Interdisciplinary multimodal pain therapy (IMPT) is a biopsychosocial treatment approach for patients with chronic pain that comprises at least psychological and physiotherapeutic interventions. Core outcome sets (COSs) are currently developed in different medical fields to standardize and improve the selection of outcome domains, and measurement instruments in clinical trials, to make trial results meaningful, to pool trial results, and to allow indirect comparison between interventions. The objective of this study was to develop a COS of patient-relevant outcome domains for chronic pain in IMPT clinical trials. An international, multiprofessional panel (patient representatives [n = 5], physicians specialized in pain medicine [n = 5], physiotherapists [n = 5], clinical psychologists [n = 5], and methodological researchers [n = 5]) was recruited for a 3-stage consensus study, which consisted of a mixed-method approach comprising an exploratory systematic review, a preparing online survey to identify important outcome domains, a face-to-face consensus meeting to agree on COS domains, and a second online survey (Delphi) establishing agreement on definitions for the domains included. The panel agreed on the following 8 domains to be included into the COS for IMPT: pain intensity, pain frequency, physical activity, emotional wellbeing, satisfaction with social roles and activities, productivity (paid and unpaid, at home and at work, inclusive presentism and absenteeism), health-related quality of life, and patient's perception of treatment goal achievement. The complexity of chronic pain in a biopsychosocial context is reflected in the current recommendation and includes physical, mental, and social outcomes. In a subsequent step, measurement instruments will be identified via systematic reviews.
Background: Although interdisciplinary multimodal pain treatment (IMPT) programs are widely regarded as treatment of choice for patients with chronic pain, there are signs that many patients are unable to maintain their treatment gains in the long term. To facilitate the maintenance of positive treatment outcomes over time, we developed two relapse prevention strategies. Objective: The main objective of this study was to explore the feasibility of these strategies within the context of IMPT programs. Methods: We performed a feasibility study using 3 workbook prototypes containing either one or both strategies. For a period of 6 months, the workbooks were made available in two IMPT facilities. Qualitative data were collected through a focus group and semistructured interviews. We performed a thematic analysis using a deductive approach with (1) applicability to the treatment program, (2) acceptability of the workbook content, and (3) form, as predefined themes. Results: The final dataset consisted of transcripts from a focus group with health care providers and 11 telephone interviews and 2 additional in-depth interviews with patients. In general, the intervention was perceived as useful, easy to use, and in line with the treatment program. The data also include suggestions to further improve the use of both strategies, including more specific implementation guidelines, revised goal-setting procedure, and development of a mobile health version. However, several factors, including a high dropout rate and small sample size, impact the external validity of our findings. Conclusions: This study should be regarded as a first step in the process of transforming the prototype workbook into an effective intervention for clinical practice. Although these initial results indicate a favorable evaluation of both behavior regulation strategies within the workbook, this study encountered multiple barriers regarding implementation and data collection that limit the generalizability of these results. Future research efforts should specifically address the fidelity of HCPs and patients and should include clear procedures regarding recruitment and use of both relapse prevention strategies during treatment.
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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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