Comparison of sole nurse and team delivered community clozapine services for people with Treatment Resistant Schizophrenia

Running title: Models of clozapine services for TRS

Heather GAGE, PhD, Professor of Health Economics, School of Economics, University of Surrey, Guildford, Surrey, GU2 7XH (Corresponding author -Email: h.gage@surrey.ac.uk; Tel: 01483 686948; Fax: 01483 689548)

Hannah FAMILY, MSc, Research Fellow, Dept. of Pharmacy and Pharmacology, University of Bath, Claverton Down, Bath, Bath and North East Somerset BA2 7AY

Fenella MURPHY, MSc, Research Fellow, School of Economics, University of Surrey, Guildford, Surrey, GU2 7XH

Peter WILLIAMS, MSc, Statistical Consultant, Dept. of Mathematics, University of Surrey, Guildford, Surrey, GU2 7XH

Jane SUTTON, PhD, Lecturer, Dept. of Pharmacy and Pharmacology, University of Bath, Claverton Down, Bath, Bath and North East Somerset BA2 7AY

Denise TAYLOR, PhD, Lecturer, Dept. of Pharmacy and Pharmacology, University of Bath, Claverton Down Bath, Bath and North East Somerset BA2 7AY

Author contributions

DT, JS and HG were responsible for the conception and design of the study. All authors participated in the analysis and interpretation of data. HG wrote the first draft of the article, and all other authors critically revised it. The final version of the paper has been approved by all authors.

Conflicts of interest: None declared.

Acknowledgements: The authors are grateful to: staff at the clozapine services; participating patients and carers; the Project Management and Patient Advisory Groups.

Funding source: The study was supported by the Pharmacy Practice Research Trust. The views expressed are those of the authors and not necessarily those of the commissioning body.

Word count main text (exclude abstract and references): 3970

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ABSTRACT

Aim: To compare sole nurse and doctor-led multidisciplinary team (MDT) delivery of community

clozapine services for people with Treatment Resistant Schizophrenia (TRS).

Background: Around 20% of people with schizophrenia are treatment resistant (fail to respond to

front line medications). Clozapine, a second line treatment, has potentially serious side effects

requiring regular monitoring. Different models of community clozapine services are emerging in the

British National Health Service but there is little evidence about which is best.

Design: Questionnaire survey of service users

Methods: All patients on the lists of seven clozapine clinics (4 sole nurse, 3 MDT) in one trust were

invited to participate, 2009-10. Forward stepwise regression was used to investigate associations

between patient wellbeing, functioning, self efficacy and satisfaction and clinic model attended,

controlling for socio-demographic and health characteristics and processes of care. Utilisation (and

costs) of other health and social services accessed were compared between models.

Results: Sixty six service users (35% participation rate) responded. Wellbeing and functioning were

associated with patient characteristics and processes of care, not clinic model. Patients managed by

sole nurses reported, over three months: more community psychiatric nurse visits (3.38 vs. 2.87,

p=.033) and hospital psychiatrist appointments (0.82 vs. 0.55, p=.074). Clinic list size affects costs per

patient.

Conclusions: MDT delivery may reduce use of other services. Although MDT delivery is regarded

best practice, sole nurses can effectively provide clozapine services and may be warranted in areas

of low population density.

238 words

Keywords:

Clozapine Community care Costs Multidisciplinary team Nurse – led Outcomes

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SUMMARY STATEMENT

Why this research is needed

In line with policy of the British National Health Service to bring care closer to peoples’ homes, routine monitoring of people with Treatment Resistant Schizophrenia (TRS) is being relocated out of hospitals to community clinics

Little evidence exists about which models of community care work best for people with TRS

Key findings

Wellbeing, functioning and self efficacy are associated with patient characteristics and processes of care, and not with whether patients attend a clinic run by a sole nurse or a doctor-led multidisciplinary team

Patients managed in clinics run by nurses, compared to those managed by a doctor-led multidisciplinary team, use more community psychiatric services and have more hospital psychiatrist appointments

There was no difference in satisfaction reported by patients attending the two types of clinic

Implications of the findings for policy / practice / research / education

Doctor-led multidisciplinary teams represent best practice, according to current guidelines, and offer a broader range of services for patients receiving clozapine

Sole nurses can effectively monitor patients who are being treated with clozapine and are warranted in areas with small numbers of patients where a team approach is unlikely to be an economic proposition

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Comparison of sole nurse and team delivered community clozapine services for people with Treatment Resistant Schizophrenia

