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| ID | Type | Description | Link |
|---|---|---|---|
| HT9425-24-1-0376 | Other Grant/Funding Number | U.S. Army Medical Research Acquisition Activity |
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| Name | Class |
|---|---|
| U.S. Army Medical Research Acquisition Activity | FED |
| Ohio State University | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinicians | Experimental | Clinician participants will all have access to any clinical implementation strategies that are developed and disseminated in the project. |
|
| Patients-Survey Cohort | No Intervention | Patient participants will be observationally followed via survey during the study to monitor patient-reported outcomes. | |
| Patients-Chart Review Only | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical implementation strategies | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient-level penetration-electronic health record (EHR) | 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) | 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) | Change in the percentage of concussion/mTBI-related encounters for which patients reported having received mTBI patient education before ED discharge (Aim 2 outcome) | 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 | 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). | Day 1 post-ED visit, Day 30 post-ED visit |
| mTBI symptom burden | Patient-rated Rivermead Post Concussion Symptoms Questionnaire total score (range 0-64; higher scores = more severe injury-related symptoms) (Aim 3 outcome). | Day 1 post-ED visit, Day 30 post-ED visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in percentage of trauma cases resulting in mTBI diagnosis | Change in the percentage of ED encounters for a traumatic injury resulting in a diagnosis of concussion or mTBI | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in clinician ratings to the Acceptability of Intervention Measure | ED clinician responses to the Acceptability of Intervention Measure (AIM), a 4 item scale with 5-point Likert-type items scaled from 1 (completely disagree) to 5 (completely agree). Total scores reflect the mean item rating (range 1 to 5); higher scores reflect greater acceptability. (Aim 2 outcome; Aim 1 will characterize pre-implementation baseline data only) |
Inclusion Criteria:
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:
Patients-Chart Review Only:
Exclusion Criteria:
ED clinicians:
• Providers that do not practice in a Froedtert & Medical College of Wisconsin emergency department.
Patients-Survey Cohort.
Patients-Chart Review Only:
• Minors under the age of 18.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8551320 | Background | 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. | |
| 28851459 | Background | 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. |
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De-identified raw data for the Patient-Survey Cohort will be made available on the Open Data Commons for Traumatic Brain Injury (ODC-TBI)
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D000070642 | Brain Injuries, Traumatic |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The study will enroll and follow emergency department clinicians and their patients. Clinicians will be the focus of the intervention.
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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.
| Patient-rated mTBI knowledge |
Patient-rated mTBI knowledge, measured with a 24-item True/False scale (total score range 0-24; higher scores = greater knowledge). Questions ask about common and uncommon mTBI symptoms and common misconceptions about mTBI signs and recovery. |
| Day 30 post-ED visit |
| Patient-rated clinical care satisfaction at Day 1 | Collected on a 5-point scale with the options Very Satisfied, Somewhat Satisfied, Neither Satisfied Nor Dissatisfied, Somewhat Dissatisfied, and Very Dissatisfied. The question is "How satisfied are you with the care you received for head injury in the Emergency Department?" | Day 1 post-ED visit |
| Patient-rated clinical care satisfaction at Day 30 | Collected on a 5-point scale with the options Very Satisfied, Somewhat Satisfied, Neither Satisfied Nor Dissatisfied, Somewhat Dissatisfied, and Very Dissatisfied. The question is "How satisfied are you with the care you received for head injury since leaving the emergency department?" | Day 30 post-ED visit |
| Pre-intervention survey period (study onset through roughly 6 months later); post- intervention survey period (roughly 18 months from study onset to 6 months later) |
| Change in clinician ratings to the Intervention Appropriateness Measure | ED clinician responses to the Intervention Appropriateness Measure (IAM), a 4 item scale with 5-point Likert-type items scaled from 1 (completely disagree) to 5 (completely agree). Total scores reflect the mean item rating (range 1 to 5); higher scores reflect greater appropriateness. (Aim 2 outcome; Aim 1 will characterize pre-implementation baseline data only) | Pre-intervention survey period (study onset through roughly 6 months later); post- intervention survey period (roughly 18 months from study onset to 6 months later) |
| Change in clinician ratings to the Feasibility of Intervention Measure | ED clinician responses to the Feasibility of Intervention Measure (FIM), a 4 item scale with 5-point Likert-type items scaled from 1 (completely disagree) to 5 (completely agree). Total scores reflect the mean item rating (range 1 to 5); higher scores reflect greater feasibility. (Aim 2 outcome; Aim 1 will characterize pre-implementation baseline data only) | Pre-intervention survey period (study onset through roughly 6 months later); post- intervention survey period (roughly 18 months from study onset to 6 months later) |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |