Will Veterans Engage in Prevention After HRA-guided Shared Decision Making?
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/12/2018 |
| Start Date: | October 1, 2014 |
| End Date: | December 30, 2017 |
The VA has committed to disseminate a web-based Healthy Living Assessment(HLA) tool and use
it as the cornerstone of a personalized prevention plan to engage patients to improve their
health behaviors that lead to high health risk. Health risk assessments done in isolation,
however, do not generally lead to behavior change. Our study will test the effectiveness of a
Shared Decision Making intervention designed to activate Veterans to enroll in effective
prevention programs. The intervention will be conducted over the telephone, by a prevention
coach, and will be linked to the patients' primary care team. The co-primary outcomes will be
patient activation and patient enrollment in prevention programs; 10-year risk of major
cardiac events will also be measured.
it as the cornerstone of a personalized prevention plan to engage patients to improve their
health behaviors that lead to high health risk. Health risk assessments done in isolation,
however, do not generally lead to behavior change. Our study will test the effectiveness of a
Shared Decision Making intervention designed to activate Veterans to enroll in effective
prevention programs. The intervention will be conducted over the telephone, by a prevention
coach, and will be linked to the patients' primary care team. The co-primary outcomes will be
patient activation and patient enrollment in prevention programs; 10-year risk of major
cardiac events will also be measured.
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.
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.
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
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