Implementation Science最新文献

{"title":"Study protocol for a hybrid type 3 effectiveness-implementation trial of a team-based implementation strategy to support educators' use of a social engagement intervention.","authors":"Jill Locke, Aksheya Sridhar, Wendy Shih, Stephanie Shire, Andria B Eisman, Emily Kim, Adora Du, Christine Espeland, Connie Kasari","doi":"10.1186/s13012-024-01414-3","DOIUrl":"10.1186/s13012-024-01414-3","url":null,"abstract":"<p><strong>Background: </strong>Remaking Recess (RR) is a school-based evidence-based peer social engagement intervention for autistic students. RR involves direct training and coaching with educators; however, educators face several barriers to implementation at both the individual- and organizational-levels. This protocol paper describes a multi-site study that will test whether an educator-level implementation strategy, coaching, with or without a school-level implementation strategy, school-based teams, will maximize educators' use (fidelity and sustainment) of RR for autistic students and their peers who are socially-isolated, rejected, or peripheral and may need additional support during recess.</p><p><strong>Methods: </strong>This study will employ a hybrid type-3 effectiveness-implementation trial. Fifty-five elementary schools will be recruited as well as 121 educators (e.g., classroom assistants, aides), 55 general and special educator teachers, and 83-138 other school personnel (e.g., administrators). Additionally, at least 118 autistic students and allistic or non-autistic classmates will be recruited as RR recipients. Participants will complete baseline assessments at the beginning of the year, and all schools will be provided RR training. Schools will be randomized to coaching with or without school-based teams. This study will measure RR fidelity (primary outcome), RR sustainment, as well as peer engagement, social network inclusion, and social skills (secondary outcomes). It is expected that coaching with school-based teams will improve both RR fidelity and social network inclusion, while coaching with and without school-based teams will result in improved peer engagement and social skills.</p><p><strong>Discussion: </strong>Previous research has documented barriers to RR implementation at both the individual- (provider) and organization-level (school). Using multi-level implementation strategies such as coaching with school-based teams may address these barriers and support RR implementation in schools. Findings from this study may guide future efforts to scale up tailored implementation strategies for use in public school districts, with the ultimate goal of increasing intervention access and improving student outcomes.</p><p><strong>Trial registration: </strong>Name of the Registry: clinicaltrials.gov.</p><p><strong>Trial registration: </strong>Clinical Trials ID: NCT06559267 . Date of Registration: August 15, 2024. Prospectively registered.</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"20 1","pages":"3"},"PeriodicalIF":8.8,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11721225/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142959204","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}

{"title":"Optimizing vaccine uptake in sub-Saharan Africa: a collaborative COVID-19 vaccination campaign in Madagascar using an adaptive approach.","authors":"Viola Pavoncello, Irina Kislaya, Diavolana Koecher Andrianarimanana, Valentina Marchese, Rivo Rakotomalala, Tahinamandranto Rasamoelina, Simon Veilleux, Ariane Guth, Alexina Olivasoa Tsiky Zafinimampera, Sonya Ratefiarisoa, Olivette Totofotsy, Cheick Oumar Doumbia, Rivomalala Rakotonavalona, Holinirina Ramananjanahary, Zely Arivelo Randriamanantany, Jürgen May, Rivo Andry Rakotoarivelo, Dewi Ismajani Puradiredja, Daniela Fusco","doi":"10.1186/s13012-024-01412-5","DOIUrl":"10.1186/s13012-024-01412-5","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic has highlighted the need for more effective immunization programs, including in limited resource settings. This paper presents outcomes and lessons learnt from a COVID-19 vaccination campaign (VC), which used a tailored adaptive strategy to optimise vaccine uptake in the Boeny region of Madagascar.</p><p><strong>Methods: </strong>Guided by the Dynamic Sustainability Framework (DSF), the VC implementation was regularly reviewed through multi-sectoral stakeholder feedback, key informant interviews, problem-solving meetings, and weekly monitoring of outcome indicators to identify and apply key adaptations. Qualitative data on processes were collected and analysed using a rapid assessment approach. Outcome indicators, including pre- and post-VC vaccine hesitancy and trends in vaccine doses administered, were analysed using generalized linear models. Additionally, vaccination coverage, geographic reach, and target population characteristics, and sustainability indicators, such as staff trained, facilities equipped, and degree of integration of operational and educational materials were also tracked.</p><p><strong>Results: </strong>Key strategy adaptations included using a proactive campaign approach, community-led awareness and outreach, particularly in remote areas, and addressing cold chain, waste management, vaccine transport, and information technology (IT) equipment gaps. Over six months, 24,888 COVID-19 vaccines were administered. The adapted strategy led to an 8% increase in doses administered weekly (RR = 1.08, CI 95%: 1.01-1.15). However, vaccine hesitancy among the unvaccinated population remained unchanged (∆ = 0.02, CI 95%: -0.04-0.08). In terms of sustainability, 340 staff were trained, and 10 primary healthcare facilities were equipped and refurbished.</p><p><strong>Conclusions: </strong>Implementing collaborative, multi-sectoral vaccination strategies that integrate healthcare services with proactive outreach and community-driven campaigns are effective in increasing vaccine coverage in resource-limited settings. It demonstrates how theory-based adaptive strategies can enhance vaccination rates, even if they do not significantly impact COVID-19 vaccine hesitancy within the community. More generally, this initiative has important implications for adult vaccination programmes other than those related to COVID-19.</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"20 1","pages":"2"},"PeriodicalIF":8.8,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11720884/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142959195","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}

{"title":"Correction: Firm, yet flexible: a fidelity debate paper with two case examples.","authors":"Bianca Albers, Lotte Verweij, Kathrin Blum, Saskia Oesch, Marie-Therese Schultes, Lauren Clack, Rahel Naef","doi":"10.1186/s13012-024-01411-6","DOIUrl":"10.1186/s13012-024-01411-6","url":null,"abstract":"","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"20 1","pages":"1"},"PeriodicalIF":8.8,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11702036/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142959186","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}

{"title":"Supporting teams with designing for dissemination and sustainability: the design, development, and usability of a digital interactive platform.","authors":"Maura M Kepper, Allison J L'Hotta, Thembekile Shato, Bethany M Kwan, Russell E Glasgow, Douglas Luke, Andrea K Graham, Ana A Baumann, Ross C Brownson, Brad Morse","doi":"10.1186/s13012-024-01410-7","DOIUrl":"10.1186/s13012-024-01410-7","url":null,"abstract":"<p><strong>Background: </strong>Designing for Dissemination and Sustainability (D4DS) principles and methods can support the development of research products (interventions, tools, findings) that match well with the needs and context of the intended audience and setting. D4DS principles and methods are not well-known or used during clinical and public health research; research teams would benefit from applying D4DS. This paper presents the development of a new digital platform for research teams to learn and apply a D4DS process to their work.</p><p><strong>Methods: </strong>A user-centered design (UCD) approach engaged users (n = 14) and an expert panel (n = 6) in an iterative design process from discovery to prototyping and testing. We led five design sessions using Zoom and Figma software over a 5-month period. Users (71% academics; 29% practitioners) participated in at least 2 sessions. Following design sessions, feedback from users was summarized and discussed to generate design decisions. A prototype was then built and heuristically tested with 11 users who were asked to complete multiple tasks within the platform while verbalizing their decision-making using the 'think aloud' procedure. The System Usability Scale (SUS) was administered at the end of each testing session. After refinements to the platform were made, usability was reassessed with 7 of 11 same users to examine changes.</p><p><strong>Results: </strong>The interactive digital platform (the D4DS Planner) has two main components: 1) the Education Hub (e.g., searchable platform with literature, videos, websites) and 2) the Action Planner. The Action Planner includes 7 interactive steps that walk users through a set of activities to generate a downloadable D4DS action plan for their project. Participants reported that the prototype tool was moderately usable (SUS = 66) but improved following refinements (SUS = 71).</p><p><strong>Conclusions: </strong>This is a first of its kind tool that supports research teams in learning about and explicitly applying D4DS to their work. The use of this publicly available tool may increase the adoption, impact, and sustainment of a wide range of research products. The use of UCD yielded a tool that is easy to use. This tool's future use and impact will be evaluated with a broader sample of community partners and projects and the tool will continue to be refined and improved.</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"19 1","pages":"82"},"PeriodicalIF":8.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11686880/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142911152","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}

