Patient-Centered Decision Support for Eosinophilic Esophagitis

Официальное название

Patient-Centered Decision Support for Eosinophilic Esophagitis: A Pilot Study

Обзор

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.

Вмешательства

• Поведенческое General education control
  Participants will complete an online survey before reviewing education material for eosinophilic esophagitis, prior to patient's clinical physician's appointment (this appointment is a standard of care visit). Participants will complete a follow-up survey approximately 3 months after the clinic appointment.
• Поведенческое Decision support tool
  Participants will complete an online survey before reviewing tailored educational materials for eosinophilic esophagitis prior to patient's clinical physician's appointment (this appointment is a standard of care visit). The intervention is a tailored, electronic decision support intervention with a patient-facing decision aid (DA) with three components-EoE knowledge/education, values clarifications, and communication. Tailored feedback from the patient will be given to the patient's provider pr

Первичные конечные точки

• Feasibility: measured as the proportion of eligible patients that consent to participate in the study [Срок оценки: Recruitment period approximately 18 months]
• Acceptability: measured on a 4-point Likert scale [Срок оценки: Approximately 4 months]

Вторичные конечные точки (4)

• Effectiveness (within-subjects) [Срок оценки: Day 1 up to approximately 1 month (after consent prior to standard of care clinic visit)]
• Effectiveness (between-subjects) [Срок оценки: Approximately 4 months]
• Preparation for Decision Making (PrepDM) scale [Срок оценки: Approximately 4 months]
• Completion rates [Срок оценки: Approximately 4 months]

Критерии участия

Критерии включения

• New EoE patient evaluations ≥18 years old at University of Michigan (UM) that have an upcoming outpatient visit in a UM-gastroenterology or allergy \& immunology clinic,
• Able to speak and read English.

Критерии исключения

• Prisoners and institutionalized individuals due to logistical limitations for use of a web app and follow-up interactions in these populations.
• Patients that have significant cognitive or visual impairment that limits interaction with the decision aid (DA)
• Patients that are terminally ill
• Patients that do not have an email address or reliable access to the internet

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT06817213 · HUM00257119 · 1K23DK129784-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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