一项定制的依从性增强（CAE-E）随机对照试验：一项混合有效性实施项目的研究方案。
A randomized controlled trial of customized adherence enhancement (CAE-E): study protocol for a hybrid effectiveness-implementation project.
机构信息
Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center, 10524 Euclid Ave. 7th floor, Cleveland, OH, 44106, USA.
出版信息
Trials. 2022 Aug 4;23(1):634. doi: 10.1186/s13063-022-06517-0.
BACKGROUND
Mood-stabilizing medications are a cornerstone of treatment for people with bipolar disorder, though approximately half of these individuals are poorly adherent with their medication, leading to negative and even severe health consequences. While a variety of approaches can lead to some improvement in medication adherence, there is no single approach that has superior adherence enhancement and limited data on how these approaches can be implemented in clinical settings. Existing data have shown an increasing need for virtual delivery of care and interactive telemedicine interventions may be effective in improving adherence to long-term medication.
METHODS
Customized adherence enhancement (CAE) is a brief, practical bipolar-specific approach that identifies and targets individual patient adherence barriers for intervention using a flexibly administered modular format that can be delivered via telehealth communications. CAE is comprised of up to four standard treatment modules including Psychoeducation, Communication with Providers, Medication Routines, and Modified Motivational Interviewing. Participants will attend assigned module sessions with an interventionist based on their reasons for non-adherence and will be assessed for adherence, functioning, bipolar symptoms, and health resource use across a 12-month period. Qualitative and quantitative data will also be collected to assess barriers and facilitators to CAE implementation and reach and adoption of CAE among clinicians in the community.
DISCUSSION
The proposed study addresses the need for practical adherence interventions that are effective, flexible, and designed to adapt to different settings and patients. By focusing on a high-risk, vulnerable group of people with bipolar disorder, and refining an evidence-based approach that will integrate into workflow of public-sector care and community mental health clinics, there is substantial potential for improving bipolar medication adherence and overall health outcomes on a broad level.
TRIAL REGISTRATION
The study was registered on ClinicalTrials.gov NCT04622150 on November 9, 2020.
背景
情绪稳定剂是治疗双相情感障碍患者的基石，但约有一半的患者对药物治疗的依从性较差，导致负面甚至严重的健康后果。虽然各种方法都可以在一定程度上提高药物依从性，但没有一种方法可以显著提高药物依从性，而且关于这些方法如何在临床环境中实施的数据也有限。现有数据表明，人们对远程医疗服务的需求不断增加，交互式远程医疗干预可能有助于提高长期药物治疗的依从性。
方法
定制化依从增强（CAE）是一种简短而实用的双相特异性方法，通过使用灵活管理的模块化格式，针对患者的个体依从性障碍进行识别和靶向干预，该格式可以通过远程医疗通信进行交付。CAE 包括最多四个标准治疗模块，包括心理教育、与提供者沟通、药物常规和改良动机访谈。根据患者的不依从原因，参与者将与干预者一起参加指定的模块会议，并在 12 个月内评估他们的依从性、功能、双相症状和卫生资源使用情况。还将收集定性和定量数据，以评估 CAE 实施的障碍和促进因素，以及 CAE 在社区临床医生中的可及性和采用情况。
讨论
拟议的研究满足了对有效、灵活且旨在适应不同环境和患者的实用依从性干预措施的需求。通过关注高风险、脆弱的双相情感障碍患者群体，并完善一种将融入公共部门护理和社区心理健康诊所工作流程的循证方法，有很大潜力改善双相情感障碍药物的依从性，并在广泛层面上改善整体健康结果。
试验注册
该研究于 2020 年 11 月 9 日在 ClinicalTrials.gov 上注册，注册号为 NCT04622150。
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