Occupational therapy in rehabilitation of complex patients: protocol for a superiority randomized controlled trial

ABSTRACT

Patient-centered, interprofessional occupational therapy is feasible in complex patients in the early phase of rehabilitation, and it contributes to meet needs in the domains of self-care, productivity, and leisure, promoting social role. We planned this single-center single-blind two-arm parallel individual patient randomized controlled trial, to verify the superiority of interprofessional experimental occupational therapy (EOT) compared to standard rehabilitation (SR) in producing higher levels of patients’ social participation assessed by the Reintegration to Normal Living Index. EOT is a patient-centered, hospital/home-based rehabilitation intervention based on the Canadian Model of Occupational Performance and Engagement. This appropriately powered study will provide evidence regarding the effectiveness of EOT on the recovery of social participation in the critical transition of complex patients from hospital to the home setting.

KEYWORDS:

• Social Participation
• Occupational Therapy
• Complex Patients
• Canadian Model of Occupational Performance and Engagement
• Randomized Controlled Trial

Acknowledgments

We thank Jacqueline Costa for the English language editing.

Declaration of interest

The authors report no conflicts of interest.

Confidentiality

The demographics and clinical data collected to support the findings of this study are restricted by the Ethics Committee of the Province of Reggio Emilia (Italy) in order to protect patient privacy. The data that support the findings of this study are available from the corresponding author (M.P.), upon reasonable request, with the permission of Azienda USL-IRCCS of Reggio Emilia, Italy.

Supplementary material

Supplemental data for this article can be accessed publisher’s website.

Additional information

Funding

The study is funded by the local health authority Azienda USL-IRCCS of Reggio Emilia, Italy. It has not received any specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The Azienda USL-IRCCS of Reggio Emilia had no role in the definition of the study design, in the collection, analysis, and interpretation of data, in the writing of the report, or in the decision to submit the article for publication. The authors had full access to all data in this study and take complete responsibility for them.

Notes on contributors

Stefania Costi

Stefania Costi is a researcher in Physical Therapy, Coordienatror of The BSc in PT at the University of Modena and Reggio Emilia and PhD candidate in Neuroscience-Sport and Motor Activities curricula at the University of Genova.

Martina Pellegrini

Martina Pellegrini is a researcher in Occupational Therapy in Reggio Emilia Hospital in Physical Medicine and Rehabilitation.

Silvio Cavuto

Silvio Cavuto is a head of Clinical Trials and Statistics Unit in an OECI recognized research hospital in Italy within AUSL – IRCCS di Reggio Emilia (Italy).

Stefania Fugazzaro

Stefania Fugazzaro is a physiatrist working in Reggio Emilia Hospital, with experience in inhospital care. She is a researcher in Physical Medicine and Rehabilitation, in particular in stroke and cancer rehabilitation.