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OpenTrials
Completed

NCT Number: NCT03241992

MyChart in Patients With Inflammatory Bowel Disease.

This study will be the first to assess the use of an electronic health records patient portal for patients with Inflammatory Bowel Disease. Patients with Inflammatory Bowel Disease (IBD), have reduced quality of life, high rates of depression and anxiety, do not receive routine preventative health maintenance (such as vaccines) at the same rate as the general public, and have low adherence to medications. The investigators are seeking to understand whether an electronic health record patient portal (EPIC's MyChart), can be utilized to improve quality of life in this patient population.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 92118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyChart Disease Specific

Behavioral

Subjects receive targeted IBD information and reminders as well as mood questionnaires.

Primary outcomes

  1. Quality of life based on the SIBDQ

    Time frame: 6 months

    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).

Secondary outcomes

  1. Satisfaction with MyChart

    Time frame: 6-months

    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..

  2. Influenza vaccine uptake

    Time frame: 6-months

    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.

  3. Pneumococcal pneumonia (PCV13, PPSV23) vaccine uptake

    Time frame: 6-months

    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.

  4. Time to Referral for Behavioral Health

    Time frame: 6-months

    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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

Utility of MyChart for Improving Quality of Life and Patient Satisfaction in Patients With Inflammatory Bowel Disease.

Acronym: MyIBD

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2017
Registry last updated
Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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