Effectiveness and Cost-Effectiveness of a Stratified Blended Physiotherapy Intervention Compared With Face-to-Face Physiotherapy in Patients With Nonspecific Low Back Pain: Cluster Randomized Controlled Trial.

BACKGROUND: Nonspecific low back pain (LBP) is a leading contributor to disability worldwide, and its socioeconomic burden is substantial. Self-management support is an important recommendation in clinical guidelines for the physiotherapy treatment of patients with LBP and may support cost-effective management. However, providing adequate individually tailored self-management support is difficult. The integration of web-based applications into face-to-face care (ie, blended care) seems promising to optimize tailored treatment and enhance patients' self-management and, consequently, may reduce LBP-related costs. OBJECTIVE: We aimed to evaluate the long-term effectiveness and cost-effectiveness of stratified blended physiotherapy (e-Exercise LBP) compared with face-to-face physiotherapy in patients with nonspecific LBP. METHODS: An economic evaluation was conducted alongside a prospective, multicenter, cluster randomized controlled trial in primary care physiotherapy. Patients with nonspecific LBP were treated with either stratified blended physiotherapy (e-Exercise LBP) (n=104) or face-to-face physiotherapy (n=104). The content of both interventions was based on the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients' risk of developing persistent LBP using the STarT Back Screening Tool. The primary clinical outcome was physical functioning (Oswestry Disability Index version 2.1a). For the economic evaluation, quality-adjusted life years (QALYs; EQ-5D-5L) and physical functioning were the primary outcomes. Secondary clinical outcomes included fear avoidance beliefs and self-reported adherence. Costs were measured from societal and health care perspectives using self-report questionnaires. Effectiveness was estimated using linear mixed models. Seemingly unrelated regression analyses were conducted to estimate total cost and effect differences for the economic evaluation. RESULTS: Neither clinically relevant nor statistically substantial differences were found between stratified blended physiotherapy and face-to-face physiotherapy regarding physical functioning (mean difference [MD] -1.1, 95% CI -3.9 to 1.7) and QALYs (MD 0.026, 95% CI -0.020 to 0.072) over 12 months. Regarding the secondary outcomes, fear avoidance beliefs showed a statistically significant improvement in favor of stratified blended physiotherapy (MD -4.3, 95% CI -7.3 to -1.3). Societal and health care costs were higher for stratified blended physiotherapy than for face-to-face physiotherapy, but the differences were not statistically significant (societal: €972 [US $1027], 95% CI -€1090 to €3264 [US -$1151 to $3448]; health care: €73 [US $77], 95% CI -€59 to €225 [US -$62 to $238]). Among the disaggregated cost categories, only unpaid productivity costs were significantly higher for stratified blended physiotherapy. From both perspectives, a considerable amount of money must be paid per additional QALY or 1-point improvement in physical functioning to reach a relatively low to moderate probability (ie, 0.23-0.81) of stratified blended physiotherapy being cost-effective compared with face-to-face physiotherapy. CONCLUSIONS: The stratified blended physiotherapy intervention e-Exercise LBP is neither more effective for improving physical functioning nor more cost-effective from societal or health care perspectives compared with face-to-face physiotherapy for patients with nonspecific LBP. TRIAL REGISTRATION: ISRCTN 94074203; https://www.isrctn.com/ISRCTN94074203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12891-020-3174-z.

The relations between business model efficiency and novelty, and outcome while accounting for managed competition contract: a quantitative study among Dutch physiotherapy primary healthcare organisations.

BACKGROUND: Since 2006, business principles have been introduced to foster efficient healthcare by way of managed competition. Managed competition is expressed by a contract between a health insurer and a physiotherapy primary healthcare organisation (PTPHO). In such a managed environment, PTPHOs have to attain treatment service quality and financial PTPHO-centred outcomes Research shows that business model designs may enhance organisation-centred outcomes. A business model is a design (efficiency or novelty) of how a firm transacts with customers, partners, and vendors; how it connects with markets. However, research on managed competition contract and business model designs, in relation to PTPHO-centred outcomes is new to the healthcare literature. PTPHOs may not know how business model designs enhance outcomes. This study aims to delineate the relations between business model efficiency and novelty, and PTPHO-centred outcomes, while accounting for managed competition contract in Dutch healthcare. METHODS: A quantitative cross-sectional design was adopted. Using a questionnaire, the relations between managed competition, business model efficiency and novelty, and PTPHO-centred outcomes were investigated among PTPHO managers (n = 138). Theory-based expectations were set up and multiple linear regression analyses were applied. RESULTS: Managed competition and business model efficiency show no relation with PTPHO-centred outcomes. Moderation of the business model efficiency and PTPHO-centred outcomes relation by managed competition contract is not detected. Business model novelty shows a positive relation with PTPHO-centred outcomes. Moderation of the business model novelty and PTPHO-centred outcomes relation by managed competition contract is found. CONCLUSIONS: There seem to be positive relations between business model novelty and PTPHO-centred outcomes on its own and moderated by managed competition contract. No relations seem to exist with business model efficiency. This implies that the combination of persistent use of health insurer-driven managed competition contracts and a naturally efficient PTPHOs may have left too few means for these organisations to contribute to healthcare reforms and attain PTPHO-centred outcomes. Organisation-driven innovation could stretch system-level regulations and provide room for new business models. Optimising contracts towards organisation-driven healthcare reform, including novelty requirements and corresponding reimbursements is suggested. PTPHO managers may want to shift their attitudes towards novel business models.

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.

A Health Care Value Framework for Physical Therapy Primary Health Care Organizations.

BACKGROUND AND OBJECTIVE: To develop a health care value framework for physical therapy primary health care organizations including a definition. METHOD: A scoping review was performed. First, relevant studies were identified in 4 databases (n = 74). Independent reviewers selected eligible studies. Numerical and thematic analyses were performed to draft a preliminary framework including a definition. Next, the feasibility of the framework and definition was explored by physical therapy primary health care organization experts. RESULTS: Numerical and thematic data on health care quality and context-specific performance resulted in a health care value framework for physical therapy primary health care organizations-including a definition of health care value, namely "to continuously attain physical therapy primary health care organization-centered outcomes in coherence with patient- and stakeholder-centered outcomes, leveraged by an organization's capacity for change." CONCLUSION: Prior literature mainly discussed health care quality and context-specific performance for primary health care organizations separately. The current study met the need for a value-based framework, feasible for physical therapy primary health care organizations, which are for a large part micro or small. It also solves the omissions of incoherent literature and existing frameworks on continuous health care quality and context-specific performance. Future research is recommended on longitudinal exploration of the HV (health care value) framework.

Effectiveness and cost-effectiveness of stratified blended physiotherapy in patients with non-specific low back pain: study protocol of a cluster randomized controlled trial.

BACKGROUND: Patient education, advice on returning to normal activities and (home-based) exercise therapy are established treatment options for patients with non-specific low back pain (LBP). However, the effectiveness of physiotherapy interventions on physical functioning and prevention of recurrent events largely depends on patient self-management, adherence to prescribed (home-based) exercises and recommended physical activity behaviour. Therefore we have developed e-Exercise LBP, a blended intervention in which a smartphone application is integrated within face-to-face care. E-Exercise LBP aims to improve patient self-management skills and adherence to exercise and physical activity recommendations and consequently improve the effectiveness of physiotherapy on patients' physical functioning. The aim of this study is to investigate the short- (3 months) and long-term (12 and 24 months) effectiveness on physical functioning and cost-effectiveness of e-Exercise LBP in comparison to usual primary care physiotherapy in patients with LBP. METHODS: This paper presents the protocol of a prospective, multicentre cluster randomized controlled trial. In total 208 patients with LBP pain were treated with either e-Exercise LBP or usual care physiotherapy. E-Exercise LBP is stratified based on the risk for developing persistent LBP. Physiotherapists are able to monitor and evaluate treatment progress between face-to-face sessions using patient input from the smartphone application in order to optimize physiotherapy care. The smartphone application contains video-supported self-management information, video-supported exercises and a goal-oriented physical activity module. The primary outcome is physical functioning at 12-months follow-up. Secondary outcomes include pain intensity, physical activity, adherence to prescribed (home-based) exercises and recommended physical activity behaviour, self-efficacy, patient activation and health-related quality of life. All measurements will be performed at baseline, 3, 12 and 24 months after inclusion. An economic evaluation will be performed from the societal and the healthcare perspective and will assess cost-effectiveness of e-Exercise LBP compared to usual physiotherapy at 12 and 24 months. DISCUSSION: A multi-phase development and implementation process using the Center for eHealth Research Roadmap for the participatory development of eHealth was used for development and evaluation. The findings will provide evidence on the effectiveness of blended care for patients with LBP and help to enhance future implementation of blended physiotherapy. TRIAL REGISTRATION: ISRCTN, ISRCTN94074203. Registered 20 July 2018 - Retrospectively registered.

