背景:尽管有显著减少并发症的潜力,许多患者没有持续接受糖尿病预防护理。我们的研究团队最近应用以用户为中心的设计冲刺方法来开发患者门户干预,使患者能够解决选定的糖尿病护理差距(例如,过去12个月没有糖尿病眼部检查)。
目的:本研究旨在评估我们的新型糖尿病护理差距干预对完成选定的循证糖尿病预防护理服务和次要结局的影响。
方法:我们正在进行一项关于干预对糖尿病护理差距影响的务实随机对照试验。从范德比尔特大学医学中心附属的初级保健诊所招募成年糖尿病(DM)患者。参与者有资格,如果他们有1型或2型DM,可以用英语阅读,年龄在18-75岁之间,有一个当前的患者门户帐户,并且可以可靠地访问具有互联网访问功能的移动设备。我们排除了患有无法使用移动设备的医疗状况的患者,视力严重困难,孕妇或计划在研究期间怀孕的妇女,和透析患者.参与者将被随机分配到干预或常规护理中。主要结果衡量标准将是4种糖尿病预防护理服务中糖尿病护理差距的数量(糖尿病眼部检查,肺炎球菌疫苗接种,血红蛋白A1c,和尿微量白蛋白)在随机化后12个月。次要结果将包括糖尿病自我效能,信心管理糖尿病一般,了解糖尿病预防护理,糖尿病困扰,患者入口满意度,以及患者在基线时启动的订单,3个月,6个月,和随机化后12个月。有序逻辑回归模型将用于量化干预对12个月随访时糖尿病护理差距数量的影响。对于二分法的次要结果,根据需要,将使用逻辑回归模型,并对临床和提供者变量进行随机影响.对于连续的次要结果,将使用回归模型。
结果:这项研究正在进行中。2022年2月结束招募;共有433名患者被随机分配。在那些随机化的人中,大多数(n=288,66.5%)是非西班牙裔白人,33.5%(n=145)是种族或少数民族,33.9%(n=147)年龄在65岁或以上,30.7%(n=133)表示健康素养有限。
结论:该研究直接检验了以下假设:患者门户干预-提醒患者选择的糖尿病护理差距,促进对其重要性的理解,与常规护理相比,允许患者开始护理将减少糖尿病护理差距。从这项研究中获得的见解可能对制定未来的干预措施以解决各种护理差距具有广泛的意义。比如癌症筛查的差距,并有助于有效的发展,可扩展,以及让患者参与慢性病管理和预防的可持续方法。
背景:ClinicalTrials.govNCT04894903;https://classic.clinicaltrials.gov/ct2/show/NCT04894903.
■DERR1-10.2196/56123。
BACKGROUND: Despite the potential to significantly reduce complications, many patients do not consistently receive diabetes preventive care. Our research team recently applied user-centered design sprint methodology to develop a patient portal intervention empowering patients to address selected diabetes care gaps (eg, no diabetes eye examination in last 12 months).
OBJECTIVE: This study aims to evaluate the effect of our novel diabetes care gap intervention on completion of selected evidence-based diabetes preventive care services and secondary outcomes.
METHODS: We are conducting a pragmatic randomized controlled trial of the effect of the intervention on diabetes care gaps. Adult patients with diabetes mellitus (DM) are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible if they have type 1 or 2 DM, can read in English, are aged 18-75 years, have a current patient portal account, and have reliable access to a mobile device with internet access. We exclude patients with medical conditions that prevent them from using a mobile device, severe difficulty seeing, pregnant women or women who plan to become pregnant during the study period, and patients on dialysis. Participants will be randomly assigned to the intervention or usual care. The primary outcome measure will be the number of diabetes care gaps among 4 DM preventive care services (diabetes eye examination, pneumococcal vaccination, hemoglobin A1c, and urine microalbumin) at 12 months after randomization. Secondary outcomes will include diabetes self-efficacy, confidence managing diabetes in general, understanding of diabetes preventive care, diabetes distress, patient portal satisfaction, and patient-initiated orders at baseline, 3 months, 6 months, and 12 months after randomization. An ordinal logistic regression model will be used to quantify the effect of the intervention on the number of diabetes care gaps at the 12-month follow-up. For dichotomous secondary outcomes, a logistic regression model will be used with random effects for the clinic and provider variables as needed. For continuous secondary outcomes, a regression model will be used.
RESULTS: This study is ongoing. Recruitment was closed in February 2022; a total of 433 patients were randomized. Of those randomized, most (n=288, 66.5%) were non-Hispanic White, 33.5% (n=145) were racial or ethnic minorities, 33.9% (n=147) were aged 65 years or older, and 30.7% (n=133) indicated limited health literacy.
CONCLUSIONS: The study directly tests the hypothesis that a patient portal intervention-alerting patients about selected diabetes care gaps, fostering understanding of their significance, and allowing patients to initiate care-will reduce diabetes care gaps compared with usual care. The insights gained from this study may have broad implications for developing future interventions to address various care gaps, such as gaps in cancer screening, and contribute to the development of effective, scalable, and sustainable approaches to engage patients in chronic disease management and prevention.
BACKGROUND: ClinicalTrials.gov NCT04894903; https://classic.clinicaltrials.gov/ct2/show/NCT04894903.
UNASSIGNED: DERR1-10.2196/56123.