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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.

ConditionsTrauma CentersTrauma PatientsTrauma (Including Fractures)Trauma InjuryRehabilitation After Neurological or Orthopaedic InjuriesRehabilitationReturn to WorkHRQOL (Health Related Quality Of Life)EQ5D5L-VAS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorHaukeland University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

15 years or younger

Not included in NTR database

Deceased before discharge from the hospital.

Not able to give informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other 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.

Treatment groups

256 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Intervention groupActive comparator 1 intervention

Trial outcomes

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.

Time frame
From baseline to 6 months after the trauma

Secondary outcomes

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.

Time frame
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).

Time frame
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)

Time frame
Baseline to 1 month, 6 months and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haukeland University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: