Cost-effectiveness of a multifaceted implementation strategy for the Dutch multidisciplinary guideline for nonspecific low back pain: design of a stepped-wedge cluster randomised controlled trial

This study comprises 25 GP practices (accounting for 53 individual GPs), 19 PT practices (accounting for 43 individual PTs), and 37 OPs. Inclusion criteria for health care providers are: practising within the municipality of Amsterdam, and regularly working with patients with LBP. Participating HCPs are allocated to one of four clusters based on defined geographical areas, which is the eligibility criterion for clusters in this trial.

Five hundred patients with LBP will be included to participate in this study. All patients registered in the practices of participating GPs and PTs receive an information leaflet about this study, and a recruitment letter from their GP/PT. Furthermore; PTs have information and recruitment posters and leaflets in their practices. Patients interested in participation can apply directly via e-mail or using a postal reply card at the research assistants’ office, where eligibility criteria are assessed prior to inclusion.

Patients are eligible if they have a minimum age of 18 and a maximum age of 75 years, have access to the Internet, have visited their GP or PT due to back complaints no later than 3 months prior to inclusion, and are diagnosed with nonspecific LBP. Nonspecific LBP is defined as low back pain (with or without motor and/or sensory deficits in one or both legs) that is not caused by underlying specific pathology (red flags), i.e., a tumour, (osteoporotic) vertebral fracture, ankylosing spondylitis, and cauda equina syndrome.

Patients having the following characteristics will be excluded from this study: serious long existing comorbidity, i.e., Alzheimer’s disease, Multiple Sclerosis, Parkinson’s disease, ALS, CVA (diagnosed 1 year prior to inclusion up to moment of inclusion), confirmed pregnancy (identified 1 year prior to inclusion up to moment of inclusion), malignancy (diagnosed 5 years prior to inclusion up to moment of inclusion), and severe psychiatric disorders, i.e., schizophrenia and bipolar disorder.

In accordance with the local regulatory guidelines and standards for human subjects protection in the Netherlands (Medical Research Involving Human Subjects Act [WMO], 2005), and the assessment of the Medical Ethics Committee of the VU University medical centre, no written informed consent for participation was necessary to be obtained from participants.

In this study, a multifaceted implementation strategy (intervention group) targeted at both the patients and the professionals will be compared to passive dissemination of the guideline (control group). For HCPs, passive dissemination encompasses digital dissemination of the guideline (i.e., HCPs will receive an e-mail with this guideline in PDF format attached). Patients are offered a website on which solely the brief patient information from the guideline is published.

HCP clusters in the intervention arm will be invited to participate in a multidisciplinary continuing medical education (CME) training session that is developed in close collaboration with a professional educationalist. The training module meets the educational requirements of the Dutch physicians and physiotherapists associations.

The training module focuses on improving collaboration and communication between various HCPs, which is practiced by means of a so called barriers and facilitators carousel, in which several small groups of HCPs first discuss the barriers they encounter in collaborating and communicating with each other. The groups then interchange these barriers and discuss strategies to overcome them. In a plenary session, the HCPs then exchange their group findings and agree upon a set of practical strategies for dealing with the encountered barriers. Furthermore, communication skills needed for managing patients with nonspecific LBP are trained by means of a case study that dictates a role-play. The case study presents a complicated case of LBP in which yellow flags (i.e., psychosocial risk factors) and blue flags (i.e., occupational risk factors) play an important role. In this role-play, the HCPs swap professions with each other and play a role from the perspective of another HCP, allowing them to think outside their own frames of reference, while they also learn to identify important yellow and blue flags and act upon them in a multidisciplinary manner. During the role-play, the HCPs are encouraged to practice the previously agreed upon strategies. After the training module, HCPs repeatedly (directly after the training, and after 3, 6, and 12 months) receive a reminder about the strategies by e-mail, along with a social map of contact details of all HCPs that attended the specific training. The training is conducted one time per cluster and takes 2,5 h. It is organized and given by at least one member of the research team (in order to assure scientific quality), and one practicing HCP (to ensure relevance and connection to daily practice).

Finally, HCPs will gain access to an interactive website, containing information on LBP and LBP guidelines, updates on the study, and a HCP forum.

Patients randomised into the intervention arm will gain access to an informative website aimed at reducing patients’ negative back beliefs and improve their cognitions. The website provides comprehensive information about LBP, such as practical advices (e.g., on self-management), working and returning to work with LBP, exercise tips and possibilities to contact researchers, HCPs, and other patients by means of a forum and social media. An important part of the implementation strategy and this website are short video messages in which actors and HCPs share their fictional experience with LBP and provide tips on self-management of and working with LBP. These videos are based on the effective Australian mass media campaign ‘Back Pain: Don’t Take It Lying Down’ [20]. The website is also available in a mobile version to be visited on any electronic device, e.g., a smartphone or tablet.

The primary outcome measure of this study is the back beliefs and expectations of patients with LBP, which will be assessed on individual level using the Back Beliefs Questionnaire [21]. Secondary outcome measures on patient level include functional status measured with the RDQ-24; quality of life measured with the EuroQol questionnaire; level of pain measured using an adapted form of the PCI questionnaire, and health care utility and productivity losses measured using the PRODISQ and TIC-P questionnaires. Measurements at patient level will take place at baseline and after 3, 6, and 12 months follow-up.

Health care provider outcomes are measured at the level of the individual HCP. Using questionnaires, HCP knowledge of and attitudes toward the guideline will be measured, as well as level of perceived self-efficacy on multidisciplinary communication and collaboration. Measurements on HCP level will take place at baseline and after 3, 6 and 12 months follow-up.

Furthermore, guideline adherence among GPs will be assessed using performance indicators (Table 1). These professional behaviours are considered indicators for adherence to this guideline, because the guideline recommends a watchful waiting approach for acute LBP, and a multidisciplinary approach to treatment for chronic LBP, while it discourages (early) referrals of LBP patients for diagnostics and specialist medical care.

To enhance quality of the data, all data from questionnaires will be collected using online questionnaires, which are programmed to reduce impossible and missing values. Data on performance indicators will be gathered using software developed to select all GP reports on consultations with patients having LBP.

The Linnan and Steckler framework for process evaluation of public health interventions and research will be used to evaluate the implementation process for this study at patient and HCP level [22]. The feasibility of the implementation strategy, barriers and facilitators for implementing the guideline, and the satisfaction of the participants (HCPs as well as patients) with the intervention are measured using questionnaires. In order to gain more in-depth knowledge on the satisfaction and experiences of the participants, semi-structured qualitative interviews with both HCPs and patients are conducted.

Subsequent to the process evaluation, a subgroup evaluation analysis amongst participating patients will be performed. Using an explorative qualitative design with semi-structured interviews, 10 patients from four ethnic backgrounds (i.e., Dutch, Moroccan, Turkish, and Surinam, which are the most common ethnicities in the city of Amsterdam) will be interviewed to gain insight into their experiences with this study (e.g., the recruitment process, the intervention received). The differences in experiences between these ethnic groups will be mapped in order to gain insight into possible barriers and facilitators in involving various ethnic groups in future (implementation) research.

An economic evaluation will be performed to measure and analyse the cost differences between the current implementation strategy and passive dissemination of the guideline in relation to the effect differences between the two groups. Direct costs related to health care utility as well as indirect costs related to productivity losses due to absenteeism and presenteeism will be analysed. Costs of the implementation strategy will be measured, valued and analysed using a bottom-up approach. Health care consumption and productivity losses will be valued using Dutch guideline prices.

Cost-effectiveness and cost-utility analyses will be performed from a societal perspective. Functional status and quality of life of the patients will be taken as outcome measures for the economic evaluation. To calculate incremental cost-effectiveness ratios (ICER) and cost-utility ratios, the differences in mean costs between the two groups will be divided by their differences in outcome measures. Confidence intervals (95 %) will be estimated using bootstrapping methods with a minimum of 5.000 replications [23]. Uncertainty of the ICERs will be graphically presented in a cost-effectiveness plane (CE plane), as well as cost-effectiveness acceptability curves (CEAC) [24, 25].

At last, a budget impact analysis will extrapolate the results of the economic evaluation to a period of 5 years in order to estimate the financial costs of applying this implementation strategy on a larger scale. This analysis will be performed from several perspectives (i.e., societal, government, and insurance) and several scenarios for application of this implementation strategy.