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
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Background: To facilitate adherence to adaptive pain management behaviors after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behavior regulation strategies. Objective: The aims of this project are (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app users. Methods: We will perform a multicenter randomized controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment program until 12 months posttreatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses. Results: The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients. Conclusions: This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After 3 years of development and feasibility testing, this formal evaluation will help determine to what extent the app will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice.
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As the population ages, more people will have comorbid disorders and polypharmacy. Medication should be reviewed regularly in order to avoid adverse drug reactions and medication-related hospital visits, but this is often not done. As part of our student-run clinic project, we investigated whether an interprofessional student-run medication review program (ISP) added to standard care at a geriatric outpatient clinic leads to better prescribing. In this controlled clinical trial, patients visiting a memory outpatient clinic were allocated to standard care (control group) or standard care plus the ISP team (intervention group). The medications of all patients were reviewed by a review panel (“gold standard”), resident, and in the intervention arm also by an ISP team consisting of a group of students from the medicine and pharmacy faculties and students from the higher education school of nursing for advanced nursing practice. For both groups, the number of STOPP/START-based medication changes mentioned in general practitioner (GP) correspondence and the implementation of these changes about 6 weeks after the outpatient visit were investigated. The data of 216 patients were analyzed (control group = 100, intervention group = 116). More recommendations for STOPP/STARTbased medication changes were made in the GP correspondence in the intervention group than in the control group (43% vs. 24%, P = < 0.001). After 6 weeks, a significantly higher proportion of these changes were implemented in the intervention group (19% vs. 9%, P = 0.001). The ISP team, in addition to standard care, is an effective intervention for optimizing pharmacotherapy and medication safety in a geriatric outpatient clinic.
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De mondgezondheid van te veel jonge kinderen in Nederland is slecht: tandbederf (cariës) komt vaak voor. Een deel van de kinderen bezoekt de mondzorgprofessional te laat. Om de mondgezondheid van deze kinderen te verbeteren is de interventie Gezonde Peutermonden ontwikkeld. Op consultatiebureaus zorgt een mondzorgcoach (mondzorgprofessional) voor coaching en begeleiding van ouders van jonge kinderen bij het aanleren van gezonde eet-/ en mondzorg gedrag. Het effect hiervan wordt momenteel in een 'clinical trial' getest. De tussentijdse resultaten zijn veelbelovend en de interventie heeft enthousiaste reacties opgeleverd. Terwijl een definitieve trialuitkomst op zich laat wachten, nemen mondzorgpraktijken het initiatief tot samenwerking met Jeugdgezondheidszorg. In de regio Heerlen en Tilburg is vanwege een hoog percentage van kinderen met tandbederf, grote belangstelling en bereidheid van mondzorgprofessionals, gemeente, GGD en zorgverzekeraar om het initiatief te nemen. Zij vragen ons om hulp en ondersteuning bij interventie implementatie in hun regio. Naar aanleiding hiervan willen wij in samenwerking met deze partijen in beide regio’s de implementatie van Gezonde Peutermonden onderzoeken. Het doel daarbij is het krijgen van inzicht in de belemmerende en bevorderende factoren bij de implementatie van Gezonde Peutermonden. Zodoende wordt beoogd de ‘beste’ implementatiestrategieën te kunnen achterhalen. Door het verzamelen van kwantitatieve en kwalitatieve gegevens middels ‘mixed methods’ wordt de context in kaart gebracht, gericht op factoren binnen en buiten de organisatie, kenmerken van de doelgroep en de zorgverleners. Scholing, een ‘toolkit’ en voorlichtingsmateriaal worden ontwikkeld en beschikbaar gesteld aan mondzorgprofessionals. Proces-en effectuitkomsten worden gemeten, waartoe gegevens worden verzameld voor, tijdens en na de implementatie van de interventie. Deze aanvraag beschrijft de extra inspanning om de interventie Gezonde Peutermonden om te zetten naar een blended vorm, combinatie van fysieke en video/telefonische consulten, en de ontwikkeling van een protocol voor de gecombineerde consulten voor kinderen tussen 0-4 jaar ten gevolge van de Covid-19 maatregelen.
