Genetically competent care for those with chronic illnesses

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Review

E ffe c ts o f N u rs e -M a n a g e d P ro to c o ls in th e O u tp a tie n t M a n a g e m e n t o f A dults W ith C h ro n ic C onditions A System atic Review and M eta-analysis R yan J. S h a w , P h D , RN; J e n n ife r R. M c D u f f ie , PhD ; C ris tin a C. H e n d rix , D N S , NP; A lis o n Edie, D N P , FNP; L in d a L in d s e y -D a v is , P h D , RN; A v is h e k N a g i, M S ; A n d rz e j S. K o sin ski, PhD ; an d Joh n W . W illia m s Jr., M D , M H S c

Background: C h an ges in fe d e ra l h e a lth p o lic y are p ro v id in g m o re access t o m ed ica l care f o r persons w ith c h ro n ic disease. P ro v id in g q u a lity care m a y re q u ire a te a m a p p ro a c h , w h ic h th e A m e ric a n C o lle g e o f Physicians calls th e "m e d ic a l h o m e ." O n e n e w m o d e l m a y in v o lv e n u rs e -m a n a g e d p ro to cols.

Purpose: T o d e te rm in e w h e th e r n u rs e -m a n a g e d p ro to c o ls are e f fe c tiv e f o r o u tp a tie n t m a n a g e m e n t o f a d u lts w ith diabetes, h y p e r te n s io n , an d h y p e rlip id e m ia .

Data Sources: MEDLINE, C o c h ra n e C e n tra l R egister o f C o n tro lle d Trials, EMBASE, a n d CINAHL fro m Jan ua ry 1 9 8 0 t h ro u g h January 2 0 1 4 .

Study Selection: T w o review e rs used e lig ib ility c rite ria t o assess all title s , ab stracts, a n d fu ll te x ts an d resolved dis a g re e m e n ts by dis cussion o r b y c o n s u ltin g a th ird review e r.

Data Extraction: O n e re v ie w e r d id d a ta a b s tra c tio n s a n d q u a lity assessments, w h ic h w e re c o n firm e d b y a s econd review e r.

Data Synthesis: F rom 2 9 5 4 studies, 1 8 w e re in c lu d e d . A ll studies used a reg istere d nurse o r e q u iv a le n t w h o titra te d m e d ic a tio n s by

f o llo w in g a p ro to c o l. In a m e ta-a na lysis, h e m o g lo b in A 1c level d e creased b y 0 .4 % (9 5 % C l, 0 .1 % t o 0 . 7 % ) (n = 8); systolic and d ia s to lic b lo o d pressure decreased b y 3 .6 8 m m H g (C l, 1 .0 5 to 6.31 m m H g ) an d 1 .5 6 m m H g (C l, 0 .3 6 t o 2 .7 6 m m H g), re s p ective ly (n = 12); to ta l cho le s te ro l level decreased b y 0 .2 4 m m o l/L (9 .3 7 m g /d L ) (C l, 0 . 5 4 - m m o l/L decrease t o 0 .0 5 - m m o l/L increase [ 2 0 .7 7 - m g / d L decrease t o 2 . 0 2 - m g / d L increase]) (n = 9); a n d lo w -d e n s ity -lip o p ro te in c h o le ste rol level decreased b y 0.31 m m o l/L (1 2 .0 7 m g /d L ) (C l, 0 . 7 3 - m m o l/L decrease t o 0 .1 1 - m m o l/L increase [ 2 8 .2 7 - m g / d L decrease t o 4 . 1 3 - m g / d L increase]) (n = 6).

Limitation: Studies had lim ite d de s c rip tio n s o f th e in te rv e n tio n s an d p ro to c o ls used.

Conclusion: A te a m a p p ro a c h t h a t uses n u rs e -m a n a g e d p ro to c o ls m a y ha ve p o s itiv e e ffe c ts o n th e o u tp a tie n t m a n a g e m e n t o f a d u lts w ith c h ro n ic c o n d itio n s , such as diabetes, h y p e rte n s io n , an d h y p e rlip id e m ia .

Primary Funding Source: U.S. D e p a rtm e n t o f V e te ra n s A ffa irs.

Ann Intern Med. 2014;161:113-121. d o i:10.7 326 /M 13 -256 7 www.annals.org For author affiliations, see end o f text.

M edical management of chronic illness consumes 75% of every health care dollar spent in the United States (1). Thus, provision of economical and accessible— yet

high-quality— care is a major concern. Diabetes mellitus, hypertension, and hyperlipidemia are prime examples of chronic diseases that cause substantial morbidity and mor tality (2, 3) and require long-term medical management. For each of these disorders, most care occurs in outpatient settings where well-established clinical practice guidelines are available (4—7). Despite the availability o f these guide lines, there are important gaps between the care recom mended and the care delivered (8-10). The shortage of primary care clinicians has been identified as 1 barrier to the provision of comprehensive care for chronic disease (11, 12) and is an impetus to develop strategies for expand ing the roles and responsibilities o f other interdisciplinary team members to help meet this increasing need.

