Background: Although there is trial evidence that complex interventions are effective for the
self-management of heart failure, little evidence supports their effectiveness in routine
practice. We used Social Practice Theory to guide a Type 1 Hybrid Trial: a mixed methods
process evaluation of a complex intervention for heart failure. ...
Background: Although there is trial evidence that complex interventions are effective for the
self-management of heart failure, little evidence supports their effectiveness in routine
practice. We used Social Practice Theory to guide a Type 1 Hybrid Trial: a mixed methods
process evaluation of a complex intervention for heart failure. The objective of this paper is
to explore the value of Social Practice Theory for implementation science.
Methods: Social Practice Theory informed a mixed methods process evaluation of a multicentre
randomised controlled trial of a 12 week home-based intervention to optimise selfcare
support for people with heart failure and their caregivers - Rehabilitation EnAblement in
Chronic Heart Failure (REACH-HF). Interviews were conducted with 19 people with heart
failure and 17 caregivers at 4 months and 12 months after recruitment into the trial. Cases
were constructed at the level of the individual, couple, facilitator and centre; and included
multi-modal process and outcome data. Evaluative coding and subsequent within- and
cross-case analyses enabled the development of a typology of relationships linking fidelity of
intervention delivery and tailoring of content to individual needs and concerns. Social
Practice Theory was used to interrogate the relationships between elements of the
intervention and their implementation.
Results: Of 216 trial participants, 107 were randomised to the intervention (REACH-HF plus
usual care). The intervention was most effective when fidelity was high and delivery was
tailored to the individual’s needs, but less effective when both tailoring and fidelity were low.
Theory-based analysis enabled us to model complex relationships between intervention
elements (competencies, materials and meanings) and social context. The findings illustrate
how intervention fidelity and tailoring are contextual and how the effectiveness of the
REACH-HF intervention depended on both optimal alignment and implementation of these
elements.
Conclusion: The study demonstrates the utility of theory-based analysis which integrates
data from multiple sources to highlight contexts and circumstances in which interventions
work best. Social Practice Theory provides a framework for guiding and analysing the
processes by which a complex intervention is evaluated in a clinical trial, and has the
potential to guide context-specific implementation strategies for clinical practice.