The study aimed to determine if group appointments called PHASE improved statin adherence and LDL outcomes, and if effects differed by ethnicity. Retrospectively, 60 patients were divided into those who did (PHASE, n=30) or did not (non-PHASE, n=30) attend PHASE. No significant differences were found between groups in LDL or adherence over 6 months. However, PHASE patients were more likely to have labs done and remain on statins long-term. Secondary analysis found some interethnic differences in adherence and LDL within groups over time.

1. • Primary endpoints:
• adherence to statin therapy, assessed at 3 and 6 months from baseline and
defined as picking up a refill of statin medication
• LDL-c outcome as measured from lab tests
• Secondary endpoint: interethnic differences in adherence and outcomes
Cardiovascular disease is a major cause of morbidity and mortality in industrialized
nations, among both men and women [1]. Some conditions known to be major risk factors
for heart attack and stroke are diabetes mellitus, hypertension, and hyperlipidemia.
Bringing blood glucose, blood pressure, and cholesterol levels into recommended
therapeutic goals determined by medical guidelines can cumulatively reduce
cardiovascular risk.
Because of the chronic nature of these risk factors and the suboptimal number (less than
10-20%) of patients reaching goal, multidisciplinary-care teams consisting of physicians,
nurses, case managers, and/or pharmacists have emerged to optimize therapy, patient
follow-up, and patient access to care [3]. Pharmacist-run ambulatory clinics have been
shown to improve outcomes because of pharmacists’ expertise in medication therapy and
adjusting therapeutic regimens. While the current literature contains studies on the effect
of pharmacist-run diabetes clinics, there is need for further studies on lipid and blood
pressure management as these are also major risk factors for cardiovascular events. In
addition, few studies are done with ethnic minority populations, although African
Americans and Latinos have worse outcomes with these risk factors compared to Whites
[3].
HMG CoA-reductase inhibitors (statins) have cardiovascular importance as they have been
shown in many studies to reduce mortality both in CAD and non-CAD patients [1, 4].
However, outcomes and medication adherence differ widely between clinical trials and
actual practice. NCEP ATP III guidelines state that adherence is one of the biggest factors
in successful statin-induced LDL-lowering [1].
Given the benefits of statin medications on cardiovascular health, this study will look at the
effect of a collaborative pharmacist-physician run Preventing Heart Attacks and Strokes
Everyday class on statin adherence and LDL-c outcome. Secondly, we will look at how
these rates may differ between ethnic groups, possibly indicating differences in access or
usage to healthcare services that may be addressed in future studies.
IntroductionIntroduction DiscussionDiscussion
The objectives of this study are to: 1) determine whether group appointments for patients
with CAD or CAD risk factors improve statin adherence and LDL-c outcomes, and 2) if the
changes differ between ethnic class, suggesting greater assistance and outreach needed
for ethnic groups known to experience health disparities.
ObjectiveObjective
Study DesignStudy Design
For the primary endpoints, 9 patients were excluded from the non-PHASE group for statin
pickup at 3 and 6 months because they were not on a statin. In the PHASE arm, 7 patients
were excluded at 3 months and 6 patients at 6 months for statin pickup. One patient from
this arm was started on a statin after the 3-month mark from the date of the PHASE class.
Eliminating patients from statistical analysis for adherence may have made the results less
accurate and resulted in a lack of statistical significance between treatment groups at 3
and 6 months when there may have been one. Ensuring that all patients were on a statin
at the start of the study as an inclusion criterion would have prevented this discrepancy.
The limited number of patients was another limitation in calculating statistical differences
between ethnic classes for statin pickup and LDL outcome. Having small sample sizes may
have made results less accurate; however, the fact that significance was detected between
ethnic groups at 3 months for statin pickup and 6 months for LDL may warrant further
studies to determine factors for these differences. For future studies, it is necessary to
have large sample sizes of the representative population in order to come to reliable
conclusions about any differences.