The patient-centered medical home concept was de veloped in an effort to serve more persons and improve chronic disease care. It is a model of primary care transfor mation that builds on other efforts, such as the chronic care model (13), and includes the following elements: patient-centered orientation toward the whole person, team-based care coordinated across the health care system and community, enhanced access to care, and a systems- based approach to quality and safety. Care teams may in clude nurses, primary care providers, pharmacists, and be- w w w .annals.org

havioral health specialists. An organizing principle for care teams is to utilize personnel at the highest level of their skill set, which is particularly relevant given the expected in crease in demand for primary care services resulting from the Patient Protection and Affordable Care Act.

W ith this increased demand, the largest health care workforce, registered nurses (RNs), may be a valuable asset alongside other nonphysician clinicians, including physi cian assistants, nurse practitioners, and clinical pharma cists, to serve more persons and improve chronic disease care. Robust evidence supports the effectiveness o f nurses in providing patient education about chronic disease and secondary prevention strategies (14-19). W ith clearly de fined protocols and training, nurses may also be able to order relevant diagnostic tests, adjust routine medications, and appropriately refer patients.

O ur purpose was to synthesize the current literature describing the effects o f nurse-managed protocols, includ-

S ee a ls o :

E d ito r ia l c o m m e n t .....................................................................153

W e b - O n ly S u p p le m e n t s

C M E q u iz

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Figure 1. S u m m a r y o f e v id e n c e s e a rc h a n d s e le c tio n .

I n c l u d e d ( n = 2 0 )

U n i q u e s t u d i e s : 1 8

C o m p a n i o n a r t i c l e s : 2 *

* Methods or follow-up articles.

ing medication adjustment, for the outpatient manage ment o f adults with common chronic conditions, namely diabetes, hypertension, and hyperlipidemia.

M e t h o d s

W e followed a standard protocol for all steps o f this review. A technical report that fully details our methods and presents results for all original research questions is available at www.hsrd.research.va.gov/publications/esp /reports.cfm. D a t a S o u r c e s a n d S e a r c h e s

In consultation with a master librarian, we searched M ED LIN E (via PubMed), Cochrane Central Register of Controlled Trials, EMBASE, and CINAHL from 1 Janu ary 1980 through 31 January 2014 for English-language, peer-reviewed publications evaluating interventions that compared nurse-managed protocols with usual care in studies targeting adults with chronic conditions (Supple ment 1, available at www.annals.org).

W e selected exemplary articles and used a Medical Subject Heading analyzer to identify terms for “nurse pro tocols.” W e added selected free-text terms and validated search terms for randomized, controlled trials (RCTs) and quasi-experimental studies, and we searched bibliographies o f exemplary studies and applicable systematic reviews for missed publications (15, 17, 2 0 -2 9 ). To assess for publi cation bias, we searched ClinicalTrials.gov to identify com pleted but unpublished studies meeting our eligibility criteria. S t u d y S e l e c t i o n , D a t a E x t r a c t i o n , a n d Q u a l i t y

A s s e s s m e n t

Two reviewers used prespecified eligibility criteria to assess all titles and abstracts (Supplement 2, available at

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www.annals.org). Eligibility criteria included the involve ment of an RN or a licensed practical nurse (LPN) func tioning beyond the usual scope of practice, such as adjust ing medications and conducting interventions based on a written protocol. Potentially eligible articles were retrieved for further evaluation. Disagreements on inclusion or ex clusion were resolved by discussion or a third reviewer. Studies excluded at full-text review are listed in Supple ment 3 (available at www.annals.org). Abstraction and quality assessment were done by 1 reviewer and confirmed by a second. We piloted the abstraction forms, designed specifically for this review, on a sample of included articles. Key characteristics abstracted included patient descriptors, setting, features of the intervention and comparator, match between the sample and target populations, extent of the nurse interventionist’s training, outcomes, and quality ele ments. Supplements 4 and 5 (available at www.annals.org) summarize quality criteria and ratings, respectively.

Because many studies were done outside the United States, we queried the authors o f such studies about the education and scope of practice o f the nurse intervention ists. Authors were e-mailed a table detailing the credential- ing and scope of practice of various U.S. nurses and asked to classify their nurse interventionist.

D a t a S y n t h e s i s a n d A n a l y s i s

The primary outcomes were the effects of nurse- managed protocols on biophysical markers (for example, glycosylated hemoglobin or hemoglobin A lc [HbAlc]), pa tient treatment adherence, nurse protocol adherence, adverse effects, and resource use. W hen quantitative syn thesis (that is, meta-analysis) was feasible, dichotomous outcomes were combined using odds ratios and continuous outcomes were combined using mean differences in random-effects models. For studies with unique but con ceptually similar outcomes, such as ordering a guideline- indicated laboratory test, we synthesized outcomes across conditions if intervention effects were sufficiently homoge neous. We used the Knapp and H artung method (30, 31) to adjust the SEs of the estimated coefficients.

For categories with several potential outcomes (for ex ample, biophysical markers) that may vary across chronic conditions, we selected outcomes for each chronic condi tion a priori: H bA lc level for diabetes, blood pressure (BP) for hypertension, and cholesterol level for hyperlipidemia. In 1 example (32), we imputed missing SDs using esti mates from similar studies.

We computed summary estimates of effect and evalu ated statistical heterogeneity using the Cochran Q and I 2 statistics. We did subgroup analyses to examine potential sources o f heterogeneity, including where the study was conducted and intervention content. Subgroup analyses in volved indirect comparisons and were subject to confound ing; thus, results were interpreted cautiously. Publication bias was assessed using a ClinicalTrials.gov search and fun-

w w w .a n n a ls .o r g

E x c l u d e d a t t h e t i t l e / a b s t r a c t

le v e l ( n = 2 6 1 5 )

E x c l u d e d ( n = 3 1 9 )

N o t E n g l i s h , w e s t e r n i z e d c o u n t r y ,

o r f u l l p u b l i c a t i o n : 5 5

N o a d u l t s w i t h d i s e a s e o f i n t e r e s t

o r c o n d u c t e d in a n o u t p a t i e n t

m e d i c a l s e t t i n g : 2 9

I n e l i g i b l e s t u d y d e s i g n o r

c o m p a r a t o r : 7 5

N o i n t e r v e n t i o n o f in t e r e s t : 1 5 3

N o o u t c o m e o f in t e r e s t : 7

S e a r c h r e s u l t s o f

r e f e r e n c e s ( n = 2 9 5 4 )

R e t r i e v e d f o r

f u l l - t e x t r e v i e w

( n = 3 3 9 )

Nurse-Managed Protocols in Managing Outpatients With Chronic Conditions R e v i e w

nel plots when at least 10 studies were included in the analysis.

W hen quantitative synthesis was not feasible, we ana lyzed data qualitatively. We gave more weight to evidence from higher-quality studies with more precise estimates of effect. The qualitative syntheses identified and documented patterns in efficacy and safety of the intervention across conditions and outcome categories. We analyzed potential reasons for inconsistency in treatment effects across studies by evaluating variables, such as differences in study popu lation, intervention, comparator, and outcome definitions.

W e followed the approach recommended by the Agency for Healthcare Research and Quality (33) to eval uate the overall strength of the body o f evidence. This approach assesses the following 4 domains: risk o f bias, consistency, directness, and precision. These domains were considered qualitatively, and a summary rating o f high, moderate, low, or insufficient evidence was assigned. R o le o f th e F u n d in g Source

The Veterans Affairs Quality Enhancement Research Initiative funded the research but did not participate in the conduct of the study or the decision to submit the manu script for publication.

R e s u l t s

O ur electronic and manual searches identified 2954 unique citations (Figure 1). O f the 23 potentially eligible studies, 4 were excluded because we could not verify whether nurses had the authority to initiate or titrate med ications and the author did not respond to our query for clarification (34—37). We excluded a trial of older adults in which we could not differentiate the target illnesses (38). Approximately two thirds of the authors we contacted for missing data or clarification responded.

We included 18 unique studies (23 004 patients) that focused on patients with elevated cardiovascular risk (Ta ble) (32, 3 9 -5 5 ). O f these, 16 were RCTs and 2 were controlled before-and-after studies on diabetes (49, 53). The comparator was usual care in all but 1 study, in which a reverse-control design was used, and each intervention served as the control for the other. Eleven studies were done in Western Europe and 7 in the United States. Me dian age o f participants was 58.3 years (range, 37.2 to 72.1 years) based on 16 studies. Approximately 47% of the par ticipants were female. Race was not reported in 84% o f the studies. Supplement 5 gives detailed study characteristics. No outstanding studies were identified through Clinical- Trials.gov. Supplement 6 provides funnel plots that assess publication bias (available at www.annals.org).

Overall, these studies displayed moderate risk of bias. Two studies were judged as having a high risk o f bias because o f inadequate randomization (44, 53), 12 were moderate risk (32, 3 9 - 4 1 , 43, 47-52, 54), and 4 were low risk (42, 45, 46, 55). O ther design issues affecting risk-of- bias ratings were possible contamination from a concurrent

Table. Study and Patient Characteristics of Included Diabetes, Hypertension, and Hyperlipidem ia Studies

Characteristic Cardiovascular Risk Studies, n ( % )

Total Studies 18 Patients* 23 004

Design RCT 16 (89) Non-RCT 2 ( 1 1 )

Location

U nited States 7 ( 3 9 ) W estern Europe 11 (61)

S etting

General medical hospital 12 (67) Specialty hospital 3 (17) Primary clinic and specialty hospital 2 ( 1 1 ) Telephone- and clinic-delivered care 1 (5.5)

Inte rv ention Target

Glucose 15 (83) Blood pressure 11 (61) Lipids 9 ( 5 0 )

Delivery Clinic visits 15 (83) Primarily telephone 3 ( 1 7 )

D uration 6 m o 2 ( 1 1 ) 12 m o 8 (44.5) > 1 2 m o t 8 (44.5)

Nurse tra in in g Specialist* 3 ( 1 7 ) Received study-specific tra inin g 10 (55) Case m anager 1 (5.5) N o t described 4 ( 2 2 )

M e d ic a tio n in itia tio n 11 (61)

Education or behavioral strategy Education 1 6 (8 9 ) Specific behavioral s tra te g y ! 3 ( 1 7 ) Self-m anagem ent plan 9 ( 5 0 )

O u tc o m e

H em oglobin A 1c level 12 (67) Blood pressure 14 (78) Cholesterol level 1 5 (8 3 ) Performance measure 13 (72) Behavioral adherence 4 ( 2 2 ) Protocol adherence 1 (6)

Risk o f b ia s /q u a lity L o w /g o o d 4 ( 2 2 ) M o d e ra te /fa ir 12 (67) H ig h /p o o r 2 (11)

RCT — randomized, controlled trial. * Number of patients represents the total mean of 22 839 and 23 170 because in 1 included study (30), hypertension and hyperlipidemia results were reported on 2 different but overlapping populations due to randomization, t Range, 14-36 mo. $ Clinical certification or diabetes nurse educator. § Motivational interviewing.

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R e v i e w Nurse-Managed Protocols in Managing Outpatients W ith Chronic Conditions

F i g u r e 2 . Effects of nurse-managed protocols on hemoglobin A1c level.

Study, Year (Reference) Nurse Protocols Total, n Usual Care Total, n

Mean (SD) Mean

A u b e rte ta l, 1 9 9 8 (4 0 ) 7.10 (1.33) 51 8.20

Bellary et al, 2 0 0 8 (4 2 ) 8.20 (1.74) 868 8.35

H ouw e lin g et al, 2009 (47) -1 .5 0 (1.35) 46 -0 .9 0

H ouw e lin g et al, 2011 (46) -0 .0 9 (1.07) 102 0.03

M acM ahon e t al, 2009 (48) -0 .3 4 (0.97) 94 0.12

O 'H are et al, 2004 (52) -0 .2 3 (1.42) 182 -0 .2 0

Taylor e t al, 2003 (32) -1 .1 4 (1.35) 61 -0 .3 5

W allym ahm ed et al, 2011 (54) 9.30 (1.40) 40 9.70

Summary ( /2 = 69 .8% )

(SD)

W eighted Mean Difference

(95% Cl), %

-1 .1 0 (-1 .6 2 t o -0 .5 8 )

-0 .1 5 (-0 .3 3 to 0.03)

-0 .6 0 (-1 .1 5 t o -0 .0 5 )

-0 .1 2 (-0 .4 3 to 0.19)

-0 .4 6 (-0 .7 4 t o -0 .1 8 )

-0 .0 3 (-0 .3 4 to 0.28)

-0 .7 9 (-1 .2 4 t o -0 .3 4 )

-0 .4 0 (-0 .9 9 to 0.19)

-0 .4 0 (-0 .7 0 t o -0 .1 0 )

intervention, unblinded outcome assessors, and incomplete outcomes data. Characteristics o f the Interventions

All 18 study interventions used a protocol and re quired the nurse to titrate medications; however, only 11 reported that the nurse was independently allowed to ini tiate new medications. All but 1 study (55) provided the actual algorithm or citation. An RN (not an advanced practice RN) was the interventionist in all U.S. studies; a nurse with an equal scope o f practice was the intervention ist in the non-U.S. studies. N o studies reported use of LPNs. In 14 studies, interventions were delivered in a nurse-led clinic (3 9 -4 2 , 44, 4 6 -5 4 ). Supervisors were nearly always physicians. O f the studies reporting nurses’ training, 3 used specialists (for example, diabetes-certified), 10 used RNs with study-specific training, and 1 used nurse case managers with experience in coordinating long-term care.

Nurse protocols included additional components, such as education or self-management, in 16 studies. Two stud ies (41, 47) did not report additional intervention. Baseline characteristics showed that patients with diabetes had an elevated H bAlc level of approximately 8.0% or greater. Most patients with hypertension had moderate hyperten sion, and patients with hyperlipidemia had borderline high lipid levels. Outcomes were assessed at 6 to 36 months, with most studies reporting outcomes at 12 months or longer. D iabetes O utcom es

O f the 15 studies done in patients with diabetes, 10 RCTs (2633 patients) targeted glucose control. Figure 2 shows the forest plot o f the random-effects meta-analysis on H bA lc level. Compared with usual care, nurse-managed protocols decreased H bA lc levels by 0.4% (95% C l, 0.1% to 0.7%) (n = 8) and effects varied substantially (Q = 23.19; I 2 = 70%). In the 2 non-RCTs (49, 53) not in cluded in Figure 2, effects of the protocols on H bA lc level

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were larger and in the same direction but had higher vari ability. Thus, nurse-managed protocols were associated with a highly variable mean decrease in H bA lc level.

O ther diabetes-related performance measures were rarely reported (Supplement 6). In 1 controlled before- and-after study (53), achieving target eye examination, uri nary m icroalbumin-creatinine ratio, and foot examination goals was reported to reach 80% to 100% using nurse- managed protocols. A second study (49) found a nonsig nificant increase in intervention patients achieving eye and foot examination goals compared with control participants. Reduction in the proportion of patients with an H bA lc level o f 8.5% or greater was achieved in 1 study (odds ratio, 1.69 [Cl, 1.25 to 2.29]) (49).

