Dataset Information

Innovation in Pain Rehabilitation Using Co-Design Methods During the Development of a Relapse Prevention Intervention: Case Study.

ABSTRACT:

Background

Many intervention development projects fail to bridge the gap from basic research to clinical practice. Instead of theory-based approaches to intervention development, co-design prioritizes the end users' perspective as well as continuous collaboration between stakeholders, designers, and researchers throughout the project. This alternative approach to the development of interventions is expected to promote the adaptation to existing treatment activities and to be responsive to the requirements of end users.

Objective

The first objective was to provide an overview of all activities that were employed during the course of a research project to develop a relapse prevention intervention for interdisciplinary pain treatment programs. The second objective was to examine how co-design may contribute to stakeholder involvement, generation of relevant insights and ideas, and incorporation of stakeholder input into the intervention design.

Methods

We performed an embedded single case study and used the double diamond model to describe the process of intervention development. Using all available data sources, we also performed deductive content analysis to reflect on this process.

Results

By critically reviewing the value and function of a co-design project with respect to idea generation, stakeholder involvement, and incorporation of stakeholder input into the intervention design, we demonstrated how co-design shaped the transition from ideas, via concepts, to a prototype for a relapse prevention intervention.

Conclusions

Structural use of co-design throughout the project resulted in many different participating stakeholders and stimulating design activities. As a consequence, the majority of the components of the final prototype can be traced back to the information that stakeholders provided during the project. Although this illustrates how co-design facilitates the integration of contextual information into the intervention design, further experimental testing is required to evaluate to what extent this approach ultimately leads to improved usability as well as patient outcomes in the context of clinical practice.

SUBMITTER: Elbers S

PROVIDER: S-EPMC7857944 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Innovation in Pain Rehabilitation Using Co-Design Methods During the Development of a Relapse Prevention Intervention: Case Study.

Elbers Stefan S van Gessel Christa C Renes Reint Jan RJ van der Lugt Remko R Wittink Harriët H Hermsen Sander S

Journal of medical Internet research 20210120 1

<h4>Background</h4>Many intervention development projects fail to bridge the gap from basic research to clinical practice. Instead of theory-based approaches to intervention development, co-design prioritizes the end users' perspective as well as continuous collaboration between stakeholders, designers, and researchers throughout the project. This alternative approach to the development of interventions is expected to promote the adaptation to existing treatment activities and to be responsive t ...[more]

PMID: 33470937

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Project description:BackgroundSupported self-management interventions, which assist individuals in actively understanding and managing their own health conditions, have a robust evidence base for chronic physical illnesses, such as diabetes, but have been underused for long-term mental health conditions.ObjectiveThis study aims to co-design and user test a mental health supported self-management intervention, My Personal Recovery Plan (MyPREP), that could be flexibly delivered via digital and traditional paper-based mediums.MethodsThis study adopted a participatory design, user testing, and rapid prototyping methodologies, guided by 2 frameworks: the 2021 Medical Research Council framework for complex interventions and an Australian co-production framework. Participants were aged ≥18 years, self-identified as having a lived experience of using mental health services or working in a peer support role, and possessed English proficiency. The co-design and user testing processes involved a first round with 6 participants, focusing on adapting a self-management resource used in a large-scale randomized controlled trial in the United Kingdom, followed by a second round with 4 new participants for user testing the co-designed digital version. A final round for gathering qualitative feedback from 6 peer support workers was conducted. Data analysis involved transcription, coding, and thematic interpretation as well as the calculation of usability scores using the System Usability Scale.ResultsThe key themes identified during the co-design and user testing sessions were related to (1) the need for self-management tools to be flexible and well-integrated into mental health services, (2) the importance of language and how language preferences vary among individuals, (3) the need for self-management interventions to have the option of being supported when delivered in services, and (4) the potential of digitization to allow for a greater customization of self-management tools and the development of features based on individuals' unique preferences and needs. The MyPREP paper version received a total usability score of 71, indicating C+ or good usability, whereas the digital version received a total usability score of 85.63, indicating A or excellent usability.ConclusionsThere are international calls for mental health services to promote a culture of self-management, with supported self-management interventions being routinely offered. The resulting co-designed prototype of the Australian version of the self-management intervention MyPREP provides an avenue for supporting self-management in practice in a flexible manner. Involving end users, such as consumers and peer workers, from the beginning is vital to address their need for personalized and customized interventions and their choice in how interventions are delivered. Further implementation-effectiveness piloting of MyPREP in real-world mental health service settings is a critical next step.

