Decision Support for Eosinophilic Esophagitis

Overseen By Kelcie Brophy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Cognitive impairment, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best methods to assist people with eosinophilic esophagitis (EoE) in making informed treatment decisions. EoE occurs when a type of white blood cell accumulates in the esophagus, leading to pain and difficulty swallowing. The study compares two groups: one using general educational materials and another using a patient-centered decision support tool with tailored information. The trial seeks new participants at the University of Michigan who can read and speak English and have internet access. Participants will help researchers determine if the decision tool improves understanding and readiness to begin therapy. As an unphased trial, this study allows patients to contribute to research that could enhance decision-making tools for EoE treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on decision-making support rather than medication changes.

What prior data suggests that this decision support intervention is safe for patients with eosinophilic esophagitis?

Research has shown that specific safety information for the Patient-Centered Decision Support treatment for eosinophilic esophagitis (EoE) is not available. This treatment is not a drug or medical procedure but a tool to assist patients in making informed care decisions. Since it provides information and support, no known risks or side effects exist. It resembles receiving advice or guidance and is generally considered safe for everyone. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how tailored educational materials can improve decision-making in managing eosinophilic esophagitis (EoE). Unlike traditional treatments that focus on medication or dietary changes to reduce inflammation and manage symptoms, this approach empowers patients with personalized information to make informed choices about their care. The trial aims to determine if these decision support tools can lead to better health outcomes by enhancing patient understanding and engagement.

What evidence suggests that this decision support intervention is effective for eosinophilic esophagitis?

Research has shown that many people with eosinophilic esophagitis (EoE) often feel excluded from treatment decisions, leading to uncertainty. This trial will compare two approaches: a general education control group and a decision support tool group. Early results suggest that tools focused on patient needs, like those in the decision support tool group, can be beneficial. These tools provide personalized information, enhancing patients' understanding of their treatment options. By increasing knowledge and readiness, patients are more likely to choose and adhere to a treatment that suits them. This method has been well-received by patients and shows promise in improving treatment choices. ^{1 3 4 5 6}

Who Is on the Research Team?

Joy Chang, MD, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with Eosinophilic Esophagitis (EoE) or Non-erosive Reflux Disease who are interested in learning about treatment options. Participants should be willing to use educational materials and make decisions regarding their treatment.

Inclusion Criteria

Able to speak and read English

I am over 18 and have an upcoming appointment at UM for EoE.

Exclusion Criteria

Patients that are terminally ill

Patients that do not have an email address or reliable access to the internet

Prisoners and institutionalized individuals due to logistical limitations for use of a web app and follow-up interactions in these populations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either general educational materials or tailored decision support tools to aid in treatment decision making

4 months

Follow-up

Participants are monitored for treatment knowledge, readiness to choose therapy, adherence, and follow-up

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient-Centered Decision Support

Trial Overview The study compares a decision support tool designed to help patients understand and manage EoE treatments against general education materials. It aims to see if the tool increases knowledge, readiness for therapy choice, adherence, and follow-up.

How Is the Trial Designed?

Group I: Decision support tool group Experimental Treatment 1 Intervention

Tailored educational materials

Group II: General education control group Active Control 1 Intervention

General educational materials

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study of 450 patient records from a large teaching hospital in Scotland, the overall rate of adverse events (AEs) was found to be 7.9%, with the highest rate in acute surgery (13%) and none reported in obstetrics.

A significant portion of these AEs (43%) were deemed preventable, highlighting the need for improved identification methods, as only 10% were captured by the hospital's voluntary reporting system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of adverse events in a Scottish hospital using a consensus-based methodology. Williams, DJ., Olsen, S., Crichton, W., et al.[2021]

In a study of 80 patients with eosinophilic esophagitis, both oral prednisone and swallowed fluticasone were effective in improving esophageal histology and alleviating symptoms, with prednisone showing a greater degree of histologic improvement.

Despite the greater histologic benefits of prednisone, there was no significant difference in symptom resolution or relapse rates between the two treatments, and both groups experienced a high rate of symptom relapse after therapy was stopped, indicating the need for ongoing maintenance treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of oral prednisone and topical fluticasone in the treatment of eosinophilic esophagitis: a randomized trial in children. Schaefer, ET., Fitzgerald, JF., Molleston, JP., et al.[2022]

Patients can effectively identify adverse events (AEs) they experience after surgery, providing valuable information that can enhance patient safety and improve medical records, as shown in a study of 28 surgical patients.

The study found a moderate agreement (intraclass correlation coefficient of 0.35) between patients' reports of AEs and medical records, indicating that while patients can be reliable sources of information, there is still room for improvement in communication and reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality of information on adverse events provided by the surgical patient]. Mira, JJ., Vitaller, J., Guilabert, M., et al.[2012]

The PROSPER Consortium aims to enhance safety reporting in healthcare by integrating patient-reported outcomes (PROs) into the assessment of adverse events, recognizing the importance of the patient's perspective in understanding treatment effects.

Despite advancements in technology and increased focus on patient involvement, current safety reporting still heavily relies on healthcare professionals, which can lead to under-reporting and discrepancies between patient experiences and clinician perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. Banerjee, AK., Okun, S., Edwards, IR., et al.[2022]

Patients' reactions to the disclosure of rare adverse events (AEs) vary significantly based on gender and ethnicity, with non-White men perceiving a higher risk of developing AEs compared to White men.

White women expressed more worry and a lower willingness to take medications associated with rare AEs, indicating that tailored communication strategies may be necessary to address these differences in risk perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' reaction to the disclosure of rare dreaded adverse events. Fraenkel, L., Peters, E.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06817213

Patient-Centered Decision Support for Eosinophilic ... This study will assess the efficacy of a decision support intervention to make decisions about treatment and disease management for patients with EoE and will ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/595056

Patient-Centered Decision Support for Eosinophilic ... The study team hypothesize that deploying the intervention will be feasible, and it will demonstrate high acceptability among EoE patients.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06817213/patient-centered-decision-support-for-eosinophilic-esophagitis

Patient-Centered Decision Support for Eosinophilic ... This study will assess the efficacy of a decision support intervention to make decisions about treatment and disease management for patients ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9110111/

Motivations, Barriers, and Outcomes of Patient-Reported ... Results · Shared Decision Making. Overall, 217 (42.3%) of respondents reported experiencing low SDM around EoE treatments before starting therapy ...

5. withpower.com withpower.com/trial/phase-eosinophilic-esophagitis-2-2025-cb4c0

Decision Support for Eosinophilic Esophagitis This study will assess the efficacy of a decision support intervention to make decisions about treatment and disease management for patients with EoE and will ...

6. trials.foodallergy.org trials.foodallergy.org/trials/NCT06817213

Patient-Centered Decision Support for Eosinophilic Esophagitis This study will assess the efficacy of a decision support intervention to make decisions about treatment and disease management for patients with EoE and will ...