Effective engagement of a stakeholder advisory board in severe mental illness (SMI) research: A case study of a clinical trial to improve adherence among people with SMI and hypertension.
Effective engagement of a stakeholder advisory board in severe mental illness (SMI) research: A case study of a clinical trial to improve adherence among people with SMI and hypertension.
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DOI：
10.5430/ijh.v8n2p9
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发表时间：
2022-11
期刊：
影响因子：
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通讯作者：
Levin JB
中科院分区：
文献类型：
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作者：
Paltin D;Montoya JL;Weise C;Conroy C;Radatz EE;Strange KC;Moore DJ;Sajatovic M;Levin JB
50-80%的患者抗高血压药物依从性差。一项正在进行的随机对照试验（RCT）正在评估对双相情感障碍患者依从性差的高血压患者的个性化移动健康干预。为了提高疗效，正在进行的试验获得了由患者、家属、临床医生和卫生系统管理人员组成的利益相关者咨询委员会（SAB）的指导。我们的目标是描述SAB的形成、作用、决策过程和主要贡献，作为展示有意义的社区参与精神卫生研究的一种手段。利用实施科学领域的模型和措施，11名SAB成员召开了三次会议，随后进行了定量调查，评估了SAB成员在会议期间的满意度和参与度。SAB提出的重要建议包括：1)扩大纳入/排除标准；2)实施RCT的远程实施。SAB确定的主要研究实施挑战是：1)参与者难以参与移动健康干预；2)确定监测参与者遵守随机对照试验方案的程序，并联系参与不足的参与者。数量调查表明，所有咨询委员会成员都认为会议的目标是明确的，认为他们能够参与讨论，并且听取了他们的意见。越来越多的证据表明，在临床研究中使用SABs是可行的，这一过程可以改进干预设计，增加参与者的参与度，减少与心理健康相关的污名，并产生更有效的实施战略。我们鼓励未来的研究者与SABs合作使用实施科学框架来完善他们提出的干预措施并改善临床结果
Poor adherence to antihypertensive medication occurs in 50-80% of patients. An ongoing randomized controlled trial (RCT) is evaluating a personalized mobile-health intervention in poorly adherent hypertensive persons with bipolar disorder. To enhance efficacy, the ongoing trial elicited guidance from a Stakeholder Advisory Board (SAB) comprised of patients, family members, clinicians, and health system administrators. Our goal is to describe the formation, role, decision-making process, and key contributions of the SAB as a means of demonstrating meaningful community engagement in mental health research. Using models and measures from the field of implementation science, eleven SAB members convened across three meetings followed by quantitative surveys that assessed SAB member satisfaction and engagement during the meeting. Significant suggestions from the SAB included 1) expanding inclusion/exclusion criteria, and 2) operationalizing remote implementation of the RCT. Primary study implementation challenges identified by the SAB were 1) participant difficulty engaging in the mHealth intervention, and 2) identification of procedures for monitoring participant adherence to the RCT protocol and contacting under-engaged participants. Quantitative surveys indicated that all SAB members believed that the objectives of the meetings were clear, perceived that they were able to participate in the discussions, and that they were heard. Increasing evidence demonstrates the feasibility of engaging with SABs in clinical research and that this process improves intervention design, increases participant engagement, reduces mental health-related stigma, and produces more effective implementation strategies. We encourage future investigators to use an implementation science framework in partnership with SABs to refine their proposed interventions and improve clinical outcomes