Abstract

BackgroundThe SUPPORT-HF2 randomised controlled trial compared telehealth technology alone with the same technology combined with centralised remote support, in which a clinician responds promptly to biomarker changes. The intervention was implemented differently in different sites; no overall impact was found on the primary endpoint (proportion of patients on optimum treatment). We sought to explain the trial’s findings in a qualitative evaluation.MethodsFifty-one people (25 patients, 3 carers, 18 clinicians, 4 additional researchers) were interviewed and observed in 7 UK trial sites in 2016–2018. We collected 110 pages of documents. The analysis was informed by the NASSS framework, a multi-level theoretical lens which considers non-adoption and abandonment of technologies by individuals and challenges to scale-up, spread and sustainability. In particular, we used NASSS to tease out why a ‘standardised’ socio-technical intervention played out differently in different sites.ResultsPatients’ experiences of the technology were largely positive, though influenced by the nature and severity of their illness. In each trial site, existing services, staffing levels, technical capacity and previous telehealth experiences influenced how the complex intervention of ‘telehealth technology plus centralised specialist remote support’ was interpreted and the extent to which it was adopted and used to its full potential. In some sites, the intervention was quickly mobilised to fill significant gaps in service provision. In others, it was seen as usefully extending the existing care model for selected patients. Elsewhere, the new model was actively resisted and the technology little used. In one site, centralised provision of specialist advice aligned awkwardly with an existing community-based heart failure support service.ConclusionsComplex socio-technical interventions, even when implemented in a so-called standardised way with uniform inclusion and exclusion criteria, are inevitably implemented differently in different local settings because of how individual staff members interpret the technology and the trial protocol and because of the practical realities and path dependencies of local organisations. Site-specific iteration and embedding of a new technology-supported complex intervention may be required (in addition to co-design of the user interface) before such interventions are ready for testing in clinical trials.Trial registrationBMC ISRCTN Registry 86212709. Retrospectively registered on 5 September 2014

Highlights

  • As the number of patients with heart failure grows and services are increasingly overstretched, telehealth is often depicted as a partial solution [1, 2]

  • Site-specific iteration and embedding of a new technologysupported complex intervention may be required before such interventions are ready for testing in clinical trials

  • The efficacy of telehealth solutions for heart failure has been widely studied in randomised controlled trials (RCTs), some but not all of which have shown a small benefit over usual care, as measured by reduced hospital admissions [1, 2]

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Summary

Introduction

Background As the number of patients with heart failure grows and services are increasingly overstretched, telehealth is often depicted as a partial solution [1, 2]. A total of 202 participants (mean age 71; mean left ventricular ejection fraction 33%) were selected for being at high risk of adverse outcomes or high potential to benefit from remote management; they were randomised to ‘supported medical management’ (intervention) or ‘enhanced selfmanagement’ (control, so named to avoid participants feeling they were in a no-treatment arm). Those in both arms submitted daily symptom reports and measurements of weight, blood pressure and heart rate, alongside free-text comments. We sought to explain the trial’s findings in a qualitative evaluation

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