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Author Manuscript
Arch Intern Med. Author manuscript; available in PMC 2010 October 26.
Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine; University of
Iowa, Iowa City, IA
Abstract
BackgroundOne strategy that has had the greatest effect on improving blood pressure (BP)
includes team-based care. The purpose of this systematic review was to determine the potency of
interventions for BP involving nurses or pharmacists.
MethodsA Medline search for controlled clinical trials that involved a nurse or pharmacist
intervention was conducted. Mean reductions in systolic (S) and diastolic (D) BP were determined
by two reviewers who independently abstracted data and classified the different intervention
components.
ResultsThirty-seven papers met the inclusion criteria. Education on BP medications was
significantly associated with improved BP (8.75/3.60 mm Hg). Other strategies that had large
effect sizes on SBP included: pharmacist made treatment recommendation (9.30 mm Hg), nurse
did the intervention (4.80 mm Hg), and a treatment algorithm was used (4.00 mm Hg). The
odds ratio (OR) and 95% confidence interval (CI) for controlled BP were: nurses OR=1.69 (CI =
1.48, 1.93), pharmacists within primary care clinics OR=2.17 (CI = 1.75, 2.68) and community
pharmacists OR=2.89 (CI = 1.83, 4.55), Mean reductions in SBP were: nursing studies = 5.84
8.05 mm Hg, pharmacists in clinics = 7.76 7.81 mm Hg and community pharmacists = 9.31
5.00 mm Hg but there was no significant differences between the nursing and pharmacy studies
(p0.19).
Introduction
Blood pressure (BP) is poorly controlled in the US.1-5 The 8th Joint National Committee on
Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC-8) is
currently considering strategies to improve the implementation of the guidelines and achieve
Correspondence: Barry L. Carter, Pharm.D., FCCP, FAHA, Division of Clinical and Administrative Pharmacy, Room 527, College of
Pharmacy, University of Iowa, Iowa City, Iowa, 52242, Phone: 319-335-8456, Fax: 319-353-5646 barry.carter@uiowa.edu.
Carter et al.
Page 2
Methods
Search Strategy
Walsh et al. performed their search of the MEDLINE database from January 1980 through
July 2003 and we extended the search to include papers published from January 1970
through February 2009. The search was conducted by a research librarian. Titles and
abstracts were then screened to determine if the article included team-based care of
hypertension involving pharmacists or nurses. Next, we searched the reference list of
included papers and the reviews by Walsh6 to identify additional citations. Once the full text
articles were selected, two reviewers (one Pharm.D. clinical pharmacist and one Ph.D.
nurse) independently determined if each paper met the study criteria and, if so, the reviewers
independently abstracted critical information including study design, setting, type of
intervention, components of the intervention and degree of SBP and DBP change. The
intervention components included: supplying free medications, education concerning BP
medications, counseling on lifestyle modifications, assessing medication compliance,
algorithm for treatment, home visits, intervention provider (nurse or pharmacist) could
prescribe medications, intervention provider could order laboratory, length of the study,
completion of a drug profile/medication history, physical examination was conducted, nurse
provided intervention, pharmacist provided intervention and/or whether medication
recommendations were made to a physician (as opposed to independent changes). Because
every study used different combinations of these components, the two reviewers
independently assigned a potency score for their predicted potency that the combination of
interventions in a study would have on outcomes ranging from 0 (brings about no result) to
10 (brings about best result). Disagreements between the reviewers were resolved by an
open dialog to develop consensus. Confirmation of the two reviewers findings was
adjudicated by a biostatistician.
Arch Intern Med. Author manuscript; available in PMC 2010 October 26.
Carter et al.
Page 3
We calculated effect size by determining the change in SBP (or DBP) attributable to the
intervention (int) for each study defined as:6
and
BP control was defined as a BP < 140/90 for patients with uncomplicated BP and <130/80
mm Hg for those with diabetes or chronic kidney disease.14 The net change in BP control
rates attributable to the intervention for each study was defined as:
The odds ratio and 95% confidence interval for controlled BP was calculated (22 studies)
and weighted by the sample size of the study.8, 15-35 Odds ratios could not be calculated for
15 studies.36-50 We divided the studies into three groups to evaluate potency: 1) nursing
interventions, 2) pharmacist interventions delivered in community pharmacies, and 3)
interventions by clinical pharmacists working within a primary care office. We performed a
sensitivity analyses to determine the effect of assigning studies to different categories when
they had multiple strategies (e.g. involved both community pharmacists and nurses).
Analysis
Stepwise regression analyses and non-parametric analyses were performed using the MannWhitney test to evaluate the post-intervention difference between the intervention and
control groups for mean SBP and DBP while controlling for study sample size using SPSS
17.0.0 statistical software (SPSS, Inc., Chicago, IL, Aug 23, 2008).
One study had a large number of informed dropouts and found no significant difference
between nurse management versus the physician.15 A stepwise regression analysis was
conducted without this study (n=36) to predict the effect of individual intervention
components on BP.
Unadjusted odds ratio for controlled BP were calculated so studies could be compared. Odds
ratios were compared using a simple logistics regression model using one variable,
unadjusted for any other item. We created a funnel plot of the log of the odds ratio plotted
against the standard error for each study to assess the possibility that publication bias might
exist.
Results
The literature review identified 583 citations and 37 articles that met the inclusion criteria
(Figure 1). There was good reliability between the two abstractors for their evaluations of
these studies (Pearson correlation coefficient = 0.74, p<0.001).
Each study involved unique provider qualifications and training. For instance, studies
involving community pharmacists may have included bachelor of science (B.S.) trained
Arch Intern Med. Author manuscript; available in PMC 2010 October 26.
Carter et al.
Page 4
The stepwise regression compared the studies that included a given intervention strategy,
with those studies that did not. Several individual components of the interventions were
associated with significant reductions in SBP including pharmacist recommended
medication to physician (27.2 mm Hg, p=0.002), counseling on lifestyle modification
(12.6 mm Hg, p=0.033), pharmacist performed the intervention (11.7 mm Hg,
p=0.028), an algorithm was used (8.46 mm Hg, p<0.001), a drug profile was
completed (8.28 mm Hg, p=0.001) and the overall intervention potency score assigned by
the study reviewers (p<0.001) (Table 1). For example, the regression coefficient for used
algorithm was significant (9.37, p<0.001) which indicated that given all other factors in the
model, the average reduction in SBP of the nine studies using an algorithm was 9.37 less
than the change in SBP in the 27 studies not using an algorithm. Assuming that a study used
an algorithm and no other intervention, the predicted reduction in SBP was 8.46 mm Hg
(Table 1).
The factors associated with a reduction in DBP were: referral was made to a specialist
(19.6 mm Hg, p=0.039), providing patient education about BP medications (17.6 mm
Hg, p=0.003), a drug profile was completed (7.3 mm Hg, p=0.006), a pharmacist did
the intervention (4.0 mm Hg, p=0.044) or a nurse did the intervention (3.9 mm Hg,
p=0.041). Next, a nonparametric analysis was performed because the data were not normally
distributed. The only individual component that had a significant reduction in BP was
education on BP medications (8.75/3.60 mm Hg). However, several other intervention
components had a large effect size on SBP (11.0 to 4.8 mm Hg) including: 1) free
medications (10.80 mm Hg), 2) pharmacist made treatment recommendation to the
physician (9.30 mm Hg), 3) pharmacist did the intervention (8.44 mm Hg), 4) a drug
profile was compiled (8.19 mm Hg), 5) medication compliance was assessed (7.90 mm
Hg), 6) counseling on lifestyle modification was performed (7.59 mm Hg), 7) provider of
the intervention could order laboratory tests (7.00), and 8) nurse did the intervention (4.8
mm Hg) (Table 2).
The estimated odds ratio and 95% confidence interval (CI) for controlled BP for nursing
studies was OR=1.69 (CI = 1.48, 1.93) (Figure 2a), studies involving community
pharmacists was OR=2.89 (CI = 1.83, 4.55) (Figure 2b), and studies involving pharmacists
within primary care clinics was OR=2.17 (CI = 1.75, 2.68) (Figure 2c).
In the non-parametric analyses of the 36 studies, the mean reduction in SBP was 5.84 8.05
mm Hg for nursing studies (n=16) compared to 7.76 7.81 mm Hg in the studies involving
pharmacists in clinics (n=7) and 9.31 5.00 mm Hg for studies by community pharmacists
Arch Intern Med. Author manuscript; available in PMC 2010 October 26.
Carter et al.
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(n=13). Reductions in diastolic BP were 3.46 4.15 mm Hg for nursing studies, 4.18 4.25
mm Hg for pharmacists in clinics and 4.59 4.64 mm Hg for community pharmacists (SBP
and DBP were not significantly different between any group).
We constructed a funnel plot to evaluate whether there may have been publication bias
(Figure 3). Three of four studies with the largest log odds ratios had moderate to low
standard error suggesting the absence of publication bias. However, publication bias cannot
be ruled out since there are few studies with high log odds ratios and low standard error.
Discussion
This study found that interventions involving pharmacists or nurses were associated with
significantly improved BP control. These findings extended the previous report that found
involving pharmacists or nurses was the most potent quality improvement strategy to
improve BP control.6 We also wanted to determine if specific aspects of team care were
more potent. Our analysis found that studies involving pharmacists resulted in not only
lower BP but a greater OR of achieving BP control compared to studies involving nurses.
However, the reductions in systolic BP and confidence intervals for controlled BP (Figure 2)
overlap for the different providers.
We had hypothesized that studies involving community pharmacists would be less potent
than those involving nurses or pharmacists within primary care clinics. Interestingly, studies
involving community pharmacists had the highest OR (2.89). These findings may be based
on how the reviewers categorized the studies. First, one study conducted in community
pharmacies in Portugal had an extremely high OR (29.71).22 Another study in community
pharmacy had an OR of 4.29 but this pharmacist worked closely with two physicians and
reviewed medical records of study patients in the physicians office.20 Instead, we could
have classified this as a pharmacist in the clinic which would have reduced the OR for
community pharmacy studies and increased the OR for pharmacists in clinics. Second, we
classified one study as a nursing intervention for the OR calculations but the intervention
involved both a nurse and community pharmacist (OR=1.79).19 Excluding the first two
studies and adding the third study to the analysis of community pharmacy studies would
have resulted in an OR closer to 1.8 for the community pharmacy group.
Finally, one large study was conducted within a managed care organization that involved
education by a pharmacist via the web.35 We classified this study as one within primary
care but this study did not have as great of an effect (OR=1.88) compared to studies in
which the pharmacist adjusted therapy either alone or in collaboration with physicians
(OR=7.38-9.98). Without that study, the OR would have been 3.27 for pharmacist in
clinics. It may be possible to explain our findings based on the dose, duration and potency
of the intervention. For instance, Carter conducted three studies in community pharmacies,
where the pharmacists had no prior established relationship with the physicians and the
interventions were only 4 and 5 months in length.8, 21, 23 These studies had modest OR for
controlled BP (1.56, 1.74 and 2.46). Carter recently completed a randomized controlled
effectiveness (pragmatic) study of a 6-month pharmacist intervention in 402 patients from
six family medicine clinics that was not included in this systematic review because it was
unpublished at the time of our evaluation.52 In that study, SBP was reduced 12.0 mm Hg
more in the intervention group than the control group and the OR for controlled BP was
OR= 3.2 (95% CI 2.0, 5.1). Finally, these investigators conducted an efficacy study in which
BP was controlled in 54% of patients in the control group and 89% in the intervention group
(OR 7.38, CI 3.43, 15.91).30 The main reason for high BP control in this latter study was
attributed to assertive and frequent medication intensification recommended by the
pharmacist. Thus, the OR for the 5 studies by these investigators were: community
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Carter et al.
