Division of General Internal Medicine, Department of Medicine, Michigan State University, East Lansing, MI, USA.
Center for Bioethics and Social Justice & Department of Medicine, Michigan State University, East Lansing, MI, USA.
Trials. 2022 Aug 15;23(1):659. doi: 10.1186/s13063-022-06581-6.
Despite nationwide improvements in cardiovascular disease (CVD) mortality and morbidity, CVD deaths in adults with type 2 diabetes (T2DM) are 2-4 times higher than among those without T2DM. A key contributor to these poor health outcomes is medication non-adherence. Twenty-one to 42% of T2DM patients do not take blood sugar, blood pressure (BP), or statin medications as prescribed. Interventions that foster and reinforce patient-centered communication show promise in improving health outcomes. However, they have not been widely implemented, in part due to a lack of compelling evidence for their effectiveness in real-life primary care settings.
This pragmatic cluster-randomized trial randomizes 17 teams in 12 Federally Qualified Healthcare Centers (FQHCs) to two experimental groups: intervention (group 1): Office-Gap + Texting vs. control (group 2): Texting only. Office-GAP (Office-Guidelines Applied to Practice) is a patient activation intervention to improve communication and patient-provider partnerships through brief patient and provider training in shared decision-making (SDM) and use of a guideline-based checklist. The texting intervention (Way2Health) is a cell phone messaging service that informs and encourages patients to adhere to goals, adhere to medication use and improve communication. After recruitment, patients in groups 1 and 2 will both attend (1) one scheduled group visit, (90-120 min) conducted by trained research assistants, and (2) follow-up visits with their providers after group visit at 0-1, 3, 6, 9, and 12 months. Data will be collected over 12-month intervention period. Our primary outcome is medication adherence measured using eCAP electronic monitoring and self-report. Secondary outcomes are (a) diabetes-specific 5-year CVD risk as measured with the UK Prospective Diabetes Study (UKPDS) Engine score, (b) provider engagement as measured by the CollaboRATE Shared-Decision Making measure, and (c) patient activation measures (PAM).
This study will provide a rigorous pragmatic evaluation of the effectiveness of combined mHealth, and patient activation interventions compared to mHealth alone, targeting patients and healthcare providers in safety net health centers, in improving medication adherence and decreasing CVD risk. Given that 20-50% of adults with chronic illness demonstrate medication non-adherence, increasing adherence is essential to improve CVD outcomes as well as healthcare cost savings.
The ClinicalTrials.gov registration number is NCT04874116.
尽管全国范围内心血管疾病（CVD）的死亡率和发病率都有所改善，但 2 型糖尿病（T2DM）患者的 CVD 死亡率仍然比非 T2DM 患者高 2-4 倍。造成这些健康状况不佳的一个主要原因是药物依从性差。21%至 42%的 T2DM 患者没有按照规定服用血糖、血压或他汀类药物。促进和加强以患者为中心的沟通的干预措施显示出改善健康结果的希望。然而，由于缺乏在现实生活中的初级保健环境中证明其有效性的有力证据，这些干预措施尚未得到广泛实施。
这项实用的聚类随机试验将 17 个团队随机分配到 12 个合格的联邦医疗保健中心（FQHCs）的两个实验组：干预组（第 1 组）：Office-Gap + 短信与对照组（第 2 组）：仅短信。Office-GAP（适用于实践的办公室指南）是一种患者激活干预措施，通过对共享决策制定（SDM）和使用基于指南的检查表进行简短的患者和提供者培训，改善沟通和患者-提供者伙伴关系。短信干预（Way2Health）是一种手机短信服务，通知并鼓励患者遵守目标，遵守药物使用并改善沟通。在招募后，第 1 组和第 2 组的患者将参加（1）由经过培训的研究助理进行的一次预定小组访问（90-120 分钟），以及（2）在小组访问后 0-1、3、6、9 和 12 个月与提供者进行随访。数据将在 12 个月的干预期内收集。我们的主要结果是使用 eCAP 电子监测和自我报告测量的药物依从性。次要结果是（a）使用 UKPDS 发动机评分测量的糖尿病特定 5 年 CVD 风险，（b）使用 CollaboRATE 共享决策制定措施测量的提供者参与度，以及（c）患者激活措施（PAM）。
这项研究将对结合移动健康和患者激活干预措施的有效性进行严格的实用评估，与单独使用移动健康相比，这些干预措施针对安全网医疗中心的患者和医疗保健提供者，以改善药物依从性并降低 CVD 风险。鉴于 20-50%的慢性疾病患者表现出药物不依从性，提高依从性对于改善 CVD 结果和节省医疗保健成本至关重要。
ClinicalTrials.gov 注册号为 NCT04874116。
