Project SHARE (Senior Health and Alcohol Risk Education)
2012年8月11日 更新者：Susan Ettner、University of California, Los Angeles
Costs of Preventing Alcohol Problems in Older Adults
Older adults become more sensitive to alcohol, and alcohol also interacts adversely with their common medical conditions and medications.
The aim of Project SHARE (Senior Health and Alcohol Risk Education) is to see whether patient and provider education can decrease risky alcohol use and reduce health care costs in persons 60 years of age and older.
研究概览
详细说明
Alcohol use in the elderly is an increasingly important public health problem.
Alcohol-related risks and problems in older persons may come from the interaction between alcohol and diminished health or medication use.
The proposed study is a randomized trial of the effectiveness and cost-effectiveness of an integrated patient-provider intervention to prevent risky alcohol use among older adults.
The intervention will include a tested screening and education system that was developed especially for older adults and their providers, supplemented by a well-established intervention for physicians.
The proposed research design involves randomization of 31 primary care physicians in seven clinics and their eligible patients aged 60+ to the intervention versus "usual care."
研究类型
介入性
注册 (实际的)
1186
阶段
- 阶段2
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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California
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Santa Barbara、California、美国、93111
- Sansum-Santa Barbara Medical Foundation Clinics
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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
60年 及以上 (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:
- 60 and over
- At-risk drinkers
- Patient of participating physician
Exclusion Criteria:
- Severe cognitive impairment
- Terminally ill or deceased
- Expected to move out of area or into nursing home within following year
- Could not fill out written surveys in English
- Likely dependent drinker
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：Usual care
Patients not assigned to the experimental condition received usual care, which may or may not have included alcohol education.
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实验性的：Patient-provider education
Experimental patients received an intervention consisting of the following components: written reports and educational materials, a telephone health educator intervention (at baseline, 3 and 6 months), and a brief provider intervention.
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Experimental patients received an intervention consisting of the following components: written reports and educational materials, a telephone health educator intervention (at baseline, 3 and 6 months), and a brief provider intervention.
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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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At-risk drinking at 6 month followup
大体时间：6 months
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At-risk drinking is alcohol use that (either alone or in conjunction with selected comorbidities, symptoms and/or medications) poses health risks.
It is measured using the CARET instrument developed by Moore and colleagues.
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6 months
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At-risk drinking at 12 month followup
大体时间：12 months
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At-risk drinking is alcohol use that (either alone or in conjunction with selected comorbidities, symptoms and/or medications) poses health risks.
It is measured using the CARET instrument developed by Moore and colleagues.
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Health-related quality of life at 6 months
大体时间：6 months
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Health-related quality of life (HRQL) is measured using the SF-6D.
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6 months
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Depressive symptoms
大体时间：12 months
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Depressive symptoms are measured using the Geriatric Depression Scale.
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12 months
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Mental Composite Score at 6 months
大体时间：6 months
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We used self-reported SF12 data from baseline, 6- and 12-month written surveys to construct Mental Composite Score (MCS) and Physical Composite Score (PCS).
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6 months
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Healthcare utilization
大体时间：12 months (cumulative)
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We used self-reported data from 3-month, 6-month and 12-month written patient surveys to measure cumulative healthcare utilization by type (e.g., hospitalizations, emergency department visits, physician visits, etc.) over the twelve months following baseline.
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12 months (cumulative)
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Outpatient service costs
大体时间：12 months (cumulative)
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We used administrative data on clinic-based services linked to Medicare fee schedules to construct cumulative measures of outpatient service costs (from the Medicare perspective) for the twelve months following baseline.
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12 months (cumulative)
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Direct recruitment and intervention costs
大体时间：12 months (cumulative)
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We collected data on the resources used directly for recruitment (e.g., clinic-based staff time, phones, postage, etc.) and the intervention (e.g., cost of health educator time, supplies, opportunity costs of the physician's time, etc.) spent on the intervention, to construct overall measures of the per-patient cost of recruitment and intervention.
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12 months (cumulative)
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Health-related quality of life at 12 month followup
大体时间：12 months
|
Health-related quality of life (HRQL) is measured using the SF-6D.
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12 months
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Mental Composite Score at 12 month followup
大体时间：12 months
|
We used self-reported SF12 data from baseline, 6- and 12-month written surveys to construct Mental Composite Score (MCS) and Physical Composite Score (PCS).
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12 months
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Physical Composite Score at 6 month followup
大体时间：6 months
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We used self-reported SF12 data from baseline, 6- and 12-month written surveys to construct Mental Composite Score (MCS) and Physical Composite Score (PCS).
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6 months
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Physical Composite Score at 12 month followup
大体时间：12 months
|
We used self-reported SF12 data from baseline, 6- and 12-month written surveys to construct Mental Composite Score (MCS) and Physical Composite Score (PCS).
|
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：Susan Ettner, PhD、University of California, Los Angeles
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Barnes AJ, Xu H, Tseng CH, Ang A, Tallen L, Moore AA, Marshall DC, Mirkin M, Ransohoff K, Duru OK, Ettner SL. The Effect of a Patient-Provider Educational Intervention to Reduce At-Risk Drinking on Changes in Health and Health-Related Quality of Life Among Older Adults: The Project SHARE Study. J Subst Abuse Treat. 2016 Jan;60:14-20. doi: 10.1016/j.jsat.2015.06.019. Epub 2015 Jul 8.
- Ettner SL, Xu H, Duru OK, Ang A, Tseng CH, Tallen L, Barnes A, Mirkin M, Ransohoff K, Moore AA. The effect of an educational intervention on alcohol consumption, at-risk drinking, and health care utilization in older adults: the Project SHARE study. J Stud Alcohol Drugs. 2014 May;75(3):447-57. doi: 10.15288/jsad.2014.75.447.
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
2005年5月1日
初级完成 (实际的)
2008年9月1日
研究完成 (实际的)
2009年9月1日
研究注册日期
首次提交
2005年4月6日
首先提交符合 QC 标准的
2005年4月6日
首次发布 (估计)
2005年4月7日
研究记录更新
最后更新发布 (估计)
2012年8月14日
上次提交的符合 QC 标准的更新
2012年8月11日
最后验证
2010年9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.
Patient-provider education的临床试验
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Sykehuset i Vestfold HFHospital Pharmacy Enterprise, South Eastern Norway完全的
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University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne主动，不招人
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Tulane UniversityUniversity of Alabama at Birmingham; Louisiana State University Health Sciences Center in New... 和其他合作者终止
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Brigham and Women's HospitalGordon and Betty Moore Foundation完全的
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Brigham and Women's HospitalPatient-Centered Outcomes Research Institute主动，不招人
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Dana-Farber Cancer Institute主动，不招人
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Ohio State University Comprehensive Cancer CenterAmerican Cancer Society, Inc.完全的
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London Metropolitan UniversityBarts & The London NHS Trust; Homerton University Hospital NHS Foundation Trust尚未招聘性功能障碍