Telephone-Based Program to Promote Inhaled Corticosteroid Adherence Among Individuals With Asthma
Phone Calls to Promote Adherence With Inhaled Corticosteroids
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hawaii
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Honolulu、Hawaii、美国、96817
- Center for Health Research/KPH
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Oregon
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Portland、Oregon、美国、97227
- Center for Health Research-KPNW
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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.
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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.
其他名称:
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无干预: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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Modified Medication Possession Ratio
大体时间:Measured over 19 months
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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.
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Measured over 19 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Juniper Asthma Quality of Life Questionnaire (Global Score)
大体时间:Measured at 19 months
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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.
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Measured at 19 months
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Rate of Acute Health Care Visits for Asthma
大体时间:Measured over 19 months of follow-up
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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.
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Measured over 19 months of follow-up
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合作者和调查者
调查人员
- 首席研究员:William M. Vollmer, PhD、Center for Health Research/KPNW
- 首席研究员:Cynthia Rand, PhD、Johns Hopkins University
- 首席研究员:Joan Dubanoski, PhD、Center for Health Research/KPH
- 首席研究员:Adrianne Feldstein, MD、Center for Health Research/KPNW
- 首席研究员:David Smith, PhD、Center for Health Research/KPNW
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Automated Phone-Based Refill Reminders的临床试验
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Thomas Jefferson University完全的