SPPiRE; the evolution of a multimorbidity intervention in the context of emerging evidence.

Problem

Multimorbidity guidelines recommend tailoring care to the individual and eliciting treatment priorities but specific recommendations are often missing. Developing and evaluating a complex intervention takes a considerable period of time, often by the time an intervention is ready for evaluation in a definitive randomised controlled trial (RCT) the context of the evidence base may have evolved. To avoid research waste, it is imperative that intervention design and evaluation is an iterative and adaptive process incorporating emerging evidence and novel concepts. The aim of this study is to describe the evolution of a multimorbidity intervention in this context of a rapidly evolving evidence.

Approach

The core components of the original effective intervention were identified and maintained and following an overview of the literature, novel components were added and modifications made to discretionary components. A framework that was developed to describe intervention modification was employed to describe the key features of the intervention and its evaluation that were modified. These are:• The context in which the intervention is delivered.• The content of the intervention.• The evaluation of the intervention.

Findings

Supporting prescribing in older adults with multimorbidity (SPPiRE) is a cluster RCT that was designed to evaluate the effectiveness of a complex intervention comprising a web guided medication review and professional training in reducing polypharmacy and potentially inappropriate prescribing (PIP) in older adults on 15 or more regular medicines in Irish primary care. SPPiRE built on a previous trial, Optimising prescribing for older people in primary care (OPTI-SCRIPT), which was an exploratory cluster RCT that demonstrated that a web guided medication review was effective in reducing PIP in older adults in primary care. Due to the evolving evidence base and the results of another RCT looking at a similar problem, the research question was reconsidered and the population under investigation changed from older people with an identified PIP to older people with significant polypharmacy, a proxy marker for complex multimorbidity. The core component of the OPTI-SCRIPT intervention, a GP delivered web-guided medication review, was maintained and additional components including an assessment of patient treatment priorities. To assess the effect of these new components, an additional primary outcome measure, the number of repeat medicines was included as were additional patient reported secondary outcome measures including a multimorbidity treatment burden score.

Consequences

Intervention modification is different from “intervention drift” or unplanned changes that are assessed in a trial’s process evaluation. A framework that has been implemented in public health research was adapted and used to systematically describe how and why the original OPTI-SCRIPT intervention was modified, allowing SPPiRE to build upon an effective and robustly developed intervention but also to be relevant in the context of the current literature and evidence base.