Effectiveness and cost-effectiveness of the Transmural Trauma Care Model (TTCM), a non randomized controlled multicenter trial

Trauma remains one of the most common causes of death and disability worldwide.
The economic burden of trauma is high. In the Netherlands, 80,000 patients were
treated in trauma centers in 2017. Each year, traumatic injuries cost an
estimated 300 million years of healthy life, translating to 11% of disability
adjusted life years (DALY*s) experienced worldwide. An estimated 37 million
trauma-related emergency visits occur yearly, of which 2.6 million result in a
hospital admis-sion. Traumatic disorders rank among the five most costly
medical conditions. The lifetime costs of traumatic injuries have been
estimated at $406 billion dollars, with $80 billion repre-senting healthcare
costs. The majority of trauma-related costs is due to increased absentee-ism
and lost productivity.
Due to trauma*s major clinical and economic impact there has been an increased
interest in the organization of trauma care. Trauma care is characterized as a
chain of services, consisting of pre-hospital care, resuscitation and
in-hospital care. In the last two decades, an improved organization of pre- and
in-hospital trauma care has led to a 9%-25% decrease in mortality of severe
trauma patients.
Since mortality has decreased significantly, it has been suggested that the
focus of trauma care should shift to improving HR-QOL. This is because further
improvements in survival rates are likely to be small. To improve patients*
generic and disease-specific quality of life, more attention for optimizing the
rehabilitation phase is crucial. The organization of the post-clinical
rehabilitation of trauma patients is challenging and there are no nationally or
inter-nationally coordinated trauma rehabilitation guidelines for the treatment
of outpatients with trauma. Serious gaps exist between patients* transition
from acute care to rehabilitation and their return to society. Research shows
an under- and overtreatment of trauma patients by non-experienced physical
therapists in primary care and a lack of assessment of trauma patients*
physical functioning at the outpatient clinic. A trauma surgeon is not familiar
with it and there are no clear recommendations about the choice of assessments.
After discharge from a hospital, the majority of Dutch trauma patients
rehabilitate in primary care (mostly treated by a physical therapist). In
contrast to secondary/tertiary care, guidelines an interdisciplinary
coordination is lacking in primary care and the contact between primary and
secondary care is minimal. A recent feasibility study among osteoarthritis
patients showed improvements in health-related quality of life, function and
patient satisfaction when primary care was coordinated by a clinical case
manager (mostly a hospital based physical therapist or nurse practitioner) who
was in close contact with the surgeon. Bouman recently published an article of
the effects of a fast-track rehabilitation service to tertiary care for
multi-trauma patients. While patients received fast-track rehabilitation and
usual care both improved in terms of their functional status and HR-QOL, no
differential effects between groups were found. Not a faster discharge but an
optimization of the collaboration in the reha-bilitation team as well as a
concentration of knowledge and experience seemed to have im-prove the
rehabilitation process of multi-trauma patients in both groups.
A feasibility study indicated that the implementation of a so-called Transmural
Trauma Care Model (TTCM) at a Dutch level-one trauma center was feasible, that
outcomes for patients were improved and costs were reduced. The Transmural
Trauma Care Model (TTCM) for trauma patients with at least one fracture, aims
to improve patient outcomes by refining the organization and quality of the
post-clinical rehabilitation process [1]. Next to the aforemen-tioned health
and financial effects of the TTCM, patients receiving the TTCM were also found
to be more satisfied with the communication between the primary care and
secondary care healthcare provider and with the presence of the physical
therapist during the consultation with the trauma surgeon. However, in the
feasibility study we had only access to cross-sectional control data, which may
have biased our results to some extent. Therefore, the aim of the current study
is to assess the effectiveness and cost-effectiveness of the TTCM as compared
to usual care in a longitudinal, prospective multicenter trial with a
before-and-after design.

The responsible institution for conducting the research is: Amsterdam UMC, VUmc
location. The research is set up by Amsterdam UMC (location VUmc) and will be
conducted by researchers from the Amsterdam UMC (location VUmc) and VU
University Amsterdam, in collaboration with trauma surgeons and
physiotherapists from various other Dutch hospitals.

Primary objective: The primary objective of this study is to assess the
effectiveness and cost-effectiveness of the Transmural Trauma Care Model (TTCM)
as compared to usual care.

The research question addressed is:
Is the Transmural Trauma Care Model (TTCM) effective and cost-effective
compared to usual care in post-clinical rehabilitation of trauma patients?

Answers to these questions are based upon the following validated outcomes:
a) Co-primary outcomes: generic quality of life (EQ 5D-5L) and disease-specific
quality of life (standardized Patient Reported Outcomes [PROMS]). Choice of
measurement of disease-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)
b) Secondary outcomes: 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 CAT, PROMIS-PF-UE CAT). Choice of
measurement of patient-reported health based on physical functioning depends on
trauma location:
- lower extremity/ back/ multiple fractures, more locations: PROMIS-PF
- upper extremity: PROMIS-PF-UE
c) For the economic evaluation, societal and healthcare costs are assessed.
This is described in detail in section 6 Methods (6.1.3 Other outcomes) and
section 8 Statistical analysis (8.3 Other outcomes).
d) A qualitative process evaluation is performed to evaluate the implementation
of the TTCM, and to identify possible facilitators and barriers associated with
its implementation.

Hypothesis:
The TTCM is effective and cost-effective for generic and disease-specific
quality of life, func-tional status, pain, and perceived recovery compared to
usual care. Also, patients receiving the TTCM are hypothesized to be more
satisfied with the communication between the primary care and secondary care
healthcare provider and with the presence of the physical thera-pist during the
consultation with the trauma surgeon than those receiving usual care.

