Pub Date : 2024-10-10DOI: 10.1186/s13012-024-01378-4
Elizabeth Dodds, Sarah Redsell, Stephen Timmons, Joseph C Manning
Background/aims: The measurement of implementation outcomes can establish the success of implementing evidence into practice. However, implementation outcomes are seldom measured in acute healthcare settings, such as Paediatric Intensive Care Units (PICU), and if they are used, are likely to be non-validated, site or intervention-specific measures. To address this literature gap, this systematic review of systematic reviews aims to identify validated instruments to measure implementation outcomes of new EBP interventions in a PICU setting.
Methods: A systematic review of systematic reviews was conducted in two phases. Phase One: Five electronic databases were searched between 06/10/22 and 14/10/22. Systematic reviews were selected using pre-determined eligibility criteria. Methodological quality was assessed using the Critical Appraisal Skills Programme tool and a data extraction table was used to allow further synthesis. Phase Two: Secondary eligibility criteria were used to extract and review instruments from the systematic reviews selected in Phase One. Instruments were analysed and mapped to the Consolidated Framework of Implementation Research (CFIR).
Results: Phase One: Searches resulted in 3195 unique papers. Five systematic reviews were eligible for inclusion. All examined the psychometric properties of each instrument, utilising different methods to do so; three considered their pragmatic or usability properties; and one identified instruments that were transferrable to different settings. Each systematic review identified that most included instruments had limited evidence of their validity or reliability and had poor psychometric properties. Phase two: 93 instruments were screened, and nine were eligible for analysis. After analysis and CFIR mapping, two instruments were identified as potentially adaptable to the PICU setting.
Conclusions: The methodological quality of implementation outcome measurement instruments is inadequate, warranting further validation research. Two instruments were identified that cover multiple CFIR domains and have scope to be adapted for use when implementing evidence-based practice into the PICU. Further work is needed to adapt and further validate an instrument for use in practice.
Trial registration: For transparency of procedures and methods, the protocol for this systematic review was registered with PROSPERO (registration number CRD42022361638L).
{"title":"What validated instruments, that measure implementation outcomes, are suitable for use in the Paediatric Intensive Care Unit (PICU) setting? A systematic review of systematic reviews.","authors":"Elizabeth Dodds, Sarah Redsell, Stephen Timmons, Joseph C Manning","doi":"10.1186/s13012-024-01378-4","DOIUrl":"10.1186/s13012-024-01378-4","url":null,"abstract":"<p><strong>Background/aims: </strong>The measurement of implementation outcomes can establish the success of implementing evidence into practice. However, implementation outcomes are seldom measured in acute healthcare settings, such as Paediatric Intensive Care Units (PICU), and if they are used, are likely to be non-validated, site or intervention-specific measures. To address this literature gap, this systematic review of systematic reviews aims to identify validated instruments to measure implementation outcomes of new EBP interventions in a PICU setting.</p><p><strong>Methods: </strong>A systematic review of systematic reviews was conducted in two phases. Phase One: Five electronic databases were searched between 06/10/22 and 14/10/22. Systematic reviews were selected using pre-determined eligibility criteria. Methodological quality was assessed using the Critical Appraisal Skills Programme tool and a data extraction table was used to allow further synthesis. Phase Two: Secondary eligibility criteria were used to extract and review instruments from the systematic reviews selected in Phase One. Instruments were analysed and mapped to the Consolidated Framework of Implementation Research (CFIR).</p><p><strong>Results: </strong>Phase One: Searches resulted in 3195 unique papers. Five systematic reviews were eligible for inclusion. All examined the psychometric properties of each instrument, utilising different methods to do so; three considered their pragmatic or usability properties; and one identified instruments that were transferrable to different settings. Each systematic review identified that most included instruments had limited evidence of their validity or reliability and had poor psychometric properties. Phase two: 93 instruments were screened, and nine were eligible for analysis. After analysis and CFIR mapping, two instruments were identified as potentially adaptable to the PICU setting.</p><p><strong>Conclusions: </strong>The methodological quality of implementation outcome measurement instruments is inadequate, warranting further validation research. Two instruments were identified that cover multiple CFIR domains and have scope to be adapted for use when implementing evidence-based practice into the PICU. Further work is needed to adapt and further validate an instrument for use in practice.</p><p><strong>Trial registration: </strong>For transparency of procedures and methods, the protocol for this systematic review was registered with PROSPERO (registration number CRD42022361638L).</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"19 1","pages":"70"},"PeriodicalIF":8.8,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11466035/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142402038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-04DOI: 10.1186/s13012-024-01399-z
Paul Wilson, Gregory A Aarons, Anne Sales, Dong Roman Xu, Michel Wensing, Alison Hutchinson, Rinad S Beidas, Elvin Geng
This editorial updates the scope and submission expectations of Implementation Science and Implementation Science Communications. We refine our protocol publishing policies and set out new expectations for reporting studies describing determinants and their relationship with implementation outcomes. Our central focus remains on the implementation of evidence-based interventions into healthcare practice and policy. We are most interested in rigorous empirical studies of the implementation of evidence-based healthcare interventions, practices, and policies, and the de-implementation of those that are demonstrated to be of low-value or no benefit. Alongside this, we remain interested in the systematic study of implementation mechanisms and processes and on the influences of patient, professional, and organizational behaviours. Novel theoretical and methodological developments are considered. For all submissions, we expect authors to demonstrate how their work is integrated with existing knowledge in the field and to clearly state the added value of the work to the field broadly.
{"title":"Revisiting the scope and expectations of Implementation Science and Implementation Science Communications.","authors":"Paul Wilson, Gregory A Aarons, Anne Sales, Dong Roman Xu, Michel Wensing, Alison Hutchinson, Rinad S Beidas, Elvin Geng","doi":"10.1186/s13012-024-01399-z","DOIUrl":"10.1186/s13012-024-01399-z","url":null,"abstract":"<p><p>This editorial updates the scope and submission expectations of Implementation Science and Implementation Science Communications. We refine our protocol publishing policies and set out new expectations for reporting studies describing determinants and their relationship with implementation outcomes. Our central focus remains on the implementation of evidence-based interventions into healthcare practice and policy. We are most interested in rigorous empirical studies of the implementation of evidence-based healthcare interventions, practices, and policies, and the de-implementation of those that are demonstrated to be of low-value or no benefit. Alongside this, we remain interested in the systematic study of implementation mechanisms and processes and on the influences of patient, professional, and organizational behaviours. Novel theoretical and methodological developments are considered. For all submissions, we expect authors to demonstrate how their work is integrated with existing knowledge in the field and to clearly state the added value of the work to the field broadly.</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"19 1","pages":"69"},"PeriodicalIF":8.8,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11452926/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142376339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-30DOI: 10.1186/s13012-024-01398-0
Guillaume Fontaine, Billy Vinette, Charlene Weight, Marc-André Maheu-Cadotte, Andréane Lavallée, Marie-France Deschênes, Alexandra Lapierre, Sonia A Castiglione, Gabrielle Chicoine, Geneviève Rouleau, Nikolas Argiropoulos, Kristin Konnyu, Meagan Mooney, Christine E Cassidy, Tanya Mailhot, Patrick Lavoie, Catherine Pépin, Sylvie Cossette, Marie-Pierre Gagnon, Sonia Semenic, Nicola Straiton, Sandy Middleton
<p><strong>Background: </strong>Implementation strategies targeting individual healthcare professionals and teams, such as audit and feedback, educational meetings, opinion leaders, and reminders, have demonstrated potential in promoting evidence-based nursing practice. This systematic review examined the effects of the 19 Cochrane Effective Practice and Organization Care (EPOC) healthcare professional-level implementation strategies on nursing practice and patient outcomes.</p><p><strong>Methods: </strong>A systematic review was conducted following the Cochrane Handbook, with six databases searched up to February 2023 for randomized studies and non-randomized controlled studies evaluating the effects of EPOC implementation strategies on nursing practice. Study selection and data extraction were performed in Covidence. Random-effects meta-analyses were conducted in RevMan, while studies not eligible for meta-analysis were synthesized narratively based on the direction of effects. The quality of evidence was assessed using GRADE.</p><p><strong>Results: </strong>Out of 21,571 unique records, 204 studies (152 randomized, 52 controlled, non-randomized) enrolling 36,544 nurses and 340,320 patients were included. Common strategies (> 10% of studies) were educational meetings, educational materials, guidelines, reminders, audit and feedback, tailored interventions, educational outreach, and opinion leaders. Implementation strategies as a whole improved clinical practice outcomes compared to no active intervention, despite high heterogeneity. Group and individual education, patient-mediated interventions, reminders, tailored interventions and opinion leaders had statistically significant effects on clinical practice outcomes. Individual education improved nurses' attitude, knowledge, perceived control, and skills, while group education also influenced perceived social norms. Although meta-analyses indicate a small, non-statistically significant effect of multifaceted versus single strategies on clinical practice, the narrative synthesis of non-meta-analyzed studies shows favorable outcomes in all studies comparing multifaceted versus single strategies. Group and individual education, as well as tailored interventions, had statistically significant effects on patient outcomes.</p><p><strong>Conclusions: </strong>Multiple types of implementation strategies may enhance evidence-based nursing practice, though effects vary due to strategy complexity, contextual factors, and variability in outcome measurement. Some evidence suggests that multifaceted strategies are more effective than single component strategies. Effects on patient outcomes are modest. Healthcare organizations and implementation practitioners may consider employing multifaceted, tailored strategies to address local barriers, expand the use of underutilized strategies, and assess the long-term impact of strategies on nursing practice and patient outcomes.</p><p><strong>Trial registration: </str
{"title":"Effects of implementation strategies on nursing practice and patient outcomes: a comprehensive systematic review and meta-analysis.","authors":"Guillaume Fontaine, Billy Vinette, Charlene Weight, Marc-André Maheu-Cadotte, Andréane Lavallée, Marie-France Deschênes, Alexandra Lapierre, Sonia A Castiglione, Gabrielle Chicoine, Geneviève Rouleau, Nikolas Argiropoulos, Kristin Konnyu, Meagan Mooney, Christine E Cassidy, Tanya Mailhot, Patrick Lavoie, Catherine Pépin, Sylvie Cossette, Marie-Pierre Gagnon, Sonia Semenic, Nicola Straiton, Sandy Middleton","doi":"10.1186/s13012-024-01398-0","DOIUrl":"10.1186/s13012-024-01398-0","url":null,"abstract":"<p><strong>Background: </strong>Implementation strategies targeting individual healthcare professionals and teams, such as audit and feedback, educational meetings, opinion leaders, and reminders, have demonstrated potential in promoting evidence-based nursing practice. This systematic review examined the effects of the 19 Cochrane Effective Practice and Organization Care (EPOC) healthcare professional-level implementation strategies on nursing practice and patient outcomes.</p><p><strong>Methods: </strong>A systematic review was conducted following the Cochrane Handbook, with six databases searched up to February 2023 for randomized studies and non-randomized controlled studies evaluating the effects of EPOC implementation strategies on nursing practice. Study selection and data extraction were performed in Covidence. Random-effects meta-analyses were conducted in RevMan, while studies not eligible for meta-analysis were synthesized narratively based on the direction of effects. The quality of evidence was assessed using GRADE.