Article

OBJECTIVE: To determine the feasibility, the cluster design effect and the
variance and minimal clinical importance difference in the primary outcome in a
pilot study of a structured approach to goal-setting. DESIGN: A cluster
randomized controlled trial. SETTING: Inpatient rehabilitation facilities.
SUBJECTS: People who were admitted to inpatient rehabilitation following stroke
who had sufficient cognition to engage in structured goal-setting and complete
the primary outcome measure. INTERVENTIONS: Structured goal elicitation using the
Canadian Occupational Performance Measure. MAIN MEASURES: Quality of life at 12
weeks using the Schedule for Individualised Quality of Life (SEIQOL-DW),
Functional Independence Measure, Short Form 36 and Patient Perception of
Rehabilitation (measuring satisfaction with rehabilitation). Assessors were
blinded to the intervention. RESULTS: Four rehabilitation services and 41
patients were randomized. We found high values of the intraclass correlation for
the outcome measures (ranging from 0.03 to 0.40) and high variance of the
SEIQOL-DW (SD 19.6) in relation to the minimally importance difference of 2.1,
leading to impractically large sample size requirements for a cluster randomized
design. CONCLUSIONS: A cluster randomized design is not a practical means of
avoiding contamination effects in studies of inpatient rehabilitation
goal-setting. Other techniques for coping with contamination effects are necessary.

Langue : ANGLAIS