BP O utcom es Fourteen studies reported BP outcomes: 13 RCTs

(10 362 patients) and 1 non-RCT (885 patients). Re stricted to the 12 RCTs specifically addressing BP (10 224 patients), the intervention decreased systolic BP by 3.68 mm Hg (Cl, 1.05 to —6.31 mm Hg) and diastolic BP by 1.56 mm H g (Cl, 0.36 to 2.76 mm Hg), with high vari ability (72 > 70%) (Figures 3 and 4). Funnel plots sug gested possible publication bias with systolic but not dia stolic BP (Supplement 6). Overall, nurse-managed protocols were associated with a mean decrease in systolic and diastolic BP.

Eleven of the 18 studies focused on achieving various target BPs: 10 RCTs (9707 patients) and 1 non-RCT (885 patients). W hen the analysis was restricted to RCTs, nurse- managed protocols were more likely to achieve target BP than control protocols (odds ratio, 1.41 [Cl, 0.98 to 2.02]), but these results could have been due to chance, and treatment effects were highly variable (Q = 35.20; / 2 = 74%) (Supplement 7, available at www.annals.org). Using the summary odds ratio and median event rate from the control group of the trials that implemented nurse pro tocols, we estimated the absolute treatment effect as a risk

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Nurse-Managed Protocols in Managing Outpatients W ith Chronic Conditions R e v i e w

difference o f 120 more patients achieving target total BP per 1000 patients (Cl, 6 fewer to 244 more). Funnel plots suggested some asymmetry but no clear publication bias. H y p e r l i p i d e m i a O u t c o m e s

Fifteen studies reported hyperlipidemia outcomes: 13 RCTs (14 817 patients) and 2 non-RCTs (1114 patients). O f these, 9 RCTs (3494 patients) specifically addressed total cholesterol levels and 6 RCTs specifically addressed low-density lipoprotein levels (1095 patients). In analyses restricted to these trials, the intervention was associated with a decrease in total cholesterol level. Total cholesterol levels decreased by 0.24 mmol/L (9.37 mg/dL) (Cl, 0.54- mmol/L decrease to 0.05-mmol/L increase [20.77-mg/dL decrease to 2.02-mg/dL increase]) [n = 9), and low- density lipoprotein cholesterol levels decreased by 0.31

mmol/L (12.07 mg/dL) (Cl, 0.73-mmol/L decrease to 0.11-mmol/L increase [28.27-mg/dL decrease to 4.13- mg/dL increase]) (n = 6), with marked variability in inter vention effects (72 > 89%) (Figure 4). Effects o f nurse- managed protocols on total and low-density lipoprotein cholesterol levels from the 2 non-RCTs (49, 53) were in the same direction. Reductions in total cholesterol level were not statistically significant. Overall, nurse-managed protocols were associated with a mean decrease in total and low-density lipoprotein cholesterol levels.

All 11 studies (9221 patients) targeting various total cholesterol levels were included in the quantitative analysis (Supplement 7). Nurse-managed protocols were statisti cally significantly more likely to achieve target total choles terol levels than control protocols (odds ratio, 1.54 [Cl,

Figure 3 . Effects o f n u rs e -m a n a g e d p ro tocols on systolic (to p ) an d d ia s to lic ( b o tto m ) b lo o d pressure.

Study, Year (Reference) Nurse Protocols Total, n Usual Care Total, n

Mean (SD) Mean (SD)

Bebb et al, 2007 (41) 143.30 (19.50) 743 143.10 (17.70) 677 Bellary et al, 2008 (42) 134.30 (20.36) 868 134.60 (20.36) 618 Denver et al, 2003 (44) 141.10 (19.30) 59 151.00 (21.90) 56 Houweling et al, 2009 (47) -8.60 (20.54) 46 -4.00 (14.91) 38 Houweling et al, 2011 (46) -7.40 (17.82) 102 -5.60 (16.45) 104 MacMahon et al, 2009 (48) -10.50 (17.45) 94 1.70 (19.39) 94 N ew et al, 2003 (51) 147.00 (20.23) 506 149.00 (20.23) 508 New et al, 2004 (50) 142.00 (24.00) 2474 142.17 (24.00) 2531 O'Hare et al, 2004 (52) -6.69 (21.24) 182 -2.11 (17.47) 179 Rudd et al, 2004 (55) -14.20 (16.23) 69 -5.70 (18.59) 68 Taylor et al, 2003 (32) 4.40 (17.45) 61 8.60 (19.39) 66 Wallymahmed et al, 2011 (54) 115.00 (13.00) 40 124.00 (14.00) 41

Summary (/2 = 75.1%)

- 2 0 I “1

-1 5 -1 0 - 5 0

Weighted Mean Difference, mm Hg

Weighted Mean Difference

(95% Cl), mm Hg

0.20 (-1.73 to 2.13) -0.30 (-2.40 to 1.80) -9.90 (-17.46 t o -2.34) -4.60 (-12.20 to 3.00) -1.80 (-6.49 to 2.89) -12.20 (-17.47 t o -6.93) -2.00 (-4.49 to 0.49) -0.17 (-1.50 to 1.16) -4.58 (-8.59 to -0,57) -8.50 (-14.35 t o -2.65) -4.20 (-10.61 to 2.21) -9.00 (-14.88 t o -3.12) -3.68 (-6.31 t o -1.05)

Study, Year (Reference) Nurse Protocols Total, n Usual Care Total, n

Mean (SD) Mean (SD)

Bebb et al, 2007 (41) 78.20 (10.20) 743 77.90 (10.40) 677 Bellary et al, 2008 (42) 78.40 (8.63) 868 80.31 (8.63) 618 Denver et al, 2003 (44) 79.90 (10.60) 59 82.20 (12.40) 56 Houweling et al, 2009 (47) -1.40 (9.09) 46 -2.40 (7.61) 38 Houweling et al, 2011 (46) -3.20 (10.18) 102 -1.00 (9.26) 104 MacMahon et al, 2009 (48) -5.90 (8.72) 94 -0.51 (9.69) 94 New et al, 2003 (51) 74.00 (11.29) 506 74.79 (11.29) 508 New et al, 2004 (50) 78.20 (16.06) 2474 78.11 (16.06) 2531 O'Hare et al, 2004 (52) -3.14 (10.56) 182 0.28 (10.00) 179 Rudd et al, 2004 (55) -6.50 (10.00) 69 -3.40 (7.90) 68 Taylor et al, 2003 (32) 2.20 (10.00) 61 1.90 (9.30) 66 Wallymahmed et al, 2011 (54) 65.00 (9.00) 40 69.00 (9.00) 41

Summary (/2 = 75.1 %)

Weighted Mean Difference

(95% Cl), mm Hg

0.30 (-0.77 to 1.37) -1.91 (-2.80 t o -1.02) -2.30 (-6.53 to 1.93) 1.00 (-2.57 to 4.57) -2.20 (-4.86 to 0.46) -5.39 (-8.03 to -2.75) -0.79 (-2.18 to 0.60) 0.09 (-0.80 to 0.98) -3.42 (-5.54 t o -1.30) -3.10 (-6.12 t o -0.08) 0.30 (-3.07 to 3.67) -4.00 (-7.92 to -0.08) -1.56 (-2.76 t o -0.36)

I---------------- 1----------------- -1 0 - 5 0

Weighted Mean Difference, mm Hg

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R e v i e w Nurse-Managed Protocols in Managing Outpatients W ith Chronic Conditions

F ig u re 4. E ffe c ts o f n u r s e - m a n a g e d p ro to c o ls o n t o t a l c h o le s te r o l ( t o p ) a n d l o w - d e n s i t y lip o p r o t e in c h o le s te r o l ( b o t t o m ) le v e ls .

Study, Year (Reference) Nurse Protocols

Mean (SD)

Total, n Usual Care

Mean (SD)

Total, n

Allison etal, 1999 (39) -19.00 (35.00) 80 -16.00 (35.00) 72 Bellary et al, 2008 (42) 181.50 (26.08) 868 180.35 (26.08) 618 DeBusk etal, 1994 (43) 184.55 (32.05) 243 208.88 (40.54) 244 Houweling et al, 2009 (47) -15.44 (26.00) 46 -34.74 (46.94) 38 Houweling et al, 2011 (46) -3.86 (39.30) 102 -1.93 (29.77) 104 MacMahon et al, 2009 (48) -26.64 (37.45) 94 -6.17 (37.45) 94 New etal, 2003 (51) 189.20 (41.20) 345 200.01 (41.20) 338 Taylor et al, 2003 (32) -20.60 (26.00) 61 -11.50 (29.00) 66 Wallymahmed et al, 2011 (54)

Summary U2 = 90.8%) 166.00 (38.60) 40 200.80 (38.60) 41

Weighted Mean Difference

(95% Cl), mg/dL

-3.00 (-14.14 to 8.14) 1.15 (-1.54 to 3.84) -24.33 (-30.82 to -17.84) 19.30 (2.59 to 36.01) -1.93 (-11.47 to 7.61) -20.47 (-31.18 to -9.76) -10.81 (-16.99 to -4.63) -9.10 (-18.67 to 0.47) -34.80 (-51.61 to -17.99) -9.37 (-20.77 to 2.02)

-----1----- - 4 0 - 2 0 0 2 0

Weighted Mean Difference, mg/dL

Study, Year (Reference) Nurse Protocols Total, n Usual Care Total, n

Mean (SD) Mean (SD)

Allison et al, 1999 (39) -21.00 (31.00) 80 -23.00 (30.00) 72 I DeBusk etal, 1994 (43) 106.95 (26.64) 243 131.66 (34.75) 244 ■ • Houweling et al, 2009 (47) -11.58 (26.03) 46 -23.17 (30.51) 38 MacMahon et al, 2009 (48) -20.85 (37.45) 94 -0.39 (37.45) 94 I------------ ■-------- 1 Taylor etal, 2003 (32) -19.40 (31.00) 61 -6.50 (30.00) 66 I--------■— Wallymahmed et al, 2011 (54) 84.94 (30.89) 40 111.97 (30.89) 41 I- -------- ■---------- 1

Summary (I2 = 89.1%)

- 4 5 - 2 5 0 2 5

Weighted Mean Difference, mg/dL

Weighted Mean Difference

(95% Cl), mg/dL

2.00 (-7.70 to 11.70) -24.71 (-30.21 t o -19.21) 11.59 (-0.69 to 23.87) -20.46 (-31.17 t o -9.75) -12.90 (-23.53 to -2.27) -27.03 (-40.49 to -13.57) -12.07 (-28.27 to 4.13)

To convert mg/dL to mmol/L, multiply by 0.0259.