</p><p><strong>Results: </strong>Out of 21,571 unique records, 204 studies (152 randomized, 52 controlled, non-randomized) enrolling 36,544 nurses and 340,320 patients were included. Common strategies (> 10% of studies) were educational meetings, educational materials, guidelines, reminders, audit and feedback, tailored interventions, educational outreach, and opinion leaders. Implementation strategies as a whole improved clinical practice outcomes compared to no active intervention, despite high heterogeneity. Group and individual education, patient-mediated interventions, reminders, tailored interventions and opinion leaders had statistically significant effects on clinical practice outcomes. Individual education improved nurses' attitude, knowledge, perceived control, and skills, while group education also influenced perceived social norms. Although meta-analyses indicate a small, non-statistically significant effect of multifaceted versus single strategies on clinical practice, the narrative synthesis of non-meta-analyzed studies shows favorable outcomes in all studies comparing multifaceted versus single strategies. Group and individual education, as well as tailored interventions, had statistically significant effects on patient outcomes.</p><p><strong>Conclusions: </strong>Multiple types of implementation strategies may enhance evidence-based nursing practice, though effects vary due to strategy complexity, contextual factors, and variability in outcome measurement. Some evidence suggests that multifaceted strategies are more effective than single component strategies. Effects on patient outcomes are modest. Healthcare organizations and implementation practitioners may consider employing multifaceted, tailored strategies to address local barriers, expand the use of underutilized strategies, and assess the long-term impact of strategies on nursing practice and patient outcomes.</p><p><strong>Trial registration: </str","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"19 1","pages":"68"},"PeriodicalIF":8.8,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11443951/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142332711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-27DOI: 10.1186/s13012-024-01396-2
Cristián Mansilla, Qi Wang, Thomas Piggott, Peter Bragge, Kerry Waddell, Gordon Guyatt, Arthur Sweetman, John N Lavis
Background: The COVID-19 pandemic has had an unprecedented impact in the global research production and has also increased research waste. Living evidence syntheses (LESs) seek to regularly update a body of evidence addressing a specific question. During the COVID-19 pandemic, the production and dissemination of LESs emerged as a cornerstone of the evidence infrastructure. This critical interpretive synthesis answers the questions: What constitutes an LES to support decision-making?; when should one be produced, updated, and discontinued?; and how should one be disseminated?
Methods: Searches included the Cochrane Library, EMBASE (Ovid), Health Systems Evidence, MEDLINE (Ovid), PubMed, and Web of Science up to 23 April 2024 and included articles that provide any insights on addressing the compass questions on LESs. Articles were selected and appraised, and their insights extracted. An interpretive and iterative coding process was used to identify relevant thematic categories and create a conceptual framework.
Results: Among the 16,630 non-duplicate records identified, 208 publications proved eligible. Most were non-empirical articles, followed by actual LESs. Approximately one in three articles were published in response to the COVID-19 pandemic. The conceptual framework addresses six thematic categories: (1) what is an LES; (2) what methodological approaches facilitate LESs production; (3) when to produce an LES; (4) when to update an LES; (5) how to make available the findings of an LES; and (6) when to discontinue LES updates.
Conclusion: LESs can play a critical role in reducing research waste and ensuring alignment with advisory and decision-making processes. This critical interpretive synthesis provides relevant insights on how to better organize the global evidence architecture to support their production.
背景:COVID-19 大流行对全球研究成果产生了前所未有的影响,同时也增加了研究浪费。活证据综述(LES)旨在定期更新针对特定问题的一整套证据。在 COVID-19 大流行期间,活证据综述的制作和传播成为证据基础设施的基石。这篇重要的解释性综述回答了以下问题:什么是支持决策的 LES?何时应编制、更新和终止 LES?搜索范围包括 Cochrane Library、EMBASE (Ovid)、Health Systems Evidence、MEDLINE (Ovid)、PubMed 和 Web of Science,搜索时间截止到 2024 年 4 月 23 日,其中包括对解决 LES 指南问题有任何见解的文章。对文章进行了筛选和评估,并提取了其观点。采用解释性和迭代式编码过程确定相关主题类别并创建概念框架:在已确定的 16,630 条非重复记录中,有 208 篇出版物符合条件。大部分是非实证性文章,其次是实际的 LES。大约每三篇文章中就有一篇是针对 COVID-19 大流行发表的。该概念框架涉及六个专题类别:(1)什么是 LES;(2)哪些方法有利于 LES 的编制;(3)何时编制 LES;(4)何时更新 LES;(5)如何提供 LES 的研究结果;以及(6)何时停止 LES 的更新:LES 可在减少研究浪费、确保与咨询和决策过程保持一致方面发挥关键作用。这篇重要的解释性综述就如何更好地组织全球证据架构以支持其生产提供了相关见解:试验注册:PROSPERO 注册:CRD42021241875。
{"title":"A living critical interpretive synthesis to yield a framework on the production and dissemination of living evidence syntheses for decision-making.","authors":"Cristián Mansilla, Qi Wang, Thomas Piggott, Peter Bragge, Kerry Waddell, Gordon Guyatt, Arthur Sweetman, John N Lavis","doi":"10.1186/s13012-024-01396-2","DOIUrl":"https://doi.org/10.1186/s13012-024-01396-2","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic has had an unprecedented impact in the global research production and has also increased research waste. Living evidence syntheses (LESs) seek to regularly update a body of evidence addressing a specific question. During the COVID-19 pandemic, the production and dissemination of LESs emerged as a cornerstone of the evidence infrastructure. This critical interpretive synthesis answers the questions: What constitutes an LES to support decision-making?; when should one be produced, updated, and discontinued?; and how should one be disseminated?</p><p><strong>Methods: </strong>Searches included the Cochrane Library, EMBASE (Ovid), Health Systems Evidence, MEDLINE (Ovid), PubMed, and Web of Science up to 23 April 2024 and included articles that provide any insights on addressing the compass questions on LESs. Articles were selected and appraised, and their insights extracted. An interpretive and iterative coding process was used to identify relevant thematic categories and create a conceptual framework.</p><p><strong>Results: </strong>Among the 16,630 non-duplicate records identified, 208 publications proved eligible. Most were non-empirical articles, followed by actual LESs. Approximately one in three articles were published in response to the COVID-19 pandemic. The conceptual framework addresses six thematic categories: (1) what is an LES; (2) what methodological approaches facilitate LESs production; (3) when to produce an LES; (4) when to update an LES; (5) how to make available the findings of an LES; and (6) when to discontinue LES updates.</p><p><strong>Conclusion: </strong>LESs can play a critical role in reducing research waste and ensuring alignment with advisory and decision-making processes. This critical interpretive synthesis provides relevant insights on how to better organize the global evidence architecture to support their production.</p><p><strong>Trial registration: </strong>PROSPERO registration: CRD42021241875.</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"19 1","pages":"67"},"PeriodicalIF":8.8,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11429155/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142332710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-16DOI: 10.1186/s13012-024-01395-3
