Article Text

Protocol
Better use of inhaled medication in asthma and COPD through training, preparation and counselling: the On TRACk study protocol for a cluster randomised controlled trial
  1. R te Paske1,2,
  2. Liset van Dijk1,2,
  3. Annemiek J Linn3,
  4. Job F M van Boven4,
  5. Ellen S Koster5,
  6. Marcia Vervloet1
  1. 1Nivel, Netherlands Institute for Health Services Research, Utrecht, The Netherlands
  2. 2Department of PharmacoTherapy, Epidemiology & Economics, Groningen Research Institute of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Groningen, Groningen, The Netherlands
  3. 3Amsterdam School of Communication Research/ASCoR, University of Amsterdam, Amsterdam, The Netherlands
  4. 4Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen, Groningen, The Netherlands
  5. 5Utrecht Pharmacy Practice network for Education and Research (UPPER), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands
  1. Correspondence to R te Paske; r.te.paske{at}rug.nl

Abstract

Introduction About 70% of patients with asthma and/or chronic obstructive pulmonary disease (COPD) use their inhaled medication incorrectly, leading to reduced disease control, higher healthcare use and costs. Adequate guidance from the pharmacy team from first dispense onwards can benefit patients in the long run. We propose an intervention (‘On TRACk’) to improve medication adherence and inhaler technique of adult patients with asthma and/or COPD. This intervention focuses on training pharmacy technicians (PTs) in patient-centred communication and inhalation instruction skills. In addition, patients are actively involved in refill consultations at the pharmacy. The aim of this study is to improve inhaler technique and better inhaled medication adherence among patients with asthma and/or COPD. This paper describes the study protocol.

Methods and analysis A cluster randomised controlled trial (RCT) with an intervention and control group of 15 pharmacies each will be conducted. Per intervention pharmacy, two PTs will be trained online. Each PT will include five patients who will prepare their second and third dispense counselling sessions by selecting three topics they wish to discuss. Pharmacies in the control cluster provide usual care. In total, 300 patients (150 per group) will be included. Up to 12 months after inclusion, patients complete 3-monthly follow-up questionnaires. Both a process evaluation and a cost-effectiveness analysis will be performed alongside the trial. Trial effectiveness on the patient level will be evaluated after the 12-month follow-up period.

Patient data will be collected through questionnaires and pharmacy refill data. Patients’ inhaler technique will be visually assessed by PTs. Semistructured interviews with PTs and patients will be conducted regarding implementation and fidelity. Direct and indirect health costs will be collected to assess cost-effectiveness.

The primary outcome is adherence to inhalation maintenance medication measured with pharmacy refill data. Secondary outcomes are inhaler technique, persistence, patients’ attitudes towards medication, self-efficacy in medication use and communication with their PTs.

Ethics and dissemination The study was approved by the Vrije Universiteit Amsterdam Ethics Committee (number: 2020.358). Results will be presented at (inter)national conferences and published in peer-reviewed journals. If proven to be (cost-)effective, the intervention should be considered for reimbursement and implementation in Dutch community pharmacies.

Trial registration number NL9750.

  • RESPIRATORY MEDICINE (see Thoracic Medicine)
  • MEDICAL EDUCATION & TRAINING
  • Asthma
  • Chronic airways disease
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Footnotes

  • Contributors Conceptualisation (main project idea): MV, LvD, AJL, JFMvB and ESK. Funding acquisition: MV and LvD. Training and data collection: RtP and MV. Writing—original draft: RtP and MV. Writing—review and editing: MV, LvD, AJL, JFMvB and ESK.

  • Funding This work was supported by (The Netherlands Organisation for Health Research and Development (ZonMw) grant number 80-84800-98-18089.

  • Disclaimer The funding source had and will have no role in the design, data collection, analysis or interpretation of this study, or in the decision to submit this manuscript for publication.

  • Competing interests All authors declare not to have any competing interests that are related to this study.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

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

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.