Asthma, Patient Compliance
Conditions
Keywords
asthma, patient compliance, metered dose inhalers, corticosteroids, health behaviour, prevention & control
Brief summary
The purpose of this study is to determine whether providing patient medication adherence information on inhaled corticosteroid use to clinicians will result in improved patient adherence and asthma control.
Detailed description
In 2001 an estimated 31.1 million people in the United States reported ever having had an asthma diagnosis. Asthma is a leading cause of preventable hospitalizations, and it accounts for an estimated 14 million days of missed school and 100 million days of restricted activity yearly. The routine use of anti-inflammatory medications, particularly inhaled corticosteroids (ICS), in the treatment of asthma can markedly improve symptoms and reduce complications. Yet, evidence suggests that these medications are under-prescribed by physicians and poorly taken by patients. For example, in one study of asthma patients enrolled in a large, California HMO only 71.7% of patients with severe symptoms reported having a steroid inhaler, and only 53.6% of those reported using it daily in the preceding month. Using electronic monitoring devices to record inhaler use, researchers have estimated that patients use their ICS as directed 20 to 73% of the time. Using claims-based measures of adherence we have shown that adherence to inhaled steroids is inversely correlated with the frequency of oral steroid use and asthma-related emergency room visits. In addition, these measures suggest that non-adherence to ICS is an independent predictor of asthma-related hospitalizations. In our study population, we estimated that 60% of asthma-related hospitalizations were attributable to poor adherence to ICS. Together these findings suggest that increasing ICS use may improve asthma outcomes. Studies employing health-behavioral models of adherence suggest that medication adherence is associated with treatment-related concerns regarding complications, efficacy, and benefits. Unfortunately, the results of behavioral and educational interventions to improve adherence have been disappointing. Despite, in some cases, considerable time spent with patients, these interventions have at best resulted in modest adherence improvements. Given the time, training, and resources required to implement these interventions, they are unlikely to be widely adopted in the clinical setting. Some recent studies, however, suggest that providing adherence data to clinicians may improve patient adherence. In one, clinicians gave repeated feedback to patients regarding ICS adherence; this resulted in sustained improvements over the study period. Unfortunately, this small study did not find differences in asthma outcomes. In this proposal we seek to test an asthma adherence intervention specifically designed for use in the clinical setting. Adherence measures will be generated by linking currently available electronic data. In this cluster-randomized trial, primary care physician-practice groups will be randomized to receive asthma medication adherence information electronically for patients with asthma associated with these practices. In addition to ICS adherence information, clinicians in intervention practices will have data on patient beta-agonist use to better tailor ICS therapy to disease severity. Eligible patients with asthma will be identified prior to randomizing practices and will be invited to participate. Patient surveys will be sent in the pre-intervention survey and in the post-intervention period. Patient-level outcomes will be assessed through the medical record, patient surveys, and claims data. We will perform an intention-to-treat analysis with all eligible patients identified pre-randomization included in the analysis (the primary analysis). This study is powered to allow for only 60% of the eligible patient population being seen within the first 6-months (i.e., no effect in 40% of the patient population). As a secondary analysis, we will perform a modified intention-to-treat (or per protocol) analysis, whereby we will analyze the results of only those patients in both study arms seen within the first 6-months of the intervention.
Interventions
BEHAVIORALFeedback of patient adherence information
Patient inhaled corticosteroid adherence information is being provided to physicians at clinic sites randomized to the intervention arm. Adherence information is available via electronic prescribing software, and so is available to physicians when writing, renewing, or viewing medications. Physicians at intervention sites also receive standard training in how to interpret adherence metrics and how to intervene on poor adherence.
