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Evaluation of a hypertension
medication therapy
management program in
patients with diabetes
Lourdes G. Planas, Kimberly M. Crosby, Kimberly D. Mitchell, and Kevin C. Farmer
164 • JAPhA • 4 9 : 2 • M a r /A p r 2009 www.j aph a. or g Journal of the American Pharmacists Association
Hypertension MTM program in patients with diabetes SPECIAL FEATURE
T
he estimated prevalence of hypertension among U.S. 2003–2004 indicated that only 48% of patients with diabetes
adults is 29%, with approximately 50 million people in and hypertension had achieved a blood pressure of less than
the United States diagnosed with hypertension.1,2 The 130/80 mm Hg.6 Diabetic patients with uncontrolled hyperten-
prevalence estimates of hypertension among individuals with sion may benefit from care provided by community pharmacists
diabetes vary widely, with estimates of 50% to 90% of people to help manage their medications and blood pressure.
diagnosed with diabetes having hypertension as a comorbidity.3 Previous research has indicated that community pharma-
Data from the Centers for Disease Control and Prevention indi- cists can have a positive influence on outcomes for patients
cate that 23.6 million people in the United States were affected with hypertension, including those with comorbid diabetes.9–13
by diabetes in 2007.4 This could mean that up to 21 million peo- However, studies using randomized controlled designs to dem-
ple with diabetes in the United States also had hypertension, onstrate the effect of pharmacist-driven medication therapy
which is defined as a blood pressure greater than 130/80 mm management (MTM) on quality of care for hypertensive patients
Hg or treatment with antihypertensive therapies.4–6 with diabetes are lacking. Additionally, most studies have been
Because patients with diabetes and hypertension are at an conducted in institutional or physician clinic settings instead
increased risk of cardiovascular complications and death, con- of community practice, where the majority of patients receive
trolling blood pressure is as important as maintaining glycemic care.
control.2,7 For every 10 mm Hg reduction in systolic blood pres- One intermediate outcome of MTM services is improving
sure (SBP), the risk of complications associated with diabe- patient adherence to medications. Patients often fail to take
tes is reduced by 12%.8 However, the majority of patients with medications as directed or may prematurely discontinue ther-
diabetes are not at goal blood pressure. National Health and apy. This nonadherence can be especially problematic in the
Nutrition Examination Survey (NHANES) data published for successful treatment of chronic diseases. A recent review of
139 studies found that only 59% of patients took at least 80%
of cardiovascular or diabetic medications as directed.14 A com-
At a Glance prehensive review of 50 years of adherence research found a
Synopsis: Blood pressure control among pa- 75.2% mean rate of adherence across a variety of conditions.15
tients with diabetes and hypertension was effectively Less-than-optimal medication adherence can result in poor
improved as a result of an intervention providing hy- clinical and health outcomes. In reviewing studies analyzing
pertension medication therapy management (MTM) adherence and outcomes, “good” adherence had a positive ef-
services during monthly visits to a community phar- fect on outcomes in 73% of studies.14 Research examining un-
macy. Mean systolic blood pressure (SBP) among in- controlled SBP over time found an odds ratio (OR) of 1.73 for
tervention group participants decreased 17.32 mm medication nonadherence related to uncontrolled blood pres-
Hg, whereas that for the control group increased 2.73 sure compared with SBP controlled over time.16
mm Hg (P = 0.003). The percentage of participants at
goal blood pressure increased threefold (from 16.0% Objective
to 48.0%) in the intervention group, while decreasing The objective of this study was to evaluate the effect of a
by two-thirds among control group participants (from community pharmacy–based hypertension MTM program on
20.0% to 6.67%). Intervention group participants quality of care in patients with both diabetes and hypertension.
were 12.92 times more likely than control group par- Clinical outcomes of care were blood pressure and antihyper-
ticipants to achieve goal blood pressure (P = 0.021). tensive medication adherence. This study was part of a larger
Analysis: Data have indicated that lowering blood study of patients with diabetes.
pressure significantly reduces the risks of diabetes-
related complications, yet many patients with diabetes Methods
do not meet recommended goals for blood pressure Study design and setting
control. In the United Kingdom Prospective Diabetes A randomized controlled design was used for the study. Us-
Study, a 10–mm Hg decrease in blood pressure reduced ing a generated random number list, participants in a concur-
the risk of cardiovascular morbidity and mortality from rent study evaluating a community pharmacy–based diabetes
stroke and myocardial infarction in patients with dia- management program were randomly assigned to either a con-
betes and reduced the risk of developing microvascular trol or an intervention group. Participants in the control group
complications. Community pharmacists are strategi- attended visits at baseline and 3, 6, and 9 months, during which
cally positioned to provide MTM services and effectively their blood pressure was recorded and they were informed of
communicate with providers to improve quality of care blood pressure goals for patients with diabetes. In contrast,
for patients with diabetes and hypertension. Pharma- participants in the intervention group received hypertension
cists in the current study also were able to increase the MTM services on a monthly basis during the study period.
medication adherence rate among intervention group The hypertension study was nested within a larger study
patients by 7 percentage points (from 80.5% before of patients with diabetes. Participants were screened for the
the study to 87.5% during the study period). hypertension study during their baseline visit for the diabetes
study. Patients whose blood pressure was greater than 130/80
mm Hg or who were on antihypertensive therapy were eligible Participants were screened for the hypertension study at
for the hypertension study. Eligible participants were informed their baseline diabetes study visit. Participants were eligible
about the hypertension study and were provided informed con- for the hypertension study if their blood pressure was 130/80
sent materials in addition to those for the diabetes study. mm Hg or higher or they were currently taking antihyperten-
Study visits occurred at five pharmacies in Tulsa, OK. These sive therapy. Eligible participants who provided informed con-
pharmacies were part of a larger regional pharmacy chain with sent constituted the hypertension study sample.
approximately 60 stores in the Tulsa area. An administrative Eligible individuals meeting the study criteria were referred
assistant at the regional corporate headquarters was assigned to the patient scheduler, who randomly assigned them to ei-
to contact participants to schedule appointments. Eleven phar- ther the intervention or the control group based on a previously
macists employed by the company were trained by the investi- generated random number list. The scheduler then identified
gators to provide the study intervention. the participant’s preferred pharmacy location and scheduled
The study providers received 3 days of training, which in- their baseline visit.
cluded a review and update of current hypertension pharma- The study was approved by the University of Oklahoma
cotherapy and the guidelines described in the Seventh Report Health Sciences Center Institutional Review Board.
of the Joint National Committee on Prevention, Detection,
Evaluation, and Treatment of High Blood Pressure.2 Providers Intervention
also were trained on the research protocol, documenting care, Intervention group participants received hypertension MTM
accurate measurement of blood pressure, and strategies for services on a monthly basis during the same visits in which they
integrating hypertension MTM services within diabetes man- received diabetes management services. During the visits, a de-
agement. To maximize consistent delivery of care, training was tailed history was taken to identify current or potential medical
also provided by one of the study investigators during the phar- problems. This history also included a comprehensive assess-
macist’s initial patient visit. ment of current prescription and nonprescription medications
to identify drug therapy problems. A brief physical examination
Participants was performed, during which the patient’s blood pressure was
Study participants were members of a managed care orga- recorded. Patients in the intervention group were educated on
nization (MCO) responsible for more than 100,000 enrollees. diet and lifestyle modifications to lower blood pressure. For
Individuals in this hypertension MTM study were selected from example, patients were encouraged to implement a regular
a larger study of patients with uncontrolled diabetes. Three exercise routine and make dietary changes such as reducing
recruitment methods were used to enlist individuals from this caloric or sodium intake. During visits, the role of medications
MCO into the diabetes study. was discussed with the patient and adherence to therapy was
The MCO initially screened laboratory data from members assessed. Patients were encouraged to adhere to their thera-
in the greater Tulsa area who had been continuously enrolled pies, and an individualized plan was developed for each patient
for at least 9 months. If an enrollee’s most recent glycosy- to help them manage their therapies. Patient visits were doc-
lated hemoglobin (A1C) level (within the previous 6 months) umented, and the patient’s primary care provider was sent a
was greater than 7.0% (lack of diabetes control, according to copy of the visit note. If drug therapy problems were identified,
current American Diabetes Association standards of care),17 the pharmacist provider contacted the patient’s primary care
they were identified as a potential participant for the diabetes physician via fax or telephone to make recommendations, such
study. This resulted in the MCO mailing recruitment letters to as adjusting medication doses and adding therapeutic agents.
872 individuals. The letter included a description of the study Patients’ progress toward achieving a blood pressure of lower
and a request to contact the investigators if individuals wished than 130/80 mm Hg was assessed during their next visit. Previ-
to participate. Upon contact, the investigators further screened ous recommendations made to the patient’s primary care phy-
participants for eligibility. Study participants had to be at least sician regarding changes to the hypertensive medication regi-
18 years of age, currently insured by the MCO, not pregnant or men were assessed for acknowledgement or implementation
currently enrolled in another diabetes program, and able and based on facsimile response and/or patient reporting.
willing to come to periodic visits during a 9-month period.
The second recruitment strategy involved screening at- Data analysis
tendees at a health fair sponsored by the MCO for City of Tulsa Data were entered into a Microsoft Access database and
employees. Point-of-care A1C testing was conducted. Individu- imported into SPSS version 16.0 (SPSS, Chicago) and SAS ver-
als with an A1C level greater than 7.0% and meeting the afore- sion 9.1 (SAS Institute, Cary, NC). Descriptive statistics were
mentioned eligibility criteria were asked to participate in the reported for study measures. Differences in blood pressure
study. and antihypertensive medication adherence at baseline and 9
The third recruitment procedure involved the MCO fax- months were compared between the control and intervention
ing patient referral requests to its network primary care phy- groups.
sicians. Physicians were asked to refer patients whose most Two blood pressure measures were evaluated: (1) SBP
recent A1C level was greater than 7.0% and who agreed to be levels and (2) percentage of patients at goal blood pressure
contacted by the investigators regarding study participation. (<130/80 mm Hg).2 Intention-to-treat analyses were con-
ducted. If a participant did not complete the study, his or her
166 • JAPhA • 4 9 : 2 • M a r /A p r 2009 www.j aph a. or g Journal of the American Pharmacists Association
Hypertension MTM program in patients with diabetes SPECIAL FEATURE
last blood pressure level was carried forward to represent the creased 17.32 mm Hg. This difference in SBP change between
9-month level. Participants who dropped out of the study be- the control and intervention groups (20.05 mm Hg [95% CI
fore the 3-month visit were excluded from analyses. 7.45–32.66]) was statistically significant (P = 0.003).
Adherence with medications used in the treatment of hy-
pertension was determined using prescription claims data pro- Goal blood pressure
vided by the MCO. Therefore, all prescription activity was cap- The percentages of participants at goal blood pressure lev-
tured regardless of the pharmacy used by the patient before or els at the baseline and 9-month visits are shown in Figure 2.
during the study period. The date of the participant’s baseline During the study period, the percentage of control group partic-
visit was used to discriminate prescriptions obtained 9 months ipants at blood pressure goal decreased from 20.0% to 6.67%,
before and 9 months after their baseline visit. whereas the percentage of intervention group participants at
Adherence was calculated using the continuous measure goal increased from 16.0% to 48.0%. A statistically significant
of medication acquisition method, in which the days’ supply association was observed between being in the intervention
of a medication is compared with the dates the medication is group and being at goal blood pressure (χ2 = 7.301, P = 0.007).
filled.18 To be included in the analysis, a particular prescription The odds of an intervention group participant achieving goal
medication and dosage (e.g., lisinopril 10 mg) had to be filled at blood pressure were 12.92 times (95% CI 1.47–113.77) great-
least three consecutive times during the 9 months before and/ er than that for a control group participant (P = 0.021).
or after a patient’s baseline visit.
Medication adherence
Independent-samples t tests were used to test group differ-
The mean adherence rate in the control group was 79.5%
ences in mean SBP and medication adherence. A Pearson’s chi-
before the study and 78.8% during the study period. The mean
square test was used to determine if an association existed be-
adherence rate for the intervention group was 80.5% before
tween group assignment and achieving a goal blood pressure.
the study and increased to 87.5% during the study period (Ta-
Additionally, an OR and confidence interval (CI) for achieving
ble 2). Although the mean adherence rate in the intervention
goal blood pressure in the intervention group compared with
group increased 7% while remaining fairly constant in the con-
the control group were calculated. A priori alpha levels of 0.05
trol group, the difference was not statistically significant at the
were used to test for statistical significance.
alpha 0.05 level (P = 0.0712).
Results
Study participation Discussion
A total of 65 participants enrolled in the diabetes study A 9-month community pharmacy–based hypertension
between November 29, 2005, and September 16, 2006. Of
these individuals, 52 met the eligibility criteria for and agreed Table 1. Demographics of patients with diabetes and
to participate in the hypertension study. Twenty participants hypertension participating in study (n = 52)
were randomly assigned to the control group and 32 to the in-
tervention group. The majority of participants were women, Intervention
white, and overweight/obese (Table 1). The 9-month visit for Control group group
the last enrolled patient occurred on July 17, 2007. At the con- n 20 32
clusion of the study, 40 patients were included in the intention- Gender, no. (%)
to-treat analysis (15 control group and 25 intervention group Women 12 (60.0) 21 (65.6)
patients). Men 8 (40.0) 11 (34.4)
The overall drop-out rate was 36.5%, which is slightly Age (years)
higher than that observed in previous pharmacy studies of pa- Mean ± SD 65.2 ± 14.1 64.2 ± 10.5
tients with diabetes.19–25 Drop-out rates were 35.0% and 37.5% Range 34–84 48–82
among control and intervention group participants, respective- Ethnicity, no. (%)
ly. No statistical association was observed between group as- White 18 (90.0) 24 (75.0)
signment and dropping out of the study (χ2 = 0.033, P = 0.855). Black 2 (10.0) 7 (21.9)
Among the 44 participants recruited by letters from the MCO, Hispanic 0 1 (3.1)
34.1% dropped out of the study. None of the four participants Baseline BMIa
who were recruited at a health fair dropped out of the study,
Mean ± SD (kg/m2) 29.7 ± 4.9 32.8 ± 6.9
and all four participants who were recruited by physician refer-
Normal (18.5–24.9 kg/m2), no. (%) 2 (10.5) 5 (15.6)
ral dropped out.
Overweight (25–29.9 kg/m2),
SBP no. (%) 8 (42.1) 5 (15.6)
Mean SBP levels at the baseline and 3-, 6-, and 9-month Obese (≥30 kg/m2), no. (%) 9 (47.4) 22 (68.8)
visits are shown in Figure 1. The mean control group SBP lev- Completed study, no. (%) 13 (65.0) 20 (62.5)
el increased 2.73 mm Hg between the baseline and 9-month Abbreviation used: BMI, body mass index.
a
Missing baseline BMI for one control group participant.
visits. In contrast, the mean intervention group SBP level de-
Month
Figure 1. Mean systolic blood pressure levels at baseline and 3, 6, and 9 months
60.00
% 30.00
20.00
20.00
16.00
10.00 6.67
0.00
Control (n = 15) Intervention (n = 25)
Group
MTM program was evaluated to determine its effect on quality intervention group, whereas it increased 2.73 mm Hg in the
of care among managed care enrollees with diabetes. Clinical control group. The percentage of participants at goal blood
outcomes among recipients of MTM services were compared pressure increased threefold (from 16.0% to 48.0%) in the
with those of a control group. intervention group, whereas it decreased by one-third among
The intervention program was effective at improving blood control group participants (from 20.0% to 6.67%). An inter-
pressure control. Mean SBP decreased 17.32 mm Hg in the vention group participant was 12.92 times more likely than a
168 • JAPhA • 4 9 : 2 • M a r /A p r 2009 www.j aph a. or g Journal of the American Pharmacists Association
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