Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study
IntroductionPeople 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 provide...
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| Veröffentlicht in: | BMJ neurology open 2024-12, Vol.6 (2), p.e000966 |
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| creator | Altschuck, Natalie van Munster, Marlena Stümpel, Johanne Pedrosa, David Jose Wellach, Ingmar Boebinger, Hannes Geraedts, Max Pedrosa, David Jose Geraedts, Max Pedrosa, Anna Niemand, Kati Eggers, Carsten Becker, Dirk Pohlschmidt, Nicole Doblinger, Isabel Schmidt, Kristina Wolferts, Daniel Nisslmueller, Marius Beer, Gennet Ashraf, Mohammad Osman Eberhardt, Florian Wichartz, Rebecca Samans, Birgit Gross, Volker Sohrabi, Keywan Kalbe, Elke Kerkemeyer, Linda Folkerts, Ann-Kristin Seven, Uemran Olgemoeller, Paulina Huang, Xinyu Piet, Artur Irsfeld, Mona Grzegorzek, Marcin Altschuck, Natalie Munster, Marlena van Stümpel, Johanne Boebinger, Hannes Wellach, Ingmar |
| description | IntroductionPeople 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 analysisThe 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 disseminationEthical 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 registrationThis study was registered with the German Registry for Clinical Studies (DRKS)—number: DRKS00031092. |
| doi_str_mv | 10.1136/bmjno-2024-000966 |
| format | Article |
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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 analysisThe 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 disseminationEthical 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 registrationThis study was registered with the German Registry for Clinical Studies (DRKS)—number: DRKS00031092.</description><identifier>ISSN: 2632-6140</identifier><identifier>EISSN: 2632-6140</identifier><identifier>DOI: 10.1136/bmjno-2024-000966</identifier><identifier>PMID: 39737345</identifier><language>eng</language><publisher>England: BMJ Publishing Group Ltd</publisher><subject>Case management ; Chronic illnesses ; Collaboration ; Community nursing ; Data processing ; Disease ; Health care ; Home environment ; Integrated delivery systems ; Interdisciplinary aspects ; Intervention ; PARKINSON'S DISEASE ; Patients ; Protocol ; QUALITY OF LIFE ; Smartphones ; Systems design</subject><ispartof>BMJ neurology open, 2024-12, Vol.6 (2), p.e000966</ispartof><rights>Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.</rights><rights>Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.</rights><rights>2024 Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-b414t-fac4a6db4ef8fa2d8575c9141fd39668cf074d3548d9b1dd08be3ddfc208cedf3</cites><orcidid>0000-0002-3690-1295 ; 0009-0007-7857-2139</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://neurologyopen.bmj.com/content/6/2/e000966.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://neurologyopen.bmj.com/content/6/2/e000966.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2095,27903,27904,53769,53771,55328,77406,77432</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39737345$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Altschuck, Natalie</creatorcontrib><creatorcontrib>van Munster, Marlena</creatorcontrib><creatorcontrib>Stümpel, Johanne</creatorcontrib><creatorcontrib>Pedrosa, David Jose</creatorcontrib><creatorcontrib>Wellach, Ingmar</creatorcontrib><creatorcontrib>Boebinger, Hannes</creatorcontrib><creatorcontrib>Geraedts, Max</creatorcontrib><creatorcontrib>Pedrosa, David Jose</creatorcontrib><creatorcontrib>Geraedts, Max</creatorcontrib><creatorcontrib>Pedrosa, Anna</creatorcontrib><creatorcontrib>Niemand, Kati</creatorcontrib><creatorcontrib>Eggers, Carsten</creatorcontrib><creatorcontrib>Becker, Dirk</creatorcontrib><creatorcontrib>Pohlschmidt, Nicole</creatorcontrib><creatorcontrib>Doblinger, Isabel</creatorcontrib><creatorcontrib>Schmidt, Kristina</creatorcontrib><creatorcontrib>Wolferts, Daniel</creatorcontrib><creatorcontrib>Nisslmueller, Marius</creatorcontrib><creatorcontrib>Beer, Gennet</creatorcontrib><creatorcontrib>Ashraf, Mohammad Osman</creatorcontrib><creatorcontrib>Eberhardt, Florian</creatorcontrib><creatorcontrib>Wichartz, Rebecca</creatorcontrib><creatorcontrib>Samans, Birgit</creatorcontrib><creatorcontrib>Gross, Volker</creatorcontrib><creatorcontrib>Sohrabi, Keywan</creatorcontrib><creatorcontrib>Kalbe, Elke</creatorcontrib><creatorcontrib>Kerkemeyer, Linda</creatorcontrib><creatorcontrib>Folkerts, Ann-Kristin</creatorcontrib><creatorcontrib>Seven, Uemran</creatorcontrib><creatorcontrib>Olgemoeller, Paulina</creatorcontrib><creatorcontrib>Huang, Xinyu</creatorcontrib><creatorcontrib>Piet, Artur</creatorcontrib><creatorcontrib>Irsfeld, Mona</creatorcontrib><creatorcontrib>Grzegorzek, Marcin</creatorcontrib><creatorcontrib>Altschuck, Natalie</creatorcontrib><creatorcontrib>Munster, Marlena