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

Trial Summary

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 data supports the effectiveness of the treatment Patient-Centered Decision Support for eosinophilic esophagitis?

The research highlights the need for treatments that address the long-term control of eosinophilic esophagitis, suggesting that patient-centered decision support could help tailor treatments to individual needs, potentially improving outcomes by considering patient perspectives and preferences. ^{1 2 3 4 5}

Is the Decision Support for Eosinophilic Esophagitis treatment safe for humans?

There is no specific safety data available for the Decision Support for Eosinophilic Esophagitis treatment in the provided research articles. ^{6 7 8 9 10}

How is the Patient-Centered Decision Support treatment for Eosinophilic Esophagitis different from other treatments?

Patient-Centered Decision Support is unique because it involves shared decision-making, where patients actively participate in choosing their treatment options, potentially using electronic decision-support systems to improve outcomes. This approach is different from traditional treatments that may not involve the patient as closely in the decision-making process. ^{11 12 13 14 15}

What is the purpose of this trial?

The study team is conducting this project to learn more about how patients with eosinophilic esophagitis (EoE) like to use and receive educational materials about treatment options and treatment decision making. 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 assess the feasibility and acceptability of the intervention to inform future R01-level studies. The study team hypothesize that deploying the intervention will be feasible, and it will demonstrate high acceptability among EoE patients. Additionally, that patients that use the intervention (vs general education about EoE) will report greater treatment knowledge, increased readiness to choose a therapy, adherence to therapy, and follow-up.

Research Team

Joy Chang, MD, MS

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS). [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Motivations, Barriers, and Outcomes of Patient-Reported Shared Decision Making in Eosinophilic Esophagitis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Disease Burden and Unmet Need in Eosinophilic Esophagitis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of oral prednisone and topical fluticasone in the treatment of eosinophilic esophagitis: a randomized trial in children. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Heterogeneity in Clinical, Endoscopic, and Histologic Outcome Measures and Placebo Response Rates in Clinical Trials of Eosinophilic Esophagitis: A Systematic Review. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Integrating Electronic Health Record Data into the ADEpedia-on-OHDSI Platform for Improved Signal Detection: A Case Study of Immune-related Adverse Events. [2020]

7. Scotland pubmed.ncbi.nlm.nih.gov

Detection of adverse events in a Scottish hospital using a consensus-based methodology. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Patients' reaction to the disclosure of rare dreaded adverse events. [2021]

10. Spain pubmed.ncbi.nlm.nih.gov

[Quality of information on adverse events provided by the surgical patient]. [2012]

11. England pubmed.ncbi.nlm.nih.gov

Are we measuring the right end-points? Variables that affect the impact of computerised decision support on patient outcomes: a systematic review. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Shared decision-making in food allergy: Navigating an exciting era. [2023]

13. Canada pubmed.ncbi.nlm.nih.gov

Informing Patients With Esophagogastric Cancer About Treatment Outcomes by Using a Web-Based Tool and Training: Development and Evaluation Study. [2021]

14. Australia pubmed.ncbi.nlm.nih.gov

Electronic interface for emergency department management of asthma: a randomized control trial of clinician performance. [2008]

15. Denmark pubmed.ncbi.nlm.nih.gov

The information needs and preferred roles in treatment decision-making of parents caring for infants with atopic dermatitis: a qualitative study. [2007]