Dataset Information

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.

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 .

SUBMITTER: O'Dwyer SM

PROVIDER: S-EPMC4855368 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

O'Dwyer Susan Mary SM MacHale Elaine E Sulaiman Imran I Holmes Martin M Hughes Cian C D'Arcy Shona S Rapcan Viliam V Taylor Terence T Boland Fiona F Bosnic-Anticevich Sinthia S Reilly Richard B RB Ryder Sheila A SA Costello Richard W RW

Trials 20160504 1

<h4>Background</h4>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 tes ...[more]

PMID: 27142873

Similar Datasets

Project description:INTRODUCTION:In clinical practice, it is difficult to distinguish between patients with refractory asthma from those with poorly controlled asthma, where symptoms persist due to poor adherence, inadequate inhaler technique or comorbid diseases. We designed an audio recording device which, when attached to an inhaler, objectively identifies the time and technique of inhaler use, thereby assessing both aspects of adherence. This study will test the hypothesis that feedback on these two aspects of adherence when passed on to patients improves adherence and helps clinicians distinguish refractory from difficult-to-control asthma. METHODS:This is a single, blind, prospective, randomised, clinical trial performed at 5 research centres. Patients with partially controlled or uncontrolled severe asthma who have also had at least one severe asthma exacerbation in the prior year are eligible to participate. The effect of two types of nurse-delivered education interventions to promote adherence and inhaler technique will be assessed. The active group will receive feedback on their inhaler technique and adherence from the new device over a 3-month period. The control group will also receive training in inhaler technique and strategies to promote adherence, but no feedback from the device. The primary outcome is the difference in actual adherence, a measure that incorporates time and technique of inhaler use between groups at the end of the third month. Secondary outcomes include the number of patients who remain refractory despite good adherence, and differences in the components of adherence after the intervention. Data will be analysed on an intention-to-treat and a per-protocol basis. The sample size is 220 subjects (110 in each group), and loss to follow-up is estimated at 10% which will allow results to show a 10% difference (0.8 power) in adherence between group means with a type I error probability of 0.05. TRIAL REGISTRATION NUMBER:NCT01529697; Pre-results.

Project description:BackgroundUsing patient audio recordings of medical visits to provide clinicians with feedback on their attention to patient life context in care planning can improve health care delivery and outcomes, and reduce costs. However, such an initiative can raise concerns across stakeholders about surveillance, intrusiveness and merit. This study examined the perspectives of patients, physicians and other clinical staff, and facility leaders over 3 years at six sites during the implementation of a patient-collected audio quality improvement program designed to improve patient-centered care in a non-threatening manner and with minimal effort required of patients and clinicians.MethodsPatients were invited during the first and third year to complete exit surveys when they returned their audio recorders following visits, and clinicians to complete surveys annually. Clinicians were invited to participate in focus groups in the first and third years. Facility leaders were interviewed individually during the last 6 months of the study.ResultsThere were a total of 12 focus groups with 89 participants, and 30 leadership interviews. Two hundred fourteen clinicians and 800 patients completed surveys. In a qualitative analysis of focus group data employing NVivo, clinicians initially expressed concerns that the program could be disruptive and/or burdensome, but these diminished with program exposure and were substantially replaced by an appreciation for the value of low stakes constructive feedback. They were also significantly more confident in the value of the intervention in the final year (p = .008), more likely to agree that leadership supports continuous improvement of patient care and gives feedback on outcomes (p = .02), and at a time that is convenient (p = .04). Patients who volunteered sometimes expressed concerns they were "spying" on their doctors, but most saw it as an opportunity to improve care. Leaders were supportive of the program but not yet prepared to commit to funding it exclusively with facility resources.ConclusionsA patient-collected audio program can be implemented when it is perceived as safe, not disruptive or burdensome, and as contributing to better health care.

Project description:IntroductionGeneric substitution of inhaler devices is a relatively new phenomenon. The best patient outcomes associated with generic substitution occur when prescribers obtain consent from their patients to prescribe a generic inhaler and also teach their patient how to correctly use the new device. To date, no prospective observational study has assessed the level of training required for general practitioners (GPs) to demonstrate correct inhaler technique using two dry powder inhaler devices delivering fixed-dose combination budesonide/formoterol therapy. This study aims to (1) determine the level of training required for GPs to master and maintain correct IT when using two different dry powder inhalers that are able to be substituted in clinical practice and (2) determine the number and types of errors made by GPs on each device and inhaler device preference at each training visit.MethodA randomized, parallel-group cross-over study design was used to compare the inhaler technique of participants with a Spiromax® placebo device and a Turbuhaler® placebo device. This study consisted of two visits with each participant over a period of 4 ± 1 weeks (visit 1 and visit 2). A total of six levels of assessment and five levels of training were implemented as required. Level 1, no instruction; level 2, following use of written instruction; level 3, following viewing of instructional video; level 4, expert tuition from the researcher; level 5/level 6, repeats of expert tuition from the researcher when required. Participants progressed through each level and stopped at the point at which they demonstrated device mastery. At each level, trained researchers assessed the inhaler technique of the participants. Participants were also surveyed about their previous inhaler use and training.ResultsIn total, 228 GPs participated in this study by demonstrating their ability to use a Turbuhaler® and a Spiromax® device. There was no significant difference between the proportion of participants who demonstrated device mastery with the Turbuhaler® compared with the Spiromax® at level 1, (no instruction), (119/228 (52%) versus 131/228 (57%), respectively, n = 228, p = 0.323 (McNemar's test of paired data). All but one participant had demonstrated correct inhaler technique for both devices by level 3(instructional video). There was a significant difference between the proportion of participants who demonstrated maintenance of device mastery with the Turbuhaler® compared with the Spiromax® at visit 2, level 1 (127/177 (72%) versus 151/177 (85%) respectively, p = 0.003; McNemar's test of paired data). All but two participants achieved device mastery by level 3, visit 2. More participants reported previous training with the Turbuhaler® than with Spiromax®.DiscussionThis study demonstrates that GPs are able to equally demonstrate correct use of the Turbuhaler® and Spiromax® devices, even though most had not received training on a Spiromax® device prior to this study. The significance of being able to demonstrate correct technique on these two devices equally has ramifications on practice and supported generic substitution of inhaler devices at the point of prescribing, as the most impactful measure a GP can take to ensure effective use of inhaled medicine is the correct demonstration of inhaler technique.

Project description:In an ever-changing environment, crossmodal recalibration is crucial to maintain precise and coherent spatial estimates across different sensory modalities. Accordingly, it has been found that perceived auditory space is recalibrated toward vision after consistent exposure to spatially misaligned audio-visual stimuli (VS). While this so-called ventriloquism aftereffect (VAE) yields internal consistency between vision and audition, it does not necessarily lead to consistency between the perceptual representation of space and the actual environment. For this purpose, feedback about the true state of the external world might be necessary. Here, we tested whether the size of the VAE is modulated by external feedback and reward. During adaptation audio-VS with a fixed spatial discrepancy were presented. Participants had to localize the sound and received feedback about the magnitude of their localization error. In half of the sessions the feedback was based on the position of the VS and in the other half it was based on the position of the auditory stimulus. An additional monetary reward was given if the localization error fell below a certain threshold that was based on participants' performance in the pretest. As expected, when error feedback was based on the position of the VS, auditory localization during adaptation trials shifted toward the position of the VS. Conversely, feedback based on the position of the auditory stimuli reduced the visual influence on auditory localization (i.e., the ventriloquism effect) and improved sound localization accuracy. After adaptation with error feedback based on the VS position, a typical auditory VAE (but no visual aftereffect) was observed in subsequent unimodal localization tests. By contrast, when feedback was based on the position of the auditory stimuli during adaptation, no auditory VAE was observed in subsequent unimodal auditory trials. Importantly, in this situation no visual aftereffect was found either. As feedback did not change the physical attributes of the audio-visual stimulation during adaptation, the present findings suggest that crossmodal recalibration is subject to top-down influences. Such top-down influences might help prevent miscalibration of audition toward conflicting visual stimulation in situations in which external feedback indicates that visual information is inaccurate.

Project description:Inhaler technique can be corrected with training, but skills drop off quickly without repeated training. The aim of our study was to explore the effect of novel inhaler technique labels on the retention of correct inhaler technique. In this single-blind randomized parallel-group active-controlled study, clinical pharmacists enrolled asthma patients using controller medication by Accuhaler [Diskus] or Turbuhaler. Inhaler technique was assessed using published checklists (score 0-9). Symptom control was assessed by asthma control test. Patients were randomized into active (ACCa; THa) and control (ACCc; THc) groups. All patients received a "Show-and-Tell" inhaler technique counseling service. Active patients also received inhaler labels highlighting their initial errors. Baseline data were available for 95 patients, 68% females, mean age 44.9 (SD 15.2) years. Mean inhaler scores were ACCa:5.3?±?1.0; THa:4.7?±?0.9, ACCc:5.5?±?1.1; THc:4.2?±?1.0. Asthma was poorly controlled (mean ACT scores ACCa:13.9?±?4.3; THa:12.1?±?3.9; ACCc:12.7?±?3.3; THc:14.3?±?3.7). After training, all patients had correct technique (score 9/9). After 3 months, there was significantly less decline in inhaler technique scores for active than control groups (mean difference: Accuhaler -1.04 (95% confidence interval -1.92, -0.16, P?=?0.022); Turbuhaler -1.61 (-2.63, -0.59, P?=?0.003). Symptom control improved significantly, with no significant difference between active and control patients, but active patients used less reliever medication (active 2.19 (SD 1.78) vs. control 3.42 (1.83) puffs/day, P?=?0.002). After inhaler training, novel inhaler technique labels improve retention of correct inhaler technique skills with dry powder inhalers. Inhaler technique labels represent a simple, scalable intervention that has the potential to extend the benefit of inhaler training on asthma outcomes.AsthmaREMINDER LABELS IMPROVE INHALER TECHNIQUE: Personalized labels on asthma inhalers remind patients of correct technique and help improve symptoms over time. Iman Basheti at the Applied Science Private University in Jordan and co-workers trialed the approach of placing patient-specific reminder labels on dry-powder asthma inhalers to improve long-term technique. Poor asthma control is often exacerbated by patients making mistakes when using their inhalers. During the trial, 95 patients received inhaler training before being split into two groups: the control group received no further help, while the other group received individualized labels on their inhalers reminding them of their initial errors. After three months, 67% of patients with reminder labels retained correct technique compared to only 12% of controls. They also required less reliever medication and reported improved symptoms. This represents a simple, cheap way of tackling inhaler technique errors.

Dataset Information

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.

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets