Study Site - The University
of Massachusetts Medical Center (UMMC)
The study is
conducted on the pts of 29 primary care internists at 2 practice sites
of the UMMC. At these 2 sites, these practitioners follow some 27,000
adult pts, with 300 new pts being added each month. Other UMMC primary
care sites also are available, but the volume of pts at the 2 sites chosen
makes it unnecessary to use other locations. Volume is expected to continue
to increase by 10-15% per year over the next several years. The two locations
comprise the Benedict Building, the primary outpatient facility at the
main UMMC campus, with 24 internists, and the Shrewsbury site, a satellite
facility approximately 2.5 miles away, with 5 internists. Within the Benedict
Center the physicians are divided into 4 “pods” that function as independent
units, so that the size of physician work groups is equivalent at both
sites. Follow-up appointments are made at the end of each visit, using
a linked computerized appointment system. Laboratory facilities are available
at each location.
The study location differs from
the original WATCH study which was located at the Fallon Clinic to UMMC.
When WATCH began there was only a modest primary care presence at UMMC.
Since then primary care at UMMC has grown remarkably, so that there are
now 44 primary care internists in our network and adequate numbers of
pts to carry out the proposed project successfully within our own institution.
At the same time, growth at the Fallon Clinic has slowed with increased
managed care competition. Recently the Fallon Clinic sold its hospital
(St. Vincent’s) and an undisclosed share of the Clinic itself (it is a
for-profit entity) to Orenda, a national for-profit managed care organization,
and subsequent to this Orenda itself was purchased by Tenet, an even larger
for-profit managed care organization. Given these factors, we elected
to carry out the proposed project at UMMC.
Study physicians
There are no significant group
differences between the physicians at the study sites. Of the 29 internists,
15 are male and 14 are female; 28 are board certified in internal medicine,
one is board-eligible. The mean age of the internists is 39 years. Two are Asian minority. These physicians, although affiliated with
an academic medical center, function little differently than the internists
at the Fallon Clinic used in WATCH. Clinic time for a Fallon internist
is 28 hours/week, for a UMass-Shrewsbury site internist 32 hours per week,
and for internists at the UMass-Benedict Center 25 hours/week (allowing
for 4 hours of teaching time and greater in-hospital responsibility).
The UMass-Benedict MDs see approximately 60 patients/week; the corresponding
figure for the Fallon internists in WATCH was 70/week. In fact, 65% of
our pts are under managed care contracts, with some 20% of pts in capitated
programs (half in a Fallon plan identical to that for the full-time Fallon
physicians). Thus our physicians must meet the same time and efficiency
demands as other primary care physicians, or we would not be competitive
and experience the growth that is in fact occurring.
Patient Population
This randomized controlled trial
includes 1200 primary care pts, evenly randomized into the 2 conditions
and blocked by gender, physician, and three age intervals (20-34, 35-54,
55-75).
Rationale for Patient
Population Chosen
The study population is a primary
care population. WATCH was a primary care study, and the WATCH II study
builds directly on its results. Our major interest is in altering risk
by delivering nutrition change brought about by a combination of practitioner
counseling, office support, well-designed group nutritional interventions,
and effective systems-based efforts that are synergistic with each other,
and are designed to be cost-effective. For pts who already have clinical
CHD the lipid-lowering goals are such as to require pharmacologic therapy
for the majority. (44) In a primary-care population the opposite is true
- pharmacologic therapy is not cost-effective, while nutrition-based interventions
can affect very large numbers of pts at very low cost, and thus have the
potential to reduce the population disease burden. (67, 92, 93)
Patient Eligibility
and Exclusion Criteria
A pt is eligible for this study if he/she
meets the following criteria:
1) LDL-C in the highest 25th percentile
2) is between twenty
and seventy-five years of age.
A pt is excluded
if he/she has any of the following characteristics: (Telephone
Screen)
1. an inability or unwillingness
to give informed consent;
2.
is presently or has within the prior two years been on specific pharmacologic
therapy to lower lipid levels (e.g., resins, fibric acid derivatives,
HMG-CoA reductase inhibitors, nicotinic acid);
3.
has known coronary heart disease
4.
has been referred to RDs within the prior two
years for lipid-lowering intervention;
5.
has a secondary cause of hyperlipidemia (e.g., hypothyroidism,
pregnancy);
6.
plans to move out of the area within the study period;
7.
has a psychiatric illness which limits ability to participate;
8.
has no telephone;
9.
has melanoma or a cancer other than skin cancer that is not in remission
for at least 2 years.
Pts with known CHD are excluded to maintain the primary care paradigm
of the study. Pts on drugs that can affect lipid levels (e.g., thiazide
diuretics, hormone replacement agents) will not be excluded, provided
that they have been on a stable dose of medication for at least 6 months.
Such an exclusion would eliminate large numbers of older women from the
study. Use of medications, however, will be tracked, and appropriately
considered in the analysis phase.
Changes to original protocol
- The upper age limit was increased from
70 to 75 years on 4/23/00.
- The upper limits of >300mg/dl for cholesterol and >200
mg/dl for LDL-C were removed.
- The upper limit of >400 mg/dl for triglyceride was removed
with the availability of a direct LDL measurement.
Additionally, bariatric surgery
during the study period rendered a subject ineligible.
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