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.

NCT ID: NCT07268716

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-02
• Study Completion Date: 2029-12-31

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.

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

I-POD intervention

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geir Arne Sunde, Ph.d

Role: PRINCIPAL_INVESTIGATOR

Haukeland University hospital, Surgical Department

Locations

Surgical Department, Haukeland University hospital

Bergen, , Norway

Countries

Norway

Central Contacts

Marianne Wesnes, Cand. med.

Role: CONTACT

Phone: +47 996 20 649

Email: marianne.wesnes@helse-bergen.no

Geir Arne Sunde, Ph.d.

Role: CONTACT

Phone: +47 992 04 008

Email: geir.arne.sunde@helse-bergen.no

Facility Contacts

Marianne Wesnes, Cand.med

Role: primary

Geir Arne Sunde, Ph.d

Role: backup

Other Identifiers

909877

Identifier Type: -

Identifier Source: org_study_id