1.02 to 2.31]), with substantial variability in treatment effects (Q = 71.59; / 2 = 86%). Using the summary odds ratio and median event rate from the control group of the RCTs, we estimated the absolute treatment effect as a risk difference o f 106 more patients achieving target total cho lesterol levels per 1000 patients (Cl, 5 to 196). Funnel plots did not suggest publication bias (Supplement 6). P a tie n t A d h e re n c e to T r e a tm e n t

Behavioral adherence was reported in 4 studies (39, 43, 48, 49). In 1 study, the rate o f daily medication adher ence (±SE) for the intervention group during the 6-month study was 80.5% ± 23.0% compared with 69.2% ± 31.1% for the usual care group (P = 0.03) (55). When reported, effects on lifestyle changes and medication adher ence showed an overall pattern of small positive effects associated with nurse-managed protocols. A d h e re n c e to P ro to cols

Two studies (39, 52) reported data on nurses’ adher ence to treatment protocols. W hen compared with usual care, nurses instituted pharmacologic therapy for lipid management more often (39). O ’Hare and colleagues (52) found that hypoglycemic agents and antihypertensives, in-

1 1 8 15 July 2014 Annals o f Internal Medicine Volume 161 • Number 2

eluding angiotensin-converting enzyme inhibitors, angio tensin II antagonists, and statins, were started or doses were increased by nurses following treatment protocols more of ten than in usual care groups.

A d v e rs e Effects

The included studies had few reports on adverse effects associated with nurse-managed protocols. Only 1 study on diabetes in a U.S. H M O (40) reported adverse effects. Severe low blood glucose events were identical (1.5%) at baseline and increased similarly— 2.9% in the control group compared with 3.1% in the intervention group (P = 0.158).

R esource U se

Resource use was reported in only 3 studies (45, 47, 51). Houweling and colleagues (47) found total salary costs (±SE) to be significantly lower in the intervention group (€114.6 ± €50.4) than in the control group (€138.3 ± €48.3; P < 0.001). In this same study, total costs for med ication were reported to be lower in the intervention groups (€136.3 ± €91.9) than in the control group (€149.0 ± €94.4; P > 0.05) at study completion.

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Nurse-Managed Protocols in Managing Outpatients W ith Chronic Conditions R e v i e w

Inpatient costs were reported to be substantially lower in 2 other studies. O ne study (45) estimated total inpatient costs for the intervention group at $869 535 compared with $1 702 682 for the control group (P = 0.02). The second study (51) reported decreases in costs by sex, with the intervention groups achieving a decrease o f $606 for men and $888 for women. Further, total outpatient costs were reported at $1 237 270 in the nurse-managed proto col group compared with $1 381 900 in the control group ( P = 0.47) (51).

S u b g ro u p A n a ly s is

W e did subgroup analyses comparing studies that were conducted in the United States compared with other coun tries, had targeted H bA lc alone compared with multiple conditions, and incorporated self-management plans com pared with those that did not. These analyses showed greater effects on decreasing H bA lc level only for studies done on diabetes management in the United States (—0.92 vs. —0.23; P — 0.01). Treatment variability was reduced in these subgroups. Therefore, some variability in diabetes care may be explained by country or specificity o f the in tervention. For BP and cholesterol, subgroup analysis found no statistically significant differences in treatment effects. We planned to conduct subgroup analyses examin ing the intervention primarily by clinic visits compared with telephone calls, but variability in the results was insufficient.

D i s c u s s i o n

Nurse-managed protocols in the studies we examined had a consistently positive effect on chronically ill patients. Hemoglobin A lc levels decreased by approximately 0.4% (moderate strength of evidence [SOE]). Systolic and dia stolic BP decreased by 4 mm Hg and 2 mm Hg, respec tively (moderate SOE). Total cholesterol levels decreased by 0.24 mmol/L (9.37 mg/dL), and low-density lipopro tein cholesterol levels decreased by 0.31 mmol/L (12.07 mg/dL) (low SOE). Im portant differences were found in treatment effects across studies for most outcomes. Sub group analyses explained little of this variability and showed differences only for effects on H bA lc level between non—U.S.-based and U.S.-based studies. Effects o f nurse- managed protocols on lifestyle changes and medication ad herence were reported infrequently, but when reported, they showed an overall pattern o f small positive effects (low SOE).

T he SOE was insufficient to estimate a treatment ef fect for all other outcomes: protocol adherence, adverse effects, and resource use. Indirect evidence (for example, proportion o f patients prescribed the indicated medication) suggests reasonable adherence to the protocol by nurses. Although these studies showed protocol adherence by nurses in intervention groups compared with control par ticipants, the SOE on nurse adherence was judged to be insufficient. Further, only 1 o f the 18 studies reported ad- w w w . a n n a l s . o r g

verse effects (40); therefore, the SOE was judged to be insufficient to determine the effect of nurse-managed pro tocols on adverse effects in treatment studies about chronic disease. Finally, resource use was reported in only 3 studies (45, 47, 51), so the evidence is insufficient to determine any effect.

O ur study has many strengths, including a protocol- driven review, a comprehensive search, careful quality as sessment, and rigorous quantitative synthesis methods. However, our report and the literature also have limita tions. Because inclusion criteria required medication titra tion, we may have missed studies in which nurses had autonomy to practice in other capacities beyond their scope of practice. We did not include studies of inpatient settings in which nurses might often use protocols. The literature lacked detailed descriptions of the interventions and protocols used. Studies had limited descriptions of in tervention intensity; treatment adherence; nurses’ educa tion levels, training, or supervision; protocol adherence; adverse effects; and resource use. Eleven of the 18 studies were done in countries outside the United States, which may limit applicability to U.S practices. O ther perfor mance measures were rarely reported. Studies were limited to the use of RNs; there was no report of using LPNs. Finally, the reported outcomes varied across studies and contributed to unexplained variability.

W ith changes in federal health policy, new models are needed to provide more accessible and effective chronic disease care. The implementation of a patient-centered medical home model will play a critical role in reconfigur ing team-based care and will expand the responsibilities of team members. O ur review shows that team approaches using nurse-managed protocols help improve health out comes among patients with moderately severe diabetes, hy pertension, and hyperlipidemia. In addition, RNs can suc cessfully titrate medications according to protocols for these conditions. Similar results were found on the effects o f quality improvement strategies on glycemic control in type 2 diabetes where case managers did not have to wait for physician approval to adjust medications (56). Further research is needed to understand the effects o f nurse- managed protocols in caring for complex or unstable pa tients. Supplement 8 (available at www.annals.org) pres ents a detailed table of identified evidence gaps and a framework for future research.

As the largest health care workforce group, nurses are in an ideal position to collaborate with other team mem bers in the delivery o f more accessible and effective chronic disease care. Team members, such as clinical pharmacists, may also be able to serve in similar capacities and in areas with limited health care resources (57). Thus, health care systems will need to balance the benefits and costs associ ated with each team member and determine who is best suited to take on these expanded roles. Results from our review suggest that nurse-managed protocols have positive

15 July 2014 Annals o f Internal Medicine Volume 161 • Number 2 1 1 9

Review Nurse-Managed Protocols in Managing Outpatients With Chronic Conditions

effects on outpatient care of adults with chronic conditions.

F ro m D u rh a m V eterans Affairs C e n te r for H e a lth Services Research in P rim ary Care; G eriatric Research, E d u c a tio n , a n d C linical C e n te r, D u r h a m V eterans Affairs M edical C e n te r; a n d D u k e U niversity, D u rh a m , N o r th C arolina.

D is c la im e r: T h e c o n te n t is solely th e responsibility o f th e au th o rs a n d does n o t necessarily represent th e official views o f U .S. D e p a rtm e n t o f V eterans Affairs o r D u k e U niversity. Ail w ork herein is original. All au th o rs m eet th e criteria for a u th o rsh ip , in c lu d in g acceptance o f resp o n sibility for th e scientific c o n te n t o f th e m a n u scrip t.

A c k n o w le d g m e n t: T h e au th o rs th a n k C o n n ie S ch ard t, M LS, for help w ith the litera tu re search a n d retrieval a n d Liz W in g , M A , for editorial assistance.

F in a n c ia l S upport: T h is re p o rt is based o n research c o n d u c te d by th e Evidence-based Synthesis P ro g ram (ESP) C e n te r located at the D u rh a m V eterans Affairs M edical C e n te r, D u rh a m , N o r th C a ro lin a, w h ich is fu n d e d by th e D e p a rtm e n t o f V eterans Affairs, V eterans H e a lth A d m in istration, O ffice o f R esearch a n d D ev elo p m en t, H e a lth Services Research a n d D ev e lo p m e n t (VA-ESP P roject 0 9 -0 1 0 ; 20 1 3 ). T h e first au th o r, D r. R yan Shaw, was su p p o rte d by a D e p a rtm e n t o f V eterans Affairs H e a lth Services Research a n d D ev e lo p m e n t O ffice o f A cadem ic Affiliations n u rsin g p o std o c to ral research aw ard (T P P -2 1 -0 2 1 ).

D isclosu res: D r. W illiam s reports grants fro m V eterans Affairs H e a lth Services Research a n d D e v e lo p m e n t d u rin g th e c o n d u c t o f th e study. A u th o rs n o t n a m e d here have disclosed n o conflicts o f interest. D isclosures can be view ed at w w w .ac p o n lin e .o rg /au th o rs/icm je/C o n flict O f ln te re s tF o tm s .d o ? m s N u m = M 13-2567.

R equests f o r S in g le R eprints: R yan J. Shaw, P h D , R N , H e a lth Services Research a n d D ev e lo p m e n t (1 5 2 ), 411 W e st C h a p el H ill Street, Suite 6 0 0 , D u rh a m , N C 2 7 7 0 1 ; e-m ail, ryan.shaw @ duke.edu.

C u rre n t a u th o r addresses a n d a u th o r c o n trib u tio n s are available at w w w .annals.org.

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