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. (POSTRAUMA)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rehabilitation; Trauma Injury; HRQOL (Health Related Quality Of Life); Return to Work; Trauma (Including Fractures); Trauma Patients; Trauma Centers; EQ5D5L-VAS; Rehabilitation After Neurological or Orthopaedic Injuries
• Intervention / Treatment: Other: The intervention is a tailored patient Information and Patient-managed Outpatient Digital follow-up treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marianne Wesnes, Cand. med.; Phone Number: +47 996 20 649; Email: marianne.wesnes@helse-bergen.no
• Study Contact Backup: Name: Geir Arne Sunde, Ph.d.; Phone Number: +47 992 04 008; Email: geir.arne.sunde@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Surgical Department, Haukeland University hospital
    • Contact: Marianne Wesnes, Cand.med; Phone Number: +47 996 20 649; Email: marianne.wesnes@helse-bergen.no
    • Contact: Geir Arne Sunde, Ph.d; Phone Number: +47 992 04 008; Email: geir.arne.sunde@helse-bergen.no
    • Sub-Investigator: Marianne Wesnes, Cand.med
    • Principal Investigator: Geir Arne Sunde, Ph.d

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Standard treatment and follow up after trauma according to national guidelines in the National trauma plan.
Active Comparator: Intervention group; 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; 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.; Other Names: I-POD intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	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).	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).	Baseline to 1 month, 6 months and 12 months after the trauma

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Geir Arne Sunde, Ph.d, Haukeland University hospital, Surgical Department

Study record dates

Study Major Dates

• Study Start (Estimated): March 2, 2026
• Primary Completion (Estimated): March 2, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Estimated): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: trauma; rehabilitation; HRQOL; return to work; EQ5D; multitrauma
• Additional Relevant MeSH Terms: Accidental Injuries; Wounds and Injuries
• Other Study ID Numbers: 909877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing of privacy data is not within the scope of the ethical approval granted by REK West.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No