Measurement-Based Care for Inflammatory Bowel Disease
(MBC-IBD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help people with Inflammatory Bowel Disease (IBD), a chronic condition that affects daily life. The researchers seek to determine if a new approach, called Measurement-Based Care (MBC), can improve quality of life and reduce flare-ups through close monitoring between clinic visits. Participants will either receive the new MBC approach, known as the MBC-IBD Intervention, or continue with standard care, which includes regular check-ups and educational materials. Veterans who feel their IBD significantly impacts their daily life might find this trial suitable. As an unphased trial, this study provides a unique opportunity to explore innovative care strategies that could enhance daily living for those with IBD.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this Measurement-Based Care approach is safe for Veterans with IBD?
Research has shown that measurement-based care (MBC) for inflammatory bowel disease (IBD) is safe for patients. MBC uses information from patient surveys to monitor symptoms and track treatment effectiveness over time. This method helps patients manage their condition better between doctor visits by keeping their healthcare team regularly updated.
MBC does not involve new drugs or invasive procedures, reducing the risk of side effects. It enhances communication and monitoring through self-reported questionnaires. Patients find it easy to use, with no reports of negative effects linked to MBC itself.
Overall, MBC is a helpful tool that improves care without adding extra risks.12345Why are researchers excited about this trial?
Researchers are excited about the MBC-IBD intervention because it offers a new way to manage inflammatory bowel disease by integrating measurement-based care into routine treatment. Unlike the standard care that relies heavily on clinic visits and routine biomarker assessments, MBC-IBD uses technology to provide continuous care. Patients receive automated reminders to complete weekly surveys, allowing for real-time tracking of symptoms and treatment effectiveness. This approach aims to keep patients more engaged in their care and could lead to better health outcomes by identifying issues early and adjusting treatment plans in a timely manner.
What evidence suggests that the MBC-IBD intervention is effective for managing inflammatory bowel disease?
Research has shown that Measurement-Based Care (MBC) can effectively manage inflammatory bowel disease (IBD). In this trial, participants in the MBC-IBD arm will use patient-reported outcomes (PROs), such as surveys about pain and other symptoms, to help doctors identify issues early and adjust treatments more quickly. This method aims to improve quality of life and reduce hospital visits by allowing for closer monitoring between doctor appointments. Early results indicate that patients feel more in control of their symptoms, leading to better overall health management. Overall, MBC for IBD appears promising in making life easier for those living with the condition.13678
Who Is on the Research Team?
Shirley Cohen-Mekelburg, MD MS
Principal Investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
Are You a Good Fit for This Trial?
This trial is for Veterans with Inflammatory Bowel Disease (IBD) who need better disease management. It aims to help them monitor their condition closely between clinic visits and improve their quality of life.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete baseline surveys and assessments
Treatment
Participants receive either Measurement-Based Care (MBC) or Enhanced Treatment as Usual (E-TAU) for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MBC-IBD Intervention
Trial Overview
The study tests a Measurement-Based Care (MBC) approach against Enhanced Treatment as Usual (E-TAU). MBC involves systematic collection and use of patient-reported data to adjust treatment timely, while E-TAU represents the standard care without this systematic approach.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Measurement Based Care for Inflammatory Bowel Disease - Intervention group. Veteran participants who are randomized to 12-months of MBC-IBD will be enrolled for 12 months. They will each complete surveys at baseline, 6-months, and 12-months post-randomization. These assessments require completion of self-report questionnaires which will be completed by phone or electronically using VA REDCap. MBC in IBD will not replace but rather provide care continuity between clinic visits. Patients allocated to MBC in IBD will receive automated reminders to complete weekly questionnaires.
Enhanced Treatment as Usual (E-TAU). Participants assigned to E-TAU will receive standard of care, including monitoring and treatment as directed at the discretion of their gastroenterologist. Standard of care is based on current evidence-based professional guidelines, including routine inflammatory biomarker assessments (e.g., annual fecal calprotectin), therapy plans, scheduled and as-needed clinic visits, and scheduled and as-needed telephone calls. Participants will also receive educational videos and fact sheets on various IBD-specific topics.
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Citations
A Hybrid Effectiveness-Implementation Study
The objectives of this research are to determine the effectiveness of MBC in inflammatory bowel disease (IBD) and to assess factors that influence ...
Testing the Impact of Measurement-Based Care on Quality ...
The Measurement-Based Care (MBC) for IBD study will take a systematic approach to collect, share, and act on patient reported outcome (PRO) data ...
Making a Case for Patient-Reported Outcomes in ...
Commonly used PROs in IBD include severity scales for pain, defecatory urgency, and bloody stool, and several disease-specific and generic instruments assessing.
Core Outcome Set for Inflammatory Bowel Diseases ...
A core outcome set for inflammatory bowel diseases: development and recommendations for implementation in clinical practice through an international multi- ...
Patient-Reported Outcomes Measurement Information ...
Inflammatory bowel disease (IBD) is an immune-mediated chronic disease ... A new measure of health status for clinical trials in inflammatory bowel disease.
Assessment of patient-centered outcomes (PROs) in ...
These data can aid in improving the communication of the pressing needs of IBD patients, to both the public payers and health authorities.
Pre‐implementation patient, provider, and administrator ...
1 INTRODUCTION. Measurement-based care (MBC), or the use of quantitative data to track symptom severity and response to treatment, has potential ...
Inflammatory Bowel Disease Standard Set
The Inflammatory Bowel Disease Standard Set is our recommendation of the outcomes that matter most to patients with this Disease.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.