was evaluated in the second phase. Physiotherapists and patients were mildly satisfied with the new approach. Usability of the physiotherapist dashboard to set up the e-Exercise app was considered 'OK' by physiotherapists. Patients considered the e-Exercise app to be of 'best imaginable' usability. The paper-based workbook was not used. CONCLUSION: Results of the focus groups led to the development of matched treatment options. Results of the feasibility study showed experiences with integrating stratified and blended eHealth care and have informed amendments to the Stratified Blended Physiotherapy approach for patients with neck and/or shoulder complaints ready to use within a future cluster randomized trial.

Evaluation of a blended learning approach on stratified care for physiotherapy bachelor students.

BACKGROUND: Stratified models of care are valuable for addressing psychosocial factors which influence the outcome of patients with musculoskeletal disorders. Introducing such models in undergraduate training has the potential to propagate this knowledge with evidence and foster its implementation. The objective of this paper is to explore the perception and changes in the fear-avoidance beliefs of physiotherapy students participating in a developed blended learning course on stratified care. METHODOLOGY: A mixed-methods with a convenient sample of two consecutive cohorts were given a blended learning course on stratified care for patients with low back pain. The blended learning course comprised scientific rudiments and application of stratified care in clinical practice conceptualised using the KERN' 6-step approach. The exam scores, perceptions, performance on self-reflection-tests and pre- and post-scores on The Tampa Scale for Kinesiophobia for Physiotherapists' (TSK-PT) were obtained. After gaining clinical experience, participants were invited to discuss their clinical experiences and perceptions in workshops. The quantitative data was analysed explorative-descriptively. The qualitative data was analysed following an inductive coding system with constant comparisons. RESULTS: Ninety-one participants consented to the evaluation (mean age = 22.9 ± 1.6 years), 66% were female. Exam scores correlated with time spent in training (r = 0.30) and scores on self-reflection-tests 1 and 2 (r = 0.40 and r = 0.41). Participants in both cohorts described the learning resources as promoting their interest in the subject (72% and 94%), up-to-date (91% and 93%) and helpful (91% and 97%). The fear-avoidance scores for participants decreased from 53.5 (± 9.96) to 40.1 (± 12.4) with a large effect size (d = 1.18). The regression model [F (2, 49) = 1151.2, p < 0.001] suggests that pre-TSK-PT and the interest of participants in the training predicted post-TSK-PT. The workshop participants (n = 62) all worked in clinical practice. Emerging from the analysis were 4 categories (evolving to maturity in practice, perceiving determinants of stratified care, strategising for implementation and adopting an outlook for future practice). CONCLUSION: The quality of engagement in learning, training strategy and interest in the subject contributes immensely to learning outcomes. This blended learning course was successful in reducing kinesiophobia and influencing the participants' attitude towards care with the potential of being translated into long-term practice.

New horizons in evidence-based care for older people: individual participant data meta-analysis.

Evidence-based decisions on clinical and cost-effectiveness of interventions are ideally informed by meta-analyses of intervention trial data. However, when undertaken, such meta-analyses in ageing research have typically been conducted using standard methods whereby summary (aggregate) data are extracted from published trial reports. Although meta-analysis of aggregate data can provide useful insights into the average effect of interventions within a selected trial population, it has limitations regarding robust conclusions on which subgroups of people stand to gain the greatest benefit from an intervention or are at risk of experiencing harm. Future evidence synthesis using individual participant data from ageing research trials for meta-analysis could transform understanding of the effectiveness of interventions for older people, supporting evidence-based and sustainable commissioning. A major advantage of individual participant data meta-analysis (IPDMA) is that it enables examination of characteristics that predict treatment effects, such as frailty, disability, cognitive impairment, ethnicity, gender and other wider determinants of health. Key challenges of IPDMA relate to the complexity and resources needed for obtaining, managing and preparing datasets, requiring a meticulous approach involving experienced researchers, frequently with expertise in designing and analysing clinical trials. In anticipation of future IPDMA work in ageing research, we are establishing an international Ageing Research Trialists collective, to bring together trialists with a common focus on transforming care for older people as a shared ambition across nations.

