Efficacy of client-centred occupational therapy in patients with multiple sclerosis: a cluster-randomized trial

Occupational therapy (OT) is an integral part of the care for MS patients.
Severe functional disability and reduced social participation are commonly
experienced by patients with MS. OT is aimed at reducing functional disability
and improving social participation, thus resulting in increased autonomy and
quality of life of patients.
Currently, there is a movement towards client-centred approach to OT. The
theoretical benefit is that therapy is tailored to the patient*s needs and will
therefore result in a bigger improvement in autonomy and quality of life than
regular OT. However, so far this theoretical advantage has not been established
in scientific research.
This application describes a cluster-randomised trial investigating the
efficacy of client-centred OT based on the Occupational Performance Process
Model (OPPM) as compared to usual care OT, in patients with Multiple Sclerosis
(MS).

The main research question of this study is:

Is client-centred occupational therapy according to the Occupational
Performance Process Model more effective than usual-care occuaptional therapy
in patients with multiple sclerosis?

This is a clustered randomised trial (CRT). Randomisation will take place at
the level of the cluster. The clusters are the participating hospitals and
rehabilitation centres. This means that all participating OT's within the same
centre are randomised into the same treatment condition. Likewise, all clients
who receive treatment from the same therapist fall within the same treatment
group. To ensure the comparability of the experimental and control group, the
randomisation will be stratified for type of institution (i.e. hospital or
rehabilitation centre).
Measurements will be made at the level of the institution, therapist and
client, with the focus of the study on the client level (see 'primary study
parameters' below). Data from clients will be collected prior to the start of
treatment (baseline) at 4 months (post-treatment), and at 8 months (follow-up).
A test assistant will be responsible for the client data collection.
The test assistant and the clients themselves will be blinded to their
treatment allocation. Due to the nature of the intervention, OT's will not be
blinded.

The experimental intervention comprises OT according to the OPPM.
Clients treated by OT's from the experimental group will receive OT according
to the OPPM. This means that problem identification, treatment goal setting,
treatment planning and execution, and goal evaluation will be performed in a
client-centred manner as described by the OPPM. This is a flexible, yet
focused, framework to guide the therapist and client through seven stages of a
collaborative, outcome-oriented process. The process starts with the
identification, validation and prioritising of occupational performance issues.
This is followed by selecting the appropriate theoretical approach (stage 2),
the identification of strengths, resources and environmental conditions (stage
3 and 4), the negotiation (stage 5) and implementation (stage 6) of action
plans to reach targeted outcomes. The process concludes with the evaluation of
the outcomes (40).
Prior to the inclusion period, all OT's in the experimental group will receive
a two-day course in client-centred practice according to the OPPM, provided by
the NVE. Subsequently, OT's will be asked to implement this in clinical
practice. Initial experiences will be evaluated in a booster session provided
six weeks after the course. The client inclusion period will start following
this reinforcement session. Additional booster sessions will be planned every
six months for the duration of the project's data collection period.
The control group of OT's will provide regular OT to their patients. They will
be notified beforehand that after the conclusion of this study they will be
invited to take the OPPM-course at no cost.

All patients included in this trial will receive occupational therapy. with the
associated burden and risks equal to those in the normal therapeutic setting.
The measurements for this study comprise questionnaires, interviews and a
physical examination specifically intended to assess the severity of MS. All
measurements will be performed in the participant's home setting. In total,
these measurements will take 4 hours, divided over three spearate occasions
(baseline, and 4 and 8 months follow-up).

All participants have a referral for occupational therapy and will receive
therapy accordingly.