The effect of providing feedback on inhaler technique and adherence from an electronic audio recording device, INCA®, in a community pharmacy setting: study protocol for a randomised controlled trial

Susan Mary O'Dwyer, Elaine MacHale, Imran Sulaiman, Martin Holmes, Cian Hughes, Shona D'Arcy, Viliam Rapcan, Terence Taylor, Fiona Boland, Sinthia Bosnic-Anticevich, Richard B Reilly, Sheila A Ryder, Richard W Costello, Susan Mary O'Dwyer, Elaine MacHale, Imran Sulaiman, Martin Holmes, Cian Hughes, Shona D'Arcy, Viliam Rapcan, Terence Taylor, Fiona Boland, Sinthia Bosnic-Anticevich, Richard B Reilly, Sheila A Ryder, Richard W Costello

Abstract

Background: Poor adherence to inhaled medication may lead to inadequate symptom control in patients with respiratory disease. In practice it can be difficult to identify poor adherence. We designed an acoustic recording device, the INCA® (INhaler Compliance Assessment) device, which, when attached to an inhaler, identifies and records the time and technique of inhaler use, thereby providing objective longitudinal data on an individual's adherence to inhaled medication. This study will test the hypothesis that providing objective, personalised, visual feedback on adherence to patients in combination with a tailored educational intervention in a community pharmacy setting, improves adherence more effectively than education alone.

Methods/design: The study is a prospective, cluster randomised, parallel-group, multi-site study conducted over 6 months. The study is designed to compare current best practice in care (i.e. routine inhaler technique training) with the use of the INCA® device for respiratory patients in a community pharmacy setting. Pharmacies are the unit of randomisation and on enrolment to the study they will be allocated by the lead researcher to one of the three study groups (intervention, comparator or control groups) using a computer-generated list of random numbers. Given the nature of the intervention neither pharmacists nor participants can be blinded. The intervention group will receive feedback from the acoustic recording device on inhaler technique and adherence three times over a 6-month period along with inhaler technique training at each of these times. The comparator group will also receive training in inhaler use three times over the 6-month study period but no feedback on their habitual performance. The control group will receive usual care (i.e. the safe supply of medicines and advice on their use). The primary outcome is the rate of participant adherence to their inhaled medication, defined as the proportion of correctly taken doses of medication at the correct time relative to the prescribed interval. Secondary outcomes include exacerbation rates and quality of life measures. Differences in the timing and technique of inhaler use as altered by the interventions will also be assessed. Data will be analysed on an intention-to-treat and a per-protocol basis. Sample size has been calculated with reference to comparisons to be made between the intervention and comparator clusters and indicates 75 participants per cluster. With an estimated 10 % loss to follow-up we will be able to show a 20 % difference between the population means of the intervention and comparator groups with a power of 0.8. The Type I error probability associated with the test of the null hypothesis is 0.05.

Discussion: This clinical trial will establish whether providing personalised feedback to individuals on their inhaler use improves adherence. It may also be possible to enhance the role of pharmacists in clinical care by identifying patients in whom alteration of either therapy or inhaler device is appropriate.

Registration: ClinicalTrials.gov NCT02203266 .

Keywords: Adherence; Cluster randomised trial; Community pharmacy; INCA® electronic monitor; Inhaler technique; Patient education.

Figures

Fig. 1
Fig. 1
INCA® Pharmacy Study – overview of study flow and design
Fig. 2
Fig. 2
Extract of participant respiratory diary

References

    1. To T, Stanojevic S, Moores G, Gershon AS, Bateman ED, Cruz AA, et al. Global asthma prevalence in adults: findings from the cross-sectional world health survey. BMC Public Health. 2012;12(1):204. doi: 10.1186/1471-2458-12-204.
    1. World Health Organisation. The top 10 causes of death in the world, 2000 and 2012. WHO Fact Sheet Number 310. Accessed via on 8 September 2014.
    1. Global Initiative for Asthma. Global strategy for asthma management and prevention 2014. Accessed via on 8 September 2014.
    1. Global Initiative for Chronic Obstructive Pulmonary Disease. Global strategy for the diagnosis, management and prevention of COPD 2014. Accessed via on 8 September 2014.
    1. Lavorini F, Magnan A, Dubus JC, Voshaar T, Corbetta L, Broeders M, et al. Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD. Respir Med. 2008;102(4):593–604. doi: 10.1016/j.rmed.2007.11.003.
    1. Cochrane MG, Bala MV, Downs KE, Mauskopf J, Ben-Joseph RH. Inhaled corticosteroids for asthma therapy – Patient compliance, devices, and inhalation technique. Chest. 2000;117(2):542–50. doi: 10.1378/chest.117.2.542.
    1. Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011;105(6):930–8. doi: 10.1016/j.rmed.2011.01.005.
    1. Bosnic-Anticevich SZ, Sinha H, So S, Reddel HK. Metered-dose inhaler technique: the effect of two educational interventions delivered in community pharmacy over time. J Asthma. 2010;47(3):251–6. doi: 10.3109/02770900903580843.
    1. Armour CL, Reddel HK, Lemay KS, Saini B, Smith LD, Bosnic-Anticevich SZ, et al. Feasibility and effectiveness of an evidence-based asthma service in Australian community pharmacies: a pragmatic cluster randomized trial. J Asthma. 2013;50(3):302–9. doi: 10.3109/02770903.2012.754463.
    1. Tommelein E, Mehuys E, Van Hees T, Adriaens E, Van Bortel L, Christiaens T, et al. Effectiveness of pharmaceutical care for patients with chronic obstructive pulmonary disease (PHARMACOP): a randomized controlled trial. Br J Clin Pharmacol. 2014;77(5):756–66. doi: 10.1111/bcp.12242.
    1. Mehuys E, Van Bortel L, De Bolle L, Van Tongelen I, Annemans L, Remon JP, et al. Effectiveness of pharmacist intervention for asthma control improvement. European Respiratory Journal. 2008;31(4):790-9.
    1. Armour C, Bosnic-Anticevich S, Brillant M, Burton D, Emmerton L, Krass I, et al. Pharmacy Asthma Care Program (PACP) improves outcomes for patients in the community. Thorax. 2007;62(6):496–502. doi: 10.1136/thx.2006.064709.
    1. Saini B, Krass I, Armour C. Development, implementation, and evaluation of a community pharmacy-based asthma care model. Ann Pharmacother. 2004;38(11):1954–60. doi: 10.1345/aph.1E045.
    1. García-Cárdenas V, Sabater-Hernández D, Kenny P, Martínez-Martínez F, Faus MJ, Benrimoj SI. Effect of a pharmacist intervention on asthma control. A cluster randomised trial. Respir Med. 2013;107(9):1346–55. doi: 10.1016/j.rmed.2013.05.014.
    1. Tommelein E, Mehuys E, Van Tongelen I, Brusselle G, Boussery K. Accuracy of the Medication Adherence Report Scale (MARS-5) as a quantitative measure of adherence to inhalation medication in patients with COPD. Ann Pharmacother. 2014;48(5):589–95. doi: 10.1177/1060028014522982.
    1. van de Steeg N, Sielk M, Pentzek M, Bakx C, Altiner A. Drug-adherence questionnaires not valid for patients taking blood-pressure-lowering drugs in a primary health care setting. J Eval Clin Pract. 2009;15(3):468–72. doi: 10.1111/j.1365-2753.2008.01038.x.
    1. Andrade SE, Kahler KH, Frech F, Chan KA. Methods for evaluation of medication adherence and persistence using automated databases. Pharmacoepidemiol Drug Saf. 2006;15(8):565–74. doi: 10.1002/pds.1230.
    1. Steiner JF, Prochazka AV. The assessment of refill compliance using pharmacy records: methods, validity, and applications. J Clin Epidemiol. 1997;50(1):105–16. doi: 10.1016/S0895-4356(96)00268-5.
    1. D’Arcy S, MacHale E, Seheult J, Holmes MS, Hughes C, Sulaiman I, et al. A method to assess adherence in inhaler use through analysis of acoustic recordings of inhaler events. PLoS One. 2014;9(6):e98701. doi: 10.1371/journal.pone.0098701.
    1. Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health-status for chronic air-flow limitation – the St-Georges Respiratory Questionnaire. Am Rev Respir Dis. 1992;145(6):1321–7. doi: 10.1164/ajrccm/145.6.1321.
    1. Asthma Society of Ireland. Asthma management plan and peak flow diary. Dublin: Asthma Society of Ireland; 2011.
    1. MacHale E, Costello RW, Cowman S. A nurse-led intervention study: promoting compliance with Diskus Inhaler use in asthma patients. Nurs Open. 2014;1(1):42–52. doi: 10.1002/nop2.10.
    1. Karve S, Cleves MA, Helm M, Hudson TJ, West DS, Martin BC. Good and poor adherence: optimal cut-point for adherence measures using administrative claims data. Curr Med Res Opin. 2009;25(9):2303–10. doi: 10.1185/03007990903126833.
    1. Holmes MS. arcy SD, Costello RW, Reilly RB. Acoustic Analysis of Inhaler Sounds From Community-Dwelling Asthmatic Patients for Automatic Assessment of Adherence. IEEE Journal of Translational Engineering in Health and Medicine. 2014;2:1–10. doi: 10.1109/JTEHM.2014.2310480.
    1. Schulz KF, Altman DG, Moher D, Grp C. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152(11):726–W293. doi: 10.7326/0003-4819-152-11-201006010-00232.
    1. Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ (Online) 2012;345(7881):e5661.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, Grp C. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148(4):295–309. doi: 10.7326/0003-4819-148-4-200802190-00008.
    1. McBane SE, Dopp AL, Abe A, Benavides S, Chester EA, Dixon DL, et al. Collaborative drug therapy management and comprehensive medication management – 2015. Pharmacotherapy. 2015;35(4):E39–50. doi: 10.1002/phar.1563.
    1. Doucette WR, Nevins J, McDonough RP. Factors affecting collaborative care between pharmacists and physicians. Res Social Adm Pharm. 2005;1(4):565–78. doi: 10.1016/j.sapharm.2005.09.005.
    1. Snyder ME, Zillich AJ, Primack BA, Rice KR, Somma McGivney MA, Pringle JL, et al. Exploring successful community pharmacist-physician collaborative working relationships using mixed methods. Res Soc Adm Pharm. 2010;6(4):307–23. doi: 10.1016/j.sapharm.2009.11.008.
    1. Zillich AJ, Doucette WR, Carter BL, Kreiter CD. Development and initial validation of an instrument to measure physician-pharmacist collaboration from the physician perspective. Value Health. 2005;8(1):59–66. doi: 10.1111/j.1524-4733.2005.03093.x.
    1. Vink NM, Klungel OH, Stolk RP, Denig P. Comparison of various measures for assessing medication refill adherence using prescription data. Pharmacoepidemiol Drug Saf. 2009;18(2):159–65. doi: 10.1002/pds.1698.
    1. Hahn S, Puffer S, Torgerson DJ, Watson J. Methodological bias in cluster randomised trials. BMC Med Res Methodol. 2005;5:10. doi: 10.1186/1471-2288-5-10.
    1. Jordhoy MS, Fayers PM, Ahlner-Elmqvist M, Kaasa S. Lack of concealment may lead to selection bias in cluster randomized trials of palliative care. Palliat Med. 2002;16(1):43–9. doi: 10.1191/0269216302pm523oa.

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