Condition category
Injury, Occupational Diseases, Poisoning
Date applied
13/08/2008
Date assigned
21/08/2008
Last edited
24/05/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Henk Seelen

ORCID ID

Contact details

Adelante Rehabilitation Centre (formerly: Rehabilitation Foundation Limburg)
Zandbergsweg 111
Hoensbroek
6432 CC
Netherlands
+31 (0)45 528 22 21
h.seelen@adelante-zorggroep.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw: 17088.2704; NTR1391

Study information

Scientific title

Cost-effectiveness of an integrated ‘fast track’ rehabilitation service for multi-trauma patients

Acronym

SFTRS

Study hypothesis

It is hypothesised that, from a societal point of view, the supported fast track multi-trauma rehabilitation service (SFTRS) is more (cost) effective relative to the conventional multi-trauma care service (CTCS).

As of 24/05/2011 the anticipated end date for this trial has been extended from 01/08/2011 to 31/12/2012

Ethics approval

Ethics approval received from the Medical Ethics Committee of the Rehabilitation Foundation Limburg in Hoensbroek (The Netherlands) in February 2008.

Study design

Prospective, multi-centre, non-randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request patient information material

Condition

Multi-trauma rehabilitation

Intervention

Supported fast track multi-trauma rehabilitation service:
SFTRS involves the following:
1. The rehabilitation physician from the rehabilitation centre is routinely involved at a very early stage post-trauma. This allows an early start for multidisciplinary rehabilitation treatment.
2. Early transfer (within five days after having been added to the waiting list from the rehabilitation centre) to a centralised, specialised trauma rehabilitation unit equipped with facilities for early training programs
3. Early individual rehabilitation goal setting
4. Close co-operation and exchange of views and experiences between the trauma surgeon and the rehabilitation team by, for example, monthly clinical sessions and individual patient visits by the trauma surgeon in the first weeks after discharge
5. Well-documented treatment protocols for multi-trauma patients for both the hospital and rehabilitation centre phases

Three phases can be identified in the treatment of multi-trauma patients:
1. Early rehabilitation phase
2. Stage II rehabilitation phase
3. Discharge or post-discharge phase

Phase 1: Early rehabilitation phase
In the early rehabilitation phase, the patient is not allowed to mobilise weight bearing. Consequently, the physiotherapist is concerned with maintaining joint mobility, muscle strength, sitting balance, condition and training transfers as well as treatments with non-weight-bearing conditions such as hydrotherapy and non-weight-bearing gait training. There are 10 sessions per week of 30 minutes each. In addition, fitness, gymnastics, table tennis, swimming, bowling, hand bike, wheelchair training, and archery are given. There are 2 - 3 sessions per week for each treatment modality of 60 minutes each. The occupational therapist advises on bed posture, mattress types, aids for independent daily self-care, wheelchair-dependency training and meaningful activities that can be performed while bedridden. In addition, the wheelchair accessibility and wheelchair friendliness of the patient's home are studied. If necessary, written and oral advice on temporary and long-term adaptations to the home is given and support is given and the patient is helped to apply for financial support so that the patient can return home as soon as possible. At first, this would be for a day or two at the weekend, supervised by an occupational therapist, but would later become permanent. With regard to work, the patient's job is analysed and the patient's workplace is visited. There are 4 sessions per week of 30 minutes each. The social worker and the psychologist will see every multi-trauma patient within the first week after admission. The social worker helps the patient to return home by dealing with the family and offering advice and support to the patient on financial matters, transport facilities. The social worker also contacts the employer and company doctor to look into the possibility of reintegrating the patient into their present job. The psychologist will examine the patient with regard to such things as mood disorders, post-traumatic stress syndrome (PTSS), acceptance problems and cognitive problems. The latter requires extensive neuropsychological testing. In addition, individual and group psychological counseling and specialised treatment for PTSS are given. If necessary, the rehabilitation specialist can refer the patient to a consultant in psychiatry, a consultant in neurology, a consultant in internal medicine, a consultant in rheumatology and/or a consultant in urology, who come to the rehabilitation centre.

