Type

Journal Article

Authors

Richard W Costello
Sheila A Ryder
Richard B Reilly
Sinthia Bosnic-Anticevich
Fiona Boland
Terence Taylor
Viliam Rapcan
Shona D'Arcy
Cian Hughes
Martin Holmes
and 3 others

Subjects

Psychiatry

Topics
community pharmacy sample size electronic community control groups randomised trial best practice audio feedback clinical trial

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. (2015)

Abstract 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. 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. 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. ClinicalTrials.gov NCT02203266 .
Collections Ireland -> Royal College of Surgeons in Ireland -> PubMed

Full list of authors on original publication

Richard W Costello, Sheila A Ryder, Richard B Reilly, Sinthia Bosnic-Anticevich, Fiona Boland, Terence Taylor, Viliam Rapcan, Shona D'Arcy, Cian Hughes, Martin Holmes and 3 others

Experts in our system

1
Richard W Costello
Royal College of Surgeons in Ireland
Total Publications: 62
 
2
Sheila A Ryder
Royal College of Surgeons in Ireland
Total Publications: 5
 
3
Richard Reilly
Trinity College Dublin
Total Publications: 183
 
4
Fiona Boland
Royal College of Surgeons in Ireland
Total Publications: 44
 
5
Terence E Taylor
Royal College of Surgeons in Ireland
 
6
Viliam Rapcan
Trinity College Dublin
Total Publications: 10
 
7
Shona D'Arcy
Royal College of Surgeons in Ireland
Total Publications: 12
 
8
Cian Hughes
Royal College of Surgeons in Ireland
Total Publications: 8
 
9
Martin S Holmes
Royal College of Surgeons in Ireland
Total Publications: 12