Prospective observational study investigating the predictive validity of the STarT Back tool and the clinical effectiveness of stratified care in an emergency department setting.

PURPOSE: To determine the predictive validity of the STarT Back tool (SBT) undertaken at baseline and 6 weeks to classify Emergency Department (ED) patients with LBP into groups at low, medium or high risk of persistent disability at 3 months. A secondary aim was to evaluate the clinical effectiveness of pragmatic risk-matched treatment in an ED cohort at 3 months. METHODS: A prospective observational multi-centre study took place in the physiotherapy services linked to the ED in four teaching hospitals in Dublin, Ireland. Patients were stratified into low, medium and high-risk groups at their baseline assessment. Participants received stratified care, where the content of their treatment was matched to their risk profile. Outcomes completed at baseline and 3 months included pain and disability. Linear regression analyses assessed if baseline or 6-week SBT score were predictive of disability at 3 months. Changes in the primary outcome of disability were dichotomised into those who achieved/ did not achieve a 30% improvement in their RMDQ at 6 weeks and 3 months. RESULTS: The study enrolled 118 patients with a primary complaint of LBP ± leg pain with 67 (56.7%) completing their 6-week and 3-month follow-up. Baseline RMDQ and being in medium or high risk SBT group at 6 weeks were predictive of persistent disability at 3 months. A total of 54 (80.6%) participants reported a > 30% improvement at 3 months. CONCLUSION: Disability at baseline and SBT administered at 6 weeks more accurately predicted disability at 3 months than SBT at baseline in an ED population.

Patients' and clinicians' experiences with stratified exercise therapy in knee osteoarthritis: a qualitative study.

BACKGROUND: We have developed a model of stratified exercise therapy that distinguishes three knee osteoarthritis (OA) subgroups ('high muscle strength subgroup', 'low muscle strength subgroup', 'obesity subgroup'), which are provided subgroup-specific exercise therapy (supplemented by a dietary intervention for the 'obesity subgroup'). In a large clinical trial, this intervention was found to be no more effective than usual exercise therapy. The present qualitative study aimed to explore experiences from users of this intervention, in order to identify possible improvements. METHODS: Qualitative research design embedded within a cluster randomized controlled trial in a primary care setting. A random sample from the experimental arm (i.e., 15 patients, 11 physiotherapists and 5 dieticians) was interviewed on their experiences with receiving or applying the intervention. Qualitative data from these semi-structured interviews were thematically analysed. RESULTS: We identified four themes: one theme regarding the positive experiences with the intervention and three themes regarding perceived barriers. Although users from all 3 perspectives (patients, physiotherapists and dieticians) generally perceived the intervention as having added value, we also identified several barriers, especially for the 'obesity subgroup'. In this 'obesity subgroup', physiotherapists perceived obesity as difficult to address, dieticians reported that more consultations are needed to reach sustainable weight loss and both physiotherapists and dieticians reported a lack of interprofessional collaboration. In the 'high muscle strength subgroup', the low number of supervised sessions was perceived as a barrier by some patients and physiotherapists, but as a facilitator by others. A final theme addressed barriers to knee OA treatment in general, with lack of motivation as the most prominent of these. CONCLUSION: Our qualitative study revealed a number of barriers to effective application of the stratified exercise therapy, especially for the 'obesity subgroup'. Based on these barriers, the intervention and its implementation could possibly be improved. Moreover, these barriers are likely to account at least partly for the lack of superiority over usual exercise therapy. TRIAL REGISTRATION: The Netherlands National Trial Register (NTR): NL7463 (date of registration: 8 January 2019).

Multipronged Programmatic Strategy for Preventing Secondary Fracture and Facilitating Functional Recovery in Older Patients after Hip Fractures: Our Experience in Taipei Municipal Wanfang Hospital.

