Dataset Information

Effectiveness of a blended multidisciplinary intervention for patients with moderate medically unexplained physical symptoms (PARASOL): A cluster randomized clinical trial.

ABSTRACT:

Introduction

In patients with moderate Medically Unexplained Physical Symptoms (MUPS), interventions focusing on both physical and psychological aspects are recommended. A proactive, blended and integrated physical therapy and mental health nurse intervention (PARASOL) might reduce complaints, stimulate self-management and prevent chronicity.

Objective

To investigate short- and long-term effectiveness of the PARASOL intervention compared to usual care on subjective symptom impact and quality of life in patients with moderate MUPS.

Methods

We conducted a cluster randomized clinical trial. The 12-week intervention integrated face-to-face sessions with the physical therapist and mental health nurse and access to a web-based program consisting of graded activity, exercises and information modules. Primary outcomes were subjective symptom impact, as registered with the adequate relief question, and quality of life. Secondary outcomes were severity of (psychosocial) symptoms, overall current health, physical behaviour, illness perceptions, and self-management skills. Assessment took place at baseline, after three and twelve months.

Results

Compared to usual care (n = 80), the number of patients in the PARASOL intervention (n = 80) that reported adequate short-term relief was higher (31.2% in intervention group vs. 13.7% in control group). On quality of life and secondary outcomes no significant between group differences in short- and long-term were found.

Conclusions

The PARASOL intervention does improve subjective symptom impact of patients with moderate MUPS on short-term. No additional beneficial effects on the other outcomes and the long-term were found.

SUBMITTER: van Westrienen PE

PROVIDER: S-EPMC10079131 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of a blended multidisciplinary intervention for patients with moderate medically unexplained physical symptoms (PARASOL): A cluster randomized clinical trial.

van Westrienen Paula Elisabeth PE de Wit Niek N Toonders Suze S Veenhof Cindy C Gerrits Marloes M Pisters Martijn M

PloS one 20230406 4

<h4>Introduction</h4>In patients with moderate Medically Unexplained Physical Symptoms (MUPS), interventions focusing on both physical and psychological aspects are recommended. A proactive, blended and integrated physical therapy and mental health nurse intervention (PARASOL) might reduce complaints, stimulate self-management and prevent chronicity.<h4>Objective</h4>To investigate short- and long-term effectiveness of the PARASOL intervention compared to usual care on subjective symptom impact ...[more]

PMID: 37023095

Similar Datasets

Project description:BackgroundMedically unexplained physical symptoms (MUPS) are a substantial health problem in primary care with a high burden for patients, general practitioners, and the health care system. Most studies focus on chronic MUPS patients. Little research is conducted in patients with moderate MUPS, and an effective primary care intervention for prevention of chronic MUPS is lacking.ObjectiveThe objective of our study was to identify treatment modalities based on expert opinions for the development of a multidisciplinary and blended intervention for patients with moderate MUPS to prevent chronicity.MethodsTwo focus groups with 8 and 6 experts (general practitioners, physical therapists, psychologists, and mental health nurses) were carried out. The focus groups were structured using the nominal group technique.ResultsA total of 70 ideas were generated from two nominal group meetings, and 37 of these got votes, were included in the rank order, and were sorted into 8 separate themes. According to the participants, the most important treatment modalities for a multidisciplinary and blended intervention in patients with moderate MUPS were (1) coaching to a healthier lifestyle, (2) education regarding psychosocial factors, (3) therapeutic neuroscience education, (4) multidisciplinary intake, (5) multidisciplinary cooperation and coordination, (6) relaxation or body awareness exercises, (7) clear communication by professionals to the patient, and (8) graded activity. Five independent researchers checked the ideas and linked them to themes to confirm the content analysis and check the validity of the themes.ConclusionsFrom professional expert perspectives, 8 themes should be included in a multidisciplinary and blended intervention to prevent chronicity. These themes provide a first step in developing an intervention for patients with moderate MUPS. Future research should focus on further development steps in which patients with moderate MUPS should be involved to determine if the intervention matches their needs.

Project description:Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services.Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month.This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain). The number of patients required is 242 (121 in each arm), all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions) and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity of the symptoms, improve quality of life, and reduce frequency of medical consultations.The trial was registered with ClinicalTrials.gov, number NCT01484223 [http://ClinicalTrials.gov].

Project description:BackgroundIn primary and secondary care medically unexplained symptoms (MUS) or functional somatic syndromes (FSS) constitute a major burden for patients and society with high healthcare costs and societal costs. Objectives were to provide an overview of the evidence regarding the cost-effectiveness of interventions for MUS or FSS, and to assess the quality of these studies.MethodsWe searched the databases PubMed, PsycINFO, the National Health Service Economic Evaluation Database (NHS-EED) and the CEA registry to conduct a systematic review. Articles with full economic evaluations on interventions focusing on adult patients with undifferentiated MUS or fibromyalgia (FM), irritable bowel syndrome (IBS) and chronic fatigue syndrome (CFS), with no restrictions on comparators, published until 15 June 2018, were included. We excluded preventive interventions. Two reviewers independently extracted study characteristics and cost-effectiveness data and used the Consensus on Health Economic Criteria Checklist to appraise the methodological quality.ResultsA total of 39 studies out of 1,613 articles met the inclusion criteria. Twenty-two studies reported costs per quality-adjusted life year (QALY) gained and cost-utility analyses (CUAs). In 13 CUAs the intervention conditions dominated the control conditions or had an incremental cost-effectiveness ratio below the willingness-to-pay threshold of € 50,000 per QALY, meaning that the interventions were (on average) cost-effective in comparison with the control condition. Group interventions focusing on MUS (n = 3) or FM (n = 4) might be more cost-effective than individual interventions. The included studies were heterogeneous with regard to the included patients, interventions, study design, and outcomes.ConclusionThis review provides an overview of 39 included studies of interventions for patients with MUS and FSS and the methodological quality of these studies. Considering the limited comparability due to the heterogeneity of the studies, group interventions might be more cost-effective than individual interventions.RegistrationStudy methods were documented in an international prospective register of systematic reviews (PROSPERO) protocol, registration number: CRD42017060424.

