Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury

Обзор

The purpose of this study is to develop and validate ways to provide better patient education and clinical management for individuals who go to the emergency department (ED) with concussion or mild traumatic brain injury (mTBI).

Подробное описание

The study will address three aims: (1) identify factors that help and hinder providing in-ED education to patients with mTBI prior to discharge; (2) examine the impact of tailored implementation strategies on ED providers' provision of in-ED patient education; and (3) evaluate the impact of providing patient education in the ED and through a mobile Health (mHealth) tool post-discharge on patient-level outcomes after mTBI.

Вмешательства

• Другое Clinical implementation strategies
  Clinical implementation strategies, selected based on ED clinician survey/interview findings from Aim 1 using the Implementing Promoting Action on Research Implementation in Health Services (i-PARIHS) implementation science framework

Первичные конечные точки

• Change in patient-level penetration-electronic health record (EHR) [Срок оценки: Pre-intervention baseline period (estimated study onset to 1 year later); post- intervention follow-up period (estimated 18 months from study onset to 1 year later)]
• Change in patient-level penetration-patient reported outcome (PRO) [Срок оценки: Pre-intervention baseline period (estimated study onset to 1 year later); post- intervention follow-up period (estimated 18 months from study onset to 1 year later)]
• Self-efficacy to manage mTBI symptoms [Срок оценки: Day 1 post-ED visit, Day 30 post-ED visit]
• mTBI symptom burden [Срок оценки: Day 1 post-ED visit, Day 30 post-ED visit]

Вторичные конечные точки (4)

• Change in percentage of trauma cases resulting in mTBI diagnosis [Срок оценки: Pre-intervention baseline period (estimated study onset to 1 year later); post-intervention follow-up period (estimated 18 months from study onset to 1 year later)]
• Patient-rated mTBI knowledge [Срок оценки: Day 30 post-ED visit]
• Patient-rated clinical care satisfaction at Day 1 [Срок оценки: Day 1 post-ED visit]
• Patient-rated clinical care satisfaction at Day 30 [Срок оценки: Day 30 post-ED visit]

Критерии участия

Критерии включения

ED clinicians:

• Faculty attending physician, advanced practice professional (APP), resident, fellow, or nurse who practices in an eligible Froedtert \& Medical College of Wisconsin (MCW) emergency department

Patients-Survey Cohort:

• Seen and discharged from a Froedtert \& MCW emergency department.
• Age 18 or older.
• Has a clinical diagnosis of TBI, as reflected by a relevant International Classification of Disease-10th Edition (ICD-10) code or other evidence (e.g., diagnosis and educational information in the After Visit Summary)
• Speaks English or Spanish.

Patients-Chart Review Only:

• Seen and discharged from a Froedtert \& MCW emergency department.
• Age 18 or older.
• Has a clinical diagnosis of TBI, as reflected by a relevant ICD-10 code or other evidence (e.g., diagnosis and educational information in the After Visit Summary). Note that for evaluation of Secondary Aim #1 (% trauma patients with an mTBI diagnosis), a broader sample of emergency department patients evaluated for trauma will be evaluated).

Критерии исключения

ED clinicians:

• Providers that do not practice in a Froedtert \& Medical College of Wisconsin emergency department.

Patients-Survey Cohort.

• In protective custody.
• On psychiatric hold.
• Is not own decision maker (e.g., activated healthcare power of attorney).
• Indicated Do Not Contact in their research contact preferences.
• Left the emergency department prematurely (e.g., against medical advice).
• History of serious health condition that, in the opinion of the investigator, would interfere with engagement in or validity of the survey (e.g., active thought disorder; terminal cancer; dementia).

Patients-Chart Review Only:

• Minors under the age of 18.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Medical College of Wisconsin — Milwaukee

Публикации

• King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811. PMID 8551320
• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. PMID 28851459

Идентификаторы

NCT: NCT06595914 · PRO00051478 · HT9425-24-1-0376

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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