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.

Effectiveness of remote physiotherapeutic e-Health interventions on pain in patients with musculoskeletal disorders: a systematic review.

PURPOSE: To systematically review the literature on effectiveness of remote physiotherapeutic e-Health interventions on pain in patients with musculoskeletal disorders. MATERIALS AND METHODS: Using online data sources PubMed, Embase, and Cochrane in adults with musculoskeletal disorders with a pain-related complaint. Remote physiotherapeutic e-Health interventions were analysed. Control interventions were not specified. Outcomes on effect of remote e-Health interventions in terms of pain intensity. RESULTS: From 11,811 studies identified, 27 studies were included. There is limited evidence for the effectiveness for remote e-Health for patients with back pain based on five articles. Twelve articles studied chronic pain and the effectiveness was dependent on the control group and involvement of healthcare providers. In patients with osteoarthritis (five articles), total knee surgery (two articles), and knee pain (three articles) no significant effects were found for remote e-Health compared to control groups. CONCLUSIONS: There is limited evidence for the effectiveness of remote physiotherapeutic e-Health interventions to decrease pain intensity in patients with back pain. There is some evidence for effectiveness of remote e-Health in patients with chronic pain. For patients with osteoarthritis, after total knee surgery and knee pain, there appears to be no effect of e-Health when solely looking at reduction of pain. Implications for rehabilitationThis review shows that e-Health can be an effective way of reducing pain in some populations.Remote physiotherapeutic e-Health interventions may decrease pain intensity in patients with back pain.Autonomous e-Health is more effective than no treatment in patients with chronic pain.There is no effect of e-Health in reduction of pain for patients with osteoarthritis, after total knee surgery and knee pain.

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.

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).