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Набор скоро начнётся NCT07278076

Clinical Decision-Making During FEES: The Impact of Residue Amount and Location

Без фазы С лечением Decision Making

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: education.
Кому может быть актуально
Состояния в реестре: Decision Making. Базовые параметры: Без ограничений · 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

In this study, the investigator aims to identify the threshold of food residue visualized in the throat during a FEES (fiberoptic endoscopic evaluation of swallowing) that speech-language pathologists allow before restricting a patient from eating. 60 speech-language pathologists will be required to participate, with half of them watching a pre-recorded video detailing current research about residue in the throat of pharynx. The group watching the video will then re-score their images. This investigates the impact of education on clinical decision-making. Finally, 8 clinicians will meet with the researcher individually to share their clinical decision-making rationale. With this information, the researcher hopes to identify a patient population who is at risk for diet restrictions in order to encourage speech-language pathologists to extend the swallow study and trial more compensatory strategies before restricting the patient's diet.

Подробное описание

The purpose of this research is to identify the location and threshold of pharyngeal residue at which clinicians restrict diets for patients in the outpatient setting. 60 clinicians will judge 25 pairs of photos from FEES (fiberoptic endoscopic evaluation of swallowing) where each of the five levels of pharyngeal residue (e.g. none, trace, mild, moderate, and severe) are represented. These levels are used by the standardized and validated Yale Pharyngeal Residue Severity Rating Scale (YPRSRS).11 Residue severity in both the valleculae and pyriform sinuses will be presented, creating 25 image combinations. The patient history for each pair of photographs is the same: no airway compromise has occurred, the patient is ambulatory, does not require supplemental oxygen, has no cognitive deficits and is receiving out-patient care. Clinicians will indicate at which severity level of pharyngeal residue they are most likely to restrict the diet using a Likert scale (e.g. "extremely unlikely", "unlikely", "neutral", "likely", and "extremely unlikely"). Observing diet restrictions when pharyngeal residue reaches moderate levels would support our hypothesis that clinicians make risk-averse recommendations.

The other aim of this project is to evaluate the impact of evidence-based education on clinician decision-making regarding pharyngeal residue and location. Half of the clinicians will be randomized to the treatment group and watch a recorded 30-minute pre-recorded video presentation about research on pharyngeal residue before they complete the image assessment task. Using this information, a comparison can be made with diet restriction patterns between the educated (treatment) and non-educated (control) groups, potentially demonstrating whether evidence-based clinical research reduces fear-based decision-making. Should the investigators observe that the experimental group restricts diets less than the control group, the hypothesis that clinicians and patients benefit from evidence-based clinical education would be accurate.

Finally, the researcher would like to determine the rationale behind clinician decision-making. During the qualitative portion of this study, the researcher will interview eight clinicians. Clinicians will be chosen from the original group of 60 to participate in a structured interview to investigate the rationale behind their clinical decision-making. An analysis will be completed to determine the distribution of clinicians who chose to restrict the diet compared to those who did not. The clinicians chosen will reflect the ratio of restrictive and non-restrictive clinicians. The researchers anticipate that clinicians who watched the recorded research presentation are less likely to restrict diets based on pharyngeal residue alone regardless of the location. In collecting data, a bottom-up descriptive approach will be utilized. A phenomenological framework will investigate the various factors that might impact a clinician's decision to restrict a diet.

Вмешательства

  • Другое education
    In the second aim of the study, 30 (50%) of the clinicians participating in the study will watch a 30-minute educational presentation about current research on clinical decision making and aspiration risks of pharyngeal residue after they complete the image assessment task (Specific Aim 1). Several peer-reviewed articles will be presented via video recording. These articles support several key tenets of this research study and include: 1) recommendations should be based on clinical experience an

Первичные конечные точки

  • If a diet restriction occurs based on the residue amount and location [Срок оценки: In one year since the initiation of the study]
Вторичные конечные точки (2)
  • Identifying if education impacts how pharyngeal residue is interpreted [Срок оценки: In one year since the initiation of the study]
  • Ivestigating the rationale behind clinical decision making during pharyngeal residue management [Срок оценки: In one year since the initiation of the study]

Критерии участия

Критерии включения

  • Speech language pathologists with at least one year of experience conducting FEES (flexible endoscopic evaluations of swallowing)

Критерии исключения

  • Anyone who is not a speech pathologist, or has less than one year of experience conducting FEES.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07278076 · 25093017

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