Jordana L Clayton, Rebecca L Utz, Nancy Aruscavage, Sara G Bybee, Sharon E Bigger, Eli Iacob, Kara B Dassel
{"title":"Using community engagement with <i>FRAME</i>: Framework for reporting adaptations and modifications to evidence-based interventions.","authors":"Jordana L Clayton, Rebecca L Utz, Nancy Aruscavage, Sara G Bybee, Sharon E Bigger, Eli Iacob, Kara B Dassel","doi":"10.1016/j.conctc.2024.101398","DOIUrl":null,"url":null,"abstract":"<p><p>Community engagement is increasingly considered a key component of intervention development, as it can leverage community members' knowledge, experiences, and insights to create a nuanced intervention which meets the needs, preferences, and realities of the population of interest. Community engagement exists along a spectrum from outreach to the community to partnership with community members and organizations, and all levels of community engagement can benefit from systematic documentation of community feedback and decision-making processes. This paper demonstrates how we utilized the \"Framework for Reporting Adaptations and Modifications to Evidence-based Interventions\" (FRAME; Wiltsey Stirman et al., 2019) model to track and report adaptations to our dementia end-of-life care planning intervention based on community engagement via a project-specific Community Advisory Board (CAB). Using FRAME, we generated a comprehensive report of the iterative changes made to our pilot intervention, including whether the change was planned, who made the decision to modify the intervention, the nature of the change, its relationship to intervention fidelity, and the reason for the change. This process ensured that we effectively integrated feedback and assistance from our CAB, increased the appropriateness of our intervention for our population of interest, established criteria to monitor intervention fidelity, and prepared our team to run a rigorous clinical trial of the revised intervention. Clinical Trial Registration Number: NCT05909189.</p>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"101398"},"PeriodicalIF":1.4000,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664155/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.conctc.2024.101398","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/12/1 0:00:00","PubModel":"eCollection","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Community engagement is increasingly considered a key component of intervention development, as it can leverage community members' knowledge, experiences, and insights to create a nuanced intervention which meets the needs, preferences, and realities of the population of interest. Community engagement exists along a spectrum from outreach to the community to partnership with community members and organizations, and all levels of community engagement can benefit from systematic documentation of community feedback and decision-making processes. This paper demonstrates how we utilized the "Framework for Reporting Adaptations and Modifications to Evidence-based Interventions" (FRAME; Wiltsey Stirman et al., 2019) model to track and report adaptations to our dementia end-of-life care planning intervention based on community engagement via a project-specific Community Advisory Board (CAB). Using FRAME, we generated a comprehensive report of the iterative changes made to our pilot intervention, including whether the change was planned, who made the decision to modify the intervention, the nature of the change, its relationship to intervention fidelity, and the reason for the change. This process ensured that we effectively integrated feedback and assistance from our CAB, increased the appropriateness of our intervention for our population of interest, established criteria to monitor intervention fidelity, and prepared our team to run a rigorous clinical trial of the revised intervention. Clinical Trial Registration Number: NCT05909189.
期刊介绍:
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.