Patients' Perspectives on the Usability of a Blended Approach to an Integrated Intervention for Patients With Medically Unexplained Physical Symptoms: Mixed Methods Study.

BACKGROUND: Medically unexplained physical symptoms are physical symptoms, such as pain, fatigue, and dizziness, that persist for more than a few weeks and cannot be explained after adequate medical examination. Treatment for preventing the chronicity of symptoms is recommended. A promising approach is identifying patients who are at risk and subsequently offering a blended care intervention that focuses on promoting self-management while using eHealth as a supportive tool. When these interventions match with a patient's expectations, their effectiveness grows. OBJECTIVE: This study aimed to obtain more insights into usability from the patient perspective to improve future interventions. METHODS: A mixed methods design (ie, the use of qualitative and quantitative data) was used. Through semistructured interviews, in-depth insights were gained into patients' perspectives on usability. The analysis process was continuous and iterative. Data were synthesized and categorized into different themes. The System Usability Scale, which measures the usability of a system, was used to compare participants that found usability to be low, medium, or high. This study was approved by the Medical Ethical Committee Utrecht (approval number: 17-391/C). RESULTS: Saturation was reached after interviewing 13 participants. The following four themes emerged from the interviews: motivations and expectations prior to participating in the program, the applicability of e-coaching, the role of health care professionals, and the integrated design of the blended approach. CONCLUSIONS: The successful implementation of integrated blended care interventions based on patients' perspectives requires matching treatments to patients' individual situations and motivations. Furthermore, personalizing the relative frequency of face-to-face appointments and e-coaching can improve usability.

Demographic and health-related factors associated with reduced work functioning in people with moderate medically unexplained physical symptoms: a cross-sectional study.

BACKGROUND: Medically 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. METHODS: Data 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. RESULTS: Absenteeism 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. CONCLUSIONS: Severity 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.

Identification of patients with moderate medically unexplained physical symptoms in primary care with a five years follow-up.

BACKGROUND: Patients with medically unexplained physical symptoms (MUPS) are common in primary care, with a spectrum from mild to moderate and chronic MUPS. The burden of chronic MUPS is high, and early identification of moderate MUPS patients is important to prevent chronicity. The PRESUME screening method to identify moderate MUPS patients in primary care was developed, but insight in prognostic accuracy is needed. Therefore, our objective is to determine the prognostic accuracy for identification of moderate MUPS patients using the screening method with 5 year follow-up. METHODS: The PRESUME screening method consists of three subsequent steps based on consultation frequency, exclusion of medical/psychiatric diagnosis and identification of MUPS. In a random 10% sample of patients from the Julius General Practitioners Network (n = 114.185), patients were identified with mild, moderate or chronic MUPS in 2008 (index year), using routine care data. In 5 years follow-up we calculated predictive values and odds ratio's for sustained MUPS related symptoms. RESULTS: In 2008, 789 patients (6.9% of the patient population) were identified as having mild, moderate or chronic MUPS. On average 55.5% of the moderate MUPS patients in 2008, still had MUPS related symptoms or developed chronic MUPS in 5 year follow-up. Positive predictive values for maintaining MUPS related symptoms or worsening was 67% after 1 year, and 48.7% after 5 years for moderate MUPS patients. CONCLUSION: The prognostic accuracy of the PRESUME screening method using electronic medical record data for identification of moderate MUPS patients is moderate. However, it might be a useful method to identify patients at increased risk of moderate MUPS, if combined with a validity check by the GP.

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

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.

Identifying Treatment Modalities for a Multidisciplinary and Blended Care Intervention for Patients With Moderate Medically Unexplained Physical Symptoms: Qualitative Study Among Professionals.

BACKGROUND: Medically 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. OBJECTIVE: The 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. METHODS: Two 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. RESULTS: A 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. CONCLUSIONS: From 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.

Effectiveness of a Blended Multidisciplinary Intervention for Patients with Moderate Medically Unexplained Physical Symptoms (PARASOL): Protocol for a Cluster Randomized Clinical Trial.

BACKGROUND: Medically unexplained physical symptoms are an important health problem in primary care, with a spectrum from mild to chronic. The burden of chronic medically unexplained physical symptoms is substantial for patients, health care professionals, and society. Therefore, early identification of patients with moderate medically unexplained physical symptoms is needed in order to prevent chronicity. The preventive screening of medically unexplained physical symptoms (PRESUME) screening method was developed using data from the electronic medical record of the patients' general practitioner and demonstrated its prognostic accuracy to identify patients with moderate medically unexplained physical symptoms. In the next step, we developed a proactive blended and integrated mental health and physical therapy intervention program (PARASOL) to reduce complaints of moderate medically unexplained physical symptoms, stimulate self-management, and prevent chronicity. OBJECTIVE: The primary objective of this study is to investigate the effectiveness of the blended PARASOL intervention on the impact of symptoms and quality of life in patients with moderate medically unexplained physical symptoms compared with usual care. Secondary objectives are to study the effect on severity of physical and psychosocial symptoms, general health, physical behavior, illness perception, and self-efficacy in patients with moderate medically unexplained physical symptoms as well as to determine the cost-effectiveness of the program. METHODS: This paper presents the study protocol of a multicenter cluster randomized clinical trial. Adult patients with moderate medically unexplained physical symptoms will be identified from electronic medical record data using the PRESUME screening method and proactively recruited for participation in the study. Cluster randomization will be performed at the level of the participating health care centers. In total 248 patients with moderate medically unexplained physical symptoms (124 patients per arm) are needed. The PARASOL intervention is a 12-week blended primary care program consisting of 4 face-to-face consultations with the mental health nurse and 5 physical therapy sessions, supplemented with a Web-based program. The Web-based program contains (1) information modules and videos on self-management and educative themes, (2) videos and instructions on prescribed home exercises, and (3) assignments to gradually increase the physical activity. The program is directed at patients' perception of symptoms as well as modifiable prognostic risk factors for chronicity using therapeutic neuroscience education. It encourages self-management, as well as an active lifestyle using a cognitive behavioral approach and graded activity. Primary outcomes are impact of symptoms and quality of life. Secondary outcomes are severity of physical and psychosocial symptoms, general health, physical behavior, illness perceptions, self-efficacy, and cost-effectiveness. All measurements will be performed at baseline, 3 and 12 months after baseline. Retrospective cost questionnaires will also be sent at 6 and 9 months after baseline and these will be used for the cost-effectiveness analysis. RESULTS: The intervention has been developed, and the physical therapists and mental health nurses in the participating experimental health care centers have received two days of training on the content of the blended PARASOL intervention. The recruitment of health care centers started in June 2016 and inclusion of patients began in March 2017. Follow-up assessments of patients are expected to be completed in March 2019. CONCLUSIONS: This study is the first randomized clinical trial to determine the effectiveness (including cost-effectiveness) of a proactive, blended, and integrated mental health and physical therapy care program for patients with moderate medically unexplained physical symptoms. The findings will help to improve the treatment for patients with moderate medically unexplained physical symptoms and prevent chronicity. TRIAL REGISTRATION: Netherlands Trial Register NTR6755; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6755 (Archived by WebCite at http://www.webcitation.org/6ywporY7u).