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Randomized Controlled Trial
. 2017 Aug 1;12(1):99.
doi: 10.1186/s13012-017-0629-1.

Supporting prescribing in older people with multimorbidity and significant polypharmacy in primary care (SPPiRE): a cluster randomised controlled trial protocol and pilot

Caroline McCarthy  1 , Barbara Clyne  2 , Derek Corrigan  2 , Fiona Boland  2 , Emma Wallace  2 , Frank Moriarty  2 , Tom Fahey  2 , Carmel Hughes  3 , Paddy Gillespie  4 , Susan M Smith  2
Affiliations
Randomized Controlled Trial

Supporting prescribing in older people with multimorbidity and significant polypharmacy in primary care (SPPiRE): a cluster randomised controlled trial protocol and pilot

Caroline McCarthy et al. Implement Sci. .

Abstract

Background: Multimorbidity, defined as the presence of at least two chronic conditions, becomes increasingly common in older people and is associated with poorer health outcomes and significant polypharmacy. The National Institute for Clinical Excellence (NICE) recently published a multimorbidity guideline that advises providing an individualised medication review for all people prescribed 15 or more repeat medicines. This study incorporates this guideline and aims to assess the effectiveness of a complex intervention designed to support general practitioners (GPs) to reduce potentially inappropriate prescribing and consider deprescribing in older people with multimorbidity and significant polypharmacy in Irish primary care.

Methods: This study is a cluster randomised controlled trial, involving 30 general practices and 450 patients throughout Ireland. Practices will be eligible to participate if they have at least 300 patients aged 65 years and over on their patient panel and if they use either one of the two predominant practice management software systems in use in Ireland. Using a software patient finder tool, practices will identify and recruit patients aged 65 years and over, who are prescribed at least 15 repeat medicines. Once baseline data collection is complete, practices will be randomised using minimisation by an independent third party to either intervention or control. Given the nature of the intervention, it is not possible to blind participants or study personnel. GPs in intervention practices will receive login details to a website where they will access training videos and a template for conducting an individualised structured medication review, which they will undertake with each of their included patients. Control practices will deliver usual care over the 6-month study period. Primary outcome measures pertain to the individual patient level and are the proportion of patients with any PIP and the number of repeat medicines.

Discussion: Disease-specific approaches in multimorbidity may be inappropriate and result in fragmented and poorly co-ordinated care. This pragmatic study is evaluating a complex intervention that is relevant across multiple conditions and addresses potential concerns around medicines safety in this vulnerable group of patients. The potential for system-wide implementation will be explored with a parallel mixed methods process evaluation.

Trial registration: ISRCTN: 12752680 , Registered 20 October 2016.

Keywords: Complex intervention; Deprescribing; Multimorbidity; Patient priorities; Polypharmacy; Potentially inappropriate prescribing (PIP); Randomised controlled trial.

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Conflict of interest statement

Ethics approval and consent to participate

Full ethical approval for the study was granted by the Irish College of General Practitioners Research Ethics Committee. (ICGP REC; SPPiRE study). Informed consent will be sought from all patients and GPs participating in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Development and evaluation of SPPiRE, adapted from MRC framework [31]. Legend: Adaptation of the MRC framework showing the evolution of the SPPiRE intervention based on previous outcome and process evaluations, piloting and feasibility work and emerging evidence
Fig. 2
Fig. 2
Flow of practices and patients through RCT
Fig. 3
Fig. 3
SPPiRE medication review process. Abbreviations: PIP potentially inappropriate prescription, ADR adverse drug reaction
See this image and copyright information in PMC

References

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