Videos to Aid Decision Making for Fibroid Treatment
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Video on uterine fibroids.
- Кому может быть актуально
- Состояния в реестре: Uterine Bleeding, Decision Aid. Базовые параметры: 18 лет — 55 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Use of Video Aids Versus Usual Care for Reduction in Decisional Conflict in Fibroid Treatment
Обзор
Uterine fibroids are a common condition that can cause heavy and/or painful menstrual bleeding. There are many treatment options, but they vary in efficacy, side effects, short-term recovery and long-term implications for future fertility. Patients can have difficulty deciding between these options. In this study, the investigators will randomly assign patients seeking treatment for fibroids to receive an educational video on fibroids and their treatment, versus usual care (no video). The investigators will assess their decisional conflict with and without exposure to the video using a validated survey to see if exposure to the educational video helps them make decisions.
Подробное описание
Decisional conflict is defined as personal uncertainty regarding which course of action to take when choice among different options involves risk, regret, or challenge to personal life values. Some factors that influence decisional conflict are inadequate knowledge, unclear values, inadequate support, and the perception that an ineffective decision has been made. In this study, the investigators hope to target the factor of inadequate knowledge to see if an educational-style video can decrease decisional conflict in patients with fibroids. This will be completed via assessment using a validated decisional conflict scale score the DCS-10. DCS-10 scores range from 0 to 100 with a larger number indicating a higher level of decisional conflict. Scores above 37.5 are associated with decision delay. Through improving knowledge via an educational video about fibroids, the investigators wish to determine if decisional conflict can be minimized.
This will be a randomized, single-blinded trial. Patients in the intervention arm will be sent an educational video on fibroids prior to their visit to discuss fibroid treatment options. All patients will receive routine clinical care and counseling regarding treatment options at their visit. After the visit, patients will complete a DCS-10 survey. Survey instruments will be sent via text message using the Way to Health platform, timed to automatically send based on appointment date.
Pilot data shows an average post-visit DCS-10 score of 29 within this gynecologic population. With the recommended effect size of 0.4 in the literature on DCS-10, a sample size of 154 patients is needed. The investigators anticipate study recruitment will take approximately six months. Individual participation in the study will begin when patients are sent an invitation to participate soon after scheduling a visit to discuss fibroid treatment. It will end with a post-visit DCS-10 survey within one week of the visit. The survey will take approximately 5 minutes to complete and the video duration is 5 minutes, for a total of 10 minutes of participant time after enrollment. Based on the time between scheduling and completing this visit, the time between enrollment and final survey collection will be approximately 1-12 weeks. Chart review will occur to capture treatment decisions within 12 weeks of visit.
Вмешательства
- Поведенческое Video on uterine fibroids
Patients will be sent a link to a 5 minute video on uterine fibroids including their diagnosis, symptoms and treatment options prior to their scheduled appointment.
Первичные конечные точки
- Decisional Conflict Scale [Срок оценки: 1 weeks after appointment]
Вторичные конечные точки (3)
- Treatment selected [Срок оценки: 12 weeks post appointment]
- Time to treatment [Срок оценки: 12 weeks post appointment]
- Length of visit [Срок оценки: Baseline]
Критерии участия
Критерии включения
- Diagnosis of uterine fibroids
- Scheduled appointment to discuss management of fibroids in an outpatient clinical site associated with the Hospital of the University of Pennsylvania
Критерии исключения
- Age <18 or >55
- Uterine or cervical cancer
- Cervical dysplasia grade 2-3 within the last 12 mo
- Pregnancy
- Menopause
- Decision made prior to the study intake to have a surgical procedure for treatment of fibroids
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
США · 1 центр
- Hospital of the University of Pennsylvania — Philadelphia
Идентификаторы
NCT: NCT07072364 · OBGYN-GYN-QI-1