Measurement-Based Care for Inflammatory Bowel Disease

(MBC-IBD Trial)

Not yet recruiting at 3 trial locations
SC
NM
Overseen ByNicolle Marinec, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

SC

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

Veteran patients receiving IBD care at one of the four sites
Veteran patients must have willingness and ability to participate in study procedures
My IBD affects my quality of life, scoring less than 60 on the SIBDQ.
See 1 more

Exclusion Criteria

I am a veteran with severe health conditions that could affect my treatment priorities.
Clinic staff without any experience with MBC in IBD
I am a veteran with an ostomy or have had surgery to create a connection between my small intestine and anus.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline surveys and assessments

1 week
1 visit (virtual or phone)

Treatment

Participants receive either Measurement-Based Care (MBC) or Enhanced Treatment as Usual (E-TAU) for 12 months

12 months
Weekly questionnaires (virtual), 3 major assessments at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: MBC-IBDExperimental Treatment1 Intervention
Group II: E-TAUActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

A Hybrid Effectiveness-Implementation StudyThe 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 SetThe Inflammatory Bowel Disease Standard Set is our recommendation of the outcomes that matter most to patients with this Disease.
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