Abstract
Background
The results of rehabilitation trials are often not fully attained when the intervention is implemented beyond the initial trial. One of the key reasons is that a patients’ ability and/or capacity to take part in their own healthcare is not considered in the trial design yet has significant impact on the outcomes during the implementation phase.
Body of text
We propose a shift from a therapist-focus to patient-focus in trial design, through addressing patient engagement as a core consideration in trials. We argue that engaging patients in any rehabilitation program is a process of behavioural change. Exercise prescription is used as an example to illustrate how the Behaviour Change Wheel can be applied to analyse barriers and facilitators associated with patients’ capabilities, opportunities and motivations in integrating trial interventions into their daily life. We propose a framework to assist in this shift.
Conclusion
A core part of implementing rehabilitation interventions at the primary care level requires patient engagement. Related aspects of interventions should be identified and assessed using the COM-B model at the outset of trial design to ensure that the results are realistic, meaningful and transferable, so as to enable real impact.
Implications for Rehabilitation
Rehabilitation programs tested in clinical trials often focus on the therapists’ effort and the program itself.
Engaging patients in any rehabilitation program is a process of behaviour change of patients.
Our proposed framework based on the COM-B model, including the Behaviour Change Wheel, enriches rehabilitation trial design through considering core aspects of patient engagement to ensure the real impact of any rehabilitation program can be achieved.
Acknowledgements
Staff members at School of Health and Biomedical Sciences, RMIT University, contributed to the initial discussion on the Framework for Engaging Patients in their Own Healthcare at various stages of the project.
Authors’ contributions
ZZ and IS initiated the concept. ZZ, JL, IS and SB drafted the manuscript. SB applied the concept to exercise prescription, the key example in the manuscript. AH, AM and DWLW contributed to the development of concept. All authors contributed to the revision of the drafts, and read and approved the final manuscript.
Disclosure statement
ZZ, SB, IS and DWLW lead various projects examining patient engagement in surgery, exercise, medication adherence and pain management. There are no other competing interests to declare.
Authors’ information
All authors are researchers and have health care practitioner qualifications. ZZ, JL, AH, DWLW are in the field of Chinese medicine, AM and SB exercise science and IS pharmacy. In our clinical and research work, we have identified a significant gap in research translation, and limitations in the design of clinical trials at the primary health level. Those factors inspired us to develop a framework and the write-up of this manuscript.