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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03241992
Other study ID # H-35695
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2017
Est. completion date January 20, 2019

Study information

Verified date January 2019
Source Boston Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date January 20, 2019
Est. primary completion date January 20, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MyChart Disease Specific
Subjects receive targeted IBD information and reminders as well as mood questionnaires.

Locations

Country Name City State
United States Boston Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 6 months
Secondary 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.. 6-months
Secondary 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. 6-months
Secondary 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. 6-months
Secondary 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. 6-months
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