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Interventions supporting long term adherence and decreasing cardiovascular events after myocardial infarction (ISLAND): pragmatic randomised controlled trial.
The BMJ ( IF 93.6 ) Pub Date : 2020-06-10 , DOI: 10.1136/bmj.m1731
Noah M Ivers 1, 2, 3, 4, 5, 6 , Jon-David Schwalm 7, 8 , Zachary Bouck 2 , Tara McCready 7 , Monica Taljaard 9, 10 , Sherry L Grace 11, 12 , Jennifer Cunningham 7 , Beth Bosiak 2 , Justin Presseau 9, 10 , Holly O Witteman 13 , Neville Suskin 14, 15 , Harindra C Wijeysundera 4, 5, 16, 17 , Clare Atzema 4, 5, 16, 17 , R Sacha Bhatia 2, 4, 5, 6, 17 , Madhu Natarajan 7, 8 , Jeremy M Grimshaw 9, 10, 18
Affiliation  

Objective To test a scalable health system intervention to improve long term adherence to secondary prevention treatments among patients who have had a recent myocardial infarction. Design Three arm, pragmatic randomised controlled trial with blinded outcome assessment. Setting Nine cardiac centres in Ontario, Canada. Participants 2632 patients with obstructive coronary artery disease after a myocardial infarction, identified from a centralised cardiac registry. Interventions Participants were randomised 1:1:1 to receive usual care, five mail-outs developed through a user centred design process, or mail-outs plus phone calls. The phone calls were delivered first by an interactive automated system to screen for non-adherence to treatment. Trained lay health workers followed up as necessary. Interventions were coordinated centrally but delivered from each patient’s hospital site. Main outcome measures Co-primary outcomes were completion of cardiac rehabilitation and adherence to recommended medication. Data were collected by blinded assessors through patient report and from administrative health databases at 12 months. Results 2632 patients (mean age 66, 71% male) were randomised: 878 to the full intervention (mail plus phone calls), 878 to mail only, and 876 to usual care. Of the respondents, 174 (27%) of 643 in the usual care group, 200 (32%) of 628 in the mail only group, and 196 (37%) of 531 allocated to the full intervention completed cardiac rehabilitation (adjusted odds ratio 1.55, 95% confidence interval 1.18 to 2.03). In the mail plus phone group, 11.7%, 6.0%, 14.4%, 32.9%, and 35.0% reported adherence to 0, 1, 2, 3, and 4 drug classes after one year, respectively, in comparison with 12.5%, 6.8%, 13.6%, 30.2%, and 36.8% in the mail only group, and 12.2%, 8.4%, 13.1%, 30.3%, and 36.1% in the usual care group, respectively (mail only v usual care, odds ratio 0.98, 95% confidence interval 0.81 to 1.19; full intervention v usual care, 0.99, 0.82 to 1.20). Conclusions Scalable interventions delivered by mail plus phone can increase completion of cardiac rehabilitation after myocardial infarction but not adherence to medication. More intensive interventions should be tested to improve adherence to medication and to evaluate the association between attendance at cardiac rehabilitation and adherence to medication. Trial registration ClinicalTrials.gov [NCT02382731][1], registered 9 March 2015 before any patient enrolment. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02382731&atom=%2Fbmj%2F369%2Fbmj.m1731.atom

中文翻译:

支持长期坚持治疗并减少心肌梗死后心血管事件的干预措施(ISLAND):实用的随机对照试验。

目的测试可扩展的卫生系统干预措施,以改善近期患有心肌梗塞的患者对二级预防治疗的长期依从性。设计三臂,实用的随机对照试验,结果评估为盲目。在加拿大安大略省设置9个心脏中心。参与者2632名患有心肌梗塞的梗阻性冠状动脉疾病患者,是通过集中性心脏登记系统确定的。干预措施参与者按照1:1的比例随机接受常规护理,通过以用户为中心的设计流程开发五次邮寄,或者邮寄加电话。首先通过交互式自动系统传递电话,以筛选是否坚持治疗。受过训练的非专业卫生人员会根据需要进行跟进。干预是集中协调的,但要从每个患者的医院现场进行。主要结局指标共同主要结局是完成心脏康复和坚持推荐用药。盲人评估者通过患者报告和12个月的行政健康数据库收集数据。结果2632例患者(平均年龄66岁,男性71%)被随机分配:878例接受全面干预(邮件加电话),878例仅接受邮件,876例接受常规护理。在受访者中,常规护理组中的643名患者中有174名(27%),仅邮件组中的628名中有200名(32%),而531名中的196名(37%)中有196名(37%)被分配给完全干预完成心脏康复(调整后的优势比) 1.55,95%置信区间1.18至2.03)。在邮件加电话组中,报告遵循0、1、2、3、11.7%,6.0%,14.4%,32.9%和35.0%,和一年后的4种药物类别,而仅邮件组分别为12.5%,6.8%,13.6%,30.2%和36.8%,以及12.2%,8.4%,13.1%,30.3%和36.1%在常规护理组中,分别为(仅邮件与常规护理,优势比为0.98,95%置信区间为0.81至1.19;全面干预与常规护理,为0.99、0.82至1.20)。结论通过邮件和电话进行的可扩展干预措施可以增加心肌梗死后心脏康复的完成率,但不能坚持药物治疗。应该测试更深入的干预措施,以提高对药物的依从性,并评估心脏康复的出勤率与药物依从性之间的关联。试验注册ClinicalTrials.gov [NCT02382731] [1],于任何患者入组前于2015年3月9日注册。[1]:
更新日期:2020-06-10
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