Background: Medically unexplained symptoms (MUS) are highly prevalent and pose a burden both on patients and on health care. In a pilot study psychosomatic therapy delivered by specialised therapists for patients with MUS showed promising results with regard to patient’s acceptability, feasibility and effects on symptoms. The aim of this study is to establish whether psychosomatic therapy by specialised psychosomatic exercise therapists is costeffective in decreasing symptoms and improving functioning in patients who frequently consult their general practitioner (GP) with MUS. Methods: A randomised effectiveness trial with an economic evaluation in primary care with 158 patients aged 18 years and older who are frequently consulting their GP with MUS. Patients will be assigned to psychosomatic therapy in addition to usual care or usual care only. Psychosomatic therapy is a multi-component and tailored intervention, aiming to empower patients by applying psycho-education, relaxation techniques, mindfulness, cognitive approaches and/or graded activity. Patients assigned to the psychosomatic therapy receive 6 to 12 sessions of psychosomatic therapy, of 30–45 min each, delivered by a specialised exercise or physical therapist. Primary outcome measure is patient-specific functioning and disability, measured with the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are symptom severity, consultation frequency and referrals to secondary care, patient satisfaction, quality of life and costs. Assessments will be carried out at baseline, and after 4 and 12 months. An economic evaluation alongside the trial will be conducted from a societal perspective, with quality-adjusted life years (QALYs) as outcome measure. Furthermore, a mixed-methods process evaluation will be conducted. Discussion: We expect that psychosomatic therapy in primary care for patients who frequently attend the GP for MUS will improve symptoms and daily functioning and disability, while reducing consultation frequency and referrals to secondary care. We expect that the psychosomatic therapy provides value for money for patients with MUS.Trial registration: Netherlands Trial Register, ID: NL7157 (NTR7356). Registered 13 July 2018.Keywords: Psychosomatic therapy, Study protocol, Primary care, Randomised controlled trial, Medically unexplained symptoms, Cost-effectiveness
MULTIFILE
Background: Rising healthcare costs, an increasing general practitioner shortage and an aging population have made healthcare organization transformation a priority. To meet these challenges, traditional roles of non-medical members have been reconsidered. Within the domain of physiotherapy, there has been significant interest in Extended Scope Physiotherapy (ESP). Although studies have focused on the perceptions of different stakeholders in relation to ESP, there is a large variety in the interpretation of ESP. Aim: To identify a paradigm of ESP incorporating goals, roles and tasks, to provide a consistent approach for the implementation of ESP in primary care. Methods: An exploratory, qualitative multi-step design was used containing a scoping review, focus groups and semi-structured interviews. The study population consisted of patients, physiotherapists, general practitioners and indirect stakeholders such as lecturers, health insurers and policymakers related to primary care physiotherapy. The main topics discussed in the focus groups and semi-structured interviews were the goals, skills and roles affiliated with ESP. The ‘framework’ method, developed by Ritchie & Spencer, was used as analytical approach to refine the framework. Results: Two focus groups and twelve semi-structured interviews were conducted to explore stakeholder perspectives on ESP in Dutch primary care. A total of 11 physiotherapists, six general practitioners, five patients and four indirect stakeholders participated in the study. There was a lot of support for ‘decreasing healthcare costs’, ‘tackling increased health demand’ and ‘improving healthcare effectiveness’ as main goals of ESP. The most agreement was reached on ‘triaging’, ‘referring to specialists’ and ‘ordering diagnostic imaging’ as tasks fitting for ESP. Most stakeholders also supported ‘working in a multidisciplinary team’, ‘working as a consultant’ and ‘an ESP role separated from a physiotherapist role’ as roles of ESP. Conclusions: Based on the scoping review, focus groups and interviews with direct and indirect stakeholders, it appears that there is sufficient support for ESP in the Netherlands. This study provides a clear presentation of how ESP can be conceptualized in primary care. A pilot focused on determining the feasibility of ESP in Dutch primary care will be the next step.
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 paperbased 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.
