Musculoskeletal trauma
Conditions
Interventions
Once informed consent has been given and Baseline CRFs completed, the participant will be randomised by the local research team using a web-based service. Those participants randomised to the PROMOTE
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 16 years or older 2. Surgically treated lower extremity fracture as part of a major trauma (classified as a lower limb fracture [pelvis and below] with an Injury Severity Score > = 16 as per Trauma Audit and Research Network (TARN) eligibility OR a single lower extremity complex fracture [pelvis and acetabular fractures or multiple/open/comminuted fractures]). 3. Able to provide informed consent 4. Initially operated for their lower limb injury within the last 7 days
Exclusion criteria
Exclusion criteria: 1. Clinically significant brain or spinal cord injury (i.e,. patients with a central nervous system injury sufficient to be on a dedicated neurological injury rehabilitation pathway) 2. Unable to adhere to the trial procedures or complete questionnaires 3. Unable to access the intervention materials (i.e., no internet access)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient study engagement is measured using the screening and recruitment data at 0 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intervention adherence is measured using treatment records at baseline and each treatment session 2. Healthcare provider intervention delivery fidelity is measured using quality assurance audio recordings/site visits to assess the delivery of the PROMOTE intervention 3. Participant retention rate is measured using outcome data availability at the end of the study 4. Study and intervention acceptability, feasibility, barriers and facilitators are measured using patient and staff focus groups/interviews during the study period 5. Mobility and function are measured using Disability Rating Index (DRI) at baseline, 6 weeks and 3 months post-randomisation 6. Pain intensity is measured using the PROMIS Numeric Rating Scale at baseline, 6 weeks and 3 months post-randomisation 7. Pain interference is measured using PROMIS Pain Interference at baseline, 6 weeks and 3 months post-randomisation 8. Pain self-efficacy is measured using the Pain Self-Efficacy Questionnaire (PSEQ) at baseline, 6 weeks and 3 months post-randomisation 9. Pain catastrophising is measured using the Pain Catastrophizing Scale (PCS) at baseline, 6 weeks and 3 months post-randomisation 10. Depression and anxiety are measured using the Patient Health Questionnaire (PHQ4) at baseline, 6 weeks and 3 months post-randomisation 11. Pain medication use is measured using a bespoke pain medication questionnaire at baseline, 6 weeks and 3 months post-randomisation 12. Complications are measured using bespoke complications questionnaire at baseline, 6 weeks and 3 months post-randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactKylea Draper
Outcome results
None listed