Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)
2017年6月26日 更新者：VA Office of Research and Development
Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)
This randomized control study tested the feasibility of two communication enhancement interventions: one with veterans who had a stroke and demonstrated poorly controlled hypertension; the other with VA primary care providers who provided routine outpatient medical care to these veterans.
This study intervened with both members of the provider-patient dyad in an attempt to improve the self-management of hypertension by improving communication during visits to the VA outpatient clinic, specifically by enabling veterans to communicate their questions and concerns about chronic disease self-management to their providers more effectively, and to help providers improve their ability to communicate more effectively with this population of veterans.
研究概览
地位
完全的
详细说明
The communication intervention had two goals; (a) coaching to enhance veteran's abilities to communicate their questions and concerns about self-management for hypertension to their physician; and (b) improving provider's communication skills for enhancing and encouraging self-management of hypertension.
A health educator met with each participating veteran in the intervention arm prior to the 2nd visit to develop a plan for enhancing communication about self-management of hypertension.
The PI provided the Four Habits communication training to the 5 primary care providers in the intervention arm. Two clinic visits between each participating provider-patient pair were videotaped and coded.
This project had a goal of enrolling 10 VA primary care providers to participate in the randomized control trial and 30 veterans (3 veterans from the panel of each of the 10 participating providers) who had a stroke and now demonstrated poorly controlled hypertension. The study evaluated the difference between the two groups, and compared the content of the provider-patient conversations around hypertension management.
研究类型
介入性
注册 (实际的)
26
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Indiana
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Indianapolis、Indiana、美国、46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
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Indianapolis、Indiana、美国、46202-2884
- Richard Roudebush VA Medical Center, Indianapolis
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 99年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Veteran:
- Veteran is a patient of the enrolled provider
- History of prior stroke
- Poorly controlled hypertension with at least one measurement >140/90 mm Hg in the past 12 months
- Complete a 6-item screen for cognitive and language impairment with a score of 3 or higher
- Sign the VA Media consent for use of picture and/or voice
Provider:
- Primary care provider, Medicine Service
- Sign VA media consent for use of picture and/or voice
Exclusion Criteria:
- Life expectancy is less than 6 months
- Non-English language patients
- Inability to provide informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 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：Arm 1: Intervention-Veterans
Veterans enrolled in the "Intervention-Veterans" arm received a copy of the NIA guide for "Talking with Your Doctor" [Informational Guide for Patients].
Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor [Educational Coaching].
To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit.
The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
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Veterans received a copy of the NIA guide for "Talking with Your Doctor".
This pamphlet was specifically developed for this purpose (updated in 2002).
It has pictorials and is written at an 8th grade level.
an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor [Coaching].
To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit.
The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
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有源比较器：Arm 2: Control-Veterans
Veterans enrolled in the "Control-Veterans" arm received a copy of the NIA guide for "Talking with Your Doctor" [Informational Guide for Patients].
This pamphlet was specifically developed for this purpose (updated in 2002).
It has pictorials and is written at an 8th grade level.
|
Veterans received a copy of the NIA guide for "Talking with Your Doctor".
This pamphlet was specifically developed for this purpose (updated in 2002).
It has pictorials and is written at an 8th grade level.
|
|
实验性的：Arm 3: Intervention-Physicians
Primary care providers randomly assigned to the "Intervention-Physicians" arm of this study received a copy of the Four Habits of Highly Effective Physicians [Monograph for Physicians].
The Four Habits provided practical evidence-based advice for improving patient-physician communication.
Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients [Video-Assisted Coaching], but before seeing them for follow-ups.
The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management.
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Physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups.
The main goal of this video-assisted coaching session was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management.
Primary care providers randomly assigned to the "Intervention-Physicians" arm of this study received a copy of the Four Habits of Highly Effective Physicians.
The Four Habits provided practical evidence-based advice for improving patient-physician communication.
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有源比较器：Arm 4: Control-Physicians
Primary care providers randomly assigned to the "Control-Physicians" arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual [Control].
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The primary care providers randomly assigned to the "Control-Physicians" arm did not receive any additional coaching or resources and conducted their practice as usual.
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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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Patient Activation Measure
大体时间：12 months
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Veteran self-management of hypertension measured via the 13-item, (0-100 point range), Patient Activation Measure (PAM).
Administered at baseline (1st visit) and after each additional follow-up visit during the next 12-months (+2 max).
Rasch conversion changed raw scores to the PAM interval measure.
Reported outcome is difference in mean PAM scores at baseline and during 12-month follow-up.
If a participant had two PAM scores during the follow-up period, the average of the two was taken to calculate a combined follow-up score.
Higher PAM scores represent higher levels of self-activation.
Research on the PAM measure indicates that each point increase in PAM score correlates to a 2% decrease in hospitalization and a 2% increase in medication adherence.
Ranges for Baseline PAM scores: Intervention = 46.1 (min) to 84.3 (max); Control = 43.2
(min) to 77 (max).
Ranges for Follow-up PAM scores: Intervention = 48.4
(min) to 100 (max); Control = 45.1 (min) to 80.1 (max).
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12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Richard M. Frankel, PhD、Richard L. Roudebush VA Medical Center, Indianapolis, IN
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2009年9月1日
初级完成 (实际的)
2012年9月30日
研究完成 (实际的)
2017年1月30日
研究注册日期
首次提交
2010年5月28日
首先提交符合 QC 标准的
2010年6月1日
首次发布 (估计)
2010年6月2日
研究记录更新
最后更新发布 (实际的)
2017年8月1日
上次提交的符合 QC 标准的更新
2017年6月26日
最后验证
2017年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.