Randomized Controlled Trial of Group Prevention Coaching

Cardiovascular (CV) event prevention (e.g., myocardial infarction, cerebrovascular accident)
remains the single most important public health problem in the United States, and
cardiovascular disease is a leading cause of death among VA users. Improving the provision of
prevention services is a primary focus of the Secretary's New Models of Care Transformational
Initiative. However, prevention has been challenging to achieve. Multifactorial behavioral
interventions are effective in treating a number of chronic illnesses (e.g., hypertension,
diabetes), but less is known about their ability to reduce risk among patients without a
unifying chronic illness. Group visits are an efficient, effective strategy for delivering a
multifactorial behavior change intervention; the VA is committed to the group visit strategy
to address a wide array of primary care problems. Groups have been shown to be an effective
means of improving a number of outcomes in a number of individual diseases, but, again, their
role in cardiovascular prevention among patients without a single common illness is unknown.
Coaching is a type of multi-factorial behavioral intervention that involves goal-setting, and
working to overcome barriers to behavior change. Coaching can be performed one-on-one, but
coaching interventions have been delivered in group settings. The investigators have shown,
in a 150-subject RCT, that group coaching plus individualized telephone coaching reduces
cardiovascular risk, but the population in that study was very different from typical VA
users. The investigators propose a three-site, two-arm randomized trial measuring the
effectiveness of a group prevention coaching (GPC) intervention in improving cardiovascular
risk, compared to VA usual care. The study will be performed at the Durham, Buffalo, and
Syracuse VAMCs. Each arm will have 200 patients; patients will be VA users without prior
history of cardiovascular event, but with at least 5% risk of such an event, and with either
inadequately controlled hypertension or dyslipidemia, or current smoking. The GPC
intervention will focus on changing a behavior of the patient's choice that is likely to lead
to improvements in cholesterol, blood pressure, or to smoking cessation. Behaviors that will
be reinforced will include but not be limited to healthy eating, decreased caloric intake,
increased physical activity, stress reduction, and participatory decision making with
physicians. Barriers to these behaviors will be identified. The coach will adopt a
problem-solving approach to overcoming the above barriers and reinforcing the above
behaviors; problem-solving is a well-described framework for behavior change. The GPC
coach/interventionist for will be either the facility's Health Behavior Coordinator (HBC) or
a person hired for the research enterprise but trained and credentialed identically to an
HBC. All outcomes will be obtained at baseline, 6, and 12 months after enrollment by blinded
research personnel. The primary outcome will be change in 10-year risk of fatal coronary
event or non-fatal MI 6 months after enrollment, as measured by Framingham Risk Score. Key
secondary outcomes will include dietary content by Food Frequency Questionnaire, physical
activity as measured by International Physical Activity Questionnaire, and weight. The
investigators will also determine if group cohesion, as measured by the Group Dynamics
Inventory, influences the effectiveness of GPC. The investigators well also assess whether
time spent in contact with a coach influences the effectiveness, by database log-in
timekeeping strategies.

Inclusion Criteria:

- A diagnosis of inadequately controlled hypertension, as defined by an outpatient ICD-9
code of 401.x and a most recent blood pressure with either systolic > 140 mmHg or
diastolic > 90 mmHg

- OR (2) inadequately controlled dyslipidemia, as defined by most recent total
cholesterol > 200 mg/dl or HDL cholesterol < 35 mg/dl

- OR (3) current smoking, which can be identified using the CPRS Health Factor tied
to the smoking clinical reminder.

- Medication-taking status for these illnesses is neither required nor excluded.

Exclusion Criteria:

- Subjects with very high risk of cardiovascular event, as determined by any personal
history of coronary artery disease (CAD) or other major cardiovascular disease (ICD-9
code of 410-414, or 425-429)

- cerebrovascular disease (code 433-438)

- peripheral arterial disease (codes 440.x or 443.x)