MyChart in Patients With Inflammatory Bowel Disease. (MyIBD)
Utility of MyChart for Improving Quality of Life and Patient Satisfaction in Patients With Inflammatory Bowel Disease.
研究概览
详细说明
This study will be a single site randomized control trial.
Patients will be randomized into a control arm and intervention arm. At baseline the investigators will obtain demographic data, quality of life measures, and satisfaction with MyChart for those patients who are alrealy active portal users. The control arm will receive periodic messages through MyChart that are not specific to IBD. The intervention arm will receive more specific disease related information such as IBD educational information, reminders to take their medications, and reminders to get vaccinated. The intervention arm will also receive questionnaires that assess their mood (depression and anxiety). The investigators will then inform the primary gastroenterologist for those patients in whom mild, moderate or severe depression and anxiety is identified. At the end the study, in both groups investigators will measure quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), a validated questionnaire for measuring health-related quality of life in patients with Crohn's and Ulcerative Colitis. Secondary outcomes will include: Satisfaction with Mychart as measured by a MyChart satisfaction survey, time to referral to mental health provider for patients identified with mild, moderate, or severe depression, or anxiety (PROMIS Depression and Anxiety Questionnaires), and Vaccine uptake (using a simple yes/no questionnaire asking patients if they received Flu, PCV13 or PPSV23.
The findings of this study will allow future clinicians to better understand how a patient portal can be utilized as a tool for the management of patients with IBD. This findings may lead to increased physician and patient engagement with the MyChart patient portal.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、92118
- Boston Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Men and Women 18 years and older with a diagnosis of Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis, or Indeterminate Colitis by standard criteria) who are scheduled for an upcoming appointment at the outpatient gastroenterology clinic or infusion unit.
Exclusion Criteria:
- Non-English speaking patients
- Patients identified by their physicians as being too cognitively impaired to participate
- Patients without access to computer with internet
- Patients not expected to be in the study area for the duration of the study such as patients only seen for a one time second opinion
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：MyChart Intervention
Subjects in the control arm will be enrolled in MyChart during the consent process and receive MyChart Disease Specific targeted IBD information and reminders as well as mood questionnaires.
At week 2 subjects will receive reminders to get vaccinated with another reminder sent at 3 months.
At month 1, subjects will receive the Promis Adult Short Form questionnaires for depression and anxiety through MyChart.
If a subject is identified as having mild, moderate or a severe mood disorder a message will be sent to their gastroenterologist with a recommendation to discuss the results with the patient and to consider a referral to mental health services.
Subjects will also receive educational information about IBD every 6 weeks along with reminders to take their medications.
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Subjects receive targeted IBD information and reminders as well as mood questionnaires.
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无干预：Usual Care
Subjects in the control arm will be enrolled in MyChart during the consent process if they are not previously enrolled.
Enrollment in MyChart will provide them with access to their medical record and the ability to send or receive messages with their gastroenterologist or any other providers they see at our institution.
For patients with IBD it is standard practice to discuss medication adherence, vaccinations, and their mood at each appointment.
Subjects will receive generic, non-IBD related messages through MyChart.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Quality of life based on the SIBDQ
大体时间：6 months
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Quality of life will be measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) which is a 10 item health-related quality of life (HRQoL) tool measuring physical, social, and emotional status (scores can range from 10-70, poor to good HRQoL).
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Satisfaction with MyChart
大体时间：6-months
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The 14 item embedded MyChart Satisfaction Survey will be used to measure satisfaction.
Responses for 12 of the questions are answered on a scale of 0 to 10 where 10=Strongly Agree, 5=Neither Agree nor Disagree, and 0=Strongly Disagree, so the higher the score for those questions the greater the satisfaction.
there is also a question about the number of times myChart was used and an open-ended comments question..
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6-months
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Influenza vaccine uptake
大体时间：6-months
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To measure vaccine uptake for flu the patients will be asked if they received the flu shot in the previous year.
A chart review will be done to confirm the self reported information.
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6-months
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Pneumococcal pneumonia (PCV13, PPSV23) vaccine uptake
大体时间：6-months
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To measure PCV13, PPSV23 vaccine uptake for pneumococcal pneumonia the patients will be asked if they received the vaccine in the previous year.
A chart review will be done to confirm the self reported information.
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6-months
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Time to Referral for Behavioral Health
大体时间：6-months
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After a patient has been identified as having anxiety or depression and a message has been sent to their healthcare provider the time it takes the provider to refer the patient to behavioral health will be measured.
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6-months
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合作者和调查者
调查人员
- 首席研究员：Jason Reich, MD、Boston Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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