The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment.
The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment.
复制标题
DOI：
10.1177/1740774516631530
复制
发表时间：
2016-06
期刊：
影响因子：
--
通讯作者：
Diabetes Telephone Study Team
中科院分区：
文献类型：
--
作者：
Adams AS;Bayliss EA;Schmittdiel JA;Altschuler A;Dyer W;Neugebauer R;Jaffe M;Young JD;Kim E;Grant RW;Diabetes Telephone Study Team
症状性糖尿病周围神经病变的有效药物管理面临的挑战包括可用药物的有效性有限，频繁的副作用，以及需要进行持续的症状评估和治疗滴定以获得最大疗效。我们在这里提出的理由和实施的挑战，糖尿病电话研究，随机试验，旨在改善药物治疗，滴定和生活质量的患者有症状的糖尿病周围神经病变。我们实施了一项实用的群集随机对照试验，以测试自动交互式语音应答工具的有效性，该工具旨在为医生提供有关新处方糖尿病周围神经病变药物反应的实时患者报告数据。2014年9月，在北方加州Kaiser Permanente糖尿病登记处治疗患者的1，830名初级保健医生被随机分配到干预组或对照组。分配给干预组医生的患者在处方药物以缓解糖尿病周围神经病变症状后，每2个月接受3次简短的互动电话。这些电话为患者提供了报告症状、副作用、药物剂量自我滴定和治疗总体满意度的机会。我们计划比较干预组和对照组接受三次非交互式自动教育电话的患者自我报告的生活质量的变化。这项临床试验的成功实施需要强有力的利益相关者参与，以帮助定制干预措施，并解决诸如提供者时间限制等务实问题。截至2015年10月27日，我们筛选了2，078名患者，其中1，447名符合参与资格。我们同意并招募了1，206名或83%的合格人员。在登记的学生中，53%为女性，平均年龄为67岁（标准差12）。种族构成是56%的白色，8%的亚洲人，13%的黑人或非洲裔美国人，19%的西班牙裔或拉丁美洲人。需要创新的策略来指导改善有症状的糖尿病周围神经病变患者的医疗服务。该试验旨在评估患者治疗经验的实时收集和临床反馈是否可以减轻患者症状负担。临床试验的实施密切涉及临床护理需要研究人员与临床医生合作。如果成功，这种干预提供了一个关键的信息反馈回路，将通过广泛使用的交互式语音应答技术优化糖尿病周围神经病变药物滴定。
Challenges to effective pharmacologic management of symptomatic diabetic peripheral neuropathy include the limited effectiveness of available medicines, frequent side effects, and the need for ongoing symptom assessment and treatment titration for maximal effectiveness. We present here the rationale and implementation challenges of the Diabetes Telephone Study, a randomized trial designed to improve medication treatment, titration and quality of life among patients with symptomatic diabetic peripheral neuropathy. We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines. 1,830 primary care physicians treating patients in the diabetes registry at Kaiser Permanente Northern California were randomized into the intervention or control arm in September 2014. Patients assigned to physicians in the intervention group receive three brief interactive calls every 2 months after a medication is prescribed to alleviate diabetic peripheral neuropathy symptoms. These calls provide patients with the opportunity to report on symptoms, side effects, self-titration of medication dose and overall satisfaction with treatment. We plan to compare changes in self-reported quality of life between the intervention group and patients in the control group who receive three non-interactive automated educational phone calls. Successful implementation of this clinical trial required robust stakeholder engagement to help tailor the intervention and to address pragmatic concerns such as provider time constraints. As of October 27, 2015, we had screened 2,078 patients, 1,447 of whom were eligible for participation. We consented and enrolled 1,206 or 83% of those eligible. Among those enrolled, 53% are women and the mean age is 67 (sd 12). The racial ethnic make-up is 56% white, 8% Asian, 13% black or African American, and 19% Hispanic or Latino. Innovative strategies are needed to guide improvements in healthcare delivery for patients with symptomatic diabetic peripheral neuropathy. This trial aims to assess whether real-time collection and clinical feedback of patient treatment experiences can reduce patient symptom burden. Implementation of a clinical trial closely involving clinical care required researchers to partner with clinicians. If successful, this intervention provides a critical information feedback loop that would optimize diabetic peripheral neuropathy medication titration through widely available interactive voice response technology.
登录
查看更多内容
影响因子：
3.5
作者：
Walters, SJ;Brazier, JE
通讯作者：
Brazier, JE
影响因子：
2
作者：
Moore, Kelly L.;Neugebauer, Romain;van der Laan, Mark J.
通讯作者：
van der Laan, Mark J.
影响因子：
5.4
作者：
Hernán, MA;Hernández-Díaz, S;Robins, JM
通讯作者：
Robins, JM
影响因子：
16.2
作者：
Gordois, A;Scuffham, P;Tobian, JA
通讯作者：
Tobian, JA
影响因子：
120.7
作者：
Jaffe, Marc G.;Lee, Grace A.;Young, Joseph D.;Sidney, Stephen;Go, Alan S.
通讯作者：
Go, Alan S.