NCT03241992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2019

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

August 4, 2017

Last Update Submit

January 24, 2019

Conditions

Keywords

Inflammatory Bowel DiseaseIBDElectronic Health RecordPatient PortalQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Satisfaction with MyChart

    6-months

  • Influenza vaccine uptake

    6-months

  • Pneumococcal pneumonia (PCV13, PPSV23) vaccine uptake

    6-months

  • Time to Referral for Behavioral Health

    6-months

Study Arms (2)

MyChart Intervention

EXPERIMENTAL

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.

Behavioral: MyChart Disease Specific

Usual Care

NO INTERVENTION

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.

Interventions

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

MyChart Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 92118, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Jason Reich, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow, Gastroenterology. General Internal Medicine Department

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 8, 2017

Study Start

November 15, 2017

Primary Completion

January 20, 2019

Study Completion

January 20, 2019

Last Updated

January 28, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations