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Original research
Cluster randomised controlled trial evaluating the clinical and humanistic impact of a pharmacist-led minor ailment service
  1. Sarah Dineen-Griffin,
  2. Shalom I Benrimoj,
  3. Kris Rogers,
  4. Kylie A Williams,
  5. Victoria Garcia-Cardenas
  1. Graduate School of Health, University of Technology Sydney, Ultimo, New South Wales, Australia
  1. Correspondence to Mrs Sarah Dineen-Griffin, Graduate School of Health, University of Technology Sydney, Ultimo 2007, New South Wales, Australia; sarah.dineen-griffin{at}uts.edu.au

Abstract

Background Community pharmacists are well positioned to support patients’ minor ailments. The objective was to evaluate the clinical and humanistic impact of a minor ailment service (MAS) in community pharmacy compared with usual pharmacist care (UC).

Methods A cluster randomised controlled trial was conducted. Intervention patients received MAS, which included a consultation with the pharmacist. MAS pharmacists were trained in clinical pathways and communication systems mutually agreed with general practitioners and received monthly support. Control patients received UC. All patients were followed up by telephone at 14 days. Clinical and humanistic impact were defined by primary (appropriate referral rate and appropriate non-prescription medicine rate) and secondary outcomes (clinical product-based intervention rate, referral adherence, symptom resolution, reconsultation and EuroQol EQ-5D visual analogue scale (VAS)).

Results Patients (n=894) were recruited from 30 pharmacies and 82% (n=732) responded to follow-up. Patients receiving MAS were 1.5 times more likely to receive an appropriate referral (relative rate (RR)=1.51; 95% CI 1.07 to 2.11; p=0.018) and were five times more likely to adhere to referral, compared with UC (RR=5.08; 95%CI 2.02 to 12.79; p=0.001). MAS patients (94%) achieved symptom resolution or relief at follow-up, while this was 88% with UC (RR=1.06; 95% CI 1 to 1.13; p=0.035). MAS pharmacists were 1.2 times more likely to recommend an appropriate medicine (RR 1.20, 95% CI 1.1 to 1.3; p=0.000) and were 2.6 times more likely to perform a clinical product-based intervention (RR=2.62, 95% CI 1.28 to 5.38; p=0.009), compared with UC. MAS patients had a greater mean difference in VAS at follow-up (4.08; 95% CI 1.23 to 6.87; p=0.004). No difference in reconsultation was observed (RR=0.98; 95% CI 0.75 to 1.28; p=0.89).

Conclusion The study demonstrates improved clinical and humanistic outcomes with MAS. National implementation is a means to manage minor ailments more effectively in the Australian health system.

Trial registration number ACTRN12618000286246.

  • minor ailments
  • minor ailment services
  • quality use of medicines
  • self-care
  • self-medication
  • cluster randomised controlled trial
  • community pharmacy
  • pharmacist
  • professional pharmacy services
  • pharmacy practice research

https://doi.org/10.1136/bmjqs-2019-010608

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    Footnotes

    • Twitter @sarahdgriffin

    • Contributors SDG was study chief investigator involved in codesign, study methods, led the delivery of the cluster randomised controlled trial (cRCT) including design of data collection tools and oversight of data collection, contributed to the analysis of the cRCT data, data analysis interpretation, led drafting of the manuscript and review and the editorial process. VGC was study coinvestigator involved in codesign, study methods, assisted with the design of data collection tools and oversight of data collection, and review of the manuscript. KR led the statistical design, carried out the sample size calculation and statistical analysis and assisted with data analysis interpretation. KAW was study coinvestigator involved in codesign, study methods, oversight of data collection and review of the manuscript. SIB was study chief investigator involved in codesign, study methods, design of data collection tools and oversight of data collection, data analysis interpretation and extensively involved in review of drafts and the editorial process. All authors have read and approved the final manuscript. The study funders did not have any influence with study design, data collection, management, analysis, interpretation, the writing of the manuscript or decision to submit for publication.

    • Funding This study was funded by Consumer Healthcare Products Australia (formerly the Australian Self-Medication Industry) and the University of Technology Sydney.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The University of Technology Sydney Human Research Ethics Committee provided approval to undertake the study (ETH17-1350).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available on reasonable request.