Cost-effectiveness of a blended physiotherapy intervention compared to usual physiotherapy in patients with hip and/or knee osteoarthritis: a cluster randomized controlled trial.

BACKGROUND: Blended physiotherapy, in which physiotherapy sessions and an online application are integrated, might support patients in taking an active role in the management of their chronic condition and may reduce disease related costs. The aim of this study was to evaluate the cost-effectiveness of a blended physiotherapy intervention (e-Exercise) compared to usual physiotherapy in patients with osteoarthritis of hip and/or knee, from the societal as well as the healthcare perspective. METHODS: This economic evaluation was conducted alongside a 12-month cluster randomized controlled trial, in which 108 patients received e-Exercise, consisting of physiotherapy sessions and a web-application, and 99 patients received usual physiotherapy. Clinical outcome measures were quality-adjusted life years (QALYs) according to the EuroQol (EQ-5D-3 L), physical functioning (HOOS/KOOS) and physical activity (Actigraph Accelerometer). Costs were measured using self-reported questionnaires. Missing data were multiply imputed and bootstrapping was used to estimate statistical uncertainty. RESULTS: Intervention costs and medication costs were significantly lower in e-Exercise compared to usual physiotherapy. Total societal costs and total healthcare costs did not significantly differ between groups. No significant differences in effectiveness were found between groups. For physical functioning and physical activity, the maximum probability of e-Exercise being cost-effective compared to usual physiotherapy was moderate (< 0.82) from both perspectives. For QALYs, the probability of e-Exercise being cost-effective compared to usual physiotherapy was 0.68/0.84 at a willingness to pay of 10,000 Euro and 0.70/0.80 at a willingness to pay of 80,000 Euro per gained QALY, from respectively the societal and the healthcare perspective. CONCLUSIONS: E-Exercise itself was significantly cheaper compared to usual physiotherapy in patients with hip and/or knee osteoarthritis, but not cost-effective from the societal- as well as healthcare perspective. The decision between both interventions can be based on the preferences of the patient and the physiotherapist. TRIAL REGISTRATION: NTR4224 (25 October 2013).

Characteristics of insufficiently active participants that benefit from health-enhancing physical activity (HEPA) promotion programs implemented in the sports club setting.

BACKGROUND: Health-enhancing physical activity (HEPA) promotion programs are implemented in sports clubs. The purpose of this study was to examine the characteristics of the insufficiently active participants that benefit from these programs. METHODS: Data of three sporting programs, developed for insufficiently active adults, were used for this study. These sporting programs were implemented in different sports clubs in the Netherlands. Participants completed an online questionnaire at baseline and after six months (n = 458). Of this sample, 35.1% (n = 161) was insufficiently active (i.e. not meeting HEPA levels) at baseline. Accordingly, two groups were compared: participants who were insufficiently active at baseline, but increased their physical activity to HEPA levels after six months (activated group, n = 86) versus participants who were insufficiently active both at baseline and after six months (non-activated group, n = 75). Potential associated characteristics (demographic, social, sport history, physical activity) were included as independent variables in bivariate and multivariate logistic regression analyses. RESULTS: The percentage of active participants increased significantly from baseline to six months (from 64.9 to 76.9%, p < 0.05). The bivariate logistic regression analyses showed that participants in the activated group were more likely to receive support from family members with regard to their sport participation (62.8% vs. 42.7%, p = 0.02) and spent more time in moderate-intensity physical activity (128 ± 191 min/week vs. 70 ± 106 min/week, p = 0.02) at baseline compared with participants in the non-activated group. These results were confirmed in the multivariate logistic regression analyses: when receiving support from most family members, there is a 216% increase in the odds of being in the activated group (OR = 2.155; 95% CI: 1.118-4.154, p = 0.02) and for each additional 1 min/week spent in moderate-intensity physical activity, the odds increases with 0.3% (OR = 1.003; 95% CI: 1.001-1.006, p = 0.02). CONCLUSIONS: The results suggest that HEPA sporting programs can be used to increase HEPA levels of insufficiently active people, but it seems a challenge to reach the least active ones. It is important that promotional strategies and channels are tailored to the target group. Furthermore, strategies that promote family support may enhance the impact of the programs.

Treatment of hip/knee osteoarthritis in Dutch general practice and physical therapy practice: an observational study.

BACKGROUND: A multidisciplinary, guideline-based Stepped-Care-Strategy (SCS), has recently been developed to improve the management of hip and knee osteoarthritis (OA). To date, it is unknown to what extent current Dutch OA care is consistent with the SCS, both with respect to the content of care as well as the sequence of care. Furthermore, there is a lack of clarity regarding the role of different health care providers in the performance of OA care according to the SCS. Therefore, the main purpose of this study is to describe the content of primary care in patients with hip/knee OA, including the compliance to the SCS and taking into account the introduction of patient self-referral to physical therapy. METHODS: Data were used from NIVEL Primary Care Database. In total, 12.118 patients with hip/knee OA who visited their GP or physical therapist were selected. Descriptive statistics were used to compare the content of care in GP-referred and self-referred patients to physical therapy. RESULTS: Content of care performed by GPs mostly concerned consultations, followed by NSAID prescriptions and referrals to secondary care. Both prescriptions of acetaminophen and referrals to physical therapy respectively dietary therapy were rarely mentioned. Nevertheless, still 65% of the patients in physical therapy practice were referred by their GP. Compared to GP-referred patients, self-referred patients more often presented recurrent complaints and were treated less often by activity-related exercise therapy. Education was rarely registered as singular intervention, neither in GP-referred nor in self-referred patients. CONCLUSION: In accordance with the SCS, less advanced interventions are more often applied than more advanced interventions. To optimize the adherence to the SCS, GPs could reconsider the frequent use of NSAIDs instead of analgesics and the low referral rate to allied health care. Self-referral to physical therapy partially distorts both the low referral rate in general practice and the low application rate of education as singular intervention in physical therapy practice. Further research is recommended to evaluate the effects of task-shifting in OA care, taking into account the content of the SCS.

Effectiveness and cost-effectiveness of a blended exercise intervention for patients with hip and/or knee osteoarthritis: study protocol of a randomized controlled trial.

BACKGROUND: Exercise therapy in patients with hip and/or knee osteoarthritis is effective in reducing pain, increasing physical activity and physical functioning, but costly and a burden for the health care budget. A web-based intervention is cheap in comparison to face-to-face exercise therapy and has the advantage of supporting in home exercises because of the 24/7 accessibility. However, the lack of face-to-face contact with a professional is a disadvantage of web-based interventions and is probably one of the reasons for low adherence rates. In order to combine the best of two worlds, we have developed the intervention e-Exercise. In this blended intervention face-to-face contacts with a physical therapist are partially replaced by a web-based exercise intervention. The aim of this study is to investigate the short- (3 months) and long-term (12 months) (cost)-effectiveness of e-Exercise compared to usual care physical therapy. Our hypothesis is that e-Exercise is more effective and cost-effective in increasing physical functioning and physical activity compared to usual care. METHODS/DESIGN: This paper presents the protocol of a prospective, single-blinded, multicenter cluster randomized controlled trial. In total, 200 patients with OA of the hip and/or knee will be randomly allocated into either e-Exercise or usual care (physical therapy). E-Exercise is a 12-week intervention, consisting of maximum five face-to-face physical therapy contacts supplemented with a web-based program. The web-based program contains assignments to gradually increase patients' physical activity, strength and stability exercises and information about OA related topics. Primary outcomes are physical activity and physical functioning. Secondary outcomes are health related quality of life, self-perceived effect, pain, tiredness and self-efficacy. All measurements will be performed at baseline, 3 and 12 months after inclusion. Retrospective cost questionnaires will be sent at 3, 6, 9 and 12 months and used for the cost-effectiveness and cost-utility analysis. DISCUSSION: This study is the first randomized controlled trial in the (cost)-effectiveness of a blended exercise intervention for patients with osteoarthritis of the hip and/or knee. The findings will help to improve the treatment of patients with osteoarthritis. TRIAL REGISTRATION: NTR4224.

The contribution of lifestyle coaching of overweight patients in primary care to more autonomous motivation for physical activity and healthy dietary behaviour: results of a longitudinal study.

