Hankins J S, Potter M B, Fernandez M E, Melvin C, DiMartino L, Jacobs S R, Bosworth H B, King A A, Simon J, Glassberg J A, Kutlar A, Gordeuk V R, Shah N, Baumann A A, Klesges L M
Department of Hematology, St. Jude Children's Research Hospital, Memphis, TN, United States.
Department of Family and Community Medicine, University of California San Francisco School of Medicine, San Francisco, CA, United States.
Front Health Serv. 2023 Jan 20;2:1024541. doi: 10.3389/frhs.2022.1024541. eCollection 2022.
Sickle Cell Disease (SCD) is a progressive genetic disease that causes organ damage and reduces longevity. Hydroxyurea is an underutilized evidence-based medication that reduces complications and improves survival in SCD. In a multi-site clinical trial, part of the NIH-funded Sickle Cell Disease Implementation Consortium (SCDIC), we evaluate the implementation of a multi-level and multi-component mobile health (mHealth) patient and provider intervention to target the determinants and context of low hydroxyurea use. Given the complexity of the intervention and contextual variability in its implementation, we combined different behavioral and implementation theories, models, and frameworks to facilitate the evaluation of the intervention implementation. In this report, we describe engagement with stakeholders, planning of the implementation process, and final analytical plan to evaluate the implementation outcomes.
During 19 meetings, a 16-member multidisciplinary SCDIC implementation team created, conceived, and implemented a project that utilized Intervention Mapping to guide designing an intervention and its evaluation plan. The process included five steps: (1) needs assessment of low hydroxyurea utilization, (2) conceptual framework development, (3) intervention design process, (4) selection of models and frameworks, and (5) designing evaluation of the intervention implementation.
Behavioral theories guided the needs assessment and the design of the multi-level mHealth intervention. In designing the evaluation approach, we combined two implementation frameworks to best account for the contextual complexity at the organizational, provider, and patient levels: (1) the Consolidated Framework for Implementation Research (CFIR) that details barriers and facilitators to implementing the mHealth intervention at multiple levels (users, organization, intervention characteristics, broader community), and (2) the Technology Acceptance Model (TAM), a conceptual model specific for explaining the intent to use new information technology (including mHealth). The Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM) framework was used to measure the outcomes.
Our research project can serve as a case study of a potential approach to combining different models/frameworks to help organize and plan the evaluation of interventions to increase medication adherence. The description of our process may serve as a blueprint for future studies developing and testing new strategies to foster evidence-based treatments for individuals living with SCD.
镰状细胞病（SCD）是一种渐进性遗传疾病，会导致器官损伤并缩短寿命。羟基脲是一种未得到充分利用的循证药物，可减少SCD的并发症并提高生存率。在一项多中心临床试验中，作为美国国立卫生研究院资助的镰状细胞病实施联盟（SCDIC）的一部分，我们评估了一种多层次、多组件的移动健康（mHealth）患者和提供者干预措施的实施情况，以针对羟基脲使用量低的决定因素和背景。鉴于干预措施的复杂性及其实施中的背景变异性，我们结合了不同的行为和实施理论、模型及框架，以促进对干预措施实施情况的评估。在本报告中，我们描述了与利益相关者的参与情况、实施过程的规划以及评估实施结果的最终分析计划。
在19次会议期间，一个由16名成员组成的多学科SCDIC实施团队创建、构思并实施了一个项目，该项目利用干预映射来指导设计一项干预措施及其评估计划。该过程包括五个步骤：（1）对羟基脲低利用率的需求评估；（2）概念框架的制定；（3）干预措施设计过程；（4）模型和框架的选择；（5）设计对干预措施实施情况的评估。
行为理论指导了需求评估和多层次mHealth干预措施的设计。在设计评估方法时，我们结合了两个实施框架，以最好地考虑组织、提供者和患者层面的背景复杂性：（1）实施研究综合框架（CFIR），该框架详细说明了在多个层面（用户、组织、干预措施特征、更广泛的社区）实施mHealth干预措施的障碍和促进因素；（2）技术接受模型（TAM），这是一个专门用于解释使用新信息技术（包括mHealth）意图的概念模型。采用到达效果采用实施与维持（RE-AIM）框架来衡量结果。
我们的研究项目可作为一个案例研究，展示一种结合不同模型/框架来帮助组织和规划干预措施评估以提高药物依从性的潜在方法。我们对过程的描述可作为未来研究的蓝图，这些研究旨在开发和测试新策略，以促进为SCD患者提供循证治疗。