BEHAVIORALActive control group
Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 56 Years
Healthy volunteers
No
Inclusion criteria
(patient-level): * Age 5-56 years * Physician diagnosis of asthma * Continuous HMO enrollment with prescription drug rider * Electronic prescription of an inhaled corticosteroid
Exclusion criteria
(patient-level): * Diagnosis of chronic obstructive pulmonary disease * Diagnosis of congestive heart failure Inclusion Criteria (practice-level): * Primary care practice (i.e., pediatrics, family practice, or internal medicine) within the health system. A practice is defined as a group of physicians who by virtue of speciality or geography care for a relatively contained population of patients and who cross-cover the care of these patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Adherence to Inhaled Corticosteroids (ICS) | 1 year | Adherence to ICS medication was measured during the last 3 months of the intervention (i.e., for the time period of 9-12 months post-randomization). Adherence was measured using pharmacy claims data, and represents the percent of prescribed medication taken. The normal range for this value is 0-100%. |
Secondary
| Measure | Time frame |
|---|---|
| Asthma-related Hospitalizations | 1 year |
| Oral Steroid Use | 1 year |
| Patient Self-efficacy to ICS Treatment | survey following intervention period |
| Asthma-related Emergency Room Visits | 1 year |
| Patient-physician Communication (Patient Reported Measure) | survey following intervention period |
| Patient Medical Care Costs | 1 year |
| Readiness to Improve ICS Adherence (Transtheoretical Model) | survey following intervention period |
Countries
United States
Participant flow
Recruitment details
Health system primary care providers (i.e., in the areas of family practice, internal medicine, and pediatrics) were invited to participate. Physicians who consented to participate were grouped according to practice.
Pre-assignment details
One hundred ninety-two (92%) of the 207 primary care staff clinicians, representing 34 pre-defined primary care practices within the health system, agreed to participate. One clinic was not included a priori since it functioned as the primary resident clinic for internal medicine trainees.
Participants by arm
| Arm | Count |
|---|---|
| Patient Medication Adherence Feedback In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified. | 1,335 |
| Usual Care Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software. | 1,363 |
| Total | 2,698 |
Baseline characteristics
| Characteristic | Usual Care | Patient Medication Adherence Feedback | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 604 Participants | 591 Participants | 1195 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 759 Participants | 744 Participants | 1503 Participants |
| Age Continuous | 27.7 years STANDARD_DEVIATION 38.5 | 25.6 years STANDARD_DEVIATION 37.3 | 26.6 years STANDARD_DEVIATION 37.9 |
| Region of Enrollment United States | 1363 participants | 1335 participants | 2698 participants |
| Sex: Female, Male Female | 753 Participants | 737 Participants | 1490 Participants |
| Sex: Female, Male Male | 610 Participants | 598 Participants | 1208 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,335 | 0 / 1,363 |
| serious Total, serious adverse events | 0 / 1,335 | 0 / 1,363 |
Outcome results
Primary
Patient Adherence to Inhaled Corticosteroids (ICS)
Adherence to ICS medication was measured during the last 3 months of the intervention (i.e., for the time period of 9-12 months post-randomization). Adherence was measured using pharmacy claims data, and represents the percent of prescribed medication taken. The normal range for this value is 0-100%.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Medication Adherence Feedback | Patient Adherence to Inhaled Corticosteroids (ICS) | 21.3 Percent of ICS medication taken | Standard Deviation 2.5 |
| Usual Care | Patient Adherence to Inhaled Corticosteroids (ICS) | 23.3 Percent of ICS medication taken | Standard Deviation 2.2 |
Secondary
Asthma-related Emergency Room Visits
Time frame: 1 year
Secondary
Asthma-related Hospitalizations
Time frame: 1 year
Secondary
Oral Steroid Use
Time frame: 1 year
Secondary
Patient Medical Care Costs
Time frame: 1 year
Secondary
Patient-physician Communication (Patient Reported Measure)
Time frame: survey following intervention period
Secondary
Patient Self-efficacy to ICS Treatment
Time frame: survey following intervention period
Secondary
Readiness to Improve ICS Adherence (Transtheoretical Model)
Time frame: survey following intervention period