Surgical Department, Haukeland University hospital
Bergen, 5021, Norway
Location contact
Geir Arne Sunde, Ph.d
CONTACT
Geir Arne Sunde, Ph.d
PRINCIPAL_INVESTIGATOR
Marianne Wesnes, Cand.med
CONTACT
Marianne Wesnes, Cand.med
SUB_INVESTIGATOR
NCT Number: NCT07268716
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.
Trial opening soon.
Get Notified16 year and older
All sexes
Interventional
Not applicable
Bergen, 5021, Norway
Geir Arne Sunde, Ph.d
CONTACT
Geir Arne Sunde, Ph.d
PRINCIPAL_INVESTIGATOR
Marianne Wesnes, Cand.med
CONTACT
Marianne Wesnes, Cand.med
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: From baseline to 6 months after the trauma
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.
Time frame: 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.
Time frame: Baseline to 1 month, 6 months and 12 months after the trauma
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).
Time frame: Baseline to 1 month, 6 months and 12 months
Contact information is provided by the study sponsor or research team.
Geir Arne Sunde, Ph.d.
CONTACT
Marianne Wesnes, Cand. med.
CONTACT
Haukeland University Hospital
Other
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).
Acronym: POSTRAUMA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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