Nicole L. Johnson, Jennifer Van Tiem, Erin Balkenende, DeShauna Jones, Julia E. Friberg, Emily E. Chasco, Jane Moeckli, Kenda S. Steffensmeier, Melissa J. A. Steffen, Kanika Arora, Borsika A. Rabin, Heather Schacht Reisinger
Communication is considered an inherent element of nearly every implementation strategy. Often it is seen as a means for imparting new information between stakeholders, representing a Transaction orientation to communication. From a Process orientation, communication is more than information-exchange and is acknowledged as being shaped by (and shaping) the individuals involved and their relationships with one another. As the field of Implementation Science (IS) works to strengthen theoretical integration, we encourage an interdisciplinary approach that engages communication theory to develop richer understanding of strategies and determinants of practice. We interviewed 28 evaluators, 12 implementors, and 12 administrators from 21 Enterprise-Wide Initiatives funded by the Department of Veteran Affairs Office of Rural Health. Semi-structured interviews focused on experiences with implementation and evaluation strategies. We analyzed the interviews using thematic analysis identifying a range of IS constructs. Then we deductively classified those segments based on a Transaction or Process orientation to communication. We organized findings using the two IS constructs most commonly discussed in interviews: Collaboration and Leadership Buy-in. The majority of segments coded as Collaboration (n = 34, 74%) and Leadership Buy-in (n = 31, 70%) discussed communication from a Transaction orientation and referred to communication as synonymous with information exchange, which emphasizes the task over the relationships between the individuals performing the tasks. Conversely, when participants discussed Collaboration and Leadership Buy-in from a Process orientation, they acknowledged both constructs as the result of long-term efforts to develop positive relationships based on trust and respect, and emphasized the time costliness of such strategies. Our findings demonstrate that participants who discussed communication from a Process orientation recognized the nuance and complexity of interpersonal interactions, particularly in the context of IS. Efficient, reliable information exchange is a critical but often overemphasized element of implementation. Practitioners and researchers must recognize and incorporate the larger role of communication in IS. Two suggestions for engaging a Process orientation to communication are to: (a) use interview probes to learn how communication is enacted, and (b) use process-oriented communication theories to develop interventions and evaluation tools.
{"title":"Gaps in communication theory paradigms when conducting implementation science research: qualitative observations from interviews with administrators, implementors, and evaluators of rural health programs","authors":"Nicole L. Johnson, Jennifer Van Tiem, Erin Balkenende, DeShauna Jones, Julia E. Friberg, Emily E. Chasco, Jane Moeckli, Kenda S. Steffensmeier, Melissa J. A. Steffen, Kanika Arora, Borsika A. Rabin, Heather Schacht Reisinger","doi":"10.1186/s13012-024-01395-3","DOIUrl":"https://doi.org/10.1186/s13012-024-01395-3","url":null,"abstract":"Communication is considered an inherent element of nearly every implementation strategy. Often it is seen as a means for imparting new information between stakeholders, representing a Transaction orientation to communication. From a Process orientation, communication is more than information-exchange and is acknowledged as being shaped by (and shaping) the individuals involved and their relationships with one another. As the field of Implementation Science (IS) works to strengthen theoretical integration, we encourage an interdisciplinary approach that engages communication theory to develop richer understanding of strategies and determinants of practice. We interviewed 28 evaluators, 12 implementors, and 12 administrators from 21 Enterprise-Wide Initiatives funded by the Department of Veteran Affairs Office of Rural Health. Semi-structured interviews focused on experiences with implementation and evaluation strategies. We analyzed the interviews using thematic analysis identifying a range of IS constructs. Then we deductively classified those segments based on a Transaction or Process orientation to communication. We organized findings using the two IS constructs most commonly discussed in interviews: Collaboration and Leadership Buy-in. The majority of segments coded as Collaboration (n = 34, 74%) and Leadership Buy-in (n = 31, 70%) discussed communication from a Transaction orientation and referred to communication as synonymous with information exchange, which emphasizes the task over the relationships between the individuals performing the tasks. Conversely, when participants discussed Collaboration and Leadership Buy-in from a Process orientation, they acknowledged both constructs as the result of long-term efforts to develop positive relationships based on trust and respect, and emphasized the time costliness of such strategies. Our findings demonstrate that participants who discussed communication from a Process orientation recognized the nuance and complexity of interpersonal interactions, particularly in the context of IS. Efficient, reliable information exchange is a critical but often overemphasized element of implementation. Practitioners and researchers must recognize and incorporate the larger role of communication in IS. Two suggestions for engaging a Process orientation to communication are to: (a) use interview probes to learn how communication is enacted, and (b) use process-oriented communication theories to develop interventions and evaluation tools.","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"40 1","pages":""},"PeriodicalIF":7.2,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142252224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-16DOI: 10.1186/s13012-024-01393-5
Jennifer Shuldiner, Meagan Lacroix, Marianne Saragosa, Catherine Reis, Kevin L. Schwartz, Sharon Gushue, Valerie Leung, Jeremy Grimshaw, Michael Silverman, Kednapa Thavorn, Jerome A. Leis, Michael Kidd, Nick Daneman, Mina Tradous, Bradley Langford, Andrew M. Morris, Jonathan Lam, Gary Garber, Jamie Brehaut, Monica Taljaard, Michelle Greiver, Noah Michael Ivers
Unnecessary antibiotic prescriptions in primary care are common and contribute to antimicrobial resistance in the population. Audit and feedback (A&F) on antibiotic prescribing to primary care can improve the appropriateness of antibiotic prescribing, but the optimal approach is uncertain. We performed two pragmatic randomized controlled trials of different approaches to audit and feedback. The trial results showed that A&F was associated with significantly reducing antibiotic prescribing. Still, the effect size was small, and the modifications to the A&F interventions tested in the trials were not associated with any change. Herein, we report a theory-informed qualitative process evaluation to explore potential mechanisms underlying the observed effects. Ontario family physicians in the intervention arms of both trials who were sent A&F letters were invited for one-on-one interviews. Purposive sampling was used to seek variation across interested participants in personal and practice characteristics. Qualitative analysis utilized inductive and deductive techniques informed by the Clinical Performance Feedback Intervention Theory. Modifications to the intervention design tested in the trial did not alter prescribing patterns beyond the changes made in response to the A&F overall for various reasons. Change in antibiotic prescribing in response to A&F depended on whether it led to the formation of specific intentions and whether those intentions translated to particular behaviours. Those without intentions to change tended to feel that their unique clinical context was not represented in the A&F. Those with intentions but without specific actions taken tended to express a lack of self-efficacy for avoiding a prescription in contexts with time constraints and/or without an ongoing patient relationship. Many participants noted that compared to overall prescribing, A&F on antibiotic prescription duration was perceived as new information and easily actionable. Our findings indicate that contextual factors, including the types of patients and the setting where they are seen, affect how clinicians react to audit and feedback. These results suggest a need to test tailored feedback reports that reflect the context of how, where, and why physicians prescribe antibiotics so that they might be perceived as more personal and more actionable. Clinical Trial registration IDs: NCT04594200, NCT05044052.
{"title":"Process evaluation of two large randomized controlled trials to understand factors influencing family physicians’ use of antibiotic audit and feedback reports","authors":"Jennifer Shuldiner, Meagan Lacroix, Marianne Saragosa, Catherine Reis, Kevin L. Schwartz, Sharon Gushue, Valerie Leung, Jeremy Grimshaw, Michael Silverman, Kednapa Thavorn, Jerome A. Leis, Michael Kidd, Nick Daneman, Mina Tradous, Bradley Langford, Andrew M. Morris, Jonathan Lam, Gary Garber, Jamie Brehaut, Monica Taljaard, Michelle Greiver, Noah Michael Ivers","doi":"10.1186/s13012-024-01393-5","DOIUrl":"https://doi.org/10.1186/s13012-024-01393-5","url":null,"abstract":"Unnecessary antibiotic prescriptions in primary care are common and contribute to antimicrobial resistance in the population. Audit and feedback (A&F) on antibiotic prescribing to primary care can improve the appropriateness of antibiotic prescribing, but the optimal approach is uncertain. We performed two pragmatic randomized controlled trials of different approaches to audit and feedback. The trial results showed that A&F was associated with significantly reducing antibiotic prescribing. Still, the effect size was small, and the modifications to the A&F interventions tested in the trials were not associated with any change. Herein, we report a theory-informed qualitative process evaluation to explore potential mechanisms underlying the observed effects. Ontario family physicians in the intervention arms of both trials who were sent A&F letters were invited for one-on-one interviews. Purposive sampling was used to seek variation across interested participants in personal and practice characteristics. Qualitative analysis utilized inductive and deductive techniques informed by the Clinical Performance Feedback Intervention Theory. Modifications to the intervention design tested in the trial did not alter prescribing patterns beyond the changes made in response to the A&F overall for various reasons. Change in antibiotic prescribing in response to A&F depended on whether it led to the formation of specific intentions and whether those intentions translated to particular behaviours. Those without intentions to change tended to feel that their unique clinical context was not represented in the A&F. Those with intentions but without specific actions taken tended to express a lack of self-efficacy for avoiding a prescription in contexts with time constraints and/or without an ongoing patient relationship. Many participants noted that compared to overall prescribing, A&F on antibiotic prescription duration was perceived as new information and easily actionable. Our findings indicate that contextual factors, including the types of patients and the setting where they are seen, affect how clinicians react to audit and feedback. These results suggest a need to test tailored feedback reports that reflect the context of how, where, and why physicians prescribe antibiotics so that they might be perceived as more personal and more actionable. Clinical Trial registration IDs: NCT04594200, NCT05044052.","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"4 1","pages":""},"PeriodicalIF":7.2,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142252225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-11DOI: 10.1186/s13012-024-01392-6
Birgitte Graverholt, Birgitte Espehaug, Donna Ciliska, Thomas Potrebny
Improving the uptake of relevant and reliable research is an important priority in long-term care to achieve sustainable and high-quality services for the increasingly older population. The purpose was to assess the effectiveness of a tailored, adaptive and a multifaceted KT capacity program, relative to usual practice, on the implementation of National Early Warning Score 2 (NEWS2). This study was carried out as a pragmatic cluster-randomized controlled trial. The capacity program consisted of an educational part to address implementation capacity gaps and a facilitation-upon-implementation part to address a relevant knowledge gap in nursing homes. A collective decision was made to address the challenge of early detection of clinical deterioration among nursing home residents, by implementing the (NEWS2) as clinical innovation. Public nursing homes in a Norwegian municipality (n = 21) with a total of 1 466 beds were eligible for inclusion. The study-period spanned over a 22-month period, including a 12-month follow-up. Data was extracted from the Electronic Patient Journal system and analyzed using multilevel growth model analysis. The intervention had a large effect on the use of NEWS2 among care staff in intervention nursing homes, compared to the control group (standardized mean difference, d = 2.42). During the final month of the implementation period, residents in the intervention group was assessed with NEWS2 1.44 times (95% CI: 1.23, 1.64) per month, which is almost four times more often than in the control group (mean = 0.38, 95% CI: 0.19, 0.57). During the follow-up period, the effect of the intervention was not only sustained in the intervention group but there was a substantial increase in the use of NEWS2 in both the intervention (mean = 1.75, 95% CI: 1.55, 1.96) and control groups (mean = 1.45, 95% CI: 1.27, 1.65). This tailored implementation strategy had a large effect on the use of NEWS2 among care staff, demonstrating that integrated knowledge translation strategies can be a promising strategy to achieve evidence-based care in the nursing home sector. ISRCTN12437773 . Registered 19/3 2020, retrospectively.