{"title":"Generalizing from qualitative data: a case example using critical realist thematic analysis and mechanism mapping to evaluate a community health worker-led screening program in India.","authors":"Kathryn Broderick, Arthi Vaidyanathan, Matthew Ponticiello, Misha Hooda, Vaishali Kulkarni, Andrea Chalem, Puja Chebrolu, Ashlesha Onawale, Ana Baumann, Jyoti Mathad, Radhika Sundararajan","doi":"10.1186/s13012-024-01407-2","DOIUrl":"10.1186/s13012-024-01407-2","url":null,"abstract":"<p><strong>Background: </strong>A central goal of implementation science is to generate insights that allow evidence-based practices to be successfully applied across diverse settings. However, challenges often arise in preserving programs' effectiveness outside the context of their intervention development. We propose that qualitative data can inform generalizability via elucidating mechanisms of an intervention. Critical realist thematic analysis provides a framework for applying qualitative data to identify causal relationships. This approach can be used to develop mechanism maps, a tool rooted in policy that has been used in health systems interventions, to explain how and why interventions work. We illustrate use of these approaches through a case example of a community health worker (CHW)-delivered gestational diabetes (GDM) screening intervention in Pune, India. CHWs successfully improved uptake of oral glucose tolerance tests (OGTT) among pregnant women, however clinical management of GDM was suboptimal.</p><p><strong>Methods: </strong>Qualitative interviews were conducted with 53 purposively sampled participants (pregnant women, CHWs, maternal health clinicians). Interview transcripts were reviewed using a critical realist thematic analysis approach to develop a coding scheme pertinent to our research questions: \"What caused high uptake of GDM screening?\" and \"Why did most women with GDM referred to clinics did not receive evidence-based management?\". Mechanism maps were retrospectively generated using short- and long-term outcomes as fenceposts to illustrate causal pathways of the CHW-delivered program and subsequent clinical GDM management.</p><p><strong>Results: </strong>Critical realist thematic analysis generated mechanism maps showed that CHWs facilitated GDM screening uptake through affective, cognitive and logistic pathways of influence. Lack of evidence-based treatment of GDM at clinics was caused by 1) clinicians lacking time or initiative to provide GDM counseling and 2) low perceived pre-test probability of GDM in this population of women without traditional risk factors. Mechanism mapping identified areas for adaptation to improve the intervention for future iterations.</p><p><strong>Conclusions: </strong>Mechanism maps created by repeated engagement following the critical realist thematic analysis method can provide a retrospective framework to understand causal relationships between factors driving intervention successes or failures. This process, in turn, can inform the generalizability of health programs by identifying constituent factors and their interrelationships that are central to implementation.</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"19 1","pages":"81"},"PeriodicalIF":8.8,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11667965/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142886498","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}

{"title":"Systems analysis and improvement to optimize opioid use disorder care quality and continuity for patients exiting jail (SAIA-MOUD).","authors":"Sarah Gimbel, Anirban Basu, Emily Callen, Abraham D Flaxman, Omeid Heidari, Julia E Hood, Anna Kellogg, Eli Kern, Judith I Tsui, Ericka Turley, Kenneth Sherr","doi":"10.1186/s13012-024-01409-0","DOIUrl":"10.1186/s13012-024-01409-0","url":null,"abstract":"<p><strong>Background: </strong>Between 2012-2022 opioid-related overdose deaths in the United States, including Washington State, have risen dramatically. Opioid use disorder (OUD) is a complex, chronic, and criminalized illness with biological, environmental, and social causes. One-fifth of people with OUD have recent criminal-legal system involvement; > 50% pass through WA jails annually. Medications for Opioid Use Disorder (MOUD) can effectively treat OUD. WA has prioritized improving access to MOUD, including for those in jails. As patients in jail settings are systematically marginalized due to incarceration, it is critical to foster connections to MOUD services upon release, an acknowledged period of high overdose risk. Currently, there is insufficient focus on developing strategies to foster linkages between jail-based MOUD and referral services. The Systems Analysis and Improvement Approach (SAIA), an evidence-based implementation strategy, may optimize complex care cascades like MOUD provision and improve linkages between jail- and community-based providers. SAIA bundles systems engineering tools into an iterative process to guide care teams to visualize cascade drop-offs and prioritize steps for improvement; identify modifiable organization-level bottlenecks; and propose, implement, and evaluate modifications to overall cascade performance. The SAIA-MOUD study aims to strengthen the quality and continuity of MOUD care across jail and referral clinics in King County, WA, and ultimately reduce recidivism and mortality.</p><p><strong>Methods: </strong>We will conduct a quasi-experimental evaluation of SAIA effectiveness on improving MOUD care cascade quality and continuity for patients receiving care in jail and exiting to referral clinics; examine determinants of SAIA-MOUD adoption, implementation, and sustainment; and determine SAIA-MOUD's cost and cost-effectiveness. Clinic teams with study team support will deliver the SAIA-MOUD intervention at the jail-based MOUD program and three referral clinics over a two-year intensive phase, followed by a one-year sustainment phase where SAIA implementation will be led by King County Jail MOUD staff without study support to enable pragmatic evaluation of sustained implementation.</p><p><strong>Discussion: </strong>SAIA packages user-friendly systems engineering tools to guide decision-making by front-line care providers to identify low-cost, contextually appropriate health care improvement strategies. By integrating SAIA into MOUD care provision in jail and linked services, this pragmatic trial is designed to test a model for national scale-up.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06593353 (registered 09/06/2024; https://register.</p><p><strong>Clinicaltrials: </strong>gov/prs/beta/studies/S000EVJR00000029/recordSummary ).</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"19 1","pages":"80"},"PeriodicalIF":8.8,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11656616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142857037","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}

{"title":"Firm, yet flexible: a fidelity debate paper with two case examples.","authors":"Bianca Albers, Lotte Verweij, Kathrin Blum, Saskia Oesch, Marie-Therese Schultes, Lauren Clack, Rahel Naef","doi":"10.1186/s13012-024-01406-3","DOIUrl":"10.1186/s13012-024-01406-3","url":null,"abstract":"<p><strong>Background: </strong>In healthcare research and practice, intervention and implementation fidelity represent the steadfast adherence to core components of research-supported interventions and the strategies employed for their implementation. Evaluating fidelity involves determining whether these core components were delivered as intended. Without fidelity data, the results of complex interventions cannot be meaningfully interpreted. Increasingly, the necessity for firmness and strict adherence by implementers and their organizations has been questioned, with calls for flexibility to accommodate contextual conditions. This shift makes contemporary fidelity a balancing act, requiring researchers to navigate various tensions. This debate paper explores these tensions, drawing on experiences from developing fidelity assessments in two ongoing effectiveness-implementation hybrid trials.</p><p><strong>Main body: </strong>First, given often scarce knowledge about the core components of complex interventions and implementation strategies, decisions about fidelity requirements involve a degree of subjective reasoning. Researchers should make these decisions transparent using theory or logic models. Second, because fidelity is context-dependent and applies to both interventions and implementation strategies, researchers must rethink fidelity concepts with every study while balancing firmness and flexibility. This is particularly crucial for hybrid studies, with their differing emphasis on intervention and implementation fidelity. Third, fidelity concepts typically focus on individual behaviors. However, since organizational and system factors also influence fidelity, there is a growing need to define fidelity criteria at these levels. Finally, as contemporary fidelity concepts prioritize flexible over firm adherence, building, evaluating, and maintaining fidelity in healthcare research has become more complex. This complexity calls for intensified efforts to expand the knowledge base for pragmatic and adaptive fidelity measurement in trial and routine healthcare settings.</p><p><strong>Conclusion: </strong>Contemporary conceptualizations of fidelity place greater demands on how fidelity is examined, necessitating the expansion of fidelity frameworks to include organizational and system levels, the service- and study-specific conceptualizations of intervention and implementation fidelity, and the development of pragmatic approaches for assessing fidelity in research and practice. Continuing to build knowledge on how to balance requirements for firmness and flexibility remains a crucial task within the field of implementation science.</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"19 1","pages":"79"},"PeriodicalIF":8.8,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11619306/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787916","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}

{"title":"Building capacity in dissemination and implementation research: the presence and impact of advice networks.","authors":"Allison J L'Hotta, Rebekah R Jacob, Stephanie Mazzucca-Ragan, Russell E Glasgow, Sharon E Straus, Wynne E Norton, Ross C Brownson","doi":"10.1186/s13012-024-01408-1","DOIUrl":"10.1186/s13012-024-01408-1","url":null,"abstract":"<p><strong>Background: </strong>As dissemination and implementation (D&I) research increases, we must continue to expand training capacity and research networks. Documenting, understanding, and enhancing advice networks identifies key connectors and areas where networks are less established. In 2012 Norton et al. mapped D&I science advice and collaboration networks. The current study builds on this work and aims to map current D&I research advice networks.</p><p><strong>Methods: </strong>D&I researchers in the United States (US) and Canada were identified through a combination of publication metrics, and key persons identified networks and were invited to participate (n = 1,576). In this social network analysis study, participants completed an online survey identifying up to 10 people from whom they sought and/or gave advice on D&I research. Participants identified four types of advice received: research methods, grant, career, or another type (e.g., work/life balance). We used descriptive statistics to characterize the sample and network metrics and visualizations to describe the composition of advice networks.</p><p><strong>Results: </strong>A total of 482 individuals completed the survey. Eighty-six (18%) worked in Canada and 396 (82%) in the US. Respondents had varying D&I research expertise levels; 14% beginner expertise, 45% intermediate, 29% advanced, and 12% expert. The advice network included 978 connected nodes/individuals. For all research types, out-degree, or advice giving, was higher for those with advanced or expert-level expertise (6.9 and 11.9, respectively) than those with beginner or intermediate expertise (0.8 and 2.2, respectively). Respondents reporting White race reported giving (out-degree = 5.2) and receiving (in-degree = 6.1) more advice compared to individuals reporting Asian (out-degree = 2.9, in-degree = 5.3), Black (out-degree = 2.3, in-degree = 5.2), or other races (out-degree = 2.5, in-degree = 5.4). Assortativity analyses revealed 98% of network ties came from individuals within the same country. The top two reasons for advice seeking were trusting the individual to give good advice (78%) and the individual's knowledge/experience in specific D&I content (69%).</p><p><strong>Conclusions: </strong>The D&I research network is becoming more dispersed as the field expands. Findings highlight opportunities to further connect D&I researchers in the US and Canada, individuals with emerging skills in D&I research, and minoritized racial groups. Expanding peer mentoring opportunities, especially for minoritized groups, can enhance the field's capacity for growth.</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"19 1","pages":"78"},"PeriodicalIF":8.8,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11605852/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142755749","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}

{"title":"Ethical issues in implementation science: perspectives from a National Heart, Lung, and Blood Institute workshop.","authors":"Neal W Dickert, Donna Spiegelman, Jennifer S Blumenthal-Barby, Garth Graham, Steven Joffe, Jeremy M Kahn, Nancy E Kass, Scott Y H Kim, Meeta P Kerlin, Aisha T Langford, James V Lavery, Daniel D Matlock, Kathleen N Fenton, George A Mensah","doi":"10.1186/s13012-024-01403-6","DOIUrl":"10.1186/s13012-024-01403-6","url":null,"abstract":"<p><p>Ethical issues arise in the context of implementation science that may differ from those encountered in other research settings. This report, developed out of a workshop convened by the Center for Translation Research and Implementation Science within the United States National Heart, Lung, and Blood Institute, identifies six key themes that are important to the assessment of ethical dimensions of implementation science. First, addressing ethical challenges in implementation science does not require new ethical principles, commitments, or regulations. However, it does require understanding of the specific contexts arising in implementation research related to both study design and the intervention being implemented. Second, implementation research involves many different types of people in research, including patients, clinicians, administrators, the social networks of any of these, and the general population. These individuals play different roles that may entail different ethical considerations, obligations, and vulnerabilities. Third, the appropriateness of and need for informed consent in implementation research is connected to the role of the subject/participant, the nature of the intervention, and the design of the study. Even where traditional \"full\" consent processes are unnecessary or inappropriate, communication and engagement are critical. Similarly, even when research is exempt and informed consent unnecessary, Data Safety and Monitoring Board oversight of implementation studies may be advisable to ensure quality, address unexpected consequences, and identify overwhelming evidence of benefit. Fourth, implementation science is often explicitly designed to encourage specific behaviors and discourage others. There is a need for clarity regarding when efforts at behavioral change enhance or threaten autonomy and how to protect participants whose autonomy is threatened. Fifth, there is significant overlap between implementation science and quality improvement, and the ideal regulatory oversight structure for implementation science remains unclear. It is critical to encourage learning and growth while assuring appropriate protections. Sixth, implementation research takes place across a range of social and cultural contexts. Engagement and collaboration with stakeholders in designing and executing implementation trials and studies- especially when vulnerabilities exist- is essential. Attention to these themes will help ensure that implementation science fulfills its goal of advancing the practice of health care within a sound ethical framework.</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"19 1","pages":"77"},"PeriodicalIF":8.8,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11577597/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142677763","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}

{"title":"Can an evidence-based mental health intervention be implemented into preexisting home visiting programs using implementation facilitation? Study protocol for a three variable implementation effectiveness context hybrid trial.","authors":"Elissa Z Faro, DeShauna Jones, Morolake Adeagbo, Hyunkeun Cho, Grace Swartzendruber, Karen M Tabb, S Darius Tandon, Kelli Ryckman","doi":"10.1186/s13012-024-01402-7","DOIUrl":"10.1186/s13012-024-01402-7","url":null,"abstract":"<p><strong>Background: </strong>Perinatal mental health conditions are the most common complication of pregnancy and childbirth (1 in 8 women). When left untreated, perinatal depression and anxiety adversely affects the entire family with pregnancy complications and negative outcomes including preterm birth, impaired mother-infant bonding, impaired lactation, substance abuse, divorce, suicide, and infanticide. Significant disparities persist in the diagnosis and treatment of perinatal depression and anxiety and these inequities are often intersectional. Preliminary research with stakeholders including community advisory boards, underrepresented and minority birthing people, and state departments of health, demonstrates the importance of social support as a mechanism for reducing disparities in perinatal depression, particularly in rural geographies. Home visiting programs (HVPs) can provide the social support needed to improve mental health outcomes in pregnant and postpartum women. Our project aims to explore the impact of context on the implementation of a mental health intervention, focusing on the lived experiences of diverse populations served by HVPs to reduce disparities in adverse maternal outcomes.</p><p><strong>Methods: </strong>Using implementation facilitation, our study will engage multilevel stakeholders (e.g., policymakers, front-line implementers, and intervention recipients) to adapt facilitation to integrate a maternal mental health intervention (i.e., Mothers and Babies) across two midwestern, rural states (Iowa and Indiana) with multiple HVP models. Given the complexity and heterogeneity of the contexts in which Mothers and Babies will be integrated, a three variable hybrid implementation-effectiveness-context trial will test the adapted facilitation strategy compared with implementation as usual (i.e., standard education) and will assess contextual factors related to the outcomes. Using an evidence-based implementation strategy that tailors implementation delivery to the needs of the specific populations and context may improve fidelity and adoption, particularly in rural states where residents have limited access to care.</p><p><strong>Discussion: </strong>The immediate impact of this research will be to show whether adapted facilitation can improve the uptake and fidelity of Mothers and Babies across multiple HVP models and thus positively affect depressive symptoms and perceived stress of recipients. Our implementation protocol may be used by researchers, practitioners, and policy makers to better integrate evidence-based interventions into diverse contexts, leading to more equitable implementation and improved health outcomes.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT06575894, registered on August 29, 2024 https://clinicaltrials.gov/study/NCT06575894?id=NCT06575894&rank=1 .</p>","PeriodicalId":54995,"journal":{"name":"Implementation Science","volume":"19 1","pages":"76"},"PeriodicalIF":8.8,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11556184/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142633173","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}