This study is a multicenter trial in ten hospitals in The Netherlands with a
controlled before-after design and economic evaluation. The non-randomized
nature of the trial is dealt with using propensity score weights.
In this project, the pre- and in-hospital trauma care remains unchanged and is
described in the LNAZ (Landelijk Netwerk Acute Zorg) recommendations [26]. At
the start of the study, all par-ticipating hospitals include 322 patients in a
control group. Inclusion takes place during the patients* first outpatient
consultation with a trauma surgeon at the outpatient clinic of the
participating hospitals. The control group receives usual care, where the
trauma surgeon per-forms post-clinical consultations individually (2 to 10
consultations, depending on the severity of the trauma). The trauma surgeon
focuses on fracture- and wound healing and medication management. Based on the
clinical judgment of the surgeon, a patient might be referred to primary care,
but there is no standardized policy for these referrals. If referred to a
physical therapist, patients typically select their own physical therapist in
primary care. Control group measurements take place at baseline, 6 weeks
(co-primary outcomes only), 3 months, 6 months and 9 months. After the control
period of investigating usual care, the Transmural Trauma Care Model is
implemented in each hospital during a 6-month implementation phase.
Subsequently, participating hospitals again include 322 patients, but now in
the intervention group. Again, inclusion takes place at the patients* first
outpatient consultation with a trauma surgeon and measurements take place at
baseline, 6 weeks (co-primary outcomes only), 3 months, 6 months and 9 months
(Figure 1).
Treatment adherence in the control group is registered using the following
process variables: number of post- clinical consultations of the trauma
surgeon, referral to primary care well or not and if so number of sessions
attend by a patient at the primary care physical therapist. In the intervention
group treatment adherence is registered using the following process variables:
is the outpatient consultation provided by a trauma surgeon and a physical
therapist (yes/no), is the standardized referral form used (yes/no), are the
functional goals described (yes/no), are e-mails exchanged between hospital
physical therapist and network physical therapist (yes/no) and the number of
sessions attend by a patient at the primary care physical therapist.

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 rehabilitation (i.e. improved health
outcomes and reduced costs) by an increased focus on physical functioning,
quality of life and a regular feedback loop between the hospital-team and the
primary care physical therapy- network.
In the TTCM, a multidisciplinary team consisting of a trauma surgeon and a
specialized hospi-talized based physical therapist examines the patients during
his or her outpatient consulta-tions and coordinates the complete process of
rehabilitation from the beginning to the end. Individual goal setting, an
improved alignment of primary and secondary care (e.g. through a structured
communication process), and a well-educated network of primary care physical
therapists are important pillars of the TTCM.
This is accomplished by de following four components of the TTCM:
1) Intake and follow-up consultations by a multidisciplinary team on the
outpatient clinic:
This joint consultation is carried out by a trauma surgeon and a specialized
hospital-based trauma physical therapist. The trauma surgeon is responsible for
medical procedures (e.g. indicating surgery, fracture- and wound healing),
whereas the physical therapist assesses physical function (e.g. mobility).
Before the intake the patient agrees with presence of a phys-ical therapist
during this consultation on the outpatient consultation of the trauma surgeon.
2) Coordination and individual goal setting:
The hospital team coordinates the care, and the hospital-based physical
therapist acts as a case manager throughout the rehabilitation process.
Treatment goals are formulated at a functional level for each individual
patient.
3) A transmural trauma rehabilitation primary care network of specifically
trained trauma physical therapists:
The innovative 'trauma rehabilitation physical therapy- network' consists of
about 40 primary care physical therapists per hospital. All network physical
therapists receive a at least two-day training by the hospital team, during
which they are trained in treating patients with trauma.
4) E-health support for transmural communication (between hospital based
physical therapist and network physical therapist) and treatment according to
protocols:
A secured e-mail system is implemented in order to enable communication between
the hos-pital physical therapist and the network physical therapist allowing
them to exchange patient data. Moreover, electronic patient records are adapted
and ten already developed rehabilita-tion protocols for the most common
fractures (e.g. hip) are used by the primary care physical therapist. The
protocols are linked to a secured email device through which case manager and
primary care physical therapist communicate.

The risks associated with participation in this study are equal to the risks
associated with daily practice. Currently, daily practice differs per hospital
and treating doctor.
Based on the clinical judgment of the surgeon, a patient might be referred to
primary care, but there is no standardized policy for these referrals. If
referred to a physical therapist, patients select their own physical therapist
in primary care. After implementing the TTCM daily practice is clearly
structured, individual patient-oriented choices can be made and well-educated
networks exist. Previous research in other patient groups indicates that
post-clinical care organized in networks of experienced and specialized
healthcare providers is likely to result in better clinical outcomes and lower
costs compared to usual care models. Therefore, there is no additional risk for
participants for taking part in this study.
Every treatment is associated with some risks. Patients receive the treatment
that is usual in the participating hospital. As a result of this treatment, as
with any medical and/or physical therapy treatment, patients can experience
some short-term increase in discomfort and/or pain. The estimated extra risks
associated with the study are minimal and no complications are expected. The
TTCM has already been investigated in a feasibility study in Amsterdam UMC,
location VUmc. Since then the TTCM is part of usual care in Amsterdam UMC,
location VUmc. The feasibility study of Wiertsema [1] showed no additional
risks to the patients due to TTCM. The limited additional burden that patients
may experience is, completing questionnaires (both groups).