Project description:BackgroundMedically Unexplained Physical Symptoms (MUPS) are prevalent among primary care patients and frequently lead to diminished quality of life, increased healthcare costs, and decreased work participation. We aimed to examine the effects of a work-focused structured communication tool based on cognitive-behavioral therapy in patients with MUPS.MethodsIn a Norwegian two-arm cluster randomized trial, the effectiveness of the structured communication tool Individual Challenge Inventory Tool (ICIT) was compared to usual care for patients with MUPS using a two-arm cluster randomized design. Enrollment period was between March 7 and April 1, 2022. Ten groups (clusters) of 103 General Practitioners (GPs) were randomized to provide the ICIT or usual care for 11 weeks. Patients received two or more sessions with their GP, and outcomes were assessed individually. Primary outcome was patient-reported change in function, symptoms, and quality of life measured by the Patient Global Impression of Change (PGIC). Secondary outcomes included sick leave, work-related self-efficacy (RTW-SE), health-related quality of life (RAND-36), and patient experiences with consultants (PEQ). The trial was registered on ClinicalTrials.gov (NCT05128019).FindingsA total of 541 patients with MUPS were enrolled in the study. In the intervention group 76% (n = 223) showed a significant overall improvement in function, symptoms, and quality of life as measured by the PGIC, compared to 38% (n = 236) in the usual care group (mean difference -0.8 ([95% CI -1.0 to -0.6]; p < 0.0001). At 11 weeks, the intervention group had a 27-percentage point decrease in sick leave (from 52.0 to 25.2), compared to 4-percentage point decrease (from 49.7 to 45.7) in the usual care group. Furthermore, compared to usual care, the intervention group reported significant improvements in work-related self-efficacy, health-related quality of life, and greater satisfaction with the communication during the consultations. No adverse events were reported.InterpretationThe implementation of the structured communication tool ICIT in primary care significantly improved patient outcomes and reduced sick leave among patients with MUPS.FundingThe study was funded by The Norwegian Research Fund for General Practice.

Project description:BackgroundMedically unexplained physical symptoms (MUPS) are a leading cause of reduced work functioning. It is not known which factors are associated with reduced work functioning in people with moderate MUPS. Insight in these factors can contribute to prevention of reduced work functioning, associated work-related costs and in MUPS becoming chronic. Therefore, the aim of this study was to identify which demographic and health-related factors are associated with reduced work functioning, operationalized as impaired work performance and absenteeism, in people with moderate MUPS.MethodsData of 104 participants from an ongoing study on people with moderate MUPS were used in this cross-sectional study. Ten independent variables were measured at baseline to determine their association with reduced work functioning: severity of psychosocial symptoms (four domains, measured with the Four-Dimensional Symptom Questionnaire), physical health (RAND 36-Item Health Survey), moderate or vigorous physical activity (Activ8 activity monitor), age, sex, education level and duration of complaints. Two separate multivariable linear regression analyses were performed with backward stepwise selection, for both impaired work performance and absenteeism.ResultsAbsenteeism rate rose with 2.5 and 0.6% for every increased point on the Four-Dimensional Symptom Questionnaire for domain 'depression' (B = 0.025, SE = 0.009, p = .006) and domain 'somatization' (B = 0.006, SE = 0.003, p = .086), respectively. An R2 value of 0.118 was found. Impaired work performance rate rose with 0.2 and 0.5% for every increased point on the Four-Dimensional Symptom Questionnaire for domain 'distress' (B = 0.002, SE = 0.001, p = .084) and domain 'somatization' (B = 0.005, SE = 0.001, p < .001), respectively. An R2 value of 0.252 was found.ConclusionsSeverity of distress, probability of a depressive disorder and probability of somatization are positively associated with higher rates of reduced work functioning in people with moderate MUPS. To prevent long-term absenteeism and highly impaired work performance severity of psychosocial symptoms seem to play a significant role. However, because of the low percentage of explained variance, additional research is necessary to gain insight in other factors that might explain the variance in reduced work functioning even better.

Dataset Information

Effectiveness of a blended multidisciplinary intervention for patients with moderate medically unexplained physical symptoms (PARASOL): A cluster randomized clinical trial.

Introduction

Objective

Methods

Results

Conclusions

Publications

Effectiveness of a blended multidisciplinary intervention for patients with moderate medically unexplained physical symptoms (PARASOL): A cluster randomized clinical trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets