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

Browse trials for

• Brain Concussion 637
• Brain Injuries, Traumatic 1,721
• Emergencies 1,328

Keywords

• Education
• Systems of care
• Emergency department
• Implementation science

Brain Concussion

637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.

This study's planned enrollment of 5,831 is above the median of 63 across 446 interventional studies indexed under Brain Concussion.

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 548 studies on the registry; 122 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.

Study arms

• Experimental
  Clinicians

  Clinician participants will all have access to any clinical implementation strategies that are developed and disseminated in the project.

  Other: Clinical implementation strategies

• No intervention
  Patients-Survey Cohort

  Patient participants will be observationally followed via survey during the study to monitor patient-reported outcomes.

• No intervention
  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.

Interventions

• OtherClinical 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

Primary outcomes

1. 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)

   Time frame: 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)

2. 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)

   Time frame: 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)

3. 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).

   Time frame: Day 1 post-ED visit, Day 30 post-ED visit

4. 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).

   Time frame: Day 1 post-ED visit, Day 30 post-ED visit

Secondary outcomes

1. 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

   Time frame: 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)

2. 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.

   Time frame: Day 30 post-ED visit

3. 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?"

   Time frame: Day 1 post-ED visit

4. 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?"

   Time frame: Day 30 post-ED visit

Other outcomes

1. 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)

   Time frame: 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)

2. 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)

   Time frame: 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)

3. 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)

   Time frame: 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)

Publications

• 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. PubMed 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. PubMed 28851459 ↗

Individual participant data

Plan to share: Yes — De-identified raw data for the Patient-Survey Cohort will be made available on the Open Data Commons for Traumatic Brain Injury (ODC-TBI)