Feasibility study of a single-blind randomised controlled trial of an occupational therapy intervention

ABSTRACT

Background: Several factors facilitate or hinder efficacy research in occupational therapy. Strategies are needed, therefore, to support the successful implementation of trials. Aim: To assess the feasibility of conducting a randomised controlled trial (RCT). The main feasibility objectives of this study were to assess the process, resources, management, and scientific basis of a trial RCT. Material and methods: A total of 10 occupational therapists, between the ages of 30 and 55 (M 43.4; SD 8.3) with seven to 26 years’ (M 14.3; SD 6.1) experience, participated in this study. Qualitative data collected included minutes of meetings, reports, and field notes. The data were analysed based on the principles of content analysis, using feasibility objectives as the main categories. Results: Data analysis revealed strengths in relation to retention and inclusion criteria of participants, the study protocol, study organisation, and the competence of researchers. Weaknesses were found related to recruitment, randomisation, data collection, time for training and communication, commitment, and design. Conclusion: The findings indicated that there are several factors which had a considerable impact on the implementation of an RCT in practice. However, it was useful to assess methods and procedures of the trial RCT as a basis to refine research plans.

KEYWORDS:

• Implementation
• practice
• pilot study

Acknowledgements

The authors especially thank all children, their parents, and occupational therapists who participated in this study, especially Susanne Rönnfeld, who coordinated the work of occupational therapist practitioners. Furthermore, they would like to thank Barbara Aegler for her contribution as the blinded AMPS rater, André Meichtry for his statistical expertise and support, and Linda Tickle-Degnen for sharing with them her expert advice related to feasibility studies and RCTs. Moreover, thanks are offered to the authors’ colleagues at Umeå University and the ZHAW who were involved in peer debriefing, especially Magnus Zingmark and Ellinor Larson for their continuous and enriching support.

This study was funded by the Swiss National Science Foundation (Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung DORE-Förderinstrument für praxisorientierte Forschung 13DPD6-127161) and supported by the Austrian, German, and Swiss Associations of Occupational Therapy (Ergotherapie Austria, Deutscher Verband der Ergotherapeuten E. V. and ErgotherapeutInnen Verband Schweiz), as well as by an internal grant of the School of Health Professions at the ZHAW.