Effectiveness and cost-effectiveness of the Transmural Trauma Care Model (TTCM) investigated in a multicenter trial with a controlled before-and-after design: a study protocol

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28487

Enrollment

644

Registered

2019-11-14

Start date

2019-11-14

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

One or more fracture(s) as a result of a trauma

Interventions

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 wi

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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)).	—

Contacts

Public ContactJulia Ratter

Amsterdam UMC locatie VUmc

j.ratter@amsterdamumc.nl020 – 44 44744

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)