{"title":"The effectiveness of a knowledge translation intervention on the implementation of NEWS2 in nursing homes, a pragmatic cluster RCT","authors":"Birgitte Graverholt, Birgitte Espehaug, Donna Ciliska, Thomas Potrebny","doi":"10.1186/s13012-024-01392-6","DOIUrl":"https://doi.org/10.1186/s13012-024-01392-6","url":null,"abstract":"Improving the uptake of relevant and reliable research is an important priority in long-term care to achieve sustainable and high-quality services for the increasingly older population. The purpose was to assess the effectiveness of a tailored, adaptive and a multifaceted KT capacity program, relative to usual practice, on the implementation of National Early Warning Score 2 (NEWS2). This study was carried out as a pragmatic cluster-randomized controlled trial. The capacity program consisted of an educational part to address implementation capacity gaps and a facilitation-upon-implementation part to address a relevant knowledge gap in nursing homes. A collective decision was made to address the challenge of early detection of clinical deterioration among nursing home residents, by implementing the (NEWS2) as clinical innovation. Public nursing homes in a Norwegian municipality (n = 21) with a total of 1 466 beds were eligible for inclusion. The study-period spanned over a 22-month period, including a 12-month follow-up. Data was extracted from the Electronic Patient Journal system and analyzed using multilevel growth model analysis. The intervention had a large effect on the use of NEWS2 among care staff in intervention nursing homes, compared to the control group (standardized mean difference, d = 2.42). During the final month of the implementation period, residents in the intervention group was assessed with NEWS2 1.44 times (95% CI: 1.23, 1.64) per month, which is almost four times more often than in the control group (mean = 0.38, 95% CI: 0.19, 0.57). During the follow-up period, the effect of the intervention was not only sustained in the intervention group but there was a substantial increase in the use of NEWS2 in both the intervention (mean = 1.75, 95% CI: 1.55, 1.96) and control groups (mean = 1.45, 95% CI: 1.27, 1.65). This tailored implementation strategy had a large effect on the use of NEWS2 among care staff, demonstrating that integrated knowledge translation strategies can be a promising strategy to achieve evidence-based care in the nursing home sector. ISRCTN12437773 . Registered 19/3 2020, retrospectively.","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"24 1","pages":""},"PeriodicalIF":7.2,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142191571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-11DOI: 10.1186/s13012-024-01394-4
Sanne Peters, Lisa Guccione, Jill Francis, Stephanie Best, Emma Tavender, Janet Curran, Katie Davies, Stephanie Rowe, Victoria J. Palmer, Marlena Klaic
Co-design with consumers and healthcare professionals is widely used in applied health research. While this approach appears to be ethically the right thing to do, a rigorous evaluation of its process and impact is frequently missing. Evaluation of research co-design is important to identify areas of improvement in the methods and processes, as well as to determine whether research co-design leads to better outcomes. We aimed to build on current literature to develop a framework to assist researchers with the evaluation of co-design processes and impacts. A multifaceted, iterative approach, including three steps, was undertaken to develop a Co-design Evaluation Framework: 1) A systematic overview of reviews; 2) Stakeholder panel meetings to discuss and debate findings from the overview of reviews and 3) Consensus meeting with stakeholder panel. The systematic overview of reviews included relevant papers published between 2000 and 2022. OVID (Medline, Embase, PsycINFO), EBSCOhost (Cinahl) and the Cochrane Database of Systematic reviews were searched for papers that reported co-design evaluation or outcomes in health research. Extracted data was inductively analysed and evaluation themes were identified. Review findings were presented to a stakeholder panel, including consumers, healthcare professionals and researchers, to interpret and critique. A consensus meeting, including a nominal group technique, was applied to agree upon the Co-design Evaluation Framework. A total of 51 reviews were included in the systematic overview of reviews. Fifteen evaluation themes were identified and grouped into the following seven clusters: People (within co-design group), group processes, research processes, co-design context, people (outside co-design group), system and sustainment. If evaluation methods were mentioned, they mainly included qualitative data, informal consumer feedback and researchers’ reflections. The Co-Design Evaluation Framework used a tree metaphor to represent the processes and people in the co-design group (below-ground), underpinning system- and people-level outcomes beyond the co-design group (above-ground). To evaluate research co-design, researchers may wish to consider any or all components in the tree. The Co-Design Evaluation Framework has been collaboratively developed with various stakeholders to be used prospectively (planning for evaluation), concurrently (making adjustments during the co-design process) and retrospectively (reviewing past co-design efforts to inform future activities).
{"title":"Evaluation of research co-design in health: a systematic overview of reviews and development of a framework","authors":"Sanne Peters, Lisa Guccione, Jill Francis, Stephanie Best, Emma Tavender, Janet Curran, Katie Davies, Stephanie Rowe, Victoria J. Palmer, Marlena Klaic","doi":"10.1186/s13012-024-01394-4","DOIUrl":"https://doi.org/10.1186/s13012-024-01394-4","url":null,"abstract":"Co-design with consumers and healthcare professionals is widely used in applied health research. While this approach appears to be ethically the right thing to do, a rigorous evaluation of its process and impact is frequently missing. Evaluation of research co-design is important to identify areas of improvement in the methods and processes, as well as to determine whether research co-design leads to better outcomes. We aimed to build on current literature to develop a framework to assist researchers with the evaluation of co-design processes and impacts. A multifaceted, iterative approach, including three steps, was undertaken to develop a Co-design Evaluation Framework: 1) A systematic overview of reviews; 2) Stakeholder panel meetings to discuss and debate findings from the overview of reviews and 3) Consensus meeting with stakeholder panel. The systematic overview of reviews included relevant papers published between 2000 and 2022. OVID (Medline, Embase, PsycINFO), EBSCOhost (Cinahl) and the Cochrane Database of Systematic reviews were searched for papers that reported co-design evaluation or outcomes in health research. Extracted data was inductively analysed and evaluation themes were identified. Review findings were presented to a stakeholder panel, including consumers, healthcare professionals and researchers, to interpret and critique. A consensus meeting, including a nominal group technique, was applied to agree upon the Co-design Evaluation Framework. A total of 51 reviews were included in the systematic overview of reviews. Fifteen evaluation themes were identified and grouped into the following seven clusters: People (within co-design group), group processes, research processes, co-design context, people (outside co-design group), system and sustainment. If evaluation methods were mentioned, they mainly included qualitative data, informal consumer feedback and researchers’ reflections. The Co-Design Evaluation Framework used a tree metaphor to represent the processes and people in the co-design group (below-ground), underpinning system- and people-level outcomes beyond the co-design group (above-ground). To evaluate research co-design, researchers may wish to consider any or all components in the tree. The Co-Design Evaluation Framework has been collaboratively developed with various stakeholders to be used prospectively (planning for evaluation), concurrently (making adjustments during the co-design process) and retrospectively (reviewing past co-design efforts to inform future activities).","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"23 1","pages":""},"PeriodicalIF":7.2,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142191572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-04DOI: 10.1186/s13012-024-01391-7
Zephanie Tyack, Steven McPhail, Gregory A Aarons, Kelly McGrath, Andrew Barron, Hannah Carter, Sarah Larkins, Adrian Barnett, Eloise Hummell, Ruth Tulleners, Olivia Fisher, Gillian Harvey, Lee Jones, Kate Murray, Bridget Abell
Background: A dramatic decline in mental health of people worldwide in the early COVID-19 pandemic years has not recovered. In rural and remote Australia, access to appropriate and timely mental health services has been identified as a major barrier to people seeking help for mental ill-health. From 2020 to 2021 a care navigation model, Navicare, was co-designed with rural and remote communities in the Greater Whitsunday Region of Central Queensland in Australia. The Exploration, Preparation, Implementation and Sustainment (EPIS) framework was used to design and guide multiple aspects of a multisite study, The Bridging Study, to evaluate the implementation of Navicare in Australia.
Methods: A community-engaged hybrid effectiveness-implementation study design will focus on the tailored implementation of Navicare at three new sites as well as monitoring implementation at an existing site established since 2021. Study outcomes assessed will include sustained access as the co-primary outcome (measured using access to Navicare mental health referral services) and Proctor's Implementation Outcomes of feasibility, acceptability, appropriateness, adoption, fidelity, implementation cost, and sustainability. Data collection for the implementation evaluation will include service usage data, community consultations, interviews, and workshops; analysed using mixed methods and guided by EPIS and other implementation frameworks. Pre-post effectiveness and cost-consequence study components are embedded in the implementation and sustainment phases, with comparison to pre-implementation data and value assessed for each EPIS phase using hospital, service, and resource allocation data. A scaling up strategy will be co-developed using a national roundtable forum in the final year of the study. Qualitative exploration of other aspects of the study (e.g., mechanisms of action and stakeholder engagement) will be conducted.
Discussion: Our study will use tailoring to local sites and a community-engaged approach to drive implementation of a mental health care navigation service in rural and remote Australia, with expected benefits to mental healthcare access. This approach is consistent with policy recommendations nationally and internationally as building blocks for rural health including the World Health Organization Framework for Action on Strengthening Health Systems to Improve Health Outcomes.
Trial registration: Prospectively registered on April 2, 2024, on the Australian New Zealand Clinical Trials Registry, no. ACTRN12624000382572. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386665&isReview=true .
