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ID
Source
Brief title
Health condition
One or more fracture(s) as a result of a trauma
Sponsors and support
Intervention
Outcome measures
Primary outcome
The co-primary outcomes are generic and disease-specific HR-QOL. Generic HR-QOL will be measured using the EQ-5D-5L (30). Utility values will be estimated using the Dutch tariff. Quality-adjusted life-years (QALYs) will be calculated using linear interpolation between measurement points.
Depending on the diagnosis, disease-specific HR-QOL will be measured using one of the following four standardized Patient-Reported Outcomes questionnaires [PROMS]:
• Upper extremity: QuickDASH DLV (Disabilities of the Arm, Shoulder, and Hand)
• 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)
An overall disease-specific HR-QOL score of the PROMS is calculated by converting the overall scores of the aforementioned questionnaires to a scale from 0-100, with higher scores representing more functional problems.
Secondary outcome
Secondary outcomes include functional status (Patient-Specific Functional Scale PSFS), pain (11-point NRS), patient satisfaction (11-point NRS), perceived recovery (7-point Global Perceived Effect Scale) and patient-reported health based on physical functioning (PROMIS-PF(-UE)).
Background summary
Objective: The organization of the rehabilitation of trauma patients in primary care is challenging, and there are currently no guidelines for an optimal treatment. A recent feasibility study showed that the implementation of the Transmural Trauma Care Model (TTCM) at a Dutch level-one trauma center was feasible, that patient outcomes were improved, and that costs were reduced. The current study aims to assess the effectiveness and cost-effectiveness of the TTCM as compared to usual care.
Methods: A multicenter trial with a controlled before-and-after design will be performed at ten hospitals in the Netherlands. First, participating hospitals will include 322 patients in the control group, receiving usual care as provided in the participating hospitals. Subsequently, the TTCM will be implemented in all participating hospitals, and hospitals will include an additional 322 patients in the intervention group. The TTCM consists of a multidisciplinary team with a trauma surgeon, a specialized, hospital-based physical therapist and an educated and trained network of primary care trauma physical therapists. The main aim of the TTCM is to improve trauma rehabilitation by an increased focus on generic and disease-specific health related-quality of life, and therefore these are the co-primary outcomes. Secondary outcomes will include pain, patient satisfaction, perceived recovery, and patient-reported physical functioning. For the economic evaluation, societal and healthcare costs will be measured. Measurements will take place at baseline and after 6 weeks, 3, 6, and 9 months. Analyses will be based on the intention-to-treat principle. Missing data will be handled using longitudinal data analyses in the effect analyses and by multiple imputation in the economic evaluation.
Conclusion: This research will give insight into the effectiveness and cost-effectiveness of the Transmural Trauma Care Model (TTCM) in a multicenter trial.
Study objective
We hypothesize that the TTCM improves generic and disease-specific HR-QOL and that it is cost-effective compared with usual care from both the healthcare and societal perspective.
Study design
baseline, 6 weeks, 3 months, 6 months, and 9 months
Intervention
TTCM: In the TTCM, a multidisciplinary team consisting of a trauma surgeon and a specialized, hospital-based physical therapist will examine patients during their first outpatient consultations and will coordinate their entire rehabilitation process. The TTCM consists of four main elements: 1) Intake and follow-up consultations by a multidisciplinary team at the outpatient clinic, 2) Coordination and individual goal setting, 3) an educated and trained network of primary care trauma physical therapists, and 4) secure e-mail communication between hospital-based physical therapists and network physical therapists
Inclusion criteria
Patients older than 16 years with one or more fracture(s) as a result of a trauma, who have received medical treatment at an emergency department or have been admitted to a hospital will be invited to participate.
Exclusion criteria
Patients with traumatic brain injury, pathological fractures, severe psychopathology, cognitive limitations, insufficient knowledge of the Dutch language, as well as patients living in an institution or refusing to sign informed consent, will be excluded.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8163 |
| Other | METc Amsterdam UMC, location VUmc : 2019.419 (A2019.471) |