BACKGROUND: Combined lifestyle interventions (CLIs) have been advocated as an effective instrument in efforts to reduce overweight and obesity. The odds of maintaining higher levels of physical activity (PA) and healthier dietary behaviour improve when people are more intrinsically motivated to change their behaviour. To promote the shift towards more autonomous types of motivation, facilitator led CLIs have been developed including lifestyle coaching as key element. The present study examined the shift in types of motivation to increase PA and healthy dieting among participants of a primary care CLI, and the contribution of lifestyle coaching to potential changes in motivational quality. METHODS: This prospective cohort study included participants of 29 general practices in the Netherlands that implemented a CLI named 'BeweegKuur'. Questionnaires including items on demographics, lifestyle coaching and motivation were sent at baseline and after 4 months. Aspects of motivation were assessed with the Behavioural Regulation and Exercise Questionnaire (BREQ-2) and the Regulation of Eating Behaviour Questionnaire (REBS). We performed a drop out analysis to identify selective drop-out. Changes in motivation were analysed with t-tests and effect size interpretations (Cohen's d), and multivariate regression analysis was used to identify predictors of motivational change. RESULTS: For physical activity, changes in motivational regulation were fully in line with the tenets of Self Determination Theory and Motivational Interviewing: participants made a shift towards a more autonomous type of motivation (i.e. controlled types of motivation decreased and autonomous types increased). Moreover, an autonomy supportive coaching style was generally found to predict a larger shift in autonomous types of motivation. For healthy dietary behaviour, however, except for a small decrease in external motivation, no favourable changes in different types of motivation were observed. The relation between coaching and motivation appeared to be influenced by the presence of physical activity guidance in the programme. CONCLUSIONS: Motivation of participants of a real life primary care CLI had changed towards a more autonomous motivation after 4 months of intervention. Autonomy-supportive lifestyle coaching contributed to this change with respect to physical activity. Lifestyle coaching for healthy diet requires thorough knowledge about the problem of unhealthy dieting and solid coaching skills.

Effectiveness of Start to Run, a 6-week training program for novice runners, on increasing health-enhancing physical activity: a controlled study.

BACKGROUND: The use of the organized sports sector as a setting for health-promotion is a relatively new strategy. In the past few years, different countries have been investing resources in the organized sports sector for promoting health-enhancing physical activity. In the Netherlands, National Sports Federations were funded to develop and implement "easily accessible" sporting programs, aimed at the least active population groups. Start to Run, a 6-week training program for novice runners, developed by the Dutch Athletics Organization, is one of these programs. In this study, the effects of Start to Run on health-enhancing physical activity were investigated. METHODS: Physical activity levels of Start to Run participants were assessed by means of the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH) at baseline, immediately after completing the program and six months after baseline. A control group, matched for age and sex, was assessed at baseline and after six months. Compliance with the Dutch physical activity guidelines was the primary outcome measure. Secondary outcome measures were the total time spent in physical activity and the time spent in each physical activity intensity category and domain. Changes in physical activity within groups were tested with paired t-tests and McNemar tests. Changes between groups were examined with multiple linear and logistic regression analyses. RESULTS: In the Start to Run group, the percentage of people who met the Dutch Norm for Health-enhancing Physical Activity, Fit-norm and Combi-norm increased significantly, both in the short- and longer-term. In the control group, no significant changes in physical activity were observed. When comparing results between groups, significantly more Start to Run participants compared with control group participants were meeting the Fit-norm and Combi-norm after six months. The differences in physical activity between groups in favor of the Start to Run group could be explained by an increase in the time spent in vigorous-intensity activities and sports activities. CONCLUSIONS: Start to Run positively influences levels of health-enhancing physical activity of participants, both in the short- and longer-term. Based on these results, the use of the organized sports sector as a setting to promote health-enhancing physical activity seems promising.

The cost effectiveness of behavioural graded activity in patients with osteoarthritis of hip and/or knee.

OBJECTIVE: To evaluate whether exercise treatment based on behavioural graded activity comprising booster sessions is a cost-effective treatment for patients with osteoarthritis of the hip and/or knee compared with usual care. METHODS: An economic evaluation from a societal perspective was carried out alongside a randomised trial involving 200 patients with osteoarthritis of the hip and/or knee. Outcome measures were pain, physical functioning, self-perceived change and quality of life, assessed at baseline, 13, 39 and 65 weeks. Costs were measured using cost diaries for the entire follow-up period of 65 weeks. Cost and effect differences were estimated using multilevel analysis. Uncertainty around the cost-effectiveness ratios was estimated by bootstrapping and graphically represented on cost-effectiveness planes. RESULTS: 97 patients received behavioural graded activity, and 103 patients received usual care. At 65 weeks, no differences were found between the two groups in improvement with respect to baseline on any of the outcome measures. The mean (95% confidence interval) difference in total costs between the groups was -euro773 (-euro2360 to euro772)--that is, behavioural graded activity resulted in less cost but this difference was non-significant. As effect differences were small, a large incremental cost-effectiveness ratio of euro 51,385 per quality adjusted life year was found for graded activity versus usual care. CONCLUSIONS: This study provides no evidence that behavioural graded activity is either more effective or less costly than usual care. Yielding similar results to usual care, behavioural graded activity seems an acceptable method for treating patients with osteoarthritis of the hip and/or knee.