{"title":"Evaluating the tailored implementation of a multisite care navigation service for mental health in rural and remote Australia (The Bridging Study): protocol for a community-engaged hybrid effectiveness-implementation study.","authors":"Zephanie Tyack, Steven McPhail, Gregory A Aarons, Kelly McGrath, Andrew Barron, Hannah Carter, Sarah Larkins, Adrian Barnett, Eloise Hummell, Ruth Tulleners, Olivia Fisher, Gillian Harvey, Lee Jones, Kate Murray, Bridget Abell","doi":"10.1186/s13012-024-01391-7","DOIUrl":"10.1186/s13012-024-01391-7","url":null,"abstract":"<p><strong>Background: </strong>A dramatic decline in mental health of people worldwide in the early COVID-19 pandemic years has not recovered. In rural and remote Australia, access to appropriate and timely mental health services has been identified as a major barrier to people seeking help for mental ill-health. From 2020 to 2021 a care navigation model, Navicare, was co-designed with rural and remote communities in the Greater Whitsunday Region of Central Queensland in Australia. The Exploration, Preparation, Implementation and Sustainment (EPIS) framework was used to design and guide multiple aspects of a multisite study, The Bridging Study, to evaluate the implementation of Navicare in Australia.</p><p><strong>Methods: </strong>A community-engaged hybrid effectiveness-implementation study design will focus on the tailored implementation of Navicare at three new sites as well as monitoring implementation at an existing site established since 2021. Study outcomes assessed will include sustained access as the co-primary outcome (measured using access to Navicare mental health referral services) and Proctor's Implementation Outcomes of feasibility, acceptability, appropriateness, adoption, fidelity, implementation cost, and sustainability. Data collection for the implementation evaluation will include service usage data, community consultations, interviews, and workshops; analysed using mixed methods and guided by EPIS and other implementation frameworks. Pre-post effectiveness and cost-consequence study components are embedded in the implementation and sustainment phases, with comparison to pre-implementation data and value assessed for each EPIS phase using hospital, service, and resource allocation data. A scaling up strategy will be co-developed using a national roundtable forum in the final year of the study. Qualitative exploration of other aspects of the study (e.g., mechanisms of action and stakeholder engagement) will be conducted.</p><p><strong>Discussion: </strong>Our study will use tailoring to local sites and a community-engaged approach to drive implementation of a mental health care navigation service in rural and remote Australia, with expected benefits to mental healthcare access. This approach is consistent with policy recommendations nationally and internationally as building blocks for rural health including the World Health Organization Framework for Action on Strengthening Health Systems to Improve Health Outcomes.</p><p><strong>Trial registration: </strong>Prospectively registered on April 2, 2024, on the Australian New Zealand Clinical Trials Registry, no. ACTRN12624000382572. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386665&isReview=true .</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"19 1","pages":"62"},"PeriodicalIF":8.8,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11373177/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142134538","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-19DOI: 10.1186/s13012-024-01385-5
Anna C Raper, Benita L Weathers, Theodore G Drivas, Colin A Ellis, Colleen Morse Kripke, Randall A Oyer, Anjali T Owens, Anurag Verma, Paul E Wileyto, Colin C Wollack, Wenting Zhou, Marylyn D Ritchie, Robert A Schnoll, Katherine L Nathanson
Background: Germline genetic testing is recommended for an increasing number of conditions with underlying genetic etiologies, the results of which impact medical management. However, genetic testing is underutilized in clinics due to system, clinician, and patient level barriers. Behavioral economics provides a framework to create implementation strategies, such as nudges, to address these multi-level barriers and increase the uptake of genetic testing for conditions where the results impact medical management.
Methods: Patients meeting eligibility for germline genetic testing for a group of conditions will be identified using electronic phenotyping algorithms. A pragmatic, type 3 hybrid cluster randomization study will test nudges to patients and/or clinicians, or neither. Clinicians who receive nudges will be prompted to either refer their patient to genetics or order genetic testing themselves. We will use rapid cycle approaches informed by clinician and patient experiences, health equity, and behavioral economics to optimize these nudges before trial initiation. The primary implementation outcome is uptake of germline genetic testing for the pre-selected health conditions. Patient data collected through the electronic health record (e.g. demographics, geocoded address) will be examined as moderators of the effect of nudges.
Discussion: This study will be one of the first randomized trials to examine the effects of patient- and clinician-directed nudges informed by behavioral economics on uptake of genetic testing. The pragmatic design will facilitate a large and diverse patient sample, allow for the assessment of genetic testing uptake, and provide comparison of the effect of different nudge combinations. This trial also involves optimization of patient identification, test selection, ordering, and result reporting in an electronic health record-based infrastructure to further address clinician-level barriers to utilizing genomic medicine. The findings may help determine the impact of low-cost, sustainable implementation strategies that can be integrated into health care systems to improve the use of genomic medicine.
Trial registration: ClinicalTrials.gov. NCT06377033. Registered on March 31, 2024. https://clinicaltrials.gov/study/NCT06377033?term=NCT06377033&rank=1.
{"title":"Protocol for a type 3 hybrid implementation cluster randomized clinical trial to evaluate the effect of patient and clinician nudges to advance the use of genomic medicine across a diverse health system.","authors":"Anna C Raper, Benita L Weathers, Theodore G Drivas, Colin A Ellis, Colleen Morse Kripke, Randall A Oyer, Anjali T Owens, Anurag Verma, Paul E Wileyto, Colin C Wollack, Wenting Zhou, Marylyn D Ritchie, Robert A Schnoll, Katherine L Nathanson","doi":"10.1186/s13012-024-01385-5","DOIUrl":"10.1186/s13012-024-01385-5","url":null,"abstract":"<p><strong>Background: </strong>Germline genetic testing is recommended for an increasing number of conditions with underlying genetic etiologies, the results of which impact medical management. However, genetic testing is underutilized in clinics due to system, clinician, and patient level barriers. Behavioral economics provides a framework to create implementation strategies, such as nudges, to address these multi-level barriers and increase the uptake of genetic testing for conditions where the results impact medical management.</p><p><strong>Methods: </strong>Patients meeting eligibility for germline genetic testing for a group of conditions will be identified using electronic phenotyping algorithms. A pragmatic, type 3 hybrid cluster randomization study will test nudges to patients and/or clinicians, or neither. Clinicians who receive nudges will be prompted to either refer their patient to genetics or order genetic testing themselves. We will use rapid cycle approaches informed by clinician and patient experiences, health equity, and behavioral economics to optimize these nudges before trial initiation. The primary implementation outcome is uptake of germline genetic testing for the pre-selected health conditions. Patient data collected through the electronic health record (e.g. demographics, geocoded address) will be examined as moderators of the effect of nudges.</p><p><strong>Discussion: </strong>This study will be one of the first randomized trials to examine the effects of patient- and clinician-directed nudges informed by behavioral economics on uptake of genetic testing. The pragmatic design will facilitate a large and diverse patient sample, allow for the assessment of genetic testing uptake, and provide comparison of the effect of different nudge combinations. This trial also involves optimization of patient identification, test selection, ordering, and result reporting in an electronic health record-based infrastructure to further address clinician-level barriers to utilizing genomic medicine. The findings may help determine the impact of low-cost, sustainable implementation strategies that can be integrated into health care systems to improve the use of genomic medicine.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov. NCT06377033. Registered on March 31, 2024. https://clinicaltrials.gov/study/NCT06377033?term=NCT06377033&rank=1.</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"19 1","pages":"61"},"PeriodicalIF":8.8,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11331805/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142005965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}