Lifestyle interventions to reduce second stroke risk are complex. For effective translation into practice, interventions must be specific to end-user needs and described in detail for replication. This study used an Integrated Knowledge Translation (IKT) approach and the Template for Intervention Description and Replication (TIDieR) checklist to co-design and describe a telehealth-delivered diet program for stroke survivors. Stroke survivors and carers (n = 6), specialist dietitians (n = 6) and an IKT research team (n = 8) participated in a 4-phase co-design process. Phase 1: the IKT team developed the research questions, and identified essential program elements and workshop strategies for effective co-design. Phase 2: Participant co-design workshops used persona and journey mapping to create user profiles to identify barriers and essential program elements. Phase 3: The IKT team mapped Phase 2 data to the TIDieR checklist and developed the intervention prototype. Phase 4: Co-design workshops were conducted to refine the prototype for trial. Rigorous IKT co-design fundamentally influenced intervention development. Modifications to the protocol based on participant input included ensuring that all resources were accessible to people with aphasia, an additional support framework and resources specific to outcome of stroke. The feasibility and safety of this intervention is currently being pilot tested (randomised controlled trial; 2019/ETH11533, ACTRN12620000189921).
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
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