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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、92118
- Boston Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quality of life based on the SIBDQ
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Satisfaction with MyChart
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Jason Reich, MD、Boston Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
MyChart Disease Specificの臨床試験
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Yale UniversityNational Library of Medicine (NLM)まだ募集していません
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Ann & Robert H Lurie Children's Hospital of ChicagoHealth Resources and Services Administration (HRSA)募集
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The Cleveland ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完了
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Masonic Cancer Center, University of MinnesotaGT Biopharma, Inc.募集