broken bone fracture
Conditions
Interventions
In this project, pre- and in-hospital trauma care remains unchanged and is
described in the LNAZ (Landelijk Netwerk Acute Zorg) recommendations [26]. The
main aim of the TTCM is to improve trauma re
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age >= 16 years old • 1 or more fracture(s) as a result of a trauma • Able to fill in online questionnaires in Dutch • Able to give informed consent • At least one outpatient consultation of the trauma surgeon
Exclusion criteria
Exclusion criteria: • Patients with traumatic brain injury • Pathological fractures • Severe psychopathology (e.g. schizophrenia, high risk suicidality) • Cognitive limitations • Living in an institution (e.g. nursing home) • Does not speak/ understand Dutch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary outcomes The co-primary outcomes are generic quality of life (EQ 5D-5L) and disease-specific quality of life (standardized Patient Reported Outcomes [PROMS]). Choice of measurement of dis-ease-specific quality of life depends on trauma location: - upper extremity: QuickDASH DLV - lower extremity: Lower Extremity Functional Scale (LEFS) - multiple fractures and/or more locations: Groningen activiteiten restrictie schaal (GARS) - back: The Roland Morris Disability Questionnaire (RMDQ) Co-primary outcomes are measured at baseline, 6 weeks, 3 months, 6 months and 9 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline, relevant patient characteristics and important prognostic variables are measured (patient characteristics/ trauma characteristics). Secondary outcomes include functional status (Patient-Specific Functional Scale PSFS), pain (11-point NRS), patient satisfaction (11-point NRS), perceived recovery (7- point Global Per-ceived Effect Scale) and patient-reported health based on physical functioning (PROMIS-PF(-UE)). For the economic evaluation, societal and healthcare costs are measured. Sec-ondary outcomes are measured at baseline, 3 months, 6 months and 9 months. For the economic evaluation, societal as well as healthcare costs are assessed. Societal costs include all costs related to the TTCM, irrespective of who pays or benefits. Healthcare costs only include costs accruing to the formal Dutch healthcare sector. Intervention costs are micro-costed. Cost questionnaires based on the iMCQ (iMTA Medical Consumption Questionnaire), iPCQ (iMTA Productivity Cost Questionnaire), and WHO-HPQ (World Health Organization Health and Work Performance Questionnaire) are administered at baseline, 3, 6 and 9 months follow-up to collect data on healthcare utilization, the use of informal care, absenteeism, presenteeism and unpaid productivity losses [57]. Health care utilization includes the use of primary care (e.g. consultations at the general practitioner or physical therapist) and secondary care (e.g. consultations at the outpatient clinic for trauma patients, hospitalization) as well as the use of medication. Dutch standard costs are used to value healthcare costs [57]. Medication use is valued using the G-standard of the Dutch Society of Pharmacy [58]. Absenteeism is assessed by asking patients to report their total number of sick leave days [59]. Absenteeism is valued using gender-specific price weights [57]. Presenteeism is defined as reduced productivity while at work and is assessed using the WHO-HPQ [60]. Presenteeism is valued using ge | — |
Countries
Netherlands
Outcome results
None listed