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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL083433 | U.S. NIH Grant/Contract | View source | |
| R01HL083433-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated Phone-Based Refill Reminders | Experimental | Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period. |
|
| Usual Care | No Intervention | Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the "usual care" study arm, and therefore, receive no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated Phone-Based Refill Reminders | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured over 19 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at 19 months |
| Rate of Acute Health Care Visits for Asthma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William M. Vollmer, PhD | Center for Health Research/KPNW | Principal Investigator |
| Cynthia Rand, PhD | Johns Hopkins University | Principal Investigator |
| Joan Dubanoski, PhD | Center for Health Research/KPH | Principal Investigator |
| Adrianne Feldstein, MD | Center for Health Research/KPNW | Principal Investigator |
| David Smith, PhD | Center for Health Research/KPNW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Health Research/KPH | Honolulu | Hawaii | 96817 | United States | ||
| Center for Health Research-KPNW |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22691240 | Background | Vollmer WM, Xu M, Feldstein A, Smith D, Waterbury A, Rand C. Comparison of pharmacy-based measures of medication adherence. BMC Health Serv Res. 2012 Jun 12;12:155. doi: 10.1186/1472-6963-12-155. | |
| 22216772 | Result | Vollmer WM, Feldstein A, Smith DH, Dubanoski JP, Waterbury A, Schneider JL, Clark SA, Rand C. Use of health information technology to improve medication adherence. Am J Manag Care. 2011 Dec;17(12 Spec No.):SP79-87. |
| Label | URL |
|---|---|
| main outcomes, Amer J Manag Care 2011 | View source |
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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.
Recruitment occurred, starting in October 2007 via electronic medical record query. Calling campaigns ended in April 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Automated Phone-Based Refill Reminders | Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period. Automated 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. |
| FG001 | Usual Care | Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the "usual care" study arm, and therefore, receive no intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
individuals who met our inclusion/exclusion criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | fraction of days with medication | Measured over 19 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Automated Phone-Based Refill Reminders | Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period. Automated 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Vollmer, Senior Investigator | Kaiser Permanente, Center for Health Research | 503-335-6755 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
|
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. |
| Measured over 19 months of follow-up |
| Portland |
| Oregon |
| 97227 |
| United States |
| 25133772 | Result | Schneider J, Waterbury A, Feldstein A, Donovan J, Vollmer WM, Dubanoski J, Clark S, Rand C. Maximizing acceptability and usefulness of an automated telephone intervention: Lessons from a developmental mixed-methods approach. Health Informatics J. 2011 Mar;17(1):72-88. doi: 10.1177/1460458210391220. |
| Vollmer et al, BMC Hlth Serv Res 2012. contains further details on computation of primary outcome measure and its performance characteristics | View source |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Automated Phone-Based Refill Reminders |
Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period. Automated 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. |
| OG001 | Usual Care | Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the "usual care" study arm, and therefore, receive no intervention. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | unitless scale ranging from 1-7 | Measured at 19 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | number of events per year | Measured over 19 months of follow-up |
|
|
|
|
| 0 |
| 7,033 |
| 0 |
| 7,033 |
| EG001 | Usual Care | Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the "usual care" study arm, and therefore, receive no intervention. | 0 | 7,031 | 0 | 7,031 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |