Trial Outcomes & Findings for Telecommunication Enhanced Asthma Management (NCT NCT00958932)
NCT ID: NCT00958932
Last Updated: 2024-04-04
Results Overview
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.
COMPLETED
NA
1187 participants
12 months
2024-04-04
Participant Flow
Participant milestones
| Measure |
Speech Recognition (TEAM Intervention)
Speech recognition: The speech recognition intervention was designed to contact families overdue for a refill and encourage greater ICS adherence, personalizing the conversation with information in the EHR while using language designed to activate parents. Families randomized to the Intervention group received one of three speech recognition call types up to eleven times within each year depending on patterns of overdue refills. All routine clinical services, including telephone availability of asthma nurses and pharmacy staff, were available to both Intervention and Usual Care families.
|
Speech Recognition (Usual Care)
Speech recognition: Automated, speech recognition telephone calls
|
|---|---|---|
|
Overall Study
STARTED
|
590
|
597
|
|
Overall Study
COMPLETED
|
452
|
447
|
|
Overall Study
NOT COMPLETED
|
138
|
150
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telecommunication Enhanced Asthma Management
Baseline characteristics by cohort
| Measure |
Speech Recognition (TEAM Intervention)
n=590 Participants
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.
|
Speech Recognition (Usual Care)
n=597 Participants
Speech recognition: Automated, speech recognition telephone calls
|
Total
n=1187 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.1 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
8.2 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
8.2 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
229 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
424 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
361 Participants
n=5 Participants
|
402 Participants
n=7 Participants
|
763 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
80 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
330 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
669 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
139 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
146 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
292 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
431 Participants
n=5 Participants
|
449 Participants
n=7 Participants
|
880 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
590 participants
n=5 Participants
|
597 participants
n=7 Participants
|
1187 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The 899 participants remaining in the final analysis represent those who remained in the insurance network at 24 months post-randomization.
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.
Outcome measures
| Measure |
Speech Recognition (TEAM Intervention)
n=452 Participants
Speech recognition: The speech recognition intervention was designed to contact families overdue for a refill and encourage greater ICS adherence, personalizing the conversation with information in the EHR while using language designed to activate parents. Families randomized to the Intervention group received one of three speech recognition call types up to eleven times within each year depending on patterns of overdue refills. All routine clinical services, including telephone availability of asthma nurses and pharmacy staff, were available to both Intervention and Usual Care families.
|
Speech Recognition (Usual Care)
n=447 Participants
Speech recognition: Automated, speech recognition telephone calls
|
|---|---|---|
|
Medication Adherence
|
.445 Proportion of Days Covered
Interval 0.433 to 0.457
|
.355 Proportion of Days Covered
Interval 0.344 to 0.366
|
SECONDARY outcome
Timeframe: Per one year of person-timeAsthma-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.
Outcome measures
| Measure |
Speech Recognition (TEAM Intervention)
n=452 Participants
Speech recognition: The speech recognition intervention was designed to contact families overdue for a refill and encourage greater ICS adherence, personalizing the conversation with information in the EHR while using language designed to activate parents. Families randomized to the Intervention group received one of three speech recognition call types up to eleven times within each year depending on patterns of overdue refills. All routine clinical services, including telephone availability of asthma nurses and pharmacy staff, were available to both Intervention and Usual Care families.
|
Speech Recognition (Usual Care)
n=447 Participants
Speech recognition: Automated, speech recognition telephone calls
|
|---|---|---|
|
Emergency Care Visits Per Person-Year
|
0.06 Number of visits per person-year
Interval 0.05 to 0.07
|
0.04 Number of visits per person-year
Interval 0.03 to 0.05
|
Adverse Events
Speech Recognition (TEAM Intervention)
Speech Recognition (Usual Care)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place