van</creatorcontrib><creatorcontrib>Stümpel, Johanne</creatorcontrib><creatorcontrib>Boebinger, Hannes</creatorcontrib><creatorcontrib>Wellach, Ingmar</creatorcontrib><creatorcontrib>ParkProReakt Collaborator Group</creatorcontrib><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><title>BMJ neurology open</title><addtitle>BMJ Neurol Open</addtitle><addtitle>BMJ Neurol Open</addtitle><description>IntroductionPeople 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 analysisThe 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 disseminationEthical 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 registrationThis study was registered with the German Registry for Clinical Studies (DRKS)—number: DRKS00031092.</description><subject>Case management</subject><subject>Chronic illnesses</subject><subject>Collaboration</subject><subject>Community nursing</subject><subject>Data processing</subject><subject>Disease</subject><subject>Health care</subject><subject>Home environment</subject><subject>Integrated delivery systems</subject><subject>Interdisciplinary aspects</subject><subject>Intervention</subject><subject>PARKINSON'S DISEASE</subject><subject>Patients</subject><subject>Protocol</subject><subject>QUALITY OF LIFE</subject><subject>Smartphones</subject><subject>Systems 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2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>BMJ neurology open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Altschuck, Natalie</au><au>van Munster, Marlena</au><au>Stümpel, Johanne</au><au>Pedrosa, David Jose</au><au>Wellach, Ingmar</au><au>Boebinger, Hannes</au><au>Geraedts, Max</au><au>Pedrosa, David Jose</au><au>Geraedts, Max</au><au>Pedrosa, Anna</au><au>Niemand, Kati</au><au>Eggers, Carsten</au><au>Becker, Dirk</au><au>Pohlschmidt, Nicole</au><au>Doblinger, Isabel</au><au>Schmidt, Kristina</au><au>Wolferts, Daniel</au><au>Nisslmueller, Marius</au><au>Beer, Gennet</au><au>Ashraf, Mohammad Osman</au><au>Eberhardt, Florian</au><au>Wichartz, Rebecca</au><au>Samans, Birgit</au><au>Gross, Volker</au><au>Sohrabi, Keywan</au><au>Kalbe, Elke</au><au>Kerkemeyer, Linda</au><au>Folkerts, Ann-Kristin</au><au>Seven, Uemran</au><au>Olgemoeller, Paulina</au><au>Huang, Xinyu</au><au>Piet, Artur</au><au>Irsfeld, Mona</au><au>Grzegorzek, Marcin</au><au>Altschuck, Natalie</au><au>Munster, Marlena van</au><au>Stümpel, Johanne</au><au>Boebinger, Hannes</au><au>Wellach, Ingmar</au><aucorp>ParkProReakt Collaborator Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study</atitle><jtitle>BMJ neurology open</jtitle><stitle>BMJ Neurol Open</stitle><addtitle>BMJ Neurol Open</addtitle><date>2024-12-01</date><risdate>2024</risdate><volume>6</volume><issue>2</issue><spage>e000966</spage><pages>e000966-</pages><issn>2632-6140</issn><eissn>2632-6140</eissn><abstract>IntroductionPeople 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 analysisThe 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 disseminationEthical 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 registrationThis study was registered with the German Registry for Clinical Studies (DRKS)—number: DRKS00031092.</abstract><cop>England</cop><pub>BMJ Publishing Group Ltd</pub><pmid>39737345</pmid><doi>10.1136/bmjno-2024-000966</doi><orcidid>https://orcid.org/0000-0002-3690-1295</orcidid><orcidid>https://orcid.org/0009-0007-7857-2139</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2632-6140 |
| ispartof | BMJ neurology open, 2024-12, Vol.6 (2), p.e000966 |
| issn | 2632-6140 2632-6140 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11683930 |
| source | BMJ Open Access Journals; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central Open Access; PubMed Central |
| subjects | Case management Chronic illnesses Collaboration Community nursing Data processing Disease Health care Home environment Integrated delivery systems Interdisciplinary aspects Intervention PARKINSON'S DISEASE Patients Protocol QUALITY OF LIFE Smartphones Systems design |
| title | Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study |
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