- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03099733
Concussion Texting Study (texting)
Development and Implementation of a Real-Time Assessment and Intervention for mTBI Patients Post-Discharge From the Emergency Department
Study Overview
Detailed Description
Traumatic brain injury (TBI) is an important cause of morbidity and mortality in children, resulting in an estimated 173,000 emergency department (ED) visits and 14,000 hospitalizations each year in the US. The estimated rate of TBI visits increased 57% from 2001-2009, and in 2010 there were more than 2.5 million TBI-related ED visits. Most patients are discharged from the ED and diagnosed with a closed head injury, minor head injury, concussion, or other unspecified head injury. After discharge, patients, family members, and other care partners may report certain mTBI symptoms that may lead to unnecessary utilization of healthcare services.
Novel, effective, and cost-effective solutions for mTBI symptom management post ED discharge are needed to improve the patient's understanding about their symptoms after discharge. Use of mobile technology to interact with mTBI patients may: 1) extend the reach of clinicians, 2) offer patients diagnosed with a mTBI a form of ongoing tailored clinical support, and 3) contribute to improved health outcomes and optimization of health care utilization. Previous research shows high compliance with text-message based interventions, measurable change in behavior, and prolonged adherence to clinical guidance. A recent randomized trial of mTBI patients showed high-compliance with text-message assessments following ED discharge, and a trend towards fewer and less severe post-mTBI symptoms in the intervention group. The investigators propose to develop and pilot a novel mobile phone text-messaging platform to perform real-time assessment and intervention of mTBI patients discharged from the ED. This intervention will empower patients to actively participate in the management of their condition. Use of this technology with the mTBI patient population is feasible and cost-effective. Over 90% of Americans own a cell phone or smartphone, and 80% send and receive text-messages.
The first objective of this research study is to develop and pilot the novel use of an existing technology, mobile phone text-messaging, to perform real-time assessment and feedback regarding symptoms of mTBI patients post-discharge from the ED. A second objective is to assess the effect of a brief, real-time, tailored intervention designed to impact patient and caregiver understanding of their mTBI related symptoms. The overarching goal of this proposal is to build on the work of Dr. Hirsch, et al. who found that: 1) mTBI patients report a poor understanding of concussion; 2) mTBI patients reported insufficient communication with clinicians regarding their symptoms following ED discharge (e.g., balance and sleep); and 3) mTBI patients reported poor care coordination, poor follow-up, and limited access to specialist physicians post-discharge.
Hypothesis: Based on prior work, implementation of a text-based tool for assessment and intervention of mTBI patients post-discharge from the CMC-Main & LCH EDs will improve patient engagement related to mTBI. It is anticipated that 50% of potential study subjects will elect to receive text messages and that the differences in characteristics of enrolled participants versus non-participants will not be statistically significant. It is anticipated that > 75% of participants will respond/comply with the symptom assessment messages.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 12 or greater and diagnosed with a concussion or closed head injury with intent to discharge from the ED
- Blunt trauma mechanism of injury
- GCS 14 or greater upon arrival to the ED
- The patient or caregiver owns a cell phone with text messaging capability
Exclusion Criteria:
- Penetrating trauma mechanism of injury
- The patient or caregiver does not own a cell phone with text messaging capability or is unwilling to receive text messages
- If the patient has a condition that makes him/her unable to communicate via text message
- Known unavailability (travel, planned surgery, etc.) during the follow-up period
- Planned admission to the hospital
- Abnormal CT, if obtained
- Social issues that preclude follow-up
- Alcoholism
- Major psychiatric or personality disorder
- Incarceration or arrest
- Baseline cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: concussion
patients who present to ED with concussion
|
Participants will receive text message assessment and tailored intervention messages daily over the 14-day/two-week study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility assessment
Time Frame: Study duration (one year, anticipated)
|
The intervention will be determined to be feasible if the majority of subjects respond to the text messages and complete follow-up, and if the majority of subjects that are approached agree to participate.
The demographic and baseline characteristics of participants and non-participants will be assessed for significant differences that may have influenced the feasibility assessment.
|
Study duration (one year, anticipated)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identify obstacles associated with the text messaging instrument
Time Frame: 14 days
|
Qualitative interview with participants by phone - participants will be asked about their thought and feelings related to the study assessment tool, relationships with the study physicians, text messaging impact on care and recommended changes.
|
14 days
|
Healthcare utilization
Time Frame: 3 months
|
To gauge the safety and effectiveness of the intervention, we will determine if there are patient level factors that increase the rate of follow-up and decrease direct cost of care.
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chad Scarboro, MD, Carolinas Medical Center/Atrium Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 07-16-04A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Concussion
-
Sync-Think, Inc.CompletedBrain Injuries | Concussion, Mild | Concussion, Brain | Concussion, Severe | Concussion; Eye | Concussion, CerebralUnited States
-
BrainScope Company, Inc.CompletedBrain Injuries, Traumatic | Concussion, Mild | Concussion, Brain | Concussion, Severe | Concussion, IntermediateUnited States
-
BrainScope Company, Inc.United States Department of DefenseCompletedBrain Injuries, Traumatic | Concussion, Mild | Concussion, Brain | Concussion, Severe | Concussion, IntermediateUnited States
-
BrainScope Company, Inc.CompletedBrain Injuries, Traumatic | Concussion, Mild | Concussion, Brain | Concussion, Severe | Concussion, IntermediateUnited States
-
Spaulding Rehabilitation HospitalTerminated
-
Panam ClinicCompleted
-
University of PennsylvaniaUniversity of Oklahoma; Carnegie Mellon UniversityWithdrawnConcussion
-
Oregon Center for Applied Science, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
University Hospital, ToulouseTerminated
-
Thomas Jefferson UniversityRothman Institute OrthopaedicsTerminated
Clinical Trials on text message
-
University of California, San FranciscoUniversity of WashingtonCompleted
-
University of WashingtonUniversity of Illinois at Chicago; Kenya Medical Research InstituteCompletedHIV Infections | Acquired Immunodeficiency Syndrome | Circumcision, Male | Patient Compliance | Cellular PhoneKenya
-
Texas Tech University Health Sciences CenterTexas Tech UniversityCompletedBreast Cancer FemaleUnited States
-
University of WashingtonUniversity of California, San Francisco; Kenya Medical Research InstituteCompletedHIV Infections | Acquired Immunodeficiency SyndromeKenya
-
Emory UniversityNational Cancer Institute (NCI)RecruitingMalignant Solid Neoplasm | Hematopoietic and Lymphoid System NeoplasmUnited States
-
New York City Health and Hospitals CorporationWithdrawn
-
University of PittsburghCompleted
-
Jonsson Comprehensive Cancer CentereHealth International, INC.RecruitingObesity | Malignant NeoplasmUnited States
-
Columbia UniversityPfizerCompletedVaccinationUnited States
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)CompletedHuman PapillomavirusUnited States