Background and Objectives: The study assessed the effectiveness of a fracture liaison service (FLS) after 1 year of implementation in improving the outcomes of hip fracture surgery in older adult patients at Taipei Municipal Wanfang Hospital. Materials and Methods: The Wanfang hospital's FLS program was implemented using a multipronged programmatic strategy. The aims were to encourage the screening and treatment of osteoporosis and sarcopenia, to take a stratified care approach for patients with a high risk of poor postoperative outcomes, and to offer home visits for the assessment of environmental hazards of falling, and to improve the patient's adherence to osteoporosis treatment. The clinical data of 117 and 110 patients before and after FLS commencement, respectively, were collected from a local hip fracture registry; the data were analyzed to determine the outcomes 1 year after hip fracture surgery in terms of refracture, mortality, and activities of daily living. Results: The implementation of our FLS significantly increased the osteoporosis treatment rate after hip fracture surgery from 22.8% to 72.3%, significantly decreased the 1-year refracture rate from 11.8% to 4.9%, non-significantly decreased 1-year mortality from 17.9% to 11.8%, and improved functional outcomes 1 year after hip fracture surgery. Conclusions: Implementation of our FLS using the multipronged programmatic strategy effectively improved the outcomes and care quality after hip fracture surgery in the older adult population, offering a successful example as a valuable reference for establishing FLS to improve the outcomes in vulnerable older adults.

Predicting potential palliative care beneficiaries for health plans: A generalized machine learning pipeline.

Recognizing that palliative care improves the care quality and reduces the healthcare costs for individuals in their end of life, health plan providers strive to better enroll the appropriate target population for palliative care. Current research has not adequately addressed challenges related to proactively select potential palliative care beneficiaries from a population health perspective. This study presents a Generalized Machine Learning Pipeline (GMLP) to predict palliative needs in patients using administrative claims data. The GMLP has five steps: data cohort creation, feature engineering, predictive modeling, scoring beneficiaries, and model maintenance. It encapsulates principles of population health management, business domain knowledge, and machine learning (ML) process knowledge with an innovative data pull strategy. The GMLP was applied in a regional health plan using a data cohort of 17,197 patients. Multiple ML models were turned and evaluated against a custom performance metric based on the business requirement. The best model was an AdaBoost model with a precision of 71.43% and a recall of 67.98%. The post-implementation evaluation of the GMLP showed that it increased the recall of high mortality risk patients, improved their quality of life, and reduced the overall cost. The GMLP is a novel approach that can be applied agnostically to the data and specific ML algorithms. To the best of our knowledge, it is the first attempt to continuously score palliative care beneficiaries using administrative data. The GMLP and its use case example presented in the paper can serve as a methodological guide for different health plans and healthcare policymakers to apply ML in solving real-world clinical challenges, such as palliative care management and other similar risk-stratified care management workflows.

Integrating clinician support with intervention design as part of a programme testing stratified care for musculoskeletal pain in general practice.

BACKGROUND: Stratified care involves subgrouping patients based on key characteristics, e.g. prognostic risk, and matching these subgroups to early treatment options. The STarT-MSK programme developed and tested a new stratified primary care intervention for patients with common musculoskeletal (MSK) conditions in general practice. Stratified care involves changing General Practitioners' (GPs) behaviour, away from the current 'stepped' care approach to identifying early treatment options matched to patients' risk of persistent pain. Changing healthcare practice is challenging, and to aid the successful delivery of stratified care, education and support for GPs was required. This paper details the iterative development of a clinician support package throughout the lifespan of the programme, to support GPs in delivering the stratified care intervention. We argue that clinician support is a crucial aspect of the intervention itself, which is often overlooked. METHODS: Qualitative research with patients and GPs identified barriers and facilitators to the adoption of stratified care, which were mapped onto the Theoretical Domains Framework (TDF). Identified domains were 'translated' into an educational paradigm, and an initial version of the support package developed. This was further refined following a feasibility and pilot RCT, and a finalised support package was developed for the main RCT. RESULTS: The clinician support package comprised face-to-face sessions combining adult-learning principles with behaviour change theory in a multimethod approach, which included group discussion, simulated consultations, patient vignettes and model consultation videos. Structured support for GPs was crucial to facilitate fidelity and, ultimately, a successful trial. Clinician support is a two-way process- the study team can learn from and adapt to specific local factors and issues not previously identified. The support from senior clinicians was required to ensure 'buy in'. Monitoring of GP performance, provision of regular feedback and remedial support are important aspects of effective clinician support. CONCLUSION: Designing effective clinician support from the onset of trial intervention design, in an evidence-based, theory-informed manner, is crucial to encourage active engagement and intervention fidelity within the trial, enabling the delivery of a robust and reliable proof-of-principle trial. We offer practical recommendations for future general practice interventions.

Stratified care integrated with eHealth versus usual primary care physiotherapy in patients with neck and/or shoulder complaints: protocol for a cluster randomized controlled trial.

BACKGROUND: Neck and shoulder complaints are common in primary care physiotherapy. These patients experience pain and disability, resulting in high societal costs due to, for example, healthcare use and work absence. Content and intensity of physiotherapy care can be matched to a patient's risk of persistent disabling pain. Mode of care delivery can be matched to the patient's suitability for blended care (integrating eHealth with physiotherapy sessions). It is hypothesized that combining these two approaches to stratified care (referred to from this point as Stratified Blended Approach) will improve the effectiveness and cost-effectiveness of physiotherapy for patients with neck and/or shoulder complaints compared to usual physiotherapy. METHODS: This paper presents the protocol of a multicenter, pragmatic, two-arm, parallel-group, cluster randomized controlled trial. A total of 92 physiotherapists will be recruited from Dutch primary care physiotherapy practices. Physiotherapy practices will be randomized to the Stratified Blended Approach arm or usual physiotherapy arm by a computer-generated random sequence table using SPSS (1:1 allocation). Number of physiotherapists (1 or > 1) will be used as a stratification variable. A total of 238 adults consulting with neck and/or shoulder complaints will be recruited to the trial by the physiotherapy practices. In the Stratified Blended Approach arm, physiotherapists will match I) the content and intensity of physiotherapy care to the patient's risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool) and II) the mode of care delivery to the patient's suitability and willingness to receive blended care. The control arm will receive physiotherapy as usual. Neither physiotherapists nor patients in the control arm will be informed about the Stratified Blended Approach arm. The primary outcome is region-specific pain and disability (combined score of Shoulder Pain and Disability Index & Neck Pain and Disability Scale) over 9 months. Effectiveness will be compared using linear mixed models. An economic evaluation will be performed from the societal and healthcare perspective. DISCUSSION: The trial will be the first to provide evidence on the effectiveness and cost-effectiveness of the Stratified Blended Approach compared with usual physiotherapy in patients with neck and/or shoulder complaints. TRIAL REGISTRATION: Netherlands Trial Register: NL8249 . Officially registered since 27 December 2019. Date of first enrollment: 30 September 2020. Study status: ongoing, data collection.

Stratified primary care versus non-stratified care for musculoskeletal pain: findings from the STarT MSK feasibility and pilot cluster randomized controlled trial.

BACKGROUND: Musculoskeletal (MSK) pain from the five most common presentations to primary care (back, neck, shoulder, knee or multi-site pain), where the majority of patients are managed, is a costly global health challenge. At present, first-line decision-making is based on clinical reasoning and stratified models of care have only been tested in patients with low back pain. We therefore, examined the feasibility of; a) a future definitive cluster randomised controlled trial (RCT), and b) General Practitioners (GPs) providing stratified care at the point-of-consultation for these five most common MSK pain presentations. METHODS: The design was a pragmatic pilot, two parallel-arm (stratified versus non-stratified care), cluster RCT and the setting was 8 UK GP practices (4 intervention, 4 control) with randomisation (stratified by practice size) and blinding of trial statistician and outcome data-collectors. Participants were adult consulters with MSK pain without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records were tagged and individuals sent postal invitations using a GP point-of-consultation electronic medical record (EMR) template. The intervention was supported by the EMR template housing the Keele STarT MSK Tool (to stratify into low, medium and high-risk prognostic subgroups of persistent pain and disability) and recommended matched treatment options. Feasibility outcomes included exploration of recruitment and follow-up rates, selection bias, and GP intervention fidelity. To capture recommended outcomes including pain and function, participants completed an initial questionnaire, brief monthly questionnaire (postal or SMS), and 6-month follow-up questionnaire. An anonymised EMR audit described GP decision-making. RESULTS: GPs screened 3063 patients (intervention = 1591, control = 1472), completed the EMR template with 1237 eligible patients (intervention = 513, control = 724) and 524 participants (42%) consented to data collection (intervention = 231, control = 293). Recruitment took 28 weeks (target 12 weeks) with > 90% follow-up retention (target > 75%). We detected no selection bias of concern and no harms identified. GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved "complete success". CONCLUSIONS: A future definitive cluster RCT of stratified care for MSK pain is feasible and is underway, following key amendments including a clinician-completed version of the stratification tool and refinements to recommended matched treatments. TRIAL REGISTRATION: Name of the registry: ISRCTN. TRIAL REGISTRATION NUMBER: 15366334. Date of registration: 06/04/2016.

Stratified primary care versus non-stratified care for musculoskeletal pain: qualitative findings from the STarT MSK feasibility and pilot cluster randomized controlled trial.

BACKGROUND: Stratified care involves subgrouping patients based on key characteristics, e.g. prognostic risk, and matching these subgroups to appropriate early treatment options. The STarT MSK feasibility and pilot cluster randomised controlled trial (RCT) examined the feasibility of a future main trial and of delivering prognostic stratified primary care for patients with musculoskeletal pain. The pilot RCT was conducted in 8 UK general practices (4 stratified care; 4 usual care) with 524 patients. GPs in stratified care practices were asked to use i) the Keele STarT MSK development tool for risk-stratification and ii) matched treatment options for patients at low-, medium- and high-risk of persistent pain. This paper reports on a nested qualitative study exploring the feasibility of delivering stratified care ahead of the main trial. METHODS: 'Stimulated-recall' interviews were conducted with patients and GPs in the stratified care arm (n = 10 patients; 10 GPs), prompted by consultation recordings. Data were analysed thematically and mapped onto the COM-B behaviour change model; exploring the Capability, Opportunity and Motivation GPs and patients had to engage with stratified care. RESULTS: Patients reported positive views that stratified care enabled a more 'structured' consultation, and felt tool items were useful in making GPs aware of patients' worries and concerns. However, the closed nature of the tool's items was seen as a barrier to opening up discussion. GPs identified difficulties integrating the tool within consultations (Opportunity), but found this easier as it became more familiar. Whilst both groups felt the tool had added value, they identified 'cumbersome' items which made it more difficult to use (Capability). Most GPs reported that the matched treatment options aided their clinical decision-making (Motivation), but identified some options that were not available to them (e.g. pain management clinics), and other options that were not included in the matched treatments but which were felt appropriate for some patients (e.g. consider imaging). CONCLUSION: This nested qualitative study, using the COM-B model, identified amendments required for the main trial including changes to the Keele STarT MSK tool and matched treatment options, targeting the COM-B model constructs, and these have been implemented in the current main trial. TRIAL REGISTRATION: ISRCTN 15366334.

Patients' and clinicians' perspectives on a 'fast-track' pathway for patients with sciatica in primary care: qualitative findings from the SCOPiC stratified care trial.

BACKGROUND: Sciatica is common and associated with significant impacts for the individual and society. The SCOPiC randomised controlled trial (RCT) (trial registration: ISRCTN75449581 ) tested stratified primary care for sciatica by subgrouping patients into one of three groups based on prognostic and clinical indicators. Patients in one group were 'fast-tracked' for a magnetic resonance imaging (MRI) scan and spinal specialist opinion. This paper reports qualitative research exploring patients' and clinicians' perspectives on the acceptability of this 'fast-track' pathway. METHODS: Semi-structured interviews were conducted with 20 patients and 20 clinicians (general practitioners, spinal specialist physiotherapists, spinal surgeons). Data were analysed thematically and findings explored using Normalisation Process Theory (NPT) and 'boundary objects' concept. RESULTS: Whilst the 'fast-track' pathway achieved a degree of 'coherence' (i.e. made sense) to both patients and clinicians, particularly in relation to providing early reassurance based on MRI scan findings, it was less 'meaningful' to some clinicians for managing patients with acute symptoms, reflecting a reluctance to move away from the usual 'stepped care' approach. Both groups felt a key limitation of the pathway was that it did not shorten patient waiting times between their spinal specialist consultation and further treatments. CONCLUSION: Findings contribute new knowledge about patients' and clinicians' perspectives on the role of imaging and spinal specialist opinion in the management of sciatica, and provide important insights for understanding the 'fast-track' pathway, as part of the stratified care model tested in the RCT. Future research into the early referral of patients with sciatica for investigation and specialist opinion should include strategies to support clinician behaviour change; as well as take into account the role of imaging in providing reassurance to patients with severe symptoms in cases where imaging reveals a clear explanation for the patient's pain, and where this is accompanied by a thorough explanation from a trusted clinical expert.

Implementing stratified care for acute low back pain in primary care using the STarT Back instrument: a process evaluation within the context of a large pragmatic cluster randomized trial.

BACKGROUND: Although risk-stratifying patients with acute lower back pain is a promising approach for improving long-term outcomes, efforts to implement stratified care in the US healthcare system have had limited success. The objectives of this process evaluation were to 1) examine variation in two essential processes, risk stratification of patients with low back pain and referral of high-risk patients to psychologically informed physical therapy and 2) identify barriers and facilitators related to the risk stratification and referral processes. METHODS: We used a sequential mixed methods study design to evaluate implementation of stratified care at 33 primary care clinics (17 intervention, 16 control) participating in a larger pragmatic trial. We used electronic health record data to calculate: 1) clinic-level risk stratification rates (proportion of patients with back pain seen in the clinic over the study period who completed risk stratification questionnaires), 2) rates of risk stratification across different points in the clinical workflow (front desk, rooming, and time with clinician), and 3) rates of referral of high-risk patients to psychologically informed physical therapy among intervention clinics. We purposively sampled 13 clinics for onsite observations, which occurred in month 24 of the 26-month study. RESULTS: The overall risk stratification rate across the 33 clinics was 37.8% (range: 14.7-64.7%). Rates were highest when patients were identified as having back pain by front desk staff (overall: 91.9%, range: 80.6-100%). Rates decreased as the patient moved further into the visit (rooming, 29.3% [range: 0-83.3%]; and time with clinician, 11.3% [range: 0-49.3%]. The overall rate of referrals of high-risk patients to psychologically informed physical therapy across the 17 intervention clinics was 42.1% (range: 8.3-70.8%). Barriers included staffs' knowledge and beliefs about the intervention, patients' needs, technology issues, lack of physician engagement, and lack of time. Adaptability of the processes was a facilitator. CONCLUSIONS: Adherence to key stratified care processes varied across primary care clinics and across points in the workflow. The observed variation suggests room for improvement. Future research is needed to build on this work and more rigorously test strategies for implementing stratified care for patients with low back pain in the US healthcare system. TRIAL REGISTRATION: Trial registration: ClinicalTrials.gov ( NCT02647658 ). Registered January 6, 2016.

The Traffic Light of Headache: Simplifying Acute Migraine Management for Physicians and Patients Using the Canadian Headache Society Guidelines.

