Oslo University Hospital is conducting a trial to assess the effectiveness of a self-management program (SEMPO) for individuals recovering from moderate to severe traumatic injuries. The study, which began in January 2024, aims to determine if SEMPO can improve patients' self-efficacy and overall recovery during the sub-acute phase after trauma.
Study Design and Setting
The research is taking place at the Department of Physical Medicine and Rehabilitation at Oslo University Hospital (OUH), the trauma referral center for the South-eastern region of Norway. Participants, aged 18–72, are recruited following a hospital stay of at least two days for a traumatic injury resulting in a New Injury Severity Score (NISS) greater than 9. The intervention is delivered 3–4 months post-injury.
Intervention: SEMPO
The SEMPO program consists of eight weekly 2.5-hour sessions for groups of 4–7 patients. It integrates psychoeducation, skills mastery, compensatory strategies, and problem-solving techniques. A telehealth version is available for those with travel constraints. The program's development involved experienced clinicians, researchers, and a user panel including individuals with lived experience of traumatic injuries and representatives from the National Association of the Traumatically Injured (LTN).
Outcome Measures
The primary outcome is the Trauma Coping Self-Efficacy Scale, measured at the 6-month follow-up. Secondary outcomes include symptom burden, physical and cognitive functioning, emotional distress, and return to work. Patients also nominate a self-selected outcome measure related to fatigue, sleep, pain, or other relevant domains. Cost-effectiveness and cost-utility data will be collected via patient surveys.
Control Group
The control group receives treatment as usual, which may vary depending on individual needs and available municipal services. The study will log the services provided to the control group to allow for comparison with the intervention group.
Sample Size and Recruitment
The study aims to include 110 patients, with 55 in each group, accounting for an anticipated 20% attrition rate. This sample size is calculated to detect a clinically relevant difference of 0.6 on the Trauma Coping Self-Efficacy Scale, assuming a standard deviation of 1, 80% power, and a 5% significance level. Patient recruitment is conducted in collaboration with the Department of Traumatology at OUH.
Randomization and Blinding
Patients are randomized to either a classical randomization arm (RA) or a self-selection arm (SA). Those in the RA are further randomized to the SEMPO intervention or the control group, while those in the SA self-select their allocation. Outcome assessors will be blinded to study allocation during follow-ups to minimize bias.
