Fit for purpose. Co-production of complex behavioural interventions. A practical guide and exemplar of co-producing a telehealth-delivered exercise intervention for people with stroke

Abstract

Background Careful development of interventions using principles of co-production is now recognized as an important step for clinical trial development, but practical guidance on how to do this in practice is lacking. This paper aims (1) provide practical guidance for researchers to co-produce interventions ready for clinical trial by describing the 4-stage process we followed, the challenges experienced and practical tips for researchers wanting to co-produce an intervention for a clinical trial; (2) describe, as an exemplar, the development of our intervention package. Method We used an Integrated Knowledge Translation (IKT) approach to co-produce a telehealth-delivered exercise program for people with stroke. The 4-stage process comprised of (1) a start-up planning phase with the co-production team. (2) Content development with knowledge user informants. (3) Design of an intervention protocol. (4) Protocol refinement. Results and reflections The four stages of intervention development involved an 11-member co-production team and 32 knowledge user informants. Challenges faced included balancing conflicting demands of different knowledge user informant groups, achieving shared power and collaborative decision making, and optimising knowledge user input. Components incorporated into the telehealth-delivered exercise program through working with knowledge user informants included: increased training for intervention therapists; increased options to tailor the intervention to participant’s needs and preferences; and re-naming of the program. Key practical tips include ways to minimise the power differential between researchers and consumers, and ensure adequate preparation of the co-production team. Conclusion Careful planning and a structured process can facilitate co-production of complex interventions ready for clinical trial. Graphical Abstract

Use of co‐design methodology in the development of cardiovascular disease secondary prevention interventions: A scoping review

“…Of these, 5738 articles were excluded based on the review of the title and abstract, and the full text was obtained for the remaining 154 articles. Based on the authors' assessment, 22 unique studies 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 published across 45 articles met the eligibility criteria and were included in this review (Figure 1 ).…”

“…Fourteen studies described the development of an e‐health intervention such as health data dashboards or online platforms, 29 , 30 , 31 , 41 , 44 , 47 , 48 mobile/tablet applications 32 , 42 , 43 , 45 and telehealth programmes. 37 , 46 , 49 Two interventions aimed to improve or address the health literacy of patients, 28 , 41 three focused on improving patient self‐empowerment and behaviour change, 34 , 41 , 49 and there were two exercise‐based interventions. 44 , 49 Almost all interventions ( n = 20) included patient education on the importance of healthy behaviours for cardiovascular health or information on self‐management of CVD risk factors (medications, exercise, diet, etc.).…”

“… 37 , 46 , 49 Two interventions aimed to improve or address the health literacy of patients, 28 , 41 three focused on improving patient self‐empowerment and behaviour change, 34 , 41 , 49 and there were two exercise‐based interventions. 44 , 49 Almost all interventions ( n = 20) included patient education on the importance of healthy behaviours for cardiovascular health or information on self‐management of CVD risk factors (medications, exercise, diet, etc.). The interventions of the included studies are described in detail in Supporting Information: File 2 .…”

A multi-stakeholder approach is needed to reduce the digital divide and encourage equitable access to telehealth

“…29 However, to improve feasibility, codesign methods should also consider addressing the gaps in digital health literacy among consumers and telehealth practitioners. [29][30][31] To further achieve equitable access, we should consider providing support to consumers, practitioners, and health services managers and building capacity to design, implement, and access telehealth services. 32,33 This support will require raising awareness about telehealth benefits among consumers and specific training for practitioners to facilitate telehealth integration into routine practice.…”

“…29 However, to improve feasibility, codesign methods should also consider addressing the gaps in digital health literacy among consumers and telehealth practitioners. 29–31…”