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.

NCT07268716 | Not Yet Recruiting DMC

• 1 other identifier: 909877
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trauma Centers; Trauma Patients; Trauma (Including Fractures); Trauma Injury; Rehabilitation After Neurological or Orthopaedic Injuries; Rehabilitation; Return to Work; HRQOL (Health Related Quality Of Life); EQ5D5L-VAS

Keywords

multitrauma; trauma; rehabilitation; return to work; HRQOL; EQ5D

Outcome Measures

Primary Outcomes (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.

  From baseline to 6 months after the trauma

Secondary Outcomes (3)

• 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.

  Baseline to 1 month and 12 months after the trauma

• 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).

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

• 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)

  Baseline to 1 month, 6 months and 12 months

Study Arms (2)

Control group

NO INTERVENTION

Standard treatment and follow up after trauma according to national guidelines in the National trauma plan.

Intervention group

ACTIVE COMPARATOR

Tailored patient information and patient-managed outpatient follow up as an adjunct to standard treatment according to national guidelines in the National trauma plan

Other: The intervention is a tailored patient Information and Patient-managed Outpatient Digital follow-up treatment

Interventions

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

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.

Also known as: I-POD intervention

Intervention group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Fulfils the national criteria for TTA and admitted to HUS following trauma
• Included in NTR database
• Able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Surgical Department, Haukeland University hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Wounds and Injuries; Accidental Injuries

Study Officials

• Geir Arne Sunde, Ph.d

  Haukeland University hospital, Surgical Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: March 2, 2026
• Primary Completion (Estimated): March 2, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)