Asthma
Conditions
Brief summary
The primary aim of this project is to conduct a randomized practical clinical trial within a large health maintenance organization to test a telephone intervention designed to improve adherence to daily asthma medications and thereby improve asthma outcomes. The investigators hypothesize that adherence with inhaled corticosteroid medications in the TEAM intervention group will be greater than in the usual care group.
Detailed description
Asthma affects more than 15 million people in the United States. Inhaled corticosteroids (ICS), the ranking treatment-of-choice, are safe and highly efficacious in controlled trials, but adherence to ICS medications in real-world settings is poor in all patient groups, especially low-income and minority patients who experience the most morbidity from asthma. Children and adults with asthma take less than half of their prescribed ICS medication. One study found that only 44% of ICS prescriptions for children with asthma were filled. Even the most effective medications have little value if not taken as prescribed. Decreasing use of ICS has been repeatedly linked to poor asthma control and increasing health care utilization. We will conduct a randomized, practical clinical trial to test the impact of a communication enhancement program for parents of 3-12 year old children with asthma in the largest health maintenance organization (HMO) within Colorado. Research in this setting has the significant advantage of not only establishing the utility of a behavior-changing strategy, but at the same time demonstrating that the strategy can be applied in a large healthcare system and sustained over time. The proposed intervention will be referred to here as the Telecommunication Enhanced Adherence Management (TEAM) program. This proposal builds upon ongoing efforts within Kaiser Permanente of Colorado (KPCO), the participating HMO, to use automated telecommunication technology to prevent diabetes, reduce cardiac risk, reduce calorie consumption, and increase exercise adherence, with the introduction of an intervention to increase adherence with daily ICS therapy. Speech Recognition (SR), the telecommunication technology used in this trial, has not previously been employed to promote adherence in a population of children treated for asthma within a large HMO. TEAM creates a theory-based enhanced communication program using SR with support from asthma care manager nurses. The Asthma Care Manager program already exists within KPCO, but with SR the frequency and quality of communication with parents is expected to improve significantly, resulting in more ICS medication refills, better persistence in ICS use, and improved asthma outcomes. Through SR calls, parents will be reminded and motivated about the importance of continued daily use of ICS medications, asked about their child's recent asthma symptoms, and given the opportunity to receive a call back from an asthma care manager or to place a request for a medication refill.
Interventions
The TEAM intervention is a program to increase communication with families, provide feedback to families about their refill adherence, assess asthma symptoms, deliver health communication messages, encourage parents to ask questions of asthma care managers, and facilitate refilling ICS prescription. Speech recognition calls will be tailored to specific situations including new or re-issued ICS prescriptions, failure to fill an initial prescription, failure to refill, or failure to refill following an ED visit, hospitalization, or oral steroid burst resulting from an asthma exacerbation.
Sponsors
Study design
Eligibility
Inclusion criteria
* 3-12 year old children with asthma requiring daily corticosteroid
Exclusion criteria
* sibling already in study * physician excludes from participation * non English Speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | 12 months | The primary outcome of this study, adherence, was expressed as a mean proportion of days covered (PDC) over 24 months. The PDC was calculated as the total number of ICS days supplied divided by the period for which the medication was prescribed. Calculation of the PDC was adjusted to account for the supply that would extend beyond the end of the study period. Comparisons were adjusted for baseline PDC, which was calculated as the ratio of number of days a patient had possession of medication divided by the number of days enrolled 1 year prior to randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Care Visits Per Person-Year | Per one year of person-time | Asthma-related emergency care events were compared between the two study groups. In health insurance data, individual records often do not cover the entire period of study because people may leave the insurance network seeking new coverage, or after moving, etc. However, this partial data is still usable when pooled to calculate numbers of events of interest per person-year. For example, one person may only be in the study for six months, and they may log an emergency room. Another person may be in the study for 18 months and log no visits. Put together, the two participants log two person years of data (6 months + 18 months = 24 months = 2 person-years in the study) and between the two of them they log one emergency room visit, which results in an outcome of 0.5 emergency care visits, on average, per person-year of data available. This measure of central tendency is calculated for the two study groups to permit comparison. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Speech Recognition (TEAM Intervention) Speech recognition: The TEAM intervention is a program to increase communication with families, provide feedback to families about their refill adherence, assess asthma symptoms, deliver health communication messages, encourage parents to ask questions of asthma care managers, and facilitate refilling ICS prescription. Speech recognition calls will be tailored to specific situations including new or re-issued ICS prescriptions, failure to fill an initial prescription, failure to refill, or failure to refill following an ED visit, hospitalization, or oral steroid burst resulting from an asthma exacerbation. | 590 |
| Speech Recognition (Usual Care) Speech recognition: Automated, speech recognition telephone calls | 597 |
| Total | 1,187 |
Baseline characteristics
| Characteristic | Total | Speech Recognition (TEAM Intervention) | Speech Recognition (Usual Care) |
|---|---|---|---|
| Age, Continuous | 8.2 years STANDARD_DEVIATION 2.2 | 8.1 years STANDARD_DEVIATION 2.6 | 8.2 years STANDARD_DEVIATION 2.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 292 Participants | 146 Participants | 146 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 880 Participants | 431 Participants | 449 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 13 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 17 Participants | 8 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 40 Participants | 17 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 154 Participants | 80 Participants | 74 Participants |
| Race (NIH/OMB) More than one race | 285 Participants | 139 Participants | 146 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 7 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 13 Participants | 2 Participants |
| Race (NIH/OMB) White | 669 Participants | 330 Participants | 339 Participants |
| Region of Enrollment United States | 1187 participants | 590 participants | 597 participants |
| Sex: Female, Male Female | 424 Participants | 229 Participants | 195 Participants |
| Sex: Female, Male Male | 763 Participants | 361 Participants | 402 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 590 | 0 / 597 |
| serious Total, serious adverse events | 0 / 590 | 0 / 597 |
Outcome results
Medication Adherence
The primary outcome of this study, adherence, was expressed as a mean proportion of days covered (PDC) over 24 months. The PDC was calculated as the total number of ICS days supplied divided by the period for which the medication was prescribed. Calculation of the PDC was adjusted to account for the supply that would extend beyond the end of the study period. Comparisons were adjusted for baseline PDC, which was calculated as the ratio of number of days a patient had possession of medication divided by the number of days enrolled 1 year prior to randomization.
Time frame: 12 months
Population: The 899 participants remaining in the final analysis represent those who remained in the insurance network at 24 months post-randomization.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Speech Recognition (TEAM Intervention) | Medication Adherence | .445 Proportion of Days Covered |
| Speech Recognition (Usual Care) | Medication Adherence | .355 Proportion of Days Covered |
Emergency Care Visits Per Person-Year
Asthma-related emergency care events were compared between the two study groups. In health insurance data, individual records often do not cover the entire period of study because people may leave the insurance network seeking new coverage, or after moving, etc. However, this partial data is still usable when pooled to calculate numbers of events of interest per person-year. For example, one person may only be in the study for six months, and they may log an emergency room. Another person may be in the study for 18 months and log no visits. Put together, the two participants log two person years of data (6 months + 18 months = 24 months = 2 person-years in the study) and between the two of them they log one emergency room visit, which results in an outcome of 0.5 emergency care visits, on average, per person-year of data available. This measure of central tendency is calculated for the two study groups to permit comparison.
Time frame: Per one year of person-time
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Speech Recognition (TEAM Intervention) | Emergency Care Visits Per Person-Year | 0.06 Number of visits per person-year |
| Speech Recognition (Usual Care) | Emergency Care Visits Per Person-Year | 0.04 Number of visits per person-year |