Hypertension Clinical Trial
Official title:
Veteran Preference For Group Visits and Its Effect on Hypertension Outcomes
To determine racial/ethnic differences in preference for group visits in veterans with poorly controlled hypertension (State 2 hypertension) and determine the effect of group visits on health outcomes among veterans with poorly controlled hypertension.
Research Design: Randomized clinical trial to assess veterans� preference for group visits
and the effect of group visits on hypertension outcomes. Hypertension affects close to 50
million persons in the U.S., with prevalence, severity, and impact being increased in
non-white Americans 1.Despite recent clinical trials associating successful antihypertensive
therapy with reductions in stroke incidence, myocardial infarction, and heart failure,
control rates remain below the Healthy People 2010 goal of 50%. The importance of blood
pressure control is recognized within the VA as two of the conditions selected for QUERI
include ischemic heart disease and congestive heart disease, and blood pressure control is a
performance measure for every VAMC 2. Clinical trials have shown that blood pressure control
can be achieved in most patients with hypertension 3. When physicians fail to prescribe
lifestyle modification, adequate doses of antihypertensive medications, or appropriate
drugs, blood pressure control may not be achieved.1 In the course of a 15-30 minute visit
with a primary care physician, lifestyle modifications may not be addressed and inertia may
prevent rapid adjustments in medication dosages or changes in drug combinations. 4. The
outpatient group visit model is an intervention developed by managed care organizations to
capitalize on economy of scale. It has significant points of departure from the existing
health care delivery system design, which focuses on acute care. The outpatient group visit
model also fosters a more collaborative effort between the physician and patient, introduces
nurses as knowledgeable team members who can be trusted to communicate important information
to patients and between patients and physicians, and promotes peer support among the
participating patients. Group visits have proven successful in high health services
utilizing elderly patients with one or more chronic illnesses. A one-year study of monthly
2-hour group visits led by a physician and nurse showed significant improvements in care
delivery as measured by decreases in emergency room visits, specialty care visits, and
hospital readmissions though no change in self-reported health and functional status were
realized. 5. Also, patients with type 2 diabetes attending group visits were shown to have
increases in quality of life measures, knowledge of type 2 diabetes, and improved metabolic
control as compared to patients in usual care. 6. Group visits offer providers more time per
visit to address process-of-care indicators and provide patients more time per visit with
their primary care physician. The monthly schedule allows for more frequent contacts between
the patients and physicians. Providers caring for patients in groups can deliver consistent
messages to multiple patients at once. Though monthly primary care visits (in groups) would
be an increase from the 4 primary care visits per year presently realized by veterans with
hypertension at the Ralph H. Johnson VAMC, the frequency is more consistent with JNC 7
guidelines for monthly visits for follow-up and monitoring after the initiation of
antihypertensive therapy. Presently, the average primary care physician at the Charleston VA
is scheduled to see 2 patients per hour. Group visits would allow the physician to see 20
patients over 2 hours. While demonstrated feasible and acceptable to elderly, chronically
ill managed care populations, and uninsured and underinsured patients with type 2 diabetes,
group visits have not been systematically tested in the Veteran�s Health Administration
system. Additionally, previous studies have not evaluated patients� acceptance of group
visits or their responses to groups according to race/ethnicity. This study seeks to inform
whether group visits are acceptable to veterans as a method of health care delivery,
regardless of race/ethnicity.
Methods: The study will assess the effect of group visits on hypertension outcomes. Veterans
with stage 2 hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure
=100 mmHg) will be identified during routine office visits. The primary care physician will
explain what group visits are using a standard script then patients will be asked if they
are willing to be seen in a group setting. Patients who indicate a willingness to receive
care in a group setting will be randomly assigned to either group visits or usual care.
Randomization will occur in blocks to insure equal number of subjects by race/ethnicity in
each of the two groups (group setting vs. usual care). We will recruit up to 8 VA primary
care physicians to participate in this study. Several have already indicated an interest in
conducting group visits.
Patient Visit Protocol: Group visits will be co-led by the patients� primary care internal
medicine physician and a clinic nurse. Each group visit session will be scheduled for two
hours consisting of: 15 minutes for "warm-up" and socialization, 30 minutes for presentation
of a health- related topic (facilitated by the physician or another team member with special
expertise), 15 minutes for break, during which time the nurse and physician will circulate,
attending to individual needs, immunizations, appointment scheduling, and other issues, 15
minutes for questions and answers, 15 minutes for planning the next session, and 30 minutes
for one-on-one consultations with the physician. Upon conclusion of the group portion of the
visit, patients will have the opportunity to see the physician individually if required.
While the group visits are intended to be the main source of medical care, patients who need
care in between scheduled group visits, or who have specific medical needs that cannot be
accommodated in the group visit (i.e. PAP smears, DRE), will be able to schedule a
one-on-one visit with their primary care provider.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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