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pharmacy studies (B.S. trained pharmacists) between 1.56-2.46; the pragmatic trial of
clinical pharmacists (Pharm.D. with residency or fellowship) 3.2 and the efficacy trial (ideal
intervention delivery) with clinical pharmacists (Pharm.D. with residency) of 7.38.
Therefore, when the literature involving team care is evaluated, it is critical to assess the
duration of the intervention, the type of organization in which the intervention is performed
(home, worksite, community pharmacy or primary care clinic) and whether the study is an
efficacy or effectiveness trial. These factors, as well as the activities of the intervention,
predict the potency of the intervention.
Studies involving community pharmacists largely involved making recommendations to
physicians by telephone or facsimile. Studies involving pharmacists in clinics typically
involved pharmacists employed in the clinic and who worked collaboratively with physician
colleagues and/or provided more autonomous care. Pharmacists within primary care clinics
work closely with physicians and the expected levels of trust and cooperation might be
higher than with community pharmacists where interaction is usually not in person and
occurs from distant locations.23, 51, 53 In fact, recommendations to change BP medications
were accepted 95% of the time from pharmacists within the same clinic30 but only 45-50%
when recommendations were made by community pharmacists.8, 21, 23 Therefore, lower
acceptance for community pharmacists recommendations could be due to lower levels of
trust and cooperation by physicians.51, 53
Many of the nursing studies did not describe the types of nurses, their educational
background or training but four studies used either registered nurses or nurse practitioners.
15, 16, 18, 42, 49 Nursing interventions seemed more likely to involve home visits, use an
algorithm and patient engagement than pharmacy studies. It is likely that many of the
interventions involving nurses or pharmacists increased patient empowerment but few
studies specifically provided such descriptions. Only 5 nursing studies described a patientled process17, 47, 49 or home BP monitoring41, 42 and 3 pharmacy studies used home BP
monitoring.23, 34, 35 We suspect that nurse practitioners would have more autonomy than
registered nurses and in some cases, nurse practitioners can prescribe medications. We could
not detect whether nursing degree or training influenced the results. However, using an
algorithm or making a home visit both had a predicted reduction in SBP of4 mm Hg.
Arch Intern Med. Author manuscript; available in PMC 2010 October 26.
Carter et al.
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only improve BP control rates but markedly improve the efficiency and productivity of the
physician.54, 55 Including many of the components of these interventions into hypertension
management programs could improve the implementation of the JNC-8 or other chronic
disease guidelines.
The vast majority of the studies (89%) were randomized controlled trials (Appendix 1). The
quality of the studies support the findings that these interventions are likely to be effective.
There were, however, large differences in the duration of the intervention (4-24 months),
sample size (26-1,534) and subject (patient) dropout (2-62%). Nearly all of the studies
adequately described the most important characteristics of the patients but many did not
adequately describe the number, education and training of the intervention pharmacists or
nurses. Our analysis could not determine if there is a preferred level of qualifications such as
a PharmD degree with residency or a MS nurse practitioner degree. Likewise, many studies
did not describe the training but those that did typically noted to 2 day training programs
on the hypertension guidelines and BP measurement. It is possible that RN nurses or B.S.
pharmacists may have required more intense or longer training than nurse practitioners or
pharmacists with PharmD degrees with residencies, but this could not be determined from
these studies. Future interventional studies of this type should specify the educational
background, postgraduate training and specific training programs for the study that were
used to implement the intervention.
