An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial.
An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial.
复制标题
DOI：
10.1186/1745-6215-14-80
复制
发表时间：
2013-03-20
期刊：
影响因子：
2.5
通讯作者：
Tannenbaum C
中科院分区：
文献类型：
--
作者：
Martin P;Tamblyn R;Ahmed S;Tannenbaum C
目前，太多的老年人使用不适当的处方，这增加了药物不良反应和不必要住院的风险。直接告知患者处方风险的健康教育计划可能会促进慢性苯二氮卓类药物使用者不适当的处方停药。这是一项采用两组平行设计的整群随机对照试验。在知情同意的情况下，将对从大蒙特利尔地区社区药房招募的250名老年慢性苯二氮卓类药物使用者进行研究。招募受试者的参与药房代表一个群集，即随机化单位。对于每招募的四家药店，使用简单的2：2随机化将群集分配到干预组和对照组。参与者将被跟踪一年。在干预组中，参与者将接受一种新的教育干预，详细说明目前可能不适当的药物的风险和安全替代方案，而对照组将等待6个月的干预，并在此期间接受常规护理。主要结局是6个月时苯二氮卓类药物使用的变化率。次要结局是风险认知的变化，停用苯二氮卓类药物的自我效能，以及激活患者与其医生或药剂师讨论更安全的处方实践。将进行意向治疗分析。在6个月随访时，将在个体水平上比较干预组和对照组之间苯二氮卓类药物使用的变化率。将计算对照组和实验组之间的风险差异，并使用稳健方差估计量估计相关的95%置信区间（CI）。作为敏感性分析（和/或如果任何混杂因素在组间不平衡），我们将通过边际模型估计干预的风险差异，该边际模型通过具有可交换相关结构的广义估计方程估计。直接以消费者为目标，促使医生和药剂师合作停用苯二氮卓类药物，是减少不适当处方的一种新方法。通过直接向长期使用者提供有关风险的知识，我们希望模仿针对个人的反吸烟运动的成功。ClinicalTrials.gov标识符：NCT 01148186
Currently, far too many older adults consume inappropriate prescriptions, which increase the risk of adverse drug reactions and unnecessary hospitalizations. A health education program directly informing patients of prescription risks may promote inappropriate prescription discontinuation in chronic benzodiazepine users. This is a cluster randomized controlled trial using a two-arm parallel-design. A total of 250 older chronic benzodiazepine users recruited from community pharmacies in the greater Montreal area will be studied with informed consent. A participating pharmacy with recruited participants represents a cluster, the unit of randomization. For every four pharmacies recruited, a simple 2:2 randomization is used to allocate clusters into intervention and control arms. Participants will be followed for 1 year. Within the intervention clusters, participants will receive a novel educational intervention detailing risks and safe alternatives to their current potentially inappropriate medication, while the control group will be wait-listed for the intervention for 6 months and receive usual care during that time period. The primary outcome is the rate of change in benzodiazepine use at 6 months. Secondary outcomes are changes in risk perception, self-efficacy for discontinuing benzodiazepines, and activation of patients initiating discussions with their physician or pharmacist about safer prescribing practices. An intention-to-treat analysis will be followed. The rate of change of benzodiazepine use will be compared between intervention and control groups at the individual level at the 6-month follow-up. Risk differences between the control and experimental groups will be calculated, and the robust variance estimator will be used to estimate the associated 95% confidence interval (CI). As a sensitivity analysis (and/or if any confounders are unbalanced between the groups), we will estimate the risk difference for the intervention via a marginal model estimated via generalized estimating equations with an exchangeable correlation structure. Targeting consumers directly as catalysts for engaging physicians and pharmacists in collaborative discontinuation of benzodiazepine drugs is a novel approach to reduce inappropriate prescriptions. By directly empowering chronic users with knowledge about risks, we hope to imitate the success of individually targeted anti-smoking campaigns. ClinicalTrials.gov identifier: NCT01148186
登录
查看更多内容
DOI：
10.1111/j.1532-5415.2011.03591.x
发表时间：
2011-10-01
影响因子：
6.3
作者：
Finkle, William D.;Der, Jane S.;VanRiper, Kurt B.
通讯作者：
VanRiper, Kurt B.
影响因子：
2.1
作者：
Gorgels, Wim;Voshaar, Richard Oude;Zitman, Frans
通讯作者：
Zitman, Frans
影响因子：
158.5
作者：
Budnitz, Daniel S.;Lovegrove, Maribeth C.;Richards, Chesley L.
通讯作者：
Richards, Chesley L.
制定和评估复杂的干预措施：新的医学研究委员会指南。
DOI：
10.1136/bmj.a1655
发表时间：
2008-09-29
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Craig P;Dieppe P;Macintyre S;Michie S;Nazareth I;Petticrew M;Medical Research Council Guidance
通讯作者：
Medical Research Council Guidance
影响因子：
6.3
作者：
American Geriatrics Society 2012 Beers Criteria Update Expert Panel
通讯作者：
American Geriatrics Society 2012 Beers Criteria Update Expert Panel