The use of implementation science theoretical approaches in hybrid effectiveness-implementation type 1 randomised trials of healthcare interventions: A scoping review
Abstract Background Hybrid type 1 effectiveness-implementation randomised controlled trials (RCTs) aim to accelerate the translation of proven clinical interventions into routine care by concurrently investigating the effectiveness of clinical interventions and the context for real-world implementat...
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| Format: | Article |
| Language: | English |
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BMC
2025-05-01
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| Series: | Implementation Science |
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| Online Access: | https://doi.org/10.1186/s13012-025-01435-6 |
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| author | Orly Atzmon Meagan E. Crowther Bei Bei Denise A. O’Connor |
| author_facet | Orly Atzmon Meagan E. Crowther Bei Bei Denise A. O’Connor |
| author_sort | Orly Atzmon |
| collection | DOAJ |
| description | Abstract Background Hybrid type 1 effectiveness-implementation randomised controlled trials (RCTs) aim to accelerate the translation of proven clinical interventions into routine care by concurrently investigating the effectiveness of clinical interventions and the context for real-world implementation. Hybrid type 1 RCTs can make use of implementation science theoretical approaches (i.e., theories, models, and frameworks) to understand barriers and facilitators to sustainable implementation of clinical interventions; however, the extent to which these approaches have been used in hybrid type 1 RCTs has not been systematically investigated. This scoping review aimed to investigate the extent to which implementation science theoretical approaches have been used in hybrid type 1 RCTs of healthcare interventions and describe which approaches have been reported and how they have been used. Methods The review was conducted in accordance with the pre-registered protocol ( https://doi.org/10.17605/OSF.IO/CJ8A7 ). Searches of six electronic databases were conducted for published hybrid type 1 RCTs evaluating any clinical intervention in any healthcare setting. The included trials were full-text, peer-reviewed primary research articles written in English, and reporting the findings of hybrid type 1 RCTs of healthcare interventions. Non-English language reports, reviews, protocols without a linked trial results report, methodological papers, opinion pieces, commentaries, books/book chapters, dissertations, and conference abstracts were excluded. Two reviewers independently selected studies, extracted data, and assessed use of theoretical approach/es. Results We identified 8,878 citations, screened 673 full-text records, and included 37 trials. Most trials were conducted in North America (68%), investigating clinical interventions for mental health problems (32%) in adults (43%). Twenty-eight (76%) trials cited use of at least one theoretical approach. The most common was the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework (43%). Theoretical approaches were most often applied (62%) to justify the implementation study design, guide selection of study materials or analyse implementation outcomes. Conclusion The majority of published hybrid type 1 effectiveness-implementation RCTs of healthcare interventions report using at least one theoretical approach to explore the context for implementation. Use of implementation science theories, models, and/or frameworks to understand the barriers and facilitators to implementation and sustainability of proven clinical interventions is likely to accelerate future translation of evidence-based practices into routine care and thus optimise patient outcomes. |
| format | Article |
| id | doaj-art-160e2a931dce490f9bf76f683505adf7 |
| institution | DOAJ |
| issn | 1748-5908 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Implementation Science |
| spelling | doaj-art-160e2a931dce490f9bf76f683505adf72025-08-20T03:07:51ZengBMCImplementation Science1748-59082025-05-0120111310.1186/s13012-025-01435-6The use of implementation science theoretical approaches in hybrid effectiveness-implementation type 1 randomised trials of healthcare interventions: A scoping reviewOrly Atzmon0Meagan E. Crowther1Bei Bei2Denise A. O’Connor3School of Psychological Sciences, Monash UniversitySchool of Psychological Sciences, Monash UniversitySchool of Psychological Sciences, Monash UniversitySchool of Public Health and Preventive Medicine, Monash UniversityAbstract Background Hybrid type 1 effectiveness-implementation randomised controlled trials (RCTs) aim to accelerate the translation of proven clinical interventions into routine care by concurrently investigating the effectiveness of clinical interventions and the context for real-world implementation. Hybrid type 1 RCTs can make use of implementation science theoretical approaches (i.e., theories, models, and frameworks) to understand barriers and facilitators to sustainable implementation of clinical interventions; however, the extent to which these approaches have been used in hybrid type 1 RCTs has not been systematically investigated. This scoping review aimed to investigate the extent to which implementation science theoretical approaches have been used in hybrid type 1 RCTs of healthcare interventions and describe which approaches have been reported and how they have been used. Methods The review was conducted in accordance with the pre-registered protocol ( https://doi.org/10.17605/OSF.IO/CJ8A7 ). Searches of six electronic databases were conducted for published hybrid type 1 RCTs evaluating any clinical intervention in any healthcare setting. The included trials were full-text, peer-reviewed primary research articles written in English, and reporting the findings of hybrid type 1 RCTs of healthcare interventions. Non-English language reports, reviews, protocols without a linked trial results report, methodological papers, opinion pieces, commentaries, books/book chapters, dissertations, and conference abstracts were excluded. Two reviewers independently selected studies, extracted data, and assessed use of theoretical approach/es. Results We identified 8,878 citations, screened 673 full-text records, and included 37 trials. Most trials were conducted in North America (68%), investigating clinical interventions for mental health problems (32%) in adults (43%). Twenty-eight (76%) trials cited use of at least one theoretical approach. The most common was the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework (43%). Theoretical approaches were most often applied (62%) to justify the implementation study design, guide selection of study materials or analyse implementation outcomes. Conclusion The majority of published hybrid type 1 effectiveness-implementation RCTs of healthcare interventions report using at least one theoretical approach to explore the context for implementation. Use of implementation science theories, models, and/or frameworks to understand the barriers and facilitators to implementation and sustainability of proven clinical interventions is likely to accelerate future translation of evidence-based practices into routine care and thus optimise patient outcomes.https://doi.org/10.1186/s13012-025-01435-6Hybrid type 1 trialHybrid type 1 effectiveness-implementation randomised controlled trialImplementation scienceTheoryModelFramework |
| spellingShingle | Orly Atzmon Meagan E. Crowther Bei Bei Denise A. O’Connor The use of implementation science theoretical approaches in hybrid effectiveness-implementation type 1 randomised trials of healthcare interventions: A scoping review Implementation Science Hybrid type 1 trial Hybrid type 1 effectiveness-implementation randomised controlled trial Implementation science Theory Model Framework |
| title | The use of implementation science theoretical approaches in hybrid effectiveness-implementation type 1 randomised trials of healthcare interventions: A scoping review |
| title_full | The use of implementation science theoretical approaches in hybrid effectiveness-implementation type 1 randomised trials of healthcare interventions: A scoping review |
| title_fullStr | The use of implementation science theoretical approaches in hybrid effectiveness-implementation type 1 randomised trials of healthcare interventions: A scoping review |
| title_full_unstemmed | The use of implementation science theoretical approaches in hybrid effectiveness-implementation type 1 randomised trials of healthcare interventions: A scoping review |
| title_short | The use of implementation science theoretical approaches in hybrid effectiveness-implementation type 1 randomised trials of healthcare interventions: A scoping review |
| title_sort | use of implementation science theoretical approaches in hybrid effectiveness implementation type 1 randomised trials of healthcare interventions a scoping review |
| topic | Hybrid type 1 trial Hybrid type 1 effectiveness-implementation randomised controlled trial Implementation science Theory Model Framework |
| url | https://doi.org/10.1186/s13012-025-01435-6 |
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