Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03099733 |
| Other study ID # |
07-16-04A |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 6, 2017 |
| Est. completion date |
February 9, 2018 |
Study information
| Verified date |
March 2019 |
| Source |
Wake Forest University Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This will be a prospective study of the implementation of a real-time assessment and
intervention of a text messaging tool in mild traumatic brain injury (mTBI) patients
post-discharge from the emergency department.
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.
