Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
研究概览
简要总结
The purpose of this study is to evaluate the effect of a novel patient portal intervention on the number of patients with diabetes care gaps (e.g., no diabetes eye exam i the last 12 months). The intervention is designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring & preventative care (e.g., annual urine microalbumin) are due and (b) allow patients to initiate orders for the care.
详细描述
Participants will be recruited from 14 VUMC-affiliate adult primary care clinics located throughout Middle Tennessee. Patients will be randomized 1:1 to the intervention or usual care. 500 adult patients with type 1 or 2 diabetes mellitus will be assigned to one of two arms. 250 will be assigned to receive access to the intervention embedded within an existing patient web portal (My Health at Vanderbilt) at Vanderbilt University Medical Center. 250 will be assigned to a usual care comparison arm with access to the currently available version of My Health at Vanderbilt without the study intervention. At enrollment, participants will complete a baseline questionnaire and diabetes health data will be abstracted from the patients' electronic health record (EHR) before being assigned to the intervention or control arm. Participants will receive additional follow-up questionnaires and diabetes health data will be abstracted from the EHR at 3-month, 6-month, and 12-month follow-ups to assess outcomes. In addition, system usage data (user analytics) will be collected throughout the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established patient with a participating primary care physician from a participating clinic
- •Type 1 or 2 diabetes mellitus
- •Able to read in English
- •Age 18 to 75 years old
- •Mobile device (smartphone or tablet) with internet access
- •Active My Health at Vanderbilt (MHAV) account
排除标准
- •A medical condition that prevents use of a mobile device
- •Pregnant or planning to become pregnant during the study period
- •Severe difficulty seeing
- •On dialysis
结局指标
主要结局
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
时间窗: Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up
Number of diabetes care gaps per patient out of four possible: 1. no diabetes eye exam in the last 12 months, 2. no hemoglobin A1C blood test in the last 6 months, 3. no urine microalbumin in the last 12 months, and 4. no pneumococcal vaccination of any kind ( i.e., never received PPSV-23, PCV-13, PCV-15, or PCV-20) The presence of a diabetes care gap will be assessed by electronic health record (EHR) abstraction.
次要结局
- Patient Initiated Orders(12-month follow-up)
- Change in Confidence Toward Managing Diabetes in General(Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up)
- Change in Understanding of Diabetes Monitoring and Preventative Care(Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up)
- Change in Diabetes Distress(Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up)
- Satisfaction/Usability of My Health at Vanderbilt(Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up)
- Change in Blood Glucose Control(Baseline to 12-month follow-up)
- Treatment Intensification(Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up)
- Change in Diabetes Self-efficacy(Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up)
- Reported Services Completed Outside Vanderbilt System(12-month follow-up)
研究者
William Martinez, MD, MS
Assistant Professor of Medicine
Vanderbilt University Medical Center