Project description:BackgroundPolyunsaturated fatty acid (PUFA) metabolism abnormalities have been long implicated in the etiology of schizophrenia. Although several randomized clinical trials have been carried out to assess the efficacy of omega-3 PUFA as add-on therapy in reducing psychopathology in populations of chronic patients with schizophrenia, only a few concern first-episode schizophrenia. The majority of these studies used a 12-week intervention based on ethyl-eicosapentaenoic acid (ethyl-EPA), however, with conflicting results. An intervention based on docosahexaenoic acid plus EPA has not been used in first-episode schizophrenia studies so far. No add-on supplementation studies have been carried out in medicated first-episode schizophrenia patients to assess the efficacy of omega-3 PUFA in preventing relapses.MethodsA randomized placebo-controlled one-center trial will be used to compare the efficacy of 26-week intervention, composed of either 1320 mg/day of EPA and 880 mg/day of DHA, or olive oil placebo with regard to symptom severity and relapse rate in first-episode schizophrenia patients. Eighty-two patients (aged 16-35) will be recruited for the study. Eligible patients will be randomly allocated to one of two intervention arms: an active arm or a placebo arm (olive oil). The primary outcome measure of the clinical evaluation is schizophrenia symptom severity measured by the Positive and Negative Syndrome Scale (PANSS). Other outcomes include depressive symptoms, patient functioning and the level of insight. Correlates of change measured during the study will include structural brain changes, oxidative stress and defense, as well as neuroplasticity indicators. Metabolic syndrome components will also be assessed throughout the study.DiscussionBy comparing 26-week administration of EPA + DHA or (placebo) olive oil as add-on therapy in reducing symptom severity and one-year relapse rate in patients with first episode schizophrenia, it is intended to provide new insights into the efficacy of omega-3 PUFA and correlates of change, and contribute to the improvement of mental health care for individuals suffering from schizophrenia.Trial registrationThis study has been registered at Clinical Trials.gov with the following number: NCT02210962 .

Project description:BackgroundHuman-centered design, or design thinking, offers an extensive toolkit of methods and strategies for user-centered engagement that lends itself well to intervention development and implementation. These methods can be applied to the fields of public health and medicine to design interventions that may be more feasible and viable in real-world contexts than those developed with different methods.ObjectiveThe design team aimed to develop approaches to building food skills among caregivers of children aged 0-5 years who are eligible for a federal food assistance program while they were in the grocery store.MethodsThey applied 3 specific human-centered design methods-Extremes and Mainstreams, Journey Mapping, and Co-Creation Sessions-to collaboratively develop intervention approaches to enhance Supplemental Nutrition Assistance Program Education (SNAP-Ed) reach and impact across food retail settings. Extremes and Mainstreams is a specific kind of purposive sampling that selects individuals based on characteristics beyond demographics. Journey Mapping is a visual tool that asks individuals to identify key moments and decision points during an experience. Co-Creation Sessions are choreographed opportunities for individuals to explicitly contribute to the design of a solution alongside research or design team members.ResultsTen caregivers with diverse lived experiences were selected to participate in remote design thinking workshops and create individual journey maps to depict their grocery store experiences. Common happy points and pain points were identified. Nine stakeholders, including caregivers, SNAP-Ed staff, and grocery store dieticians, cocreated 2 potential intervention approaches informed by caregivers' experiences and needs: a rewards program and a meal box option.ConclusionsThese 3 human-centered design methods led to a meaningful co-design process where proposed interventions aligned with caregivers' wants and needs. This case study provides other public health practitioners with specific examples of how to use these methods in program development and stakeholder engagement as well as lessons learned when adapting these methods to remote settings.

Project description:BACKGROUND:Serious gaming could support patients in learning to cope with chronic pain or functional somatic syndromes and reduce symptom burdens. OBJECTIVE:To realize this potential, insight is needed into how, why, for whom, and when it works in actual treatment circumstances. METHODS:Following a realist approach, process evaluations were performed before, during, and after a two-armed, natural quasi-experiment (n=275). A group of patients with interfering chronic pain or fatigue symptoms received a short additional blended mindfulness-based serious gaming intervention during a multidisciplinary rehabilitation program. A control group only received the regular rehabilitation program. During two sessions before and one session after the experiment, expectations about serious gaming processes were discussed in focus groups with local care providers, implementers, and experts. Patients participated in a survey (n=114) and in semistructured interviews (n=10). The qualitative data were used to develop tentative expectations about aspects of serious gaming that, in certain patients and circumstances, trigger mechanisms of learning and health outcome change. Hypotheses about indicative quantitative data patterns for tentative expectations were formulated before inspecting, describing, and analyzing-with regression models-routinely collected clinical outcome data. An updated program theory was formulated after mixing the qualitative and quantitative results. RESULTS:Qualitative data showed that a subset of patients perceived improvement of their self-awareness in moments of daily social interactions. These results were explained by patients, who played the serious game LAKA, as a "confrontation with yourself," which reflected self-discrepancies. Important characteristics of serious gaming in the study's context included innovation factors of relative advantage with experiential learning opportunity, compatibility with the treatment approach, and the limited flexibility in regard to patient preferences. Perceived patient factors included age and style of coping with stress or pain. Learning perceptions could also depend on care provider role-taking and the planning and facilitating (ie, local organization) of serious gaming introduction and feedback sessions in small groups of patients. Quantitative data showed very small average differences between the study groups in self-reported depression, pain, and fatigue changes (-.07<beta<-.17, all 95% CI upper bounds <0), which were mediated by small group differences in mindfulness (beta=.26, 95% CI .02-.51). Mindfulness changes were positively associated with patient involvement in serious gaming (n=114, beta=.36, P=.001). Acceptance of serious gaming was lower in older patients. Average health outcome changes went up to a medium size in patients that reported lower active coping with stress and lower pain coping before serious gaming. Mindfulness changes and gaming acceptance perceptions covaried with group structure and immediate feedback sessions after serious gaming. CONCLUSIONS:This study developed transferable insight into how and why serious gaming can facilitate additional learning about coping in order to reduce burdens of chronic pain or fatigue symptoms in certain patients and in actual treatment circumstances. Future studies are needed to continue the development of this fallible theory. Such research will further support decisions about using, designing, allocating, and tailoring serious gaming to optimize important patient health benefits. TRIAL REGISTRATION:Netherlands Trial Register NTR6020; https://www.trialregister.nl/trial/5754.

Project description:BackgroundPersistent postsurgical pain (PPSP) is a common complication that impacts quality of life, often necessitating long-term opioid treatment. Certain neurocognitive factors, including reduced performance on cognitive flexibility tasks, are associated with increased risk of PPSP. We examine the perceptions of surgical patients and clinicians with regard to perioperative pain management activities and needs; patient acceptance and use of a perioperative neurocognitive training intervention; and implementation feasibility.MethodsWe conducted both individual and focus group interviews with patients undergoing thoracic surgery and clinicians in an academic medical center. The Consolidated Framework for Intervention Research guided the development of interview questions related to the adoption and implementation of a neurocognitive intervention to mitigate PPSP. A thematic analysis was used to analyze the responses.ResultsForty patients and 15 clinicians participated. Interviews revealed that there is minimal discussion between clinicians and patients about PPSP. Most participants were receptive to a neurocognitive intervention to prevent PPSP, if evidence demonstrating its effectiveness were available. Potential barriers to neurocognitive training program adoption included fatigue, cognitive overload, lack of familiarity with the technology used for delivering the intervention, and immediate postoperative pain and stress. Implementation facilitators would include patient education about the intervention, incentives for its use, and daily reminders.ConclusionThe study identified several guiding principles for addressing patients' and clinicians' barriers to effectively implementing a neurocognitive training intervention to mitigate PPSP after surgery. To ensure the sustainability of neurocognitive interventions for preventing PPSP, such interventions would need to be adapted to meet patients' and clinicians' needs within the perioperative context.

Project description:There are very few drugs that prevent the relapse of Plasmodium vivax malaria in man. Tinidazole is a 5-nitroimidazole approved in the USA for the treatment of indications including amoebiasis and giardiasis. In the non-human primate relapsing Plasmodium cynomolgi/macaque malaria model, tinidazole cured one of six macaques studied with an apparent mild delay to relapse in the other five of 14-28 days compared to 11-12 days in controls. One study has demonstrated activity against P. vivax in man. Presented here are the results of a pilot phase II, randomized, open-label study conducted along the Thai-Myanmar border designed to evaluate the efficacy of tinidazole to prevent relapse of P. vivax when administered with chloroquine.This study utilized a modified triangular test sequential analysis which allows repeated statistical evaluation during the course of enrolment while maintaining a specified power and type 1 error and minimizing recruitment of subjects. Enrolment was to be halted when a pre-specified success/failure ratio was surpassed. The study was designed to have a 5% type 1 error and 90% power to show whether tinidazole would produce a relapse rate of less than 20% or greater than 45% through Day 63 of weekly follow-up after initiation of treatment and initial parasite clearance with 3 days of an oral weight based dosing of chloroquine and five days of 2 grams/day of tinidazole.All subjects cleared their parasitaemia by Day 3. Six of the first seven subjects treated with tinidazole relapsed prior to Day 63 (average Day 48.3 (range 42-56)). This exceeded the upper boundary of the triangular test and enrolment to receive tinidazole was halted. A concurrent cohort of five subjects definitively treated with standard doses of primaquine and chloroquine (historically 100% effective) showed no episodes of recurrent P. vivax parasitaemia during the 63-day protocol specified follow-up period.Tinidazole is ineffective in preventing relapse of P. vivax at the dose used. The macaque relapsing model appeared to correctly predict outcome in humans. Use of the modified triangular test allowed minimal enrolment and limited unnecessary exposure to the study drug and reduced costs. This adds weight to the ethical and economic advantages of this study design to evaluate similarly situated drugs.ClinicalTrials.gov NCT00811096.

Dataset Information

Innovation in Pain Rehabilitation Using Co-Design Methods During the Development of a Relapse Prevention Intervention: Case Study.

Background

Objective

Methods

Results

Conclusions

Publications

Innovation in Pain Rehabilitation Using Co-Design Methods During the Development of a Relapse Prevention Intervention: Case Study.

Similar Datasets

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