Phase 2: Stage II rehabilitation phase
In the Stage II rehabilitation phase, new treatment aims are added by the physiotherapist. These might include a gradual individual weight bearing scheme, co-ordination training and functional training. There are 7 therapy sessions per week of 30 minutes. In addition, fitness, gymnastics, table tennis, swimming, rowing, cycling and archery are given. This is offered in 2 - 4 sessions per week for each treatment modality of 60 minutes each.
The occupational therapist continues with the treatment goals as mentioned for phase I and trains the patient to perform household tasks, hobbies, etc. in a home-like environment. There are three sessions per week of 30 minutes each. In addition, group therapies such as occupational therapy and recreational therapy are given 2 - 4 times per week each. The social worker and the psychologist continue the work mentioned in phase I, depending on the individual needs of each patient.

Phase 3: (Post) discharge phase
In the discharge phase, the patient is prepared for living at home and is referred to local
physiotherapists, specialised sport clubs and mental health care professionals.

Conventional multi-trauma care service:
CTCS is provided in several centres. Multi-trauma patients are admitted to hospital via the A&E department. After possible surgery, they are transferred to the IC-unit, followed by the hospital's nursing ward, where the patient may stay for several days or weeks. The trauma surgeon, as chief consultant, decides whether or not a rehabilitation physician will be consulted during hospitalisation. Next, ensuing treatment may take place in the hospital's outpatient clinic, in a rehabilitation centre, in a nursing home or with a local GP or physiotherapist. Typically, each of the CTCS "stages" may have its own more-or-less autonomous treatment perspective, depending on the professional’s individual treatment views and experience.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Generic quality of life: 36-item Short Form Health Survey (SF-36)
2. Functional health status: Functional Independence Measure (FIM)

Outcome measures are collected at baseline (i.e. as soon as possible after trauma), 3, 6, 9 and 12 months post-trauma, i.e. T0, T1, T2, T3 and T4.

Secondary outcome measures

1. Extent to which individual ADL treatment goals are met: Canadian Occupational Performance Measure (COPM)
2. Anxiety and depression: Hospital Anxiety and Depression Scale (HADS)
3. Cognitive functioning: Mini-Mental State Examination (MMSE)

Next to that costs will be assessed using the PRODISQ, a cost questionnaire and data from the hospital databases. Outcome measures are collected at baseline (i.e. as soon as possible after trauma), 3, 6, 9 and 12 months post-trauma, i.e. T0, T1, T2, T3 and T4.

In studies comparing the effectiveness of different treatment regimes, differences in treatment credibility and expectancy may influence the outcome. In the proposed study the credibility/expectancy questionnaire (CEQ) will be administered directly following the explanation of the study’s rationale to patients, i.e. after informed consent has been obtained.

Overall trial start date

01/10/2008

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Multi-trauma patients admitted to one of the Accident and Emergency Departments (A&E) of the participating hospitals are included. Multi-trauma is defined as having at least two or more injuries of which at least one is life-threatening, including:
1. Trauma with an Injury Severity Scale score (ISS) greater than or equal to 16
2. Complex multiple injuries on both lower extremities
3. A combination of one upper and one lower extremity injury, the latter of which can not be used in load-bearing, or
4. Complex pelvis/acetabulum fractures

Inclusion criteria are:
1. Aged greater than or equal to 18 years, either sex
2. Multi-trauma (as defined above)
3. Hospitalisation after A&E admission
4. Rehabilitation indication, i.e. lasting impairments or handicaps are expected
5. Adequate Dutch language skills

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

164 patients admitted to one of the participating rehabilitation centres

Participant exclusion criteria

1. Alcohol and/or drug abuse
2. Severe psychiatric problems

Recruitment start date

01/10/2008

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

Adelante Rehabilitation Centre (formerly: Rehabilitation Foundation Limburg)
Hoensbroek
6432 CC
Netherlands

Sponsor information

Organisation

Adelante Rehabilitation Centre (The Netherlands)

Sponsor details

c/o Dr. H.A.M. Seelen
Zandbergsweg 111
Hoensbroek
6432 CC
Netherlands
+31 (0)45 528 22 21
h.seelen@adelante-zorggroep.nl

Sponsor type

Research organisation

Website

http://www.adelante-zorggroep.nl

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 17088.2704)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes