MyChart in Patients With Inflammatory Bowel Disease.

NCT ID: NCT03241992

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2019-01-20

Brief Summary

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.

Detailed Description

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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MyChart Disease Specific

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MyChart Disease Specific

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jason Reich

Fellow, Gastroenterology. General Internal Medicine Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Reich, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-35695

Identifier Type: -

Identifier Source: org_study_id