A blinded randomized controlled trial of motivational interviewing to improve adherence with osteoporosis medications: design of the OPTIMA trial.
A blinded randomized controlled trial of motivational interviewing to improve adherence with osteoporosis medications: design of the OPTIMA trial.
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DOI：
10.1007/s00198-009-0951-9
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发表时间：
2010-01
影响因子：
4
通讯作者：
Katz, J. N.
中科院分区：
文献类型：
--
作者：
Solomon, D. H.;Gleeson, T.;Iversen, M.;Avorn, J.;Brookhart, M. A.;Lii, J.;Losina, E.;May, F.;Patrick, A.;Shrank, W. H.;Katz, J. N.
虽然有许多有效的治疗骨质疏松症的方法，但大多数人不能长期坚持这种治疗。没有证实的干预措施可以改善骨质疏松药物依从性。我们在此报告一项旨在提高骨质疏松治疗依从性的创新性随机对照试验的设计和初始入组情况。该试验代表了学术研究人员与国家为低收入老年人提供的药品福利计划之间的合作。受益人开始治疗骨质疏松症的药物是招募的目标。我们随机选择同意的个体接受12个月的邮寄教育（对照组）或由一对一电话咨询和邮寄教育组成的干预。动机性访谈构成了咨询方案的基础，该方案由7名经过培训和监督的健康咨询师通过10个电话提供。咨询课程包括脚本对话、关于服药依从性及其障碍的开放式问题，以及结构化问题。该试验的主要终点是在12个月的干预期内测量的药物依从性。次要终点包括骨折、疗养院入院、卫生保健资源利用和死亡率。在招募的前7个月，我们筛选了3,638名潜在的符合条件的受试者。在最初的邮寄后，1115人（30.6%）选择退出电话招聘，1019人（28.0%）未能成功联系上。其余879人（24.2%）同意参与并随机分组。女性占所有群体的90%以上，平均年龄在77-80岁之间，所有群体中的大多数都是白人。骨质疏松药物在各组间的分布具有可比性，前一年使用的不同处方药的中位数为8-10种。我们已经开发了一种新的干预措施，以改善骨质疏松药物依从性。该干预措施目前正在一项大规模随机对照试验中进行测试。如果成功，干预可能代表一个有用的模式，以提高对其他慢性治疗的坚持。
While many effective treatments exist for osteoporosis, most people do not adhere to such treatments long-term. No proven interventions exist to improve osteoporosis medication adherence. We report here on the design and initial enrollment in an innovative randomized controlled trial aimed at improving adherence to osteoporosis treatments. The trial represents a collaboration between academic researchers and a state-run pharmacy benefits program for low-income older adults. Beneficiaries beginning treatment with a medication for osteoporosis are targeted for recruitment. We randomize consenting individuals to receive 12-months of mailed education (control arm) or an intervention consisting of one-on-one telephone-based counseling and the mailed education. Motivational Interviewing forms the basis for the counseling program which is delivered by seven trained and supervised health counselors over ten telephone calls. The counseling sessions include scripted dialogue, open-ended questions about medication adherence and its barriers, as well as structured questions. The primary endpoint of the trial is medication adherence measured over the 12-month intervention period. Secondary endpoints include fractures, nursing home admissions, health care resource utilization, and mortality. During the first 7 months of recruitment, we have screened 3,638 potentially eligible subjects. After an initial mailing, 1,115 (30.6%) opted out of telephone recruitment and 1,019 (28.0%) could not be successfully contacted. Of the remaining, 879 (24.2%) consented to participate and were randomized. Women comprise over 90% of all groups, mean ages range from 77–80 years old, and the majority in all groups was white. The distribution of osteoporosis medications was comparable across groups and the median number of different prescription drugs used in the prior year was 8–10. We have developed a novel intervention for improving osteoporosis medication adherence. The intervention is currently being tested in a large scale randomized controlled trial. If successful, the intervention may represent a useful model for improving adherence to other chronic treatments.
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影响因子：
5.8
作者：
Delmas, Pierre D.;Vrijens, Bernard;Watts, Nelson B.
通讯作者：
Watts, Nelson B.
影响因子：
6.2
作者：
Burge, Russel;Dawson-Hughes, Bess;Tosteson, Anna
通讯作者：
Tosteson, Anna
DOI：
10.1080/09540120701593489
发表时间：
2008-01-01
影响因子：
1.7
作者：
DiIorio, C.;Mccarty, F.;Lundberg, B.
通讯作者：
Lundberg, B.
DOI：
10.1111/j.1742-1241.2006.01059.x
发表时间：
2006-08-01
影响因子：
2.6
作者：
Cooper, A.;Drake, J.;Brankin, E.
通讯作者：
Brankin, E.
影响因子：
6.2
作者：
Curtis, Jeffrey R.;Westfall, Andrew O.;Delzell, Elizabeth
通讯作者：
Delzell, Elizabeth