Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 5,831
- 试验地点
- 2
- 主要终点
- Change in patient-level penetration-electronic health record (EHR)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Because the intervention disseminates clinical implementation strategies to clinicians, clinicians will not be masked. Patient participants will be masked to whether their outcomes are being collected pre- versus post-clinician intervention. Patient participants will not be masked with regard to having received the mHealth tool for post-discharge education.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Patients-Survey Cohort
Patient participants will be observationally followed via survey during the study to monitor patient-reported outcomes.
Patients-Chart Review Only
Patients who are not in the survey study but who meet other eligibility criteria will undergo chart review to provide electronic health record-based outcomes.
Clinicians
Clinician participants will all have access to any clinical implementation strategies that are developed and disseminated in the project.
干预措施: Clinical implementation strategies (Other)
结局指标
主要结局
Change in patient-level penetration-electronic health record (EHR)
时间窗: 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 the percentage of concussion/mTBI-related encounters for which an mTBI patient handout was documented in the Epic After Visit Summary (Aim 2 outcome)
Change in patient-level penetration-patient reported outcome (PRO)
时间窗: 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 the percentage of concussion/mTBI-related encounters for which patients reported having received mTBI patient education before ED discharge (Aim 2 outcome)
Self-efficacy to manage mTBI symptoms
时间窗: Day 1 post-ED visit, Day 30 post-ED visit
Patient ratings on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Self-Efficacy for Managing Symptoms, a 20-point scale based on 4 Likert-type items with 5 response options each (higher scores = more confidence) (Aim 3 outcome).
mTBI symptom burden
时间窗: Day 1 post-ED visit, Day 30 post-ED visit
Patient-rated Rivermead Post Concussion Symptoms Questionnaire total score (range 0-64; higher scores = more severe injury-related symptoms) (Aim 3 outcome).
次要结局
- Patient-rated clinical care satisfaction at Day 30(Day 30 post-ED visit)
- Change in percentage of trauma cases resulting in mTBI diagnosis(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(Day 30 post-ED visit)
- Patient-rated clinical care satisfaction at Day 1(Day 1 post-ED visit)
- Patient-rated clinical care satisfaction at Day 30(Day 30 post-ED visit)
研究者
Lindsay Nelson
Professor
Medical College of Wisconsin