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Trauma CentersPOSTRAUMANCT07268716

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.

A study testing The intervention is a tailored patient Information and Patient-managed Outpatient Digital follow-up treatment in people with Trauma Centers and Trauma Patients, run by Haukeland University Hospital at 1 site in Norway.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
The intervention is a tailored patient Information and Patient-managed Outpatient Digital follow-up treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
1 siteNorway
Study dates
2 Mar 2026to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marianne Wesnes, Cand. med. contact

+47 996 20 649

marianne.wesnes@helse-bergen.no

Geir Arne Sunde, Ph.d. contact

+47 992 04 008

geir.arne.sunde@helse-bergen.no

Norway1 site
  • Surgical Department, Haukeland University hospital

    Bergen, 5021

    Marianne Wesnes, Cand.med, +47 996 20 649, marianne.wesnes@helse-bergen.no

    Geir Arne Sunde, Ph.d, +47 992 04 008, geir.arne.sunde@helse-bergen.no

Other trials in Norway

About this study

Official title: A Randomized Controlled Clinical Trial to Assess the Efficacy of Tailored Patient Information and Voluntary Patient-Managed Outpatient Digital Follow-Up as an Adjunct to Standard Treatment According to National Guidelines in Adult Trauma Patients in Norway (The POSTRAUMA Trial).

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.

Read more

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.
Read the detailed description

Trauma is the leading cause of death worldwide in patients aged 1-45 years. Injuries and violence contribute to approximately 10% of all disability-adjusted life years globally. 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 compared to other medical cohorts. The socioeconomic and functional implications of trauma are significant. With the expected demographic shift toward an aging population in Norway, the incidence of trauma among older adults is also expected to increase, placing greater demands on in-hospital trauma and rehabilitation services. Socioeconomic status, gender and age have been identified as key predictors of long-term outcomes following trauma, with female and individuals with lower education levels or ongoing compensation claims often reporting poorer outcomes.

While mortality rates are decreasing due to advancements in trauma systems, prevention strategies and medical care, a significant proportion of trauma survivors experience longterm 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 is often 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, relatives, and healthcare professionals is limited.

This study aims to investigate how early rehabilitation and patient-centred care pathways can improve short and long-term outcomes for trauma patients. The objectives of the POSTRAUMA-trial is to assess the efficacy of a tailored patient information and patient managed outpatient digital follow-up (I-POD), as an adjunct to standard treatment according to the national guidelines in the National Trauma Plan (NTP) among adult trauma patients in Norway. The main research question is whether participants in the intervention group have less disability and improved health-related quality of life 6 months after the accident compared to the control group which receives standard treatment alone?

The latter part of the trial is a qualitative study which will follow the consolidated criteria for reporting qualitative studies (COREQ). SI will through in-dept and semi-structured interviews explore the participants experiences following trauma in general, and more specific to evaluate how the written patient information and digital follow-up was perceived. The SI will encourage the participants to talk about issues regarding this by asking open-ended questions in one-to-one interviews. The illness trajectory framework will be used as a theoretical framework, along with the WHOs International Classification of Functioning, Disability and Health (ICF) to ensure that preinjury, physical and biopsychosocial factors are evaluated.

Being tested
The intervention is a tailored patient Information and Patient-managed Outpatient Digital follow-up treatment
Keywords
multitrauma, trauma, rehabilitation, return to work, HRQOL, EQ5D
Medical subject headings
Wounds and Injuries, Accidental Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The intervention is a tailored patient Information and Patient-managed Outpatient Digital follow-up treatmentOther

    Also called I-POD intervention

    The objective of the POSTRAUMA-trial is to assess if the I-POD intervention combined with standard treatment according to national guidelines, lead to less disability measured by EQ5D-index, better health-related quality of life measured by EQ-VAS and increased return to studies and work compared to standard treatment after trauma.

Study groups in NCT07268716
Study groupRoleWhat they receive
Control groupNo interventionStandard treatment and follow up after trauma according to national guidelines in the National trauma plan.
Intervention groupActive comparatorTailored patient information and patient-managed outpatient follow up as an adjunct to standard treatment according to national guidelines in the National trauma plan
Receives: Other: The intervention is a tailored patient Information and Patient-managed Outpatient Digital follow-up treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EuroQol five-dimension utility score (EQ5D-index) from baseline to 6 months after the trauma in both groups.

    The primary objective is to assess the efficacy of the I-POD-intervention as an adjunct to standard treatment after trauma according to national guidelines in adult patients in Norway. The efficacy is measured as the primary endpoint: EuroQol five-dimension utility score (EQ5D-index) from baseline to 6 months after the trauma in both groups. EQ5D-index ranges from - 0,59 (worst score) to 1 (perfect health, best score). 0 equals death. Baseline is defined as the time of inclusion.

    The I-POD intervention is a tailored patient Information and Patient-managed Outpatient Digital follow-up treatment.

    Measured: From baseline to 6 months after the trauma

Secondary outcomes (3)
  1. Differences in EuroQol five-dimension utility score (EQ5D-index) between the control group and the intervention group from baseline to 1 month and 12 months after the trauma.

    EQ5D-index ranges from - 0,59 (worst score) to 1 (perfect health, best score). 0 equals death.

    Measured: Baseline to 1 month and 12 months after the trauma

  2. Differences in HRQoL between the control group and the intervention group from baseline to 1 month, 6 months and 12 months after the trauma, measured by EuroQol visual analogue scale (EQ-VAS).

    The EQ-VAS (EuroQol Visual Analogue Scale) is a standard tool used with the EQ-5D health questionnaire to measure a person's self-rated overall health on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health).

    Measured: Baseline to 1 month, 6 months and 12 months after the trauma

  3. Differences in Return to work (RTW) between the control group and the intervention group at 1 month, 6 months and 12 months after the trauma by patient-reported data at 1 month, and 6 months and 12 months by NTR-data measured with dichotomous (yes/no)

    Measured: Baseline to 1 month, 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2025
  2. Study start2 Mar 2026 (estimated)
  3. Primary completion2 Mar 2027 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled clinical trial
Masking
None (open label)
Enrolment
256 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07268716
Sponsor's protocol ID
909877
Acronym
POSTRAUMA
Status last verified
Nov 2025
First submitted
25 Nov 2025
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Sharing of privacy data is not within the scope of the ethical approval granted by REK West.

Questions about this trial

What is this clinical trial studying?

A study testing The intervention is a tailored patient Information and Patient-managed Outpatient Digital follow-up treatment in people with Trauma Centers and Trauma Patients, run by Haukeland University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marianne Wesnes, Cand. med. (+47 996 20 649, marianne.wesnes@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EuroQol five-dimension utility score (EQ5D-index) from baseline to 6 months after the trauma in both groups. (time frame: From baseline to 6 months after the trauma). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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