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MyChart in Patients With Inflammatory Bowel Disease. (MyIBD)

Primary Purpose

Inflammatory Bowel Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyChart Disease Specific
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Inflammatory Bowel Disease, IBD, Electronic Health Record, Patient Portal, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MyChart Intervention

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quality of life based on the SIBDQ
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 Outcome Measures

Satisfaction with MyChart
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..
Influenza vaccine uptake
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.
Pneumococcal pneumonia (PCV13, PPSV23) vaccine uptake
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.
Time to Referral for Behavioral Health
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.

Full Information

First Posted
August 4, 2017
Last Updated
January 24, 2019
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03241992
Brief Title
MyChart in Patients With Inflammatory Bowel Disease.
Acronym
MyIBD
Official Title
Utility of MyChart for Improving Quality of Life and Patient Satisfaction in Patients With Inflammatory Bowel Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
January 20, 2019 (Actual)
Study Completion Date
January 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Inflammatory Bowel Disease, IBD, Electronic Health Record, Patient Portal, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MyChart Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MyChart Disease Specific
Intervention Description
Subjects receive targeted IBD information and reminders as well as mood questionnaires.
Primary Outcome Measure Information:
Title
Quality of life based on the SIBDQ
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Satisfaction with MyChart
Description
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..
Time Frame
6-months
Title
Influenza vaccine uptake
Description
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.
Time Frame
6-months
Title
Pneumococcal pneumonia (PCV13, PPSV23) vaccine uptake
Description
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.
Time Frame
6-months
Title
Time to Referral for Behavioral Health
Description
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.
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Reich, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
92118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MyChart in Patients With Inflammatory Bowel Disease.

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