Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study
Introduction People with Parkinson’s disease (PwPD) experience a wide range of motor and non-motor symptoms that have a significant impact on their health and quality of life. Effective care management for PwPD involves monitoring symptoms at home, involving specialised multidisciplinary care provid...
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BMJ Publishing Group
2024-12-01
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| Series: | BMJ Neurology Open |
| Online Access: | https://neurologyopen.bmj.com/content/6/2/e000966.full |
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| author | Xinyu Huang Max Geraedts Elke Kalbe Carsten Eggers David José Pedrosa Ann-Kristin Folkerts Marcin Grzegorzek Marlena van Munster Johanne Stümpel Natalie Altschuck Ingmar Wellach Hannes Boebinger Anna Pedrosa Kati Niemand Dirk Becker Nicole Pohlschmidt Isabel Doblinger Kristina Schmidt Daniel Wolferts Marius Nisslmueller Gennet Beer Mohammad Osman Ashraf Florian Eberhardt Rebecca Wichartz Birgit Samans Volker Gross Keywan Sohrabi Linda Kerkemeyer Uemran Seven Paulina Olgemoeller Artur Piet Mona Irsfeld Marlena van Munster |
| author_facet | Xinyu Huang Max Geraedts Elke Kalbe Carsten Eggers David José Pedrosa Ann-Kristin Folkerts Marcin Grzegorzek Marlena van Munster Johanne Stümpel Natalie Altschuck Ingmar Wellach Hannes Boebinger Anna Pedrosa Kati Niemand Dirk Becker Nicole Pohlschmidt Isabel Doblinger Kristina Schmidt Daniel Wolferts Marius Nisslmueller Gennet Beer Mohammad Osman Ashraf Florian Eberhardt Rebecca Wichartz Birgit Samans Volker Gross Keywan Sohrabi Linda Kerkemeyer Uemran Seven Paulina Olgemoeller Artur Piet Mona Irsfeld Marlena van Munster |
| collection | DOAJ |
| description | Introduction People with Parkinson’s disease (PwPD) experience a wide range of motor and non-motor symptoms that have a significant impact on their health and quality of life. Effective care management for PwPD involves monitoring symptoms at home, involving specialised multidisciplinary care providers and enhancing self-management skills. This study protocol describes the process evaluation within a randomised clinical trial to assess the implementation and its impact on patient health outcomes of ParkProReakt—a proactive, multidisciplinary, digitally supported care model for community-dwelling PwPD.Methods and analysis The hybrid efficacy-implementation study will assess key implementation outcomes using the Medical Research Council framework for complex interventions alongside a randomised controlled trial. A combination of quantitative and qualitative methods will be used to assess process data from care providers and patients. The main process outcomes are fidelity, dose, feasibility and context. Context will be analysed through semistructured interviews and focus groups using the Consolidated Framework of Implementation Research. To elucidate potential facilitators and barriers to implementation and to gain deeper insights into the efficacy outcome data, quantitative and qualitative process data will be integrated at an interpretative level using mixed methods. In addition to process evaluation, potential indirect mechanisms of impact will be measured.Ethics and dissemination Ethical approval for this study was obtained from the responsible state medical ethics committees in Hesse and Hamburg, Germany. Results will be communicated to the funding body and disseminated through scientific publications.Trial registration This study was registered with the German Registry for Clinical Studies (DRKS)—number: DRKS00031092. |
| format | Article |
| id | doaj-art-e84141021bfa41bbb3cb6da816b900f5 |
| institution | Kabale University |
| issn | 2632-6140 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Neurology Open |
| spelling | doaj-art-e84141021bfa41bbb3cb6da816b900f52025-01-13T13:50:09ZengBMJ Publishing GroupBMJ Neurology Open2632-61402024-12-016210.1136/bmjno-2024-000966Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study Xinyu Huang0Max Geraedts1Elke Kalbe2Carsten Eggers3David José Pedrosa4Ann-Kristin Folkerts5Marcin Grzegorzek6Marlena van Munster7Johanne Stümpel8Natalie Altschuck9Ingmar Wellach10Hannes Boebinger11Anna PedrosaKati NiemandDirk BeckerNicole PohlschmidtIsabel DoblingerKristina SchmidtDaniel WolfertsMarius NisslmuellerGennet BeerMohammad Osman AshrafFlorian EberhardtRebecca WichartzBirgit SamansVolker GrossKeywan SohrabiLinda KerkemeyerUemran SevenPaulina OlgemoellerArtur PietMona IrsfeldMarlena van Munster2 Department of Clinical Medicine, Liaoning University of Traditional Chinese Medicine, Shenyang, ChinaInstitute for Health Services Research and Clinical Epidemiology, Philipps-Universität Marburg, Marburg, Germany1 Medical Psychology | Neuropsychology and Gender Studies & Center for Neuropsychological Diagnostics and Intervention (CeNDI), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany1Department of Neurology, University of Cologne, Cologne, GermanyCenter for Mind, Brain and Behaviour (CMBB), Philipps University Marburg, Marburg, Germany1 Medical Psychology | Neuropsychology and Gender Studies & Center for Neuropsychological Diagnostics and Intervention (CeNDI), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, GermanyInstitute of Medical Informatics, University of Lübeck, Lübeck, Germany1 Philipps-Universitat Marburg, Marburg, GermanyCenter for Life Ethics, University of Bonn, Bonn, GermanyInstitute for Health Services Research and Clinical Epidemiology, Philipps University Marburg, Marburg, GermanyPraxis für Neurologie und Psychiatrie Hamburg Walddörfer, Hamburg, GermanyInnovationsfonds & Produktportfolio, Techniker Krankenkasse, Hamburg, GermanyIntroduction People with Parkinson’s disease (PwPD) experience a wide range of motor and non-motor symptoms that have a significant impact on their health and quality of life. Effective care management for PwPD involves monitoring symptoms at home, involving specialised multidisciplinary care providers and enhancing self-management skills. This study protocol describes the process evaluation within a randomised clinical trial to assess the implementation and its impact on patient health outcomes of ParkProReakt—a proactive, multidisciplinary, digitally supported care model for community-dwelling PwPD.Methods and analysis The hybrid efficacy-implementation study will assess key implementation outcomes using the Medical Research Council framework for complex interventions alongside a randomised controlled trial. A combination of quantitative and qualitative methods will be used to assess process data from care providers and patients. The main process outcomes are fidelity, dose, feasibility and context. Context will be analysed through semistructured interviews and focus groups using the Consolidated Framework of Implementation Research. To elucidate potential facilitators and barriers to implementation and to gain deeper insights into the efficacy outcome data, quantitative and qualitative process data will be integrated at an interpretative level using mixed methods. In addition to process evaluation, potential indirect mechanisms of impact will be measured.Ethics and dissemination Ethical approval for this study was obtained from the responsible state medical ethics committees in Hesse and Hamburg, Germany. Results will be communicated to the funding body and disseminated through scientific publications.Trial registration This study was registered with the German Registry for Clinical Studies (DRKS)—number: DRKS00031092.https://neurologyopen.bmj.com/content/6/2/e000966.full |
| spellingShingle | Xinyu Huang Max Geraedts Elke Kalbe Carsten Eggers David José Pedrosa Ann-Kristin Folkerts Marcin Grzegorzek Marlena van Munster Johanne Stümpel Natalie Altschuck Ingmar Wellach Hannes Boebinger Anna Pedrosa Kati Niemand Dirk Becker Nicole Pohlschmidt Isabel Doblinger Kristina Schmidt Daniel Wolferts Marius Nisslmueller Gennet Beer Mohammad Osman Ashraf Florian Eberhardt Rebecca Wichartz Birgit Samans Volker Gross Keywan Sohrabi Linda Kerkemeyer Uemran Seven Paulina Olgemoeller Artur Piet Mona Irsfeld Marlena van Munster Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study BMJ Neurology Open |
| title | Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study |
| title_full | Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study |
| title_fullStr | Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study |
| title_full_unstemmed | Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study |
| title_short | Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study |
| title_sort | mixed methods process evaluation of a proactive approach to healthcare in parkinson s disease parkproreakt a protocol of a hybrid efficacy implementation study |
| url | https://neurologyopen.bmj.com/content/6/2/e000966.full |
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