Only one study performed a cost-effectiveness analysis.48 Clinic visit costs were
significantly higher in the pharmacist-managed clinic ($131 per patient) than the physician
clinic ($74) (p<0.001), but the costs for emergency room visits was significantly lower in
the pharmacist-managed clinic than the physician clinic ($0 vs $10.84 per patient, p<0.04).
The cost of decreasing SBP/mm Hg was $27 for the pharmacist-managed clinic and $193
for the physician clinic. The cost of decreasing DBP/mm Hg was $48 in the pharmacistmanaged clinic and $151 in the physician clinic.
Conclusion
This evaluation of team-based care in hypertension found that interventions involving nurses
or pharmacists are effective strategies to improve BP control. Several individual components
were associated with improvements in BP. Research involving team-based care must be
carefully designed, reported and interpreted to include the organizational structure in which
the intervention is performed, the education and training of the intervention providers and
the individual components of the intervention so that similar interventions can be
implemented within a given health system.
Arch Intern Med. Author manuscript; available in PMC 2010 October 26.
Carter et al.
Page 8
Supplementary Material
Refer to Web version on PubMed Central for supplementary material.
Acknowledgments
Supported, in part from National Heart, Lung, and Blood Institute grant HL070740 and the Agency for Healthcare
Research and Quality (AHRQ) Centers for Education and Research on Therapeutics Cooperative Agreement
#5U18HSO16094. Dr. Carter is also supported by the Center for Research in Implementation in Innovative
Strategies in Practice (CRIISP), Department of Veterans Affairs, Veterans Health Administration, Health Services
Research and Development Service (HFP 04-149). The views expressed in this article are those of the authors and
do not necessarily reflect the position or policy of the Department of Veterans
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Carter et al.
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Figure 1.
Carter et al.
Page 13
Figure 2.
The Odds Ratio (confidence interval) that systolic blood pressure is controlled in the
intervention group compared to the control group. Figure 2a displays 8 studies involving
nurses, Figure 2b displays 5 studies conducted in community pharmacies and Figure 2c
figure displays 9 studies involving pharmacists in primary care clinics.
Arch Intern Med. Author manuscript; available in PMC 2010 October 26.
Carter et al.
Page 14
Figure 3.
Carter et al.
Page 15
Table 1
Regression
Coefficient
Predicted
Change in
SBP (mm Hg)
Constant
1.31
NA
0.664
9.68
27.21
0.002
5.20
12.63
0.033
6.13
11.70
0.028
Algorithm used
9.37
8.46
0.000
9.55
8.28
0.001
2.76
NA
<0.001
Regression
Coefficient
Predicted
Change DBP
(mm Hg)
Constant
11.90
NA
0.010
7.71
19.61
0.039
6.65
18.55
0.080
Education on medications
5.70
17.60
0.003
Length of intervention
0.04
10.13
0.060
3.12
8.78
0.051
4.63
7.27
0.006
7.87
4.03
0.044
7.96
3.94
0.041
**
Carter et al.
Page 16
Table 2
Type of Quality
Improvement
Free medications
Education on BP
medications
8.75**[11.90, 4.25]
n = 288, 17-23, 26-30, 32, 34, 35, 37, 39-44, 46-50
3.60**[7.03, 1.00]
n = 278, 17, 18, 20-23, 26-30, 32, 34, 35, 37, 39-44,
46-50
Pharmacist did
intervention
50
50
Counseling on lifestyle
modification
Provider in intervention
could order laboratory
3.68 [5.40,0.15]
n = 916, 22, 25, 31, 33, 44, 48-50
Provider of intervention
could prescribe
medication
Pharmacist
recommended
medication to physician
Assessed medication
compliance
Physical examination
was conducted
#
When n = 2, brackets show the actual results of each study rather than interpolated interquartile range.
p < 0.10
**
p < 0.05 for Mann-Whitney analysis of reduction in systolic blood pressure and diastolic blood pressure comparing studies with the quality
improvement strategy with those without it.
Arch Intern Med. Author manuscript; available in PMC 2010 October 26.