Utilizing Electronic Clinical Decision Support to Enhance mTBI Care at the Primary Care Point of … (NCT06693778) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Utilizing Electronic Clinical Decision Support to Enhance mTBI Care at the Primary Care Point of Entry
United States3,000 participantsStarted 2023-04-01
Plain-language summary
Six primary care practices within a large Philadelphia pediatric care network will use an electronic Clinical Decision Support (eCDS) tool as standard care for concussion evaluation. The eCDS tool will include a prediction rule for children aged 5-18 assessed for mild traumatic brain injury (mTBI). The eCDS tool predicts risk for persistent symptoms and prompts referral to specialty care for those deemed high risk. This research proposes to analyze the clinical and process outcomes in these six practices relative to the rest of the care network, specifically, whether the eCDS tool reduces time to symptom resolution.
Who can participate
Age range
5 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 5-18 year old patients evaluated for mild Traumatic Brain Injury at a Children's Hospital of Philadelphia primary care practice within the study timeframe
Exclusion Criteria:
* Evidence of moderate or severe TBI
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying how a computerized decision-support tool helps primary care doctors manage mild traumatic brain injury — is that the kind of care setting I'm currently in, and would this trial change how my day-to-day concussion care is delivered?
2The main thing this trial is tracking is how many days it takes to return to my pre-injury symptom level — how is my doctor currently measuring my symptoms, and would participating in this study affect or improve that monitoring process?
3Since the trial is 'active but not recruiting,' does that mean enrollment is closed, and if so, are there similar studies or programs that could offer me access to this kind of clinical decision support for concussion care?
4This appears to be a Phase NA study focused on a care-delivery tool rather than a drug or device — what does that mean for my safety, and are there any risks to me personally from being part of a study that changes how my doctor makes treatment decisions?
5Given that this trial is about improving primary care for mild TBI, should I be asking whether my current provider already uses any evidence-based decision-support tools for concussion, or whether a referral to a concussion specialist might be a better path for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.