Asthma
Conditions
Keywords
Inhaled Corticosteroids, ICS, Adherence
Brief summary
Inhaled corticosteroids (ICS) are often prescribed as a treatment for asthma. However, many individuals who take these medications do not adhere to their prescribed treatment regimen. The purpose of this study is to evaluate the effectiveness of a telephone-based program at improving medication adherence among individuals with asthma.
Detailed description
Asthma is a serious, chronic disease that affects lung function and impairs an individual's ability to breathe normally. ICS reduce airway inflammation and are often prescribed to treat these conditions. However, poor medication adherence is a common problem that can lead to treatment failure, hospitalization, or death. A telephone-based system that uses interactive voice recognition technology to remind individuals to follow their medication regimen may prove beneficial in promoting adherence. The purpose of this study is to evaluate the effectiveness of such a telephone-based intervention at improving adherence to inhaled corticosteroid regimens among individuals with asthma. If this study proves successful, telephone-based interventions may be developed to promote treatment adherence for other chronic medical conditions. This 19-month study will enroll approximately 14,000 members of the Kaiser Permanente Northwest or Hawaii health system. Participants will be randomly assigned to either take part in the telephone intervention or receive usual medical care. Over the 19-month period, participants in the intervention group will receive between one and eight phone calls that will remind them to refill their prescriptions and offer education about ICS. If needed, the call may also offer a transfer to a pharmacy refill line or to speak with a pharmacist. Approximately 2,000 participants will complete questionnaires at study entry and at the end of the 19-month intervention period. The questionnaires will assess quality of life, respiratory health, asthma control, depression, inhaler use beliefs, and satisfaction with the intervention. Electronic medical record data and questionnaires will be used to determine adherence rates.
Interventions
BEHAVIORALAutomated Phone-Based Refill Reminders
The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Received treatment for asthma in the year prior to study entry * Received at least one respiratory medication at a Kaiser Permanente Northwest (KPNW) or Kaiser Permanente Hawaii (KPH) outpatient pharmacy in the year prior to study entry * Continuous Kaiser Permanente membership from the year prior to study entry through study entry * Willing to participate in the study
Exclusion criteria
* Excluded from primary analyses if fewer than three months of follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Medication Possession Ratio | Measured over 19 months | We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window. The MPR, and by extension the mMPR, assumes that medications were used as directed and that a new inhaled corticosteroid canister was not started until any medication on hand was exhausted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Juniper Asthma Quality of Life Questionnaire (Global Score) | Measured at 19 months | Asthma specific quality of life measurement developed by Dr. Elizabeth Juniper. This is the overall summary score and ranges from 1=poorest quality of life to 7=best quality of life. |
| Rate of Acute Health Care Visits for Asthma | Measured over 19 months of follow-up | annualized rate of acute asthma health care utilization events (urgent care, emergency department use, hospitalization) based on data derived from the electronic medical record. Each type of event was given equal weight for this analysis. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred, starting in October 2007 via electronic medical record query. Calling campaigns ended in April 2009.
Pre-assignment details
14,064 adults taking medication for asthma were pre-randomized to intervention or usual care (UC). However, only those individuals who ever qualified for an intervention call were included in the analysis sample. This included 6905 pre-existing inhaled corticosteroid (ICS) users (our primary analysis sample) and 1612 new ICS users.
Participants by arm
| Arm | Count |
|---|---|
| Automated Phone-Based Refill Reminders Intervention arm participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users. | 3,171 |
| Usual Care usual care participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users. | 3,260 |
| Total | 6,431 |
Baseline characteristics
| Characteristic | Automated Phone-Based Refill Reminders | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 777 Participants | 761 Participants | 1538 Participants |
| Age, Categorical Between 18 and 65 years | 2394 Participants | 2499 Participants | 4893 Participants |
| Age, Continuous | 53.7 years STANDARD_DEVIATION 15.3 | 53.5 years STANDARD_DEVIATION 15.3 | 53.6 years STANDARD_DEVIATION 15.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 39 Participants | 82 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1169 Participants | 1185 Participants | 2354 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1959 Participants | 2036 Participants | 3995 Participants |
| Gender Female | 2150 Participants | 2207 Participants | 4357 Participants |
| Gender Male | 1021 Participants | 1053 Participants | 2074 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 16 Participants | 20 Participants | 36 Participants |
| Race (NIH/OMB) Asian | 342 Participants | 388 Participants | 730 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants | 52 Participants | 103 Participants |
| Race (NIH/OMB) More than one race | 196 Participants | 235 Participants | 431 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 145 Participants | 130 Participants | 275 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 789 Participants | 857 Participants | 1646 Participants |
| Race (NIH/OMB) White | 1632 Participants | 1578 Participants | 3210 Participants |
| Region of Enrollment United States | 3171 participants | 3260 participants | 6431 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7,033 | 0 / 7,031 |
| serious Total, serious adverse events | 0 / 7,033 | 0 / 7,031 |
Outcome results
Primary
Modified Medication Possession Ratio
We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window. The MPR, and by extension the mMPR, assumes that medications were used as directed and that a new inhaled corticosteroid canister was not started until any medication on hand was exhausted.
Time frame: Measured over 19 months
Population: Study participants who were existing users of ICS at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Phone-Based Refill Reminders | Modified Medication Possession Ratio | .40 fraction of days with medication | Standard Deviation 0.32 |
| Usual Care | Modified Medication Possession Ratio | .38 fraction of days with medication | Standard Deviation 0.32 |
Comparison: In all of our analyses we used duration of follow-up as a weighting variable to reflect the fact that our adherence measure becomes more accurate and reliable with longer follow-up. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above. Also, sensitivity analyses that included daily oral steroid users and those with fewer than 3 months of follow-up yielded similar results to those presented here.p-value: 0.00295% CI: [0.006, 0.03]Regression, Linear
Secondary
Juniper Asthma Quality of Life Questionnaire (Global Score)
Asthma specific quality of life measurement developed by Dr. Elizabeth Juniper. This is the overall summary score and ranges from 1=poorest quality of life to 7=best quality of life.
Time frame: Measured at 19 months
Population: We assessed this outcome on a random sample of study participants that over-sampled intervention participants. All were existing users of ICS at the outset of the study who qualified for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Phone-Based Refill Reminders | Juniper Asthma Quality of Life Questionnaire (Global Score) | 4.8 unitless scale ranging from 1-7 | Standard Deviation 1.3 |
| Usual Care | Juniper Asthma Quality of Life Questionnaire (Global Score) | 4.9 unitless scale ranging from 1-7 | Standard Deviation 1.3 |
Comparison: In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.p-value: 0.17595% CI: [-0.23, 0.04]Regression, Linear
Secondary
Rate of Acute Health Care Visits for Asthma
annualized rate of acute asthma health care utilization events (urgent care, emergency department use, hospitalization) based on data derived from the electronic medical record. Each type of event was given equal weight for this analysis.
Time frame: Measured over 19 months of follow-up
Population: Study participants who were existing users of ICS at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Phone-Based Refill Reminders | Rate of Acute Health Care Visits for Asthma | 1.7 number of events per year | Standard Deviation 2.3 |
| Usual Care | Rate of Acute Health Care Visits for Asthma | 1.7 number of events per year | Standard Deviation 2 |
Comparison: In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.p-value: 0.85295% CI: [0.96, 1.06]overdispersed Poisson regression