Will Veterans Engage in Prevention After HRA-guided Shared Decision Making? (ACTIVATE)
研究概览
详细说明
Over half of all deaths, and many illnesses, can be attributed to four modifiable risk factors: tobacco use, overweight/obesity, physical inactivity, and alcohol use. There are clear links between these modifiable factors and heart disease, cancer, chronic lung disease, and stroke which continue to be the leading causes of death in the United States. Significant improvements have been made in controlling conditions that lead to heart disease, cancer and stroke (e.g., hypertension and hyperlipidemia). However, the underlying behavioral factors (e.g., obesity, tobacco use, and physical inactivity) have not been addressed as well. Prevention is particularly important for Veterans because of the high prevalence of significant risk factors for poor health. For example, more than 70% of Veterans Health Administration (VHA) patients are overweight (body mass index [BMI] 25kg/m2) and one-third are obese (BMI 30kg/m2), which is significantly higher than the US population. Smoking also remains a significant problem among Veterans, with VHA enrollment data from 2010 indicating a prevalence of 20%. Younger Veterans are at particularly high risk for developing chronic illnesses because they are more likely to be overweight/obese and smoke more heavily than non-Veterans.
The investigators propose a two-site, two-arm randomized trial measuring the effectiveness of a Shared Decision Making (SDM) intervention in activating Veterans to enroll in effective prevention services, and improve cardiovascular risk, compared to Veterans Administration (VA) usual care. The study will be performed at the Durham and Ann Arbor Veterans Administration Medical Centers (VAMCs). Each arm will have 225 patients; patients will be VA users with at least one modifiable risk factor (obese, inactive, or tobacco user) who are not currently enrolled in a prevention service. The SDM intervention will be conducted by a prevention coach, telephone based, and will use the output from VHA's Healthy Living Assessment (HLA) to engage Veterans in a conversation where individual preferences are matched to behaviors, and choices for specific prevention services. The resulting prevention action plan will be shared with the Veterans primary care team, and documented in the medical record.
Outcomes will be obtained at baseline, 1 month and 6 months after enrollment by blinded research personnel. The primary outcomes will be: 1) proportion enrolled in effective prevention services; and 2) change in the Patient Activation Measure (PAM). The secondary outcome is 10-year risk of coronary events, as measured by Framingham Risk Score (FRS). Process evaluations of the intervention and its implementation will also be conducted to inform future dissemination and implementation should it prove effective.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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North Carolina
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Durham、North Carolina、美国、27705
- Durham VA Medical Center, Durham, NC
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
To be included in the study, patients must meet the following:
- enrolled in primary care at the Durham or Ann Arbor Health Care Systems
- have one modifiable risk factor identified by a healthy living assessment (physical inactivity, overweight or obese by BMI, or tobacco user)
Exclusion Criteria:
Individuals will be excluded if they have any of the following:
- have been hospitalized for a stroke, myocardial infarction or coronary artery revascularization in the past three months
- have an active diagnosis of psychosis
- have any other health condition they feel would impede participation in the study
- reside in a nursing home
- are severely impaired in hearing or speech, so that they cannot respond to telephone calls
- have significant cognitive or memory impairment
- do not have access to a telephone
- are participating in another prevention intervention study
- are already enrolled in a formal prevention service
学习计划
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:控制
日常护理
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实验性的:Intervention
Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment
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A series of two phone sessions with a prevention coach.
The first to engage the veteran to choose a preferred prevention program and link them to Patient Aligned Care Team (PACT), and a follow-up call one month later to assess the progress of the prevention plan.
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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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Enrollment in Prevention Services
大体时间:1 and 6 months (cumulative)
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Proportion of veterans enrolled in effective prevention services including weight loss, healthy eating, physical activity, and smoking cessation programs.
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1 and 6 months (cumulative)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Activation Measures (PAM)
大体时间:Baseline assessment
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Patient Activation Measures (PAM) assesses patients capacity to manage their health.
Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors.
Minimum score is a zero and maximum is one hundred.
Higher score is better.
The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
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Baseline assessment
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Patient Activation Measures
大体时间:1 month assessment
|
Patient Activation Measures (PAM) assesses patients capacity to manage their health.
Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors.
Minimum score is a zero and maximum is one hundred.
Higher score is better.
The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
|
1 month assessment
|
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Patient Activation Measures
大体时间:6 months assessments
|
Patient Activation Measures (PAM) assesses patients capacity to manage their health.
Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors.
Minimum score is a zero and maximum is one hundred.
Higher score is better.
The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
|
6 months assessments
|
|
Framingham Risk Score
大体时间:Baseline
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The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual.
This is not a scale however, lower score indicates less risk.
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Baseline
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Framingham Risk Score
大体时间:6 months
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The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual.
This is not a scale however, lower score indicates less risk.
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6 months
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合作者和调查者
调查人员
- 首席研究员:Laura J. Damschroder, MPH、VA Ann Arbor Healthcare System, Ann Arbor, MI
- 首席研究员:Eugene Z. Oddone, MD MHSc、Durham VA Medical Center, Durham, NC
出版物和有用的链接
一般刊物
- Olsen MK, Stechuchak KM, Hung A, Oddone EZ, Damschroder LJ, Edelman D, Maciejewski ML. A data-driven examination of which patients follow trial protocol. Contemp Clin Trials Commun. 2020 Aug 13;19:100631. doi: 10.1016/j.conctc.2020.100631. eCollection 2020 Sep.
- Oddone EZ, Damschroder LJ, Gierisch J, Olsen M, Fagerlin A, Sanders L, Sparks J, Turner M, May C, McCant F, Curry D, White-Clark C, Juntilla K. A Coaching by Telephone Intervention for Veterans and Care Team Engagement (ACTIVATE): A study protocol for a Hybrid Type I effectiveness-implementation randomized controlled trial. Contemp Clin Trials. 2017 Apr;55:1-9. doi: 10.1016/j.cct.2017.01.007. Epub 2017 Jan 24.
- Oddone EZ, Gierisch JM, Sanders LL, Fagerlin A, Sparks J, McCant F, May C, Olsen MK, Damschroder LJ. A Coaching by Telephone Intervention on Engaging Patients to Address Modifiable Cardiovascular Risk Factors: a Randomized Controlled Trial. J Gen Intern Med. 2018 Sep;33(9):1487-1494. doi: 10.1007/s11606-018-4398-6. Epub 2018 May 7.
- Sloan C, Stechuchak KM, Olsen MK, Oddone EZ, Damschroder LJ, Maciejewski ML. Short-Term VA Health Care Expenditures Following a Health Risk Assessment and Coaching Trial. J Gen Intern Med. 2020 May;35(5):1452-1457. doi: 10.1007/s11606-019-05455-z. Epub 2020 Jan 2.
- Nouri SS, Damschroder LJ, Olsen MK, Gierisch JM, Fagerlin A, Sanders LL, McCant F, Oddone EZ. Health Coaching Has Differential Effects on Veterans with Limited Health Literacy and Numeracy: a Secondary Analysis of ACTIVATE. J Gen Intern Med. 2019 Apr;34(4):552-558. doi: 10.1007/s11606-019-04861-7. Epub 2019 Feb 12.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CRE 12-288
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
A de-identified, anonymized dataset will be created and shared. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by ORD.
A local privacy officer and study statistician will certify that the dataset contains no PHI prior to distribution. Data will be provided to requestor in electronic form.
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