Migraine is a disabling neurological condition and it is well described that early treatment is more effective and less likely to lead to headache recurrence. While it would seem intuitive for a migraine sufferer to treat early, despite well-established guidelines by the Canadian Headache Society, many sufferers continue to treat late. As a result, acute therapy is less effective, resulting in higher associated disability and a longer lasting attack. Pain scales can help patients determine how to treat; however, we propose a simple, easily recalled traffic light system to help patients determine which drug to use based upon how they feel. The traffic light system is based on the associated disability of the migraine attack, with green being a "I can still go" headache, a yellow being a "I have to slow down" headache, and a red being a "I have to stop" headache. The traffic light system leads to earlier more effective treatment with a reduction in migraine-associated disability.

Adaptation and Implementation of the STarT Back Risk Stratification Strategy in a US Health Care Organization: A Process Evaluation.

OBJECTIVE: To support implementation of effective treatments for back pain that can be delivered to a range of people, we summarize learnings from our process evaluation of the MATCH trial's implementation of an adaptation of the STarT Back risk-stratified care model. DESIGN: Our logic model-driven evaluation focused primarily on qualitative data sources. SETTING: This study took place in a US-based health care delivery system that had adapted and implemented the STarT Back stratified care approach. This was the first formal test of the strategy in a US setting. METHODS: Data collection included observation of implementation activities, staff/provider interviews, and post-training evaluation questionnaires. Data were analyzed using thematic analysis of qualitative data and descriptive statistics for questionnaire data. RESULTS: We found that both primary care teams and physical therapists at intervention clinics gave the training high scores on evaluation questionnaires and reported in the interviews that they found the training engaging and useful. However, there was significant variation in the extent to which the risk stratification strategy was incorporated into care. Some primary care providers reported that the intervention changed their conversations with patients and increased their confidence in working with patients with back pain. Providers using the STarT Back tool did not change referral rates for recommended matched treatments. CONCLUSIONS: These insights provide guidance for future efforts to adapt and implement the STarT Back strategy and other complex practice change interventions. They emphasize the need for primary care-based interventions to minimize complexity and the need for ongoing monitoring and feedback.

Study protocol for a controlled trial of an eHealth system utilising patient reported outcome measures for personalised treatment and care: PROMPT-Care 2.0.

BACKGROUND: Routine assessment and clinical utilisation of patient-reported outcome (PRO) measures can lead to improved patient outcomes. The PROMPT-Care eHealth system facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions, patient self-management, and shared care. Pilot testing demonstrated acceptability and feasibility of PROMPT-Care Version 1.0. This study aims to implement PROMPT-Care Version 2.0 and determine its efficacy in reducing emergency department (ED) presentations, and improving chemotherapy delivery and health service referrals, compared to usual care. METHODS: Groups eligible to participate in the intervention arm of this controlled trial are patients receiving cancer care (including follow-up). PROMPT-Care patients will complete monthly assessments (distress, symptoms, unmet needs) until voluntary withdrawal or death. In Version 1.0, the care team accessed patients' clinical feedback reports in 'real time' to guide their care, and patients received links to support their self-management, tailored to their PRO responses. Version 2.0 was extended to include: i) an additional alert system notifying the care team of ongoing unresolved clinical issues, ii) patient self-management resources, and iii) an auto-populated Treatment Summary and Survivorship Care Plan (SCP). The control population will be patients extracted from hospital databases of the general cancer patient population who were seen at the participating cancer therapy centres during the study period, with a ratio of 1:4 of intervention to control patients. A minimum sample size of 1760 (352 intervention and 1408 control) patients will detect a 14% reduction in the number of ED presentations (primary outcome) in the PROMPT-Care group compared with the control group. Intervention patients will provide feedback on system usability and value of the self-management materials; oncology staff will provide feedback on usefulness of PROMPT-Care reports, response to clinical alerts, impact on routine care, and usefulness of the SCPs; and GPs will provide feedback on the usefulness of the SCPs and attitudes towards shared-care models of survivorship care planning. DISCUSSION: This study will inform the PROMPT-Care system's impact on healthcare utilisation and utility as an alternative model for ongoing supportive care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12616000615482 ) on 12th May 2016 ( www.anzctr.org.au ).