Assess the Efficacy of Tailored Patient Information and Voluntary Patient-managed Outpatient Digi… (NCT07268716) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assess the Efficacy of Tailored Patient Information and Voluntary Patient-managed Outpatient Digital Follow-up (I-POD) as an Adjunct to Standard Treatment According to National Guidelines in the National Trauma Plan Among Adult Trauma Patients in Norway.
Norway256 participantsStarted 2026-03-02
Plain-language summary
The POSTRAUMA trial is a clinical trial at The Regional trauma centre of Western Norway, Haukeland University Hospital.
Trauma is the leading cause of death worldwide in patients aged 1-45 years. In Norway, approximately 10,000 patients are admitted to hospital annually due to trauma, with 66% being male. The mean age is 43 years for male and 48 years for female, indicating a relatively young patient population.
While mortality rates are decreasing, a significant proportion of trauma survivors experience long-term disabilities, reduced quality of life, and difficulties in returning to work. These consequences impose substantial burdens on individuals, families, and society. Considering these issues, a shift in focus is needed-from survival alone to long-term functional recovery and quality of life after trauma.
Severe trauma often requires long-term follow-up, both physically and psychosocially. Traditional follow-up can be fragmented and not tailored to individual needs. Digital patient monitoring and tailored information have the potential to improve patient pathways, but knowledge about how these are experienced by patients is limited.
The goal is to find out if Norwegian trauma patients who receive tailored patient information and patient-managed outpatient digital follow-up, in addition to standard treatment have:
* Less disability
* Return more often to work
* Improved quality of life
The study population are Norwegian trauma patients, 16 years or older at date of inclusion, who are admitted to Haukeland University hospital (HUS) following trauma with trauma team activation. 256 patients will be included in this trial.
Participants will:
* Answer a questionnaire at inclusion, one month, 6 months and 12 months.
* Participants in the intervention group will be invited to digital outpatient follow up one month after the accident.
* Some participants will be interviewed about how they experienced their trauma follow up.
Who can participate
Age range
16 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:
* 16 years or older
* Fulfils the national criteria for TTA and admitted to HUS following trauma
* Included in NTR database
* Able to give informed consent
Exclusion Criteria:
* 15 years or younger
* Not included in NTR database
* Deceased before discharge from the hospital.
* Not able to give informed consent
* Insufficient command of the Norwegian language
* Foreign tourists or nationals
* Suicide attempt or serious self-inflicted trauma
* Serious psychiatric disorders or serious ongoing substance abuse
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 uses a digital follow-up app that patients manage themselves after going home — given my specific injuries and how comfortable I am with technology, do you think I'd realistically be able to use something like that during my recovery?
2The study is measuring health-related quality of life using a tool called the EQ5D at 6 months after injury — does that timeline match up with when you'd expect to see meaningful recovery progress for someone with my type of trauma?
3Since this trial isn't recruiting yet, what is my best option for follow-up care right now, and is standard treatment under Norway's National Trauma Plan something I should be pursuing in the meantime?
4The trial involves tailored patient information alongside the digital check-ins — how does that compare to the amount and quality of information and support I'd receive through the standard care pathway if I don't join a study?
5Because this is listed as a non-phase trial focused on rehabilitation and return to work rather than a new drug or device, what do we know so far about whether digitally supported self-managed follow-up actually improves outcomes for patients like me compared to usual in-person follow-up?
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.
What they're measuring
1
EuroQol five-dimension utility score (EQ5D-index) from baseline to 6 months after the trauma in both groups.
Timeframe: From baseline to 6 months after the trauma