Strengths of the study:
•Groups were balanced on baseline characteristics
•Generalizable to Santa Clara County based on demographics
•Clinically relevant endpoints
Limitations:
•Small sample size
•Retrospective
•Short duration of study
•Inclusion criteria for being on a statin at beginning of study
ConclusionConclusion
AcknowledgmentsAcknowledgments
Our study did not find significant differences in medication adherence or lab outcomes at
any time point. However, with more patients in each treatment group and longer study
time, more accurate conclusions can be made. When comparing average LDL values
between PHASE and non-PHASE groups, three months showed a p-value of 0.35 while at
six months the p-value was 0.07, possibly indicating that lab differences were beginning to
show between groups as time went on, due to reinforced education and motivation for
those who attended the PHASE class.
In addition, the benefits of cholesterol lowering must be studied over the long term in the
context of preventing major cardiovascular events. According to PHASE management
reports, myocardial infarctions decreased by 42% between 2001-2010, and STEMIs
decreased by 62% for PHASE patients, indicating clinically significant results for ambulatory
care clinics in managing chronic conditions and preventing mortality.
Special thanks to:
•Joyce Watson, PharmD for her guidance and insight throughout this project
•Jeffrey Phan, MD for his encouragement of this study and idea development
•Lawrence Troxell, PharmD for his feedback
•James Scott, PharmD for overseeing this project
•Reggie Villacorta, MA and Tony Dao, PharmD for their invaluable assistance in data analysis
ReferencesReferences
1. Cheng CWR, Woo K, et al. Association between adherence to statin therapy and lipid control in Hong
Kong Chinese patients at high risk of coronary heart disease. Br J Clin Pharmacol. 2004 Nov;58(5):528-
35.
2. Yang CC, Jick SS, Testa MA. Discontinuation and switching of therapy after initiation of lipid-lowering
drugs: the effects of comorbidities and patient characteristics. Br J Clin Pharmacol. 2003 Jul;56(1):84-
91.
3. Gerber BS, Rapacki L, et al. Design of a trial to evaluate the impact of clinical pharmacists and
community health promoters working with African-Americans and Latinos with Diabetes. BMC Public
Health. 2012 Oct 23;12(1):891.
4. Perreault S, Blais L, et al. Persistence and determinants of statin therapy among middle-aged patients
free of cardiovascular disease. Eur J Clin Pharmacol. 2005; 61(9): 667-74.
5. Jennings BT, Marx CM. Implementation of a pharmacist-managed diabetes program. Am J Health Syst
Pharm. 2012 Nov 15;69(22):1951-3.
6. Angel E, Li J. Impact of Spanish Group Appointments on Coronary Artery Disease Prevention for Spanish-
Speaking Patients. 2008
7. Department Goals 2013 Santa Clara Medical Center. Capacity Creation & Membership Growth. 11 Mar
2013.
8. 2011 U.S. Census Bureau
ResultsResults
Table 2: Summary of primary endpoints
Table 1: Baseline characteristics of cohort groups
MethodsMethods
Impact of PHASE Group Appointments on Statin Adherence and LDL-c Outcomes
Caren Nguyen, PharmD candidate; Joyce Watson, PharmD
Western University of Health Sciences College of Pharmacy, Pomona, CA Kaiser Permanente Chronic Conditions Management, Santa Clara, CA
Baseline Characteristics
Non-PHASE group
(N = 30)
PHASE group
(N = 30)
Avg baseline LDL-c 136.1 124.5
Male
Female
15 (50%)
15 (50%)
17 (56.7%)
13 (43.3%)
Age 58.9 62.7
Race
African/African American
Asian/Asian American
Hispanic/Latino
White
Other
2 (6.7%)
9 (30%)
8 (26.7%)
11 (36.7%)
0 (0%)
2 (6.7%)
7 (24.3%)
5 (16.7%)
14 (46.7%)
2 (6.7%)
Spoken language
English 29 (96.7%) 29 (96.7%)
On statin before appointment 18 (60%) 19 (63.3%)
CHD risk factors and risk
equivalents
AAA
Atrial fibrillation
CAD
CHF
CVA/TIA
DM
Hyperlipidemia
HTN
MI
PAD
1
1
3
1
1
24
22
20
2
1
0
4
3
2
2
28
23
26
2
0
Primary Endpoints
Non-PHASE group
(N = 30)
PHASE group
(N = 30)
p-value
Adherence
Statin pickup after 3 mos
Statin pickup after 6 mos
18/21 patients (85.7%)
12/21 patients (57.1%)
23/23 (100%)
16/24 (66.7%)
0.06
0.75
LDL-c after 3 mos
Avg LDL-c
Pts who did lab test
% at goal
93.6
15/30 (50%)
10/15 (66.7%)
93.6
19/30 (63%)
12/19 (63%)
0.35
0.30
0.83
LDL-c after 6 mos
Avg LDL-c
Pts who did lab test
% at goal
113.1
11/30 (36.7%)
5/11 (45.5%)
96.9
21/30 (70%)
12/21 (57.1%)
0.07
0.01
0.24
Avg maximum LDL change -40.75 -31.15 0.20
Pts on statin after appointment 20 (66.7%) 23 (76.7%) 0.04
# CV event after appointment 1 (3.3%) 1 (3.3%) 1
OutcomesOutcomes
Above: summary of inclusion and exclusion
criteria. All patients had CAD risk and were not at
LDL-c goal, so that the effect of the group
appointment on clinical outcome can be
measured.
Left: selection process for study and control
groups.
• Patients to be included in the study were
generated from a list of patients enrolled for a
PHASE group session
• Only sessions from Feb 1, 2012 – Oct 31, 2012
were included
• Patients who did not attend the session 
control (non-PHASE) group
• Patients who attended  study (PHASE) group
A retrospective chart review:
• Patients in each group were followed for six
months after the date of the PHASE class on
the following parameters:
• LDL-c at 3 months
• Statin pickup at 3 months
• LDL-c at 6 months
• Statin pickup at 6 months
Non-PHASE
Statin pick-up at 3 months
•Difference between ethnic groups (Asian,
AA, Hispanic, White)
p = 0.03
Statin pick-up at 6 months
•Difference between ethnic groups (Asian,
AA, Hispanic, White)
p = 0.19
PHASE
Statin pick-up at 3 months
•Difference between ethnic groups (Asian,
AA, Hispanic, White)
p = 0.24
Statin pick-up at 6 months
•Difference between ethnic groups (Asian,
AA, Hispanic, White)
p = 0.27
Primary endpoints:
One-tailed unpaired t-tests were used to compare numerical data (eg. LDL-c) and chi-
squared tests were used to compare categorical data (eg. statin pickup) between groups.
There was no significant difference between groups on LDL-c values at three months (p =
0.35) or six months (p = 0.07), maximum LDL change from baseline (p = 0.20), or statin
pickup at three months (p = 0.06) or six months (p = 0.75). However, patients who
attended the PHASE class were significantly more likely to have routine lab tests done
over the long term (six months, p = 0.01) and significantly more likely to be on a statin
medication after attending the class (p = 0.04).
Patients excluded from statistical analysis were: those who were not on a statin at three
or six months, and those who did not come in for a lab test at three or six months.
Secondary endpoints:
Between group analyses for ethnic groups in each arm were done using two-tailed chi-
squared tests for statin pickup and t-tests for LDL.
Secondary endpoints showed some changes for statin pickup and LDL levels. For statin
pickup at 3 months, there was a significant difference between ethnic groups in the non-
PHASE arm (p = 0.03), but no significant difference between ethnic groups in PHASE (p =
0.236). At 6 month statin pickup, both non-PHASE and PHASE arms showed no
significant differences between ethnic groups (p = 0.188 and p = 0.265, respectively).
Table 3: Summary of secondary endpoints
Non-PHASE
LDL at 3 months
•Difference between ethnic groups (Asian,
AA, Hispanic, White)
No
significant
differences
LDL at 6 months
•Difference between ethnic groups (Asian,
AA, Hispanic, White)
No
significant
differences
PHASE
LDL at 3 months
•Difference between ethnic groups (Asian,
AA, Hispanic, White)
No
significant
differences
LDL at 6 months
•Hispanic vs White p = 0.005
In terms of LDL differences at 3 months and 6 months,
there were no significant interethnic differences in either
the non-PHASE or PHASE groups except in one scenario.
Statistical significance was observed when comparing
Hispanic vs White for 6 month LDL in the PHASE arm (p =
0.005).