Digital measurement improves treatment adherence in asthma management
Click Here to Manage Email Alerts
Key takeaways:
- 14% of the treatment group and 32% of the controls had a net increase in treatment.
- 31% of the treatment group and 18% of the controls cut their medication use in half.
A digital strategy for evidence-based asthma control led to modest improvements in medication adherence and significantly lower cost and treatment burdens, according to a study published in The Lancet Respiratory Medicine.
These findings indicate that patients should have digital assessments of inhaler adherence and lung function before considering biologic treatment, Elaine Mac Hale, MSc, program manager, INCA Research Team, RCSI University of Medicine and Health Science, Clinical Research Centre, and colleagues wrote.
The prospective, single-blinded, parallel, randomly controlled INCA Sun trial involved 213 patients with asthma aged 18 years and older (mean age, 47.2 years; standard deviation [SD],14.9) with a mean Asthma Control Test (ACT) score of 12 (SD, 3.5) and mean FEV1 percent predicted of 76% (SD, 24%) across 10 severe asthma clinics in Ireland, Northern Ireland and England.
All participants received reliever and preventer medicines outfitted with the Inhaler Compliance Assessment (INCA) device, which records and analyzes audio to determine whether the inhaler has been primed, if there was an exhalation into the inhaler before inhalation and if the inhalation flow peak inspiratory flow was less than 40 L per minute.
The system also calculates adherence to twice-daily inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) therapy and peak expiratory flow (PEF).
Patients were randomly assigned to a treatment (n = 108; 61% women) or control (n = 105; 68% women) group. The study began with a week-long run-in period before three nurse-led educational visits at day 7, week 4 and week 8 and then three physician-led treatment adjustment visits at weeks 8, 20 and 32.
During the educational visits, patients in the treatment group received visual biofeedback about how well they used their inhalers and adhered to treatment based on the data provided by the INCA system. The control group received a standardized educational program.
The treatment adjustment visits comprised fully protocol-delivered structured assessments. In the treatment group, mean rate of ICS-LABA adherence, self-reported ACT results, exacerbation history and mean PEF values informed a decision algorithm. Adherence based on pharmacy refill rates and visual assessments of inhaler technique drove assessment in the control group.
Compared with baseline, 14% of the treatment group and 32% of the controls had a net increase in treatment at week 32 (adjusted OR = 0.31; 95% CI, 0.15-0.64). Also, 11% of the treatment group and 21% of the controls needed add-on biologic therapy (aOR = 0.42; 95% CI, 0.19-0.95).
Among the 19 treatment and 25 control patients using 500 µg of fluticasone propionate once a day at baseline, doses increased to 1,000 µg a day by week 32 for 16% of treatment participants and 44% of controls (aOR = 0.23; 0.06-0.87).
Among 83 treatment and 73 control patients using 1,000 µg of fluticasone propionate once per day at baseline, doses decreased to 500 µg a day by week 32 for 31% of treatment participants and 18% of controls (aOR = 2.43; 95% CI, 1.13-5.2).
Patients with decreases in fluticasone doses (n = 39) did not experience any increase in exacerbation rates, with annualized adverse event rates of 0.92 (SD, 0.6) before dose reduction and 0.82 (SD, 0.35) afterward (95% CI, –0.33 to 1.4).
Mean adherence rates during weeks 20 to 32 included 55.5% (SD, 26.8%) for the control group and 64.9% (SD, 23.5%) for the treatment group, with a between-group difference of 9.4% (95% CI, 2.31-16.4). When adjusted for controls in a linear regression model, there was an 11.1% difference in adherence between the groups (95% CI, 4.4-17.9).
The researchers also noted broad variations in how well individuals adhered to treatment. During weeks 20 to 32, 31% of the treatment group and 17% of the controls had rates of greater than 80% (OR = 2.07; 95% CI, 1.06-4.04), whereas 25% of the treatment group and 36% of the controls had rates less than 50% (OR = 0.52; 0.28-0.97).
The researchers said they did not find any significant differences in asthma control, quality-of-life scores, lung function, biomarkers for type 2 inflammation (eosinophil counts or fractional exhaled nitric oxide) or exacerbation rates between the treatment and control groups, nor were there any significant changes in FeNO, FEV1, PEF or exacerbation rates in either group during the treatment adjustment phase.
Annual costs per patient, based on an Irish health care payer perspective, were 5,313 for the treatment group and 8,072 for the control group for a 2,759 difference and an overall annual cost savings of more than 500,000 for the full population of patients who completed the study.
The researchers also recorded 29 serious adverse events, with 16 (55%) in the treatment group and 13 (45%) in the control group. None of these events were causally linked to the intervention, to the use of salmeterol-fluticasone inhalers or to the use of the PEF or INCA device. Eleven (38%) of these events were respiratory.
In assessing physician adherence to the protocol, the researchers found 30 (5%) minor deviations across both groups, mostly due to device failures, prompting the use of other pathways. Also, the researchers said, only 26 (4%) of cases involved investigators overruling recommendations from the clinical decision platform.
By the end of the study, 10% of the treatment group and 20% of the control group met the criteria for add-on biologic treatment. Also, 31% of the treatment group had dose reductions without increases in airway inflammation, symptoms or exacerbations. These dose reductions reduced the risk for side effects with ICS care as well, the researchers added.
These findings indicate how digital technology can effectively and economically support asthma care while reducing the need for biologic treatment, the researchers said.
Perspective
Back to Top
This study highlights how better insights into home asthma management can lead to tailored treatment decisions for patients. In this case, the digital health tools allowed an improved assessment of medication adherence, administration technique and day-to-day peak flows. These data allowed clinicians in the study to reduce inhaled controller therapies and prevent potential unnecessary over-prescription of controller therapies to patients, while also not increasing their risk for asthma exacerbations.
It is surprising that despite the improved personalized care provided to patients that there were no differences in asthma control, quality of life, lung function or exacerbation rates between the groups, which are all primary goals of asthma management.
Despite this lack of benefits, I would not discount the impact the digital interventions had in reducing inhaled steroid doses and biologic prescriptions. These interventions can reduce the risk for possible steroid-related adverse effects and decrease costs to the health care system, respectively.
Better insights into a patient’s life ultimately provide better care. Similar to my experience, having a more accurate assessment of a patient’s adherence to controller therapies allows physicians to provide tailored education and subsequently make changes to their controller regimen that fit their lives. Digital health tools allow me to have a starting point for more open communication with my patients, including frank discussions of potential barriers to care.
Before prescribing a biologic, I want to account for other factors that can be contributing to poor asthma control. By addressing these factors first, I have better insights into which patients most need a biologic to control their asthma. This study had similar outcomes with the digital health information reducing the percentage of the population needing a biologic.
I was impressed to see the relatively high and sustained adherence seen in the active treatment arm. In our experience, we have seen a decline in adherence, even despite use of electronic medication monitors. This study and others have shown that combining electronic medication monitoring with feedback can improve adherence.
When assessing a patient with uncontrolled asthma, it is critical to distinguish between “difficult-to-treat” or “severe persistent” asthma, as both have different treatment strategies. In a patient with difficult-to-treat asthma, you want to address potential barriers to care, including suboptimal medication adherence, poor technique or comorbid conditions that worsen or mimic asthma.
In severe persistent asthma, a patient may need to escalate therapy, including use of a biologic. As demonstrated in this study, digital health tools can help a clinician distinguish between difficult-to-treat or severe persistent asthma, leading to tailored interventions and preventing unnecessary escalations in controller therapies.
Future studies on digital health interventions should explore the data most important to clinical decision-making, the duration of use of these tools and real-world implementation.
There are multiple electronic medication monitoring devices available to clinicians and patients, all with their own unique features. Future studies could explore what data collected by these devices are most beneficial in impacting asthma outcomes.
We have seen benefits of electronic medication monitoring accompanied by direct feedback in improving asthma control in this and other studies, but we do not know how long you need to be utilizing these devices or the frequency of feedback that is ideal to have sustained outcomes.
Additional real-world studies exploring the use of digital health tools would more accurately reflect the potential impact of these devices on asthma control. In this study, there were 100% medication refills in both the control and active treatment groups, which we would not see in practice. Real-life use may potentially accentuate the benefit of these devices to improve asthma control.
This study also used a decision support tool to guide treatment based on the data collected. Clinicians in practice would need guidance on the logistics of incorporating the data into their practice, such as who is collecting it, how often, and how best to implement changes based on the data.
Generally, 80% is used as an ideal adherence to controller therapy, but these electronic medication monitoring studies are demonstrating that a patient can potentially have good asthma control with a lower adherence. For example, the authors highlighted that there was considerable variation in adherence between individuals in both groups, but despite this variation there was no significant difference in asthma control or exacerbation differences between groups.
Collapse
Read more about
Click Here to Manage Email Alerts