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Journal of Evaluation in Clinical Practice ISSN 1365-2753
S Y S T E M AT I C R E V I E W
The effectiveness and cost-effectiveness of clinical nurse specialists in outpatient roles: a systematic review Kelley Kilpatrick RN PhD,1,5,6 Sharon Kaasalainen RN PhD,7 Faith Donald NP-PHC PhD,1,13 Kim Reid MSc,14 Nancy Carter RN PhD,1,8 Denise Bryant-Lukosius RN PhD,2,7,11 Ruth Martin-Misener RN-NP PhD,2,15 Patricia Harbman NP-PHC PhD,1,8,16 Deborah Anne Marshall PhD MHSA,17,18 Renee Charbonneau-Smith RN MSc3,9 and Alba DiCenso RN PhD4,10,12 1 Affiliate Faculty, 2Co-Director, 3Knowledge Exchange Specialist, 4Professor Emeritus, Canadian Centre for Advanced Practice Nursing Research, Hamilton, Ontario, Canada 5 Assistant Professor, Faculty of Nursing, Université de Montreal, Montreal, Quebec, Canada 6 Researcher, Hôpital Maisonneuve-Rosemont Research Centre, Montreal, Quebec, Canada 7 Associate Professor, 8Assistant Professor, 9Knowledge Exchange Specialist, 10Professor Emeritus, School of Nursing, McMaster University, Hamilton, Ontario, Canada 11 Associate Professor, Department of Oncology, McMaster University, Hamilton, Ontario, Canada 12 Professor Emeritus, Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada 13 Associate Professor, Daphne Cockwell School of Nursing, Ryerson University, Toronto, Ontario, Canada 14 Director, KJ Research, Rosemere, Quebec, Canada 15 Associate Professor, School of Nursing, Dalhousie University, Halifax, Nova Scotia, Canada 16 Postdoctoral Fellow, Health Interventions Research Centre, Ryerson University, Toronto, Ontario, Canada 17 Canada Research Chair, Health Services and Systems Research, University of Calgary, Calgary, Alberta, Canada 18 Associate Professor, Department of Community Health Sciences, Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada
Keywords ambulatory care, clinical nurse specialist, cost-effectiveness, economic evaluation, health services research, nurse specialist, nursing, outpatient care, systematic reviews Correspondence Dr Kelley Kilpatrick Hopital Maisonneuve-Rosemont Montreal, Quebec H1T 2M4 Canada E-mail: [email protected] Accepted for publication: 27 May 2014 doi:10.1111/jep.12219
Abstract Rationale, aims and objectives Increasing numbers of clinical nurse specialists (CNSs) are working in outpatient settings. The objective of this paper is to describe a systematic review of randomized controlled trials (RCTs) evaluating the cost-effectiveness of CNSs delivering outpatient care in alternative or complementary provider roles. Methods We searched CINAHL, MEDLINE, EMBASE and seven other electronic databases, 1980 to July 2012 and hand-searched bibliographies and key journals. RCTs that evaluated formally trained CNSs and health system outcomes were included. Study quality was assessed using the Cochrane risk of bias tool and the Quality of Health Economic Studies instrument. We used the Grading of Recommendations Assessment, Development and Evaluation to assess quality of evidence for individual outcomes. Results Eleven RCTs, four evaluating alternative provider (n = 683 participants) and seven evaluating complementary provider roles (n = 1464 participants), were identified. Results of the alternative provider RCTs (low-to-moderate quality evidence) were fairly consistent across study populations with similar patient outcomes to usual care, some evidence of reduced resource use and costs, and two economic analyses (one fair and one high quality) favouring CNS care. Results of the complementary provider RCTs (low-to-moderate quality evidence) were also fairly consistent across study populations with similar or improved patient outcomes and mostly similar health system outcomes when compared with usual care; however, the economic analyses were weak. Conclusions Low-to-moderate quality evidence supports the effectiveness and two fairto-high quality economic analyses support the cost-effectiveness of outpatient alternative provider CNSs. Low-to-moderate quality evidence supports the effectiveness of outpatient complementary provider CNSs; however, robust economic evaluations are needed to address cost-effectiveness.
Introduction The clinical nurse specialist (CNS) is an internationally recognized advanced practice nursing role introduced in the 1960s [1]. With 1106
specialty-based knowledge [2,3], CNSs provide leadership, administrative, research and educational supports to health care teams, organizations and health care systems [4]. Their substantive areas of practice include the management and care of complex and
Journal of Evaluation in Clinical Practice 20 (2014) 1106–1123 © 2014 John Wiley & Sons, Ltd.
K. Kilpatrick et al.
vulnerable populations, the education and support of interprofessional staff, and facilitation of change within health care systems [5]. They deliver expert clinical care to patients, families and communities and support teams to provide optimal care through the use of best evidence and improved care processes [6,7]. The educational preparation of CNSs influences their role development. There is consensus in the literature that CNSs should be prepared at the graduate level [8]. Graduate-prepared CNSs report spending significantly more time in research, leadership and professional development activities [9] and they incorporate population trends and related policy and programme development in their roles [10]. Historically, CNSs have worked in acute care; however, many now work in the community [11]. In fact, a recent survey of CNSs in Canada revealed that about 40% are in community-based settings [9]. While reviews of CNS effectiveness have shown that CNSs are associated with improved outcomes [7,12,13], none have focused specifically on the CNS role in outpatient settings or the cost-effectiveness of the role. We conducted a multi-component systematic review of randomized controlled trials (RCTs), entitled ‘A systematic review of the cost-effectiveness of nurse practitioners and clinical nurse specialists: 1980 to July 2012’. We assessed the cost-effectiveness of CNSs and nurse practitioners (NPs) in different settings (inpatient, outpatient and transition) and roles (alternative and complementary) [14]. In this paper, we summarize the results of RCTs evaluating the cost-effectiveness of CNSs delivering outpatient care in alternative or complementary roles and formulate recommendations based on the evidence.
Cost-effectiveness of outpatient CNSs
in the context of patient and provider outcomes, additional outcomes of interest were patient (e.g. health status) and provider (e.g. quality of care) measures. Studies were excluded if they did not include cost or a health system utilization outcome.
Information sources and search We worked with a medical librarian to develop comprehensive search strategies and to search bibliographic databases from 1980 to 31 July 2012 with no restrictions on country, language or publication status. We searched CINAHL, MEDLINE, EMBASE, and seven other electronic databases. We hand-searched journals in which CNS-related RCTs had been published, reviewed reference lists, contacted authors, and searched personal files and websites of nursing research and professional organizations. An in-depth description of search strategy and methods can be found in Donald et al. (under review) [14].
Study selection We uploaded citations to the web-based reference management program, RefWorks, and removed duplicate entries. Two-member teams independently screened the titles and abstracts for relevance. Those deemed relevant by either reviewer moved on to full-text review. Two-member teams independently screened the full texts and resolved discrepancies through discussion. A list of excluded studies with reason for exclusion is available on request.
Data extraction
Methods Study eligibility for inclusion We included RCTs that compared CNS outpatient care with usual care. Studies that claimed to be RCTs but did not use true randomization (e.g. allocation by day of week) were excluded. We were interested in participants of any age receiving care in all types, sizes and locations of community agencies (e.g. outpatient clinics). To be considered a CNS, the paper had to specify that the nurse had completed a graduate degree and the role reflected the CNS role definition. If the formal training of the nurse was not specified, authors were contacted. Studies were excluded if the training failed to meet our criteria or if we could not contact the author despite repeated attempts. We excluded studies if the CNS contribution could not be isolated from that of other providers and if the control group was also exposed to a CNS intervention. We included studies in which the CNS was functioning in an alternative or complementary provider role. CNSs in alternative roles provide similar services to those for whom they substitute, usually doctors. This role is evaluated through non-inferiority trials designed to determine if the new role is at least as good as or not unacceptably worse than the comparator. CNSs in complementary roles augment existing services [15] and this role is evaluated through superiority trials designed to determine if the new role results in improved outcomes compared with usual care. The primary outcome of interest was health system utilization including health resource use (e.g. emergency department visits, hospitalizations) and/or costs of health care (e.g. outpatient, inpatient). Because it is important to examine health system utilization
© 2014 John Wiley & Sons, Ltd.
A research assistant extracted data from each study regarding study characteristics, participants, intervention, outcome, length of follow-up, proportion followed to study completion and study findings. To ensure the accuracy and completeness of extracted data, research team members reviewed all data extractions. If a study was reported in multiple papers, they were extracted as one.
Quality assessment Two team members (KR and AD) independently assessed the quality of the study methods using a slightly modified version of the Cochrane risk of bias criteria [14,16]. Disagreements were resolved through discussion. We attempted to contact authors if additional information was required. Each study was assessed for overall risk of bias and categorized as low (at risk in 0–1 category), moderate (at risk in 2–3 categories), high (at risk in 4–6 categories) and very high (at risk in 7–8 categories). Two research assistants, trained by the health economist researcher (DM), independently rated the health economic quality of each study using the 16-item Quality of Health Economic Studies (QHES) instrument [17]. Discrepancies were resolved by discussion and consultation with the health economist. A summary score was generated with 0 indicating extremely poor quality and 100 indicating excellent quality. Studies were classified as extremely poor (0 to 24), poor (25 to 49), fair (50 to 74) and high (75 to 100) [18]. An in-depth assessment of the economic evaluation methods can be found in Marshall et al. [19]. Where data permitted, the quality of evidence for each outcome was evaluated using Grading of Recommendations Assess1107
Cost-effectiveness of outpatient CNSs
ment, Development and Evaluation (GRADE) system [20] and GRADEpro software (see http://tech.cochrane.org/revman/otherresources/gradepro/about-gradepro). Results of RCTs were considered initially as ‘high level’ evidence and were downgraded based on potential risk of bias, inconsistency, indirectness, imprecision and publication bias. With each downgrade from high to moderate to low to very low, the level of confidence in the estimate of effect decreases and the likelihood that further research may change the estimate increases. A common criticism of CNS studies is the small number of CNSs evaluated in any one study or across the same outcome in multiple studies raising the concern that the results may not be generalizable. Therefore, we downgraded for indirectness when fewer than 10 CNSs were evaluated as we judged 10 to be the minimum number necessary to generalize results to CNSs in similar roles. To determine the extent of imprecision, we downgraded if the optimal information size (OIS) was not met or if the 95% confidence interval (CI) overlapped no effect but included important benefit or important harm [21]. The OIS represents the sample size that would be required for a single optimally powered study using a modest estimate of treatment effect. For dichotomous outcomes, we calculated the OIS based on a relative risk difference of 20%. For continuous outcomes, we calculated the OIS using accepted minimal important differences (MIDs) and if none were identified, we extrapolated from an established MID of 0.5 points for a 7-point quality of life scale [22] for scale-based outcomes and assumed a MID of 20% of the control group mean for other continuous outcomes. For length of stay, we assumed a MID of 1.0 day. If the OIS criterion was met and the CI overlapped no difference, we judged those that were more than 20% above or below the baseline risk as imprecise for dichotomous data and those that exceeded the MID as imprecise for continuous outcomes. In cases where the quality of evidence would be downgraded for indirectness (≤10 CNSs) and for imprecision (OIS not met), we assumed a quality of evidence of ‘at most low level’. We did not apply GRADE in instances when the data required to calculate the OIS were not provided.
Results We identified 4397 unique reports and of these, 3981 were excluded during the title and abstract review and 351 were excluded during the full-text review (Fig. 1). Ultimately, 43 RCTs described in 65 papers were included in the overall review, 18 of which evaluated NPs and 25 of which evaluated CNSs [14]. Of the 25 RCTs of CNSs, 11 evaluated CNSs in an outpatient role. Below, we summarize these 11 RCTs beginning with those evaluating the alternative followed by those evaluating the complementary role.
Alternative provider outpatient CNS role The four RCTs that evaluated the alternative provider role [23–26] are described in Table 1. Three trials compared CNSs with doctors in the care of children with asthma [23], patients with diabetes [24] and men with bladder or prostate cancer undergoing radical radiotherapy [25]. One study compared CNS outpatient care with two modes of interprofessional hospital-based care for adults with rheumatoid arthritis [26]. Although in alternative provider roles, the CNSs in each of these studies relied on doctors for some part 1108
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of care management (e.g. making specialist referrals, changing drug management). Two studies evaluated one CNS [23,25], one evaluated four CNSs [24] and one evaluated six CNSs [26]. Given different study populations and outcomes across trials, we were not able to pool study findings. Tables 2 and 3 summarize patient and health system outcomes, respectively, for these four non-inferiority trials along with quality of evidence for each outcome to which we were able to apply GRADE. All outcomes were downgraded because of indirectness, and many were downgraded because of imprecision because they did not meet the OIS criterion. In a small study of 21 children with poorly controlled asthma, Alexander et al. [23] sought to reduce the use of the emergency room (ER) as a primary source of care. The CNS intervention, based on Orem’s self-care nursing model [27], involved counselling about early recognition of asthma exacerbations and self-care; medical management changes were made by the allergist. Significantly more CNS than doctor patients attended the 2-week post-ER follow-up visit and by 12 months, the CNS group had significantly fewer mean asthma-related ER visits per patient (both at most low-quality evidence). Other outcomes did not differ significantly. Arts et al. [24] randomized 337 patients with complex type 1 or 2 diabetes in a hospital-based outpatient clinic to CNSs who worked according to protocol or to doctors. At 2 years, there were no significant differences in patient outcomes (where GRADE applied, quality of evidence was at most low). The CNS group had significantly more consultations (i.e. patient visits; GRADE not applied) and longer consultations (moderate quality). Other health system outcomes did not differ significantly. The incremental costeffectiveness ratio (ICER) was €3.61 less in direct costs (i.e. costs directly related to actions and decisions made by the CNS) but €20.34 more in overall costs (i.e. outpatient and inpatient costs for patient resource utilization in all related specialties) per qualityadjusted life year (QALY) gained for the CNS intervention compared with usual care. The authors noted that the lower ICER for direct costs indicated that the CNSs provided quantitatively more care while using fewer financial resources and suggested that the higher ICER for overall costs could be explained by a higher prevalence of diabetes-related complications in the CNS group at baseline that generated higher health care costs. Faithfull et al. [25] randomized 115 men with prostate or bladder cancer receiving radical radiotherapy in one cancer clinic to CNS or doctor care. Guided by a medication and symptom management protocol, the CNS provided information on early symptom recognition, what to expect from treatment and how to manage existing problems. At 12 weeks, most patient outcomes did not differ significantly between groups except for one symptom (less constipation) and greater satisfaction with care in the CNS group. The CNS group had significantly lower outpatient appointment, microbiology, total health service and total costs. The intervention was associated with a 31% cost saving. In a study of 210 patients with rheumatoid arthritis, Tijhuis et al. (reported in four papers [26,28–30]) compared CNS outpatient care with two hospital-based control groups. The first control received inpatient care in which a multidisciplinary team delivered tailored interventions consisting of education, physiotherapy and hydrotherapy to patients over 12 days, and the second control received day-patient care consisting of the same tailored intervention over 3
© 2014 John Wiley & Sons, Ltd.
Cost-effectiveness of outpatient CNSs
Idenficaon
K. Kilpatrick et al.
Addional records idenfied through other sources (key journals, author contacts, websites, personal files, reference lists) (n = 156)
Inial record review (tle and abstract) (n = 4397)
Screening
42]
Records idenfied through electronic database searching aer duplicates removed (n = 4241)
Reasons for exclusion at inial record review (n = 3981)
Full records retrieved for assessment of eligibility (n = 416) Reasons for exclusion at full record review (n = 351) Did not meet design criteria: 35 Did not meet intervenon criteria: 210 Did not meet design and intervenon criteria: 21 Did not meet outcomes criteria: 44 Could not isolate impact of the APN: 38 Study submied for publicaon/in press (author requested that study be included in future update): 3
Included
Eligibility
Did not meet design criteria: 2468 Did not meet intervenon criteria: 902 Did not meet design and intervenon criteria: 611
NP and CNS studies included Constellaon of studies = 15 (37 papers) Single studies = 28
CNS outpaent studies included Constellaon of studies = 2 (9 papers) Single studies = 9
Flow diagram adapted from Moher et al. (2009) [44] Figure 1 Identification relevant studies.
and
screening
of
weeks.The CNS, over 12 weeks, provided information about rheumatoid arthritis, made referrals to other providers and, in consultation with the rheumatologist, prescribed joint splints, adaptive equipment and house adaptations if needed. Unlike the study by Faithfull et al. [25], patient satisfaction at the end of treatment was significantly lower for the CNS group (at most low-quality evidence for inpatient comparison and moderate quality for day-patient comparison). The authors suggest that this might be because the treatment of inpatients and day-patients was more intensive, as they were treated by more providers over a shorter period of time. At 2 years, there were no significant differences in other patient outcomes. With respect to health system outcomes, significantly fewer CNS patients received home help than inpatient controls and the CNS group had significantly lower treatment, health care and societal costs than both control groups (at most low-quality evidence). There were no significant differences between groups in QALYs.
© 2014 John Wiley & Sons, Ltd.
Complementary provider outpatient CNS role Seven RCTs evaluated the complementary provider role [31–37] (Table 1). While two studies focused on patients with mental health issues [33,37], five studies each focused on different patient populations including heart failure [31], breast cancer [35], rheumatoid arthritis [36], high-risk pregnancy [32] and residents in nursing homes [34]. Four studies evaluated one CNS [31,33,34,36], one evaluated two CNSs [35], one evaluated three CNSs [32] and one evaluated nine CNSs [37]. Given different study populations and outcomes across trials, we were unable to pool study findings. Tables 4 and 5 summarize patient and health system outcomes for these seven superiority trials along with quality of evidence for each outcome to which we were able to apply GRADE. Because 10 CNSs filled the nine CNS positions in the study by Swindle et al. [37], outcomes for this study were not downgraded because of indirectness but all others 1109
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Study objective
To compare CNSs with paediatric residents in post-ED visit follow-up of poorly controlled, non-compliant asthmatic children who used the ED as their primary source of care.
To compare CNSs and doctors in the care of patients with type 1 or 2 diabetes.
To compare CNS and doctor care of men treated with radical radiotherapy for prostate and bladder cancer.
Alexander et al. (1988) [23] USA
Arts et al. (2012) [24] NL
Faithfull et al. (2001) [25] UK
Alternative provider role
Author, year, country
A single cancer treatment clinic in Sutton, UK (two clinics were planned but the second did not recruit patients)
Academic hospital in Maastricht, Netherlands, with a catchment area of 190 000 people
General paediatric allergy clinic at LeBonheur Children’s Medical Center, Memphis, Tennessee, USA
Study setting
Table 1 Characteristics of included studies (n = 11)
115 men undergoing radical (>60 Gy) radiotherapy for prostate or bladder cancer. Median age 70 years; 83% had adeno-carcinoma of the prostate
337 type 1 or 2 diabetes patients All required insulin treatment or oral blood glucose medication and had inadequate blood glucose, blood pressure or lipids regulation Mean age 59 years; 36.4% male; BMI 29.7 kg m−2; mean HbA1c 8.01%.
21 asthmatic children (15 months to 13 years) from low-income families who used the ED as their primary care source and had no regular doctor. Participants were similar in age, % male, ED visits prior to study, and all were Medicaid recipients.
Participants
CNS made initial assessments and then had open access clinics until completion of radiotherapy. Afterwards, CNS made telephone contacts. Responsibilities included provision of information, answering of questions, education on diet, radiotherapy and how to handle urinary symptoms. CNSs followed a study-developed protocol for medication and management of symptoms.
CNS was authorized to schedule own appointments and referrals, make referrals to a dietician, a regular diabetes nurse and an ophthalmologist. CNS could order diabetes-related clinical admissions; however, referrals to specialist care required a referral by one of the participating doctors.
Alternative care (n = 169; 149 analysed): Four CNSs provided limited usual care, working according to a protocol (CNSs were doctoral or masters prepared with extensive experience in diabetes care). Control (n = 168; 145 analysed): Usual care provided by five participating doctors.
Alternative care (n = 58): Single CNS-led care (masters prepared with expertise in radiotherapy toxicity management*). Control (n = 57): Conventional medical care provided by six doctors. Routine outpatient clinic visits twice per week until completion of treatment and then 12 weeks of follow-up appointments. Both groups had access to outpatient nurses and a radiotherapy nurse.
CNS assumed major responsibility for assessment, counselling and follow-up; however, medical management remained under the direct supervision of the Allergy Division of the hospital clinic. Responsibilities included assessment of family needs, counselling/teaching for preventive health measures with a focus on asthma exacerbations and self-care.
Intervention
Alternative care (n = 11): A single CNS promoted self-care based on the Orem Self-Care Nursing Model. Control (n = 10): Primary continuity care from paediatric residents and faculty.
Comparison groups
12 weeks
2 years
12 months
Length of follow-up
Cost-effectiveness of outpatient CNSs K. Kilpatrick et al.
© 2014 John Wiley & Sons, Ltd.
© 2014 John Wiley & Sons, Ltd.
To compare the effectiveness of care delivered by a CNS, inpatient team, and day-patient team in patients with rheumatoid arthritis who have increasing functional limitations.
Chien et al. (2012) [33] China
To compare a CNS-led needs-based psycho-education programme added to usual care with usual care for newly referred patients with mental health problems.
Complementary provider role
Tijhuis et al. (2002) [26] Tijhuis et al. (2003) [28,29] van den Hout et al. (2003) [30] NL
A regional psychiatric outpatient clinic in Hong Kong, China
Outpatient clinic of the rheumatology department of six academic and non-academic hospitals in the Netherlands
79 newly referred Adult (>18 years) patients with first-episode, moderate, noticeable psychiatric symptoms but at low risk of self-harm or violence. Excluded were those receiving other psycho-education or psychosocial intervention. Mean age 25 years; 51.9% male; and mean monthly household income was $13 170 (HKD; 1 USD = 7.8 HKD)
210 rheumatoid arthritis patients with increasing difficulty in performing activities of daily living over the previous 6 weeks. Excluded were those requiring immediate hospitalization or those with an inability to reach hospital by a set time point (1000 h). Mean age 58 years; 24.8% male; and median disease duration was 1.9 years.
Complementary care (n = 39): A single psychiatric CNS administered the nurse-led psycho-education programme (NPEP) in addition to routine care (masters prepared* with training in psychosocial interventions for patients with mental health problems; experience not reported) Control (n = 40): Routine psychiatric outpatient services included medical consultation and treatment planning with attending psychiatrist every 3–6 weeks, advice and brief education from psychiatric nurses on illness and available services, and two family education sessions by a social worker.
Alternative care (n = 71): Six CNSs, each assigned to a hospital outpatient clinic, provided care in addition to regular outpatient care. Control 1 (n = 71): Inpatients stayed in hospital for 12 consecutive days and were prescribed a 9-day tailored treatment programme within a 2-week period: multidisciplinary team care (involving nurses, a rheumatologist, occupational therapist, physical therapist and a social worker), written information, hour-long educational session, physical therapy, group exercises and hydrotherapy. Control 2 (n = 68): Day patients stayed for 3 weeks, 3 days a week from 1000 h to 1600 h and received the same multidisciplinary tailored 9-day treatment programme as the inpatients but over a 3-week period. CNS met patients for a total of six 1-hour sessions weekly or biweekly and made telephone contact between sessions. Intervention addressed the following themes: orientation and engaging, understanding mental health and illness, sleep, hygiene and allaying anxiety, psychiatric treatments and medications, problem-solving and coping with mental health problems, interpersonal and communication skills, family and community support resources and future plans. Responsibilities included design of a needs-based, multi-component education programme for symptom management and resolving life problems that was implemented 3–4 weeks before first clinic consultation, design of support system to link patient and family to services, and coordination of care.
CNS treated patients on average three times each over the 12-week (average) intervention period. Each visit took about 1 hour. Responsibilities included provision of disease information, referrals to other health professionals and prescription of joint splints, adaptive equipment and house adaptations in consultation with rheumatologist. Decisions to change or introduce disease-modifying drugs, optimize non-steroidal anti-inflammatory drugs, or to administer intra-articular corticosteroid injections were left to the attending rheumatologist
2 weeks
2 years
K. Kilpatrick et al. Cost-effectiveness of outpatient CNSs
1111
1112
To compare CNS support plus usual care with usual care alone in the care of women newly diagnosed with breast cancer.
To compare CNS consultation plus usual care with usual care alone in a drug monitoring clinic for patients with rheumatoid arthritis.
Ritz et al. (2000) [35] USA
Ryan et al. (2006) [36] UK
Rheumatology follow-up outpatient clinic at a district general hospital
An integrated health care system in a mid-western suburban community, Minnesota, USA
To compare a CNS-led A cardiologist practice in telephone-enhanced Lee County, rural disease management east-central Alabama, intervention plus usual USA care to usual care alone in reducing hospital admissions and improving quality of life and self-care behaviours in patients with heart failure.
Brandon et al. (2009) [31] USA
Two university-affiliated Veteran Affairs Medical Center general medicine clinic firms in Indiana, USA
To compare CNS plus usual care with usual care alone in the care of veterans with depression.
Swindle et al. (2003) [37] USA
71 patients with rheumatoid arthritis who were starting new disease-modifying anti-rheumatic drugs. Those who required hospital admission at the start were excluded. Mean age 58.1 years; 43.7% male; 64.8% not working; and 54.9% used NSAIDs
Complementary care (n = 36): A single rheumatology CNS (doctoral preparation with 16 years experience in rheumatology*) replaced the clinic nurse and used Pendelton’s framework to assess patient needs for safety monitoring. Control (n = 35): Usual care provided by an outpatient clinic nurse supported by a rheumatologist.
CNS replaced the outpatient clinic nurse and provided the same services plus additional responsibilities. Responsibilities included assessment of problems with coping with symptoms (e.g. pain) and difficulties with functional activities; and provision of guidance on analgesia, exercise, pacing activities, goal-setting and fatigue. CNS could refer patients to other professionals to help manage joint stiffness through exercises.
12 months.
CNS contacted patient within 2 weeks 24 months (quality of diagnosis and thereafter at of life measures scheduled clinic visits, telephone calls, analysed at 12 home visits, or patient-initiated visits. months because Responsibilities pre-operatively through of poor response to post-treatment follow-up focused rates) on assessment, education, care coordination, symptom management, support, consultation and referral. CNSs were on-call from 0800–2000 h Monday through Friday and from 0800 h–noon on weekend.
Complementary care (n = 106; 78 analysed for economic outcomes): Two CNSs (masters prepared*) provided post-diagnosis ongoing support care during pre-and post-operative phases of treatment, in addition to usual medical care (experience not reported). Intervention based on Brooten’s Cost-Quality Model and the Oncology Nursing Society’s standards of advanced practice in oncology nursing. Control (n = 104; with 74 analysed for economic outcomes): Usual medical care.
210 women with newly diagnosed breast cancer (>21 years) who were referred by their doctor and were being cared for within the system. Excluded were those with a history of cancer, a co-morbidity that limited functional ability or severe psychiatric illness. Mean age 55.5 years; 97% white; 23.8% earned 6 months, capable of self-care and with telephone access. Mean age of intervention group was 60 years (age not reported for control group); 45% male; 60% African-American; 40% Caucasian; 100% with annual income 60 years). Mean age 83.4 years; 15% male; 93% white; and 56% had Medicaid insurance
173 high-risk pregnant women with 194 infants (high risk: gestational or pre-gestational diabetes mellitus, chronic hypertension, preterm labour or high risk of preterm labour) Women: Mean age 26.7 years; 93.6% black; 4.1% white; 85.5% single mothers; 93.6% had public health insurance; 35.3% with income
Journal of Evaluation in Clinical Practice ISSN 1365-2753
S Y S T E M AT I C R E V I E W
The effectiveness and cost-effectiveness of clinical nurse specialists in outpatient roles: a systematic review Kelley Kilpatrick RN PhD,1,5,6 Sharon Kaasalainen RN PhD,7 Faith Donald NP-PHC PhD,1,13 Kim Reid MSc,14 Nancy Carter RN PhD,1,8 Denise Bryant-Lukosius RN PhD,2,7,11 Ruth Martin-Misener RN-NP PhD,2,15 Patricia Harbman NP-PHC PhD,1,8,16 Deborah Anne Marshall PhD MHSA,17,18 Renee Charbonneau-Smith RN MSc3,9 and Alba DiCenso RN PhD4,10,12 1 Affiliate Faculty, 2Co-Director, 3Knowledge Exchange Specialist, 4Professor Emeritus, Canadian Centre for Advanced Practice Nursing Research, Hamilton, Ontario, Canada 5 Assistant Professor, Faculty of Nursing, Université de Montreal, Montreal, Quebec, Canada 6 Researcher, Hôpital Maisonneuve-Rosemont Research Centre, Montreal, Quebec, Canada 7 Associate Professor, 8Assistant Professor, 9Knowledge Exchange Specialist, 10Professor Emeritus, School of Nursing, McMaster University, Hamilton, Ontario, Canada 11 Associate Professor, Department of Oncology, McMaster University, Hamilton, Ontario, Canada 12 Professor Emeritus, Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada 13 Associate Professor, Daphne Cockwell School of Nursing, Ryerson University, Toronto, Ontario, Canada 14 Director, KJ Research, Rosemere, Quebec, Canada 15 Associate Professor, School of Nursing, Dalhousie University, Halifax, Nova Scotia, Canada 16 Postdoctoral Fellow, Health Interventions Research Centre, Ryerson University, Toronto, Ontario, Canada 17 Canada Research Chair, Health Services and Systems Research, University of Calgary, Calgary, Alberta, Canada 18 Associate Professor, Department of Community Health Sciences, Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada
Keywords ambulatory care, clinical nurse specialist, cost-effectiveness, economic evaluation, health services research, nurse specialist, nursing, outpatient care, systematic reviews Correspondence Dr Kelley Kilpatrick Hopital Maisonneuve-Rosemont Montreal, Quebec H1T 2M4 Canada E-mail: [email protected] Accepted for publication: 27 May 2014 doi:10.1111/jep.12219
Abstract Rationale, aims and objectives Increasing numbers of clinical nurse specialists (CNSs) are working in outpatient settings. The objective of this paper is to describe a systematic review of randomized controlled trials (RCTs) evaluating the cost-effectiveness of CNSs delivering outpatient care in alternative or complementary provider roles. Methods We searched CINAHL, MEDLINE, EMBASE and seven other electronic databases, 1980 to July 2012 and hand-searched bibliographies and key journals. RCTs that evaluated formally trained CNSs and health system outcomes were included. Study quality was assessed using the Cochrane risk of bias tool and the Quality of Health Economic Studies instrument. We used the Grading of Recommendations Assessment, Development and Evaluation to assess quality of evidence for individual outcomes. Results Eleven RCTs, four evaluating alternative provider (n = 683 participants) and seven evaluating complementary provider roles (n = 1464 participants), were identified. Results of the alternative provider RCTs (low-to-moderate quality evidence) were fairly consistent across study populations with similar patient outcomes to usual care, some evidence of reduced resource use and costs, and two economic analyses (one fair and one high quality) favouring CNS care. Results of the complementary provider RCTs (low-to-moderate quality evidence) were also fairly consistent across study populations with similar or improved patient outcomes and mostly similar health system outcomes when compared with usual care; however, the economic analyses were weak. Conclusions Low-to-moderate quality evidence supports the effectiveness and two fairto-high quality economic analyses support the cost-effectiveness of outpatient alternative provider CNSs. Low-to-moderate quality evidence supports the effectiveness of outpatient complementary provider CNSs; however, robust economic evaluations are needed to address cost-effectiveness.
Introduction The clinical nurse specialist (CNS) is an internationally recognized advanced practice nursing role introduced in the 1960s [1]. With 1106
specialty-based knowledge [2,3], CNSs provide leadership, administrative, research and educational supports to health care teams, organizations and health care systems [4]. Their substantive areas of practice include the management and care of complex and
Journal of Evaluation in Clinical Practice 20 (2014) 1106–1123 © 2014 John Wiley & Sons, Ltd.
K. Kilpatrick et al.
vulnerable populations, the education and support of interprofessional staff, and facilitation of change within health care systems [5]. They deliver expert clinical care to patients, families and communities and support teams to provide optimal care through the use of best evidence and improved care processes [6,7]. The educational preparation of CNSs influences their role development. There is consensus in the literature that CNSs should be prepared at the graduate level [8]. Graduate-prepared CNSs report spending significantly more time in research, leadership and professional development activities [9] and they incorporate population trends and related policy and programme development in their roles [10]. Historically, CNSs have worked in acute care; however, many now work in the community [11]. In fact, a recent survey of CNSs in Canada revealed that about 40% are in community-based settings [9]. While reviews of CNS effectiveness have shown that CNSs are associated with improved outcomes [7,12,13], none have focused specifically on the CNS role in outpatient settings or the cost-effectiveness of the role. We conducted a multi-component systematic review of randomized controlled trials (RCTs), entitled ‘A systematic review of the cost-effectiveness of nurse practitioners and clinical nurse specialists: 1980 to July 2012’. We assessed the cost-effectiveness of CNSs and nurse practitioners (NPs) in different settings (inpatient, outpatient and transition) and roles (alternative and complementary) [14]. In this paper, we summarize the results of RCTs evaluating the cost-effectiveness of CNSs delivering outpatient care in alternative or complementary roles and formulate recommendations based on the evidence.
Cost-effectiveness of outpatient CNSs
in the context of patient and provider outcomes, additional outcomes of interest were patient (e.g. health status) and provider (e.g. quality of care) measures. Studies were excluded if they did not include cost or a health system utilization outcome.
Information sources and search We worked with a medical librarian to develop comprehensive search strategies and to search bibliographic databases from 1980 to 31 July 2012 with no restrictions on country, language or publication status. We searched CINAHL, MEDLINE, EMBASE, and seven other electronic databases. We hand-searched journals in which CNS-related RCTs had been published, reviewed reference lists, contacted authors, and searched personal files and websites of nursing research and professional organizations. An in-depth description of search strategy and methods can be found in Donald et al. (under review) [14].
Study selection We uploaded citations to the web-based reference management program, RefWorks, and removed duplicate entries. Two-member teams independently screened the titles and abstracts for relevance. Those deemed relevant by either reviewer moved on to full-text review. Two-member teams independently screened the full texts and resolved discrepancies through discussion. A list of excluded studies with reason for exclusion is available on request.
Data extraction
Methods Study eligibility for inclusion We included RCTs that compared CNS outpatient care with usual care. Studies that claimed to be RCTs but did not use true randomization (e.g. allocation by day of week) were excluded. We were interested in participants of any age receiving care in all types, sizes and locations of community agencies (e.g. outpatient clinics). To be considered a CNS, the paper had to specify that the nurse had completed a graduate degree and the role reflected the CNS role definition. If the formal training of the nurse was not specified, authors were contacted. Studies were excluded if the training failed to meet our criteria or if we could not contact the author despite repeated attempts. We excluded studies if the CNS contribution could not be isolated from that of other providers and if the control group was also exposed to a CNS intervention. We included studies in which the CNS was functioning in an alternative or complementary provider role. CNSs in alternative roles provide similar services to those for whom they substitute, usually doctors. This role is evaluated through non-inferiority trials designed to determine if the new role is at least as good as or not unacceptably worse than the comparator. CNSs in complementary roles augment existing services [15] and this role is evaluated through superiority trials designed to determine if the new role results in improved outcomes compared with usual care. The primary outcome of interest was health system utilization including health resource use (e.g. emergency department visits, hospitalizations) and/or costs of health care (e.g. outpatient, inpatient). Because it is important to examine health system utilization
© 2014 John Wiley & Sons, Ltd.
A research assistant extracted data from each study regarding study characteristics, participants, intervention, outcome, length of follow-up, proportion followed to study completion and study findings. To ensure the accuracy and completeness of extracted data, research team members reviewed all data extractions. If a study was reported in multiple papers, they were extracted as one.
Quality assessment Two team members (KR and AD) independently assessed the quality of the study methods using a slightly modified version of the Cochrane risk of bias criteria [14,16]. Disagreements were resolved through discussion. We attempted to contact authors if additional information was required. Each study was assessed for overall risk of bias and categorized as low (at risk in 0–1 category), moderate (at risk in 2–3 categories), high (at risk in 4–6 categories) and very high (at risk in 7–8 categories). Two research assistants, trained by the health economist researcher (DM), independently rated the health economic quality of each study using the 16-item Quality of Health Economic Studies (QHES) instrument [17]. Discrepancies were resolved by discussion and consultation with the health economist. A summary score was generated with 0 indicating extremely poor quality and 100 indicating excellent quality. Studies were classified as extremely poor (0 to 24), poor (25 to 49), fair (50 to 74) and high (75 to 100) [18]. An in-depth assessment of the economic evaluation methods can be found in Marshall et al. [19]. Where data permitted, the quality of evidence for each outcome was evaluated using Grading of Recommendations Assess1107
Cost-effectiveness of outpatient CNSs
ment, Development and Evaluation (GRADE) system [20] and GRADEpro software (see http://tech.cochrane.org/revman/otherresources/gradepro/about-gradepro). Results of RCTs were considered initially as ‘high level’ evidence and were downgraded based on potential risk of bias, inconsistency, indirectness, imprecision and publication bias. With each downgrade from high to moderate to low to very low, the level of confidence in the estimate of effect decreases and the likelihood that further research may change the estimate increases. A common criticism of CNS studies is the small number of CNSs evaluated in any one study or across the same outcome in multiple studies raising the concern that the results may not be generalizable. Therefore, we downgraded for indirectness when fewer than 10 CNSs were evaluated as we judged 10 to be the minimum number necessary to generalize results to CNSs in similar roles. To determine the extent of imprecision, we downgraded if the optimal information size (OIS) was not met or if the 95% confidence interval (CI) overlapped no effect but included important benefit or important harm [21]. The OIS represents the sample size that would be required for a single optimally powered study using a modest estimate of treatment effect. For dichotomous outcomes, we calculated the OIS based on a relative risk difference of 20%. For continuous outcomes, we calculated the OIS using accepted minimal important differences (MIDs) and if none were identified, we extrapolated from an established MID of 0.5 points for a 7-point quality of life scale [22] for scale-based outcomes and assumed a MID of 20% of the control group mean for other continuous outcomes. For length of stay, we assumed a MID of 1.0 day. If the OIS criterion was met and the CI overlapped no difference, we judged those that were more than 20% above or below the baseline risk as imprecise for dichotomous data and those that exceeded the MID as imprecise for continuous outcomes. In cases where the quality of evidence would be downgraded for indirectness (≤10 CNSs) and for imprecision (OIS not met), we assumed a quality of evidence of ‘at most low level’. We did not apply GRADE in instances when the data required to calculate the OIS were not provided.
Results We identified 4397 unique reports and of these, 3981 were excluded during the title and abstract review and 351 were excluded during the full-text review (Fig. 1). Ultimately, 43 RCTs described in 65 papers were included in the overall review, 18 of which evaluated NPs and 25 of which evaluated CNSs [14]. Of the 25 RCTs of CNSs, 11 evaluated CNSs in an outpatient role. Below, we summarize these 11 RCTs beginning with those evaluating the alternative followed by those evaluating the complementary role.
Alternative provider outpatient CNS role The four RCTs that evaluated the alternative provider role [23–26] are described in Table 1. Three trials compared CNSs with doctors in the care of children with asthma [23], patients with diabetes [24] and men with bladder or prostate cancer undergoing radical radiotherapy [25]. One study compared CNS outpatient care with two modes of interprofessional hospital-based care for adults with rheumatoid arthritis [26]. Although in alternative provider roles, the CNSs in each of these studies relied on doctors for some part 1108
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of care management (e.g. making specialist referrals, changing drug management). Two studies evaluated one CNS [23,25], one evaluated four CNSs [24] and one evaluated six CNSs [26]. Given different study populations and outcomes across trials, we were not able to pool study findings. Tables 2 and 3 summarize patient and health system outcomes, respectively, for these four non-inferiority trials along with quality of evidence for each outcome to which we were able to apply GRADE. All outcomes were downgraded because of indirectness, and many were downgraded because of imprecision because they did not meet the OIS criterion. In a small study of 21 children with poorly controlled asthma, Alexander et al. [23] sought to reduce the use of the emergency room (ER) as a primary source of care. The CNS intervention, based on Orem’s self-care nursing model [27], involved counselling about early recognition of asthma exacerbations and self-care; medical management changes were made by the allergist. Significantly more CNS than doctor patients attended the 2-week post-ER follow-up visit and by 12 months, the CNS group had significantly fewer mean asthma-related ER visits per patient (both at most low-quality evidence). Other outcomes did not differ significantly. Arts et al. [24] randomized 337 patients with complex type 1 or 2 diabetes in a hospital-based outpatient clinic to CNSs who worked according to protocol or to doctors. At 2 years, there were no significant differences in patient outcomes (where GRADE applied, quality of evidence was at most low). The CNS group had significantly more consultations (i.e. patient visits; GRADE not applied) and longer consultations (moderate quality). Other health system outcomes did not differ significantly. The incremental costeffectiveness ratio (ICER) was €3.61 less in direct costs (i.e. costs directly related to actions and decisions made by the CNS) but €20.34 more in overall costs (i.e. outpatient and inpatient costs for patient resource utilization in all related specialties) per qualityadjusted life year (QALY) gained for the CNS intervention compared with usual care. The authors noted that the lower ICER for direct costs indicated that the CNSs provided quantitatively more care while using fewer financial resources and suggested that the higher ICER for overall costs could be explained by a higher prevalence of diabetes-related complications in the CNS group at baseline that generated higher health care costs. Faithfull et al. [25] randomized 115 men with prostate or bladder cancer receiving radical radiotherapy in one cancer clinic to CNS or doctor care. Guided by a medication and symptom management protocol, the CNS provided information on early symptom recognition, what to expect from treatment and how to manage existing problems. At 12 weeks, most patient outcomes did not differ significantly between groups except for one symptom (less constipation) and greater satisfaction with care in the CNS group. The CNS group had significantly lower outpatient appointment, microbiology, total health service and total costs. The intervention was associated with a 31% cost saving. In a study of 210 patients with rheumatoid arthritis, Tijhuis et al. (reported in four papers [26,28–30]) compared CNS outpatient care with two hospital-based control groups. The first control received inpatient care in which a multidisciplinary team delivered tailored interventions consisting of education, physiotherapy and hydrotherapy to patients over 12 days, and the second control received day-patient care consisting of the same tailored intervention over 3
© 2014 John Wiley & Sons, Ltd.
Cost-effectiveness of outpatient CNSs
Idenficaon
K. Kilpatrick et al.
Addional records idenfied through other sources (key journals, author contacts, websites, personal files, reference lists) (n = 156)
Inial record review (tle and abstract) (n = 4397)
Screening
42]
Records idenfied through electronic database searching aer duplicates removed (n = 4241)
Reasons for exclusion at inial record review (n = 3981)
Full records retrieved for assessment of eligibility (n = 416) Reasons for exclusion at full record review (n = 351) Did not meet design criteria: 35 Did not meet intervenon criteria: 210 Did not meet design and intervenon criteria: 21 Did not meet outcomes criteria: 44 Could not isolate impact of the APN: 38 Study submied for publicaon/in press (author requested that study be included in future update): 3
Included
Eligibility
Did not meet design criteria: 2468 Did not meet intervenon criteria: 902 Did not meet design and intervenon criteria: 611
NP and CNS studies included Constellaon of studies = 15 (37 papers) Single studies = 28
CNS outpaent studies included Constellaon of studies = 2 (9 papers) Single studies = 9
Flow diagram adapted from Moher et al. (2009) [44] Figure 1 Identification relevant studies.
and
screening
of
weeks.The CNS, over 12 weeks, provided information about rheumatoid arthritis, made referrals to other providers and, in consultation with the rheumatologist, prescribed joint splints, adaptive equipment and house adaptations if needed. Unlike the study by Faithfull et al. [25], patient satisfaction at the end of treatment was significantly lower for the CNS group (at most low-quality evidence for inpatient comparison and moderate quality for day-patient comparison). The authors suggest that this might be because the treatment of inpatients and day-patients was more intensive, as they were treated by more providers over a shorter period of time. At 2 years, there were no significant differences in other patient outcomes. With respect to health system outcomes, significantly fewer CNS patients received home help than inpatient controls and the CNS group had significantly lower treatment, health care and societal costs than both control groups (at most low-quality evidence). There were no significant differences between groups in QALYs.
© 2014 John Wiley & Sons, Ltd.
Complementary provider outpatient CNS role Seven RCTs evaluated the complementary provider role [31–37] (Table 1). While two studies focused on patients with mental health issues [33,37], five studies each focused on different patient populations including heart failure [31], breast cancer [35], rheumatoid arthritis [36], high-risk pregnancy [32] and residents in nursing homes [34]. Four studies evaluated one CNS [31,33,34,36], one evaluated two CNSs [35], one evaluated three CNSs [32] and one evaluated nine CNSs [37]. Given different study populations and outcomes across trials, we were unable to pool study findings. Tables 4 and 5 summarize patient and health system outcomes for these seven superiority trials along with quality of evidence for each outcome to which we were able to apply GRADE. Because 10 CNSs filled the nine CNS positions in the study by Swindle et al. [37], outcomes for this study were not downgraded because of indirectness but all others 1109
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Study objective
To compare CNSs with paediatric residents in post-ED visit follow-up of poorly controlled, non-compliant asthmatic children who used the ED as their primary source of care.
To compare CNSs and doctors in the care of patients with type 1 or 2 diabetes.
To compare CNS and doctor care of men treated with radical radiotherapy for prostate and bladder cancer.
Alexander et al. (1988) [23] USA
Arts et al. (2012) [24] NL
Faithfull et al. (2001) [25] UK
Alternative provider role
Author, year, country
A single cancer treatment clinic in Sutton, UK (two clinics were planned but the second did not recruit patients)
Academic hospital in Maastricht, Netherlands, with a catchment area of 190 000 people
General paediatric allergy clinic at LeBonheur Children’s Medical Center, Memphis, Tennessee, USA
Study setting
Table 1 Characteristics of included studies (n = 11)
115 men undergoing radical (>60 Gy) radiotherapy for prostate or bladder cancer. Median age 70 years; 83% had adeno-carcinoma of the prostate
337 type 1 or 2 diabetes patients All required insulin treatment or oral blood glucose medication and had inadequate blood glucose, blood pressure or lipids regulation Mean age 59 years; 36.4% male; BMI 29.7 kg m−2; mean HbA1c 8.01%.
21 asthmatic children (15 months to 13 years) from low-income families who used the ED as their primary care source and had no regular doctor. Participants were similar in age, % male, ED visits prior to study, and all were Medicaid recipients.
Participants
CNS made initial assessments and then had open access clinics until completion of radiotherapy. Afterwards, CNS made telephone contacts. Responsibilities included provision of information, answering of questions, education on diet, radiotherapy and how to handle urinary symptoms. CNSs followed a study-developed protocol for medication and management of symptoms.
CNS was authorized to schedule own appointments and referrals, make referrals to a dietician, a regular diabetes nurse and an ophthalmologist. CNS could order diabetes-related clinical admissions; however, referrals to specialist care required a referral by one of the participating doctors.
Alternative care (n = 169; 149 analysed): Four CNSs provided limited usual care, working according to a protocol (CNSs were doctoral or masters prepared with extensive experience in diabetes care). Control (n = 168; 145 analysed): Usual care provided by five participating doctors.
Alternative care (n = 58): Single CNS-led care (masters prepared with expertise in radiotherapy toxicity management*). Control (n = 57): Conventional medical care provided by six doctors. Routine outpatient clinic visits twice per week until completion of treatment and then 12 weeks of follow-up appointments. Both groups had access to outpatient nurses and a radiotherapy nurse.
CNS assumed major responsibility for assessment, counselling and follow-up; however, medical management remained under the direct supervision of the Allergy Division of the hospital clinic. Responsibilities included assessment of family needs, counselling/teaching for preventive health measures with a focus on asthma exacerbations and self-care.
Intervention
Alternative care (n = 11): A single CNS promoted self-care based on the Orem Self-Care Nursing Model. Control (n = 10): Primary continuity care from paediatric residents and faculty.
Comparison groups
12 weeks
2 years
12 months
Length of follow-up
Cost-effectiveness of outpatient CNSs K. Kilpatrick et al.
© 2014 John Wiley & Sons, Ltd.
© 2014 John Wiley & Sons, Ltd.
To compare the effectiveness of care delivered by a CNS, inpatient team, and day-patient team in patients with rheumatoid arthritis who have increasing functional limitations.
Chien et al. (2012) [33] China
To compare a CNS-led needs-based psycho-education programme added to usual care with usual care for newly referred patients with mental health problems.
Complementary provider role
Tijhuis et al. (2002) [26] Tijhuis et al. (2003) [28,29] van den Hout et al. (2003) [30] NL
A regional psychiatric outpatient clinic in Hong Kong, China
Outpatient clinic of the rheumatology department of six academic and non-academic hospitals in the Netherlands
79 newly referred Adult (>18 years) patients with first-episode, moderate, noticeable psychiatric symptoms but at low risk of self-harm or violence. Excluded were those receiving other psycho-education or psychosocial intervention. Mean age 25 years; 51.9% male; and mean monthly household income was $13 170 (HKD; 1 USD = 7.8 HKD)
210 rheumatoid arthritis patients with increasing difficulty in performing activities of daily living over the previous 6 weeks. Excluded were those requiring immediate hospitalization or those with an inability to reach hospital by a set time point (1000 h). Mean age 58 years; 24.8% male; and median disease duration was 1.9 years.
Complementary care (n = 39): A single psychiatric CNS administered the nurse-led psycho-education programme (NPEP) in addition to routine care (masters prepared* with training in psychosocial interventions for patients with mental health problems; experience not reported) Control (n = 40): Routine psychiatric outpatient services included medical consultation and treatment planning with attending psychiatrist every 3–6 weeks, advice and brief education from psychiatric nurses on illness and available services, and two family education sessions by a social worker.
Alternative care (n = 71): Six CNSs, each assigned to a hospital outpatient clinic, provided care in addition to regular outpatient care. Control 1 (n = 71): Inpatients stayed in hospital for 12 consecutive days and were prescribed a 9-day tailored treatment programme within a 2-week period: multidisciplinary team care (involving nurses, a rheumatologist, occupational therapist, physical therapist and a social worker), written information, hour-long educational session, physical therapy, group exercises and hydrotherapy. Control 2 (n = 68): Day patients stayed for 3 weeks, 3 days a week from 1000 h to 1600 h and received the same multidisciplinary tailored 9-day treatment programme as the inpatients but over a 3-week period. CNS met patients for a total of six 1-hour sessions weekly or biweekly and made telephone contact between sessions. Intervention addressed the following themes: orientation and engaging, understanding mental health and illness, sleep, hygiene and allaying anxiety, psychiatric treatments and medications, problem-solving and coping with mental health problems, interpersonal and communication skills, family and community support resources and future plans. Responsibilities included design of a needs-based, multi-component education programme for symptom management and resolving life problems that was implemented 3–4 weeks before first clinic consultation, design of support system to link patient and family to services, and coordination of care.
CNS treated patients on average three times each over the 12-week (average) intervention period. Each visit took about 1 hour. Responsibilities included provision of disease information, referrals to other health professionals and prescription of joint splints, adaptive equipment and house adaptations in consultation with rheumatologist. Decisions to change or introduce disease-modifying drugs, optimize non-steroidal anti-inflammatory drugs, or to administer intra-articular corticosteroid injections were left to the attending rheumatologist
2 weeks
2 years
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To compare CNS support plus usual care with usual care alone in the care of women newly diagnosed with breast cancer.
To compare CNS consultation plus usual care with usual care alone in a drug monitoring clinic for patients with rheumatoid arthritis.
Ritz et al. (2000) [35] USA
Ryan et al. (2006) [36] UK
Rheumatology follow-up outpatient clinic at a district general hospital
An integrated health care system in a mid-western suburban community, Minnesota, USA
To compare a CNS-led A cardiologist practice in telephone-enhanced Lee County, rural disease management east-central Alabama, intervention plus usual USA care to usual care alone in reducing hospital admissions and improving quality of life and self-care behaviours in patients with heart failure.
Brandon et al. (2009) [31] USA
Two university-affiliated Veteran Affairs Medical Center general medicine clinic firms in Indiana, USA
To compare CNS plus usual care with usual care alone in the care of veterans with depression.
Swindle et al. (2003) [37] USA
71 patients with rheumatoid arthritis who were starting new disease-modifying anti-rheumatic drugs. Those who required hospital admission at the start were excluded. Mean age 58.1 years; 43.7% male; 64.8% not working; and 54.9% used NSAIDs
Complementary care (n = 36): A single rheumatology CNS (doctoral preparation with 16 years experience in rheumatology*) replaced the clinic nurse and used Pendelton’s framework to assess patient needs for safety monitoring. Control (n = 35): Usual care provided by an outpatient clinic nurse supported by a rheumatologist.
CNS replaced the outpatient clinic nurse and provided the same services plus additional responsibilities. Responsibilities included assessment of problems with coping with symptoms (e.g. pain) and difficulties with functional activities; and provision of guidance on analgesia, exercise, pacing activities, goal-setting and fatigue. CNS could refer patients to other professionals to help manage joint stiffness through exercises.
12 months.
CNS contacted patient within 2 weeks 24 months (quality of diagnosis and thereafter at of life measures scheduled clinic visits, telephone calls, analysed at 12 home visits, or patient-initiated visits. months because Responsibilities pre-operatively through of poor response to post-treatment follow-up focused rates) on assessment, education, care coordination, symptom management, support, consultation and referral. CNSs were on-call from 0800–2000 h Monday through Friday and from 0800 h–noon on weekend.
Complementary care (n = 106; 78 analysed for economic outcomes): Two CNSs (masters prepared*) provided post-diagnosis ongoing support care during pre-and post-operative phases of treatment, in addition to usual medical care (experience not reported). Intervention based on Brooten’s Cost-Quality Model and the Oncology Nursing Society’s standards of advanced practice in oncology nursing. Control (n = 104; with 74 analysed for economic outcomes): Usual medical care.
210 women with newly diagnosed breast cancer (>21 years) who were referred by their doctor and were being cared for within the system. Excluded were those with a history of cancer, a co-morbidity that limited functional ability or severe psychiatric illness. Mean age 55.5 years; 97% white; 23.8% earned 6 months, capable of self-care and with telephone access. Mean age of intervention group was 60 years (age not reported for control group); 45% male; 60% African-American; 40% Caucasian; 100% with annual income 60 years). Mean age 83.4 years; 15% male; 93% white; and 56% had Medicaid insurance
173 high-risk pregnant women with 194 infants (high risk: gestational or pre-gestational diabetes mellitus, chronic hypertension, preterm labour or high risk of preterm labour) Women: Mean age 26.7 years; 93.6% black; 4.1% white; 85.5% single mothers; 93.6% had public health insurance; 35.3% with income