INTRODUCTION

It is estimated that over 20% of people with schizophrenia fail to respond to more than one front

line antipsychotic agent and are deemed to have ‘incomplete recovery’, or are labelled ‘treatment

resistant’ (Pantelis & Lambert 2003). Clozapine is a relatively expensive second line medication that

has been shown to reduce hospitalisation and to be overall cost-effective (Davies & Drummond

1993; Aitchison & Kerwin 1997; Seshamani 2002; Mcilwain et al 2011), but its potentially serious side

effects (particularly agranulocytosis) require regular specialist monitoring, especially in the early

months of treatment (NICE 2009). Recent policy of the British National Health Service (NHS) has

been to bring care closer to peoples’ homes (Dept. of Health 2005). Specifically the mental health

strategy advocates adult delivery models based around community (rather than hospital) care (Dept.

of Health 1999; Dept. of Health 2008). Accordingly, new local arrangements are emerging for

clozapine services so that people with treatment resistant schizophrenia (TRS) do not have to be

monitored in hospital clinics. Some new arrangements include roles for nurses and pharmacists who

are experienced in the use and associated risks of clozapine. Although the treatment environment is

critical to the patient experience, and to the development and maintenance of strong therapeutic

alliances which are known to be instrumental in enhancing concordance are recovery in people with

schizophrenia (Pantelis & Lambert 2003; NICE 2009; Suarez 2004), little evidence exists about which

models of care are best for patients, or most cost-effective.

Background

Guidance on care for people with schizophrenia within the British NHS recognises the role of

multidisciplinary community health teams (that incorporate mental health nurses, pharmacists,

social workers, psychologists and psychiatrists) for supporting patients and carers (NICE 2009). In

some localities, however, patient numbers are insufficient to warrant team delivery and individual

practitioners undertake routine monitoring of people with TRS who are taking clozapine. This paper

reports findings from a comparison of two different community models for delivery of clozapine

services in one mental health trust in Britain. Three of the seven community clozapine clinics

operated by this trust (referred to as A, B, C, and serving 62, 45 and 18 patients respectively, mean

42) were led by a doctor (either a consultant or junior psychiatrist) who made clinical decisions, and

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also had a nurse, or health care assistant (to undertake routine checks such as temperature and

blood pressure) and pharmacist (for dispensing clozapine) in attendance. The other four clinics (D, E,

F, and G, with 21, 12, 20, 11 patients, mean 16) were run by a sole nurse who had prescribing

qualifications and had been given specialist training in clozapine. Although doctors could be called

upon if needed, there was no medical cover routinely provided for the nurse-led clinic, and the

dispensing of prescriptions by a pharmacist was also at another location. All clinics followed a

centrally agreed pattern of monitoring patients, including blood tests to exclude neutropenia prior to

provision of medications. The two largest clinics used near patient testing, providing immediate

results. Most patients were scheduled to attend clinics every two weeks, except those served by

clinic E which only opened once a month, and some stabilised patients in other clinics. All patients

were also reviewed by consultants as hospital outpatients every six months.

The framework for the study was provided by the realist evaluation methodology (Pawson &Tilley

1997). In contrast to experimental studies, realist evaluations use a mix of quantitative and

qualitative methods to explore associations between contextual factors, mechanisms and outcomes

in complex and dynamic systems, such as health care organisations (Marchal et al 2012). The

approach involves the collection of information from a range of stakeholders to gain an

understanding of how the setting and process of care delivery affect outcomes and the patient

experience, with the objective of establishing what works for whom, and in what circumstances

(Pawson &Tilley 1997). This paper focuses on the findings from the quantitative analysis. Within the

context of one NHS trust, the impact of the two alternative models (sole nurse and doctor-led MDT)

on patient-related outcomes, quality of care and costs was explored. The analysis of the interviews

with health professionals is reported separately (Sutton et al, in press).

THE STUDY

Aims

The aim of the study was to compare sole nurse with doctor-led / multidisciplinary team (MDT)

clinics. The following questions were addressed. Are the characteristics of patients treated in sole

nurse and doctor-led MDT clinics similar? Is clinic model associated with self reported wellbeing,

functioning and self efficacy? How does quality of care vary between clinic model? Are there

differences in use of other health care and community services between patients managed by sole

nurses and those managed doctor-led MDT clinics? Is clinic model a factor affecting overall service

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utilisation costs at the individual patient level? What are the relative costs of providing the two types

of service?

Design

Data were collected from service users in 2009 -10, by means of a self reported questionnaire that

was purposefully designed for the study, in collaboration with medical providers. It was pilot tested

with volunteers in the local patient representative group, and simplified on the basis of the feedback

received. The final version took about 45 minutes to complete.

Participants

All patients registered at each of the seven clinics were sent information about the project by mail

and invited to participate. Clinics were geographically separated to cover the whole Trust area and

patients were generally registered with clinics closest to their homes.

Data collection from patients

A researcher visited each clinic to collect informed consent and assist service users with the

completion of the survey instrument, as needed. Full details of the variables collected in the

questionnaire are given in Table 1. It asked for background information on socio-demographic

characteristics, living situation, social support mechanisms, health status and health behaviours.

Validated instruments were used to measure patient’s wellbeing and functioning (independence in

instrumental activities of daily living and self efficacy) and to explore views about clinic processes

(satisfaction). Indicators of quality of care, including waiting time in clinic and the frequency with

which recommended monitoring tests were performed (NICE 2009), were also gathered by self report

within the questionnaire. The Client Service Receipt Inventory (Chisholm & Knapp 2006) was

customised to reflect local services and used to collect information on use of other health and social

services, and informal (unpaid) care, in the previous three months. Subject to participant approval,

individual clinic records were reviewed to validate self reported information.

TABLE 1 GOES HERE

Ethical considerations

A favourable ethical opinion was obtained from the local NHS committee.

Analysis

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Data were entered into SPSS version 16 (SPSS Inc., Chicago, IL, USA). Individual patient information

was first amalgamated at the clinic level and then by model (sole nurse and doctor–led MDT), and

descriptive statistics were calculated. The socio-demographic and health characteristics, wellbeing

and functioning of patients, quality of care and utilisation of health and social care services and

professionals were compared between models using appropriate statistical tests: the Chi-square test

(or Fisher’s Exact test where any expected cell count was <5) for categorical variables, the Mann-

Whitney U test for ordinal variables and the unpaired t-test for continuous variables.

Use of formal services was converted to costs at the individual patient level by applying nationally

validated unit costs, inclusive of employer oncosts, qualifications and facilities overheads (Curtis

2009) to physical amounts of each service and professional accessed. The total cost (in £, 2009) for

each patient was obtained by summing across all professionals and services. Patient level service

utilisation costs were amalgamated according to clinic attended (excluding clinics C and E because

only two people responded in each), and an average (per patient, per clinic) cost was calculated.

Data were not available on the length of time (hours per day) that help at home was provided, so no

costs could be derived for this form of service.

Forward stepwise regression analysis was used to investigate associations between wellbeing,

functional status, self efficacy and satisfaction (response variables) and clinic model attended

(explanatory variable), controlling for: user socio-demographic characteristics, health status

indicators and processes of care (full list of variables shown in Table 3 footnote). The drivers of

patient service use costs were also explored by regression modelling using the same explanatory

variables, and additionally wellbeing, service satisfaction, self efficacy and functioning. Two stage

regression analysis was used in all cases: an initial estimation produced a list of statistically significant

variables which were then used in a reduced form model to produce final estimations.

Validation and reliability

Validated and widely used instruments were used to collect data on the main indicators of wellbeing,

functional status and satisfaction with care. The Warwick and Edinburgh Mental Health Wellbeing

Scale (WEMWBS) shows high correlation with other mental health scales (Tennant et al 2007). The

Instrumental Activities of Daily Living Scale (Lawton & Brady 1669) has been used in over 3000

published studies, and considerable evidence exists for its reliability and concurrent validity

(Loewenstein & Mogosky, 1999). The European version of the Verona Service Satisfaction Scale was

specifically designed for community-based mental health services run by MDTs and has been shown

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to be a reliable instrument for measuring service satisfaction in people with schizophrenia, and for

use in comparative studies and in routine mental health clinical practice (Ruggieri et al 2006a). To,

avoid overburdening participants, only selected items of particular relevance to the comparison of

sole nurse with MDT clinics were used, such as responsiveness during office hours and out of hours,

help with self management, continuity of care (Table 1).

Clinic provision costs

The resources used in delivering care in the clozapine clinics were recorded during site visits and

formed the basis for calculating the cost of providing each clinic (A – G). Researchers observed clinic

processes and interviewed key staff. All clinics were situated in shared facilities with similar

equipment, so cost calculations concentrated on human resource costs. A cost was assigned to the

time input of each member of staff, according to role and grade, using nationally validated unit costs,

inclusive of employer oncosts, qualifications and institutional overheads (Curtis 2009). Costs of all

clinic staff were summed to derive a total annual cost per clinic, and an average annual cost per

patient was calculated.

RESULTS

Participation rate

A total of 66 patients (38 of 125, 30.4% in three doctor-led / MDT clinics; 28 of 64, 43.8% in four sole

nurse clinics) completed the questionnaire, an overall participation rate of 34.9%, range 11% (Clinic

C) to 70% (F).

Socio-demographic and health characteristics of participant: comparison of clinic models

Most participants had been taking clozapine for over two years. The mean age of participants was

higher in the doctor-led / MDT clinics than in the sole nurse clinics (45 vs. 39 years), and they were

more likely to report a diagnosis of hypertension (22% vs. 7%) and better health (score 7.4 vs. 6.4 on

10 point VAS). There were no other differences in patient characteristics or health behavious

between models (Table 2).

TABLE 2 GOES HERE

Factors associated with wellbeing, functioning and self efficacy

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In bivariate comparisons, patients managed in the doctor-led MDT clinics, compared to those

managed by sole nurses, tended to report better wellbeing (mean score (maximum 5) 3.33, SD 0.68

vs. 3.02, SD 0.71, p=.082) and self efficacy mean score (maximum 10) 6.75, SD 2.06 vs. 5.85, SD 2.13,

p=.097). The difference between models in patient functioning (instrumental activities of daily living

- IADL) was not statistically significant. However, multivariable regression analysis revealed that

clinic model attended was not a predictor of wellbeing, functioning or self efficacy. Patient scores on

these indicators were associated with certain patient characteristics and processes of care (Table 3,

top 3 rows).

TABLE 3 GOES HERE

Wellbeing was significantly associated with having a diagnosis of depression (score .462 less on

WEMWBS wellbeing scale (range 1-5) than someone without depression) and using recreational

drugs (score .913 less than non-users). Living alone, having left education before age of 18 and

having a diagnosis of diabetes had negative effects on mean IADL score (range 0 - 800); having a

diagnosis of asthma had a positive effect. Mean self efficacy score (range 1-10) was associated with:

number of alcohol units consumed per week (score decreases 0.052 for every extra alcohol unit

consumed); diagnosis of depression (lowers score by 1.671 relative to someone without depression);

frequency of clinic appointments per month (score rises by 0.630 for each extra appointment);

leaving full-time education before age of 16 (lowers score by 1.124 compared to those leaving later);

whether users were asked about their caffeine intake at clinic visits (raises score by .961 compared

to those stating they are usually not asked).

Quality of care: comparison of clinic models

In bivariate comparisons, participants attending doctor – led/ MDT clinics reported waiting longer to

see health professionals than those attending sole nurse clinics (mean 32 vs. 13 minutes), but were

more likely to report routine temperature taking (92% vs. 68%) and ECGs (82% vs. 52%). There was no

significant difference between models in reported satisfaction (VSSS-EU), consultation times, and

receipt of other recommended routine tests (Table 3, row 4). Regression analysis revealed that user

satisfaction was associated with waiting time in clinic (for every extra minute waited, satisfaction falls

0.008 points on the VSSS-EU (range 1-5), and receiving ECG tests (raises VSSS-EU by 0.370 compared

to patients not reporting an ECG) (Table 3). However, a strong positive association was observed

between self- reported wellbeing and service satisfaction (data not shown).

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TABLE 4 GOES HERE

Use of other services and costs: comparison of clinic models

Compared to the sole nurse clinics, there was a tendency for respondents treated in the doctor-

led /MDT clinics to report fewer outpatient visits to a psychiatrist (mean (SD) over previous three

months .82 (.86) vs. .55 (.92), p=.074). Patients attending sole nurse clinics reported significantly

more visits with a community psychiatric nurse (CPN) outside the clinic (3.38 (3.34) vs. 2.87 (5.16),

p=.033) and also significantly longer visits (32.12 (32.90) vs. 16.22 (28.39) minutes, p=.004). There

were no significant differences between models in use of any other hospital or community service,

(including GP, district nurse, physiotherapist, social worker, counsellor, day centre, hospital in-

patient, out-patient and A&E). Just over half of participants in both clinic models reported receiving

help at home (either formal (paid) or informal).

Overall the mean cost of services that participants reported they had accessed in the previous three

months was similar in both models, but standard deviations (variability between patients) were large:

sole nurse £819 (£1004) vs. doctor-led /MDT £831 (£1138). Sole nurses ran the clinics with the

highest and lowest per patient service utilisation costs (clinic D, £1272 (£1617); G £253 (£187). The

median cost of service utilisation of participants in sole nurse clinics (£513) was almost twice that of

participants in doctor – led /MDT clinics (£283).

Factors that were associated with incurring higher service utilisation costs were: reporting a diagnosis

of CHD, asthma or alcohol / substance abuse (raised costs by £1234, £1049, £930.80 respectively

compared to patients not reporting those conditions); lower self efficacy (for every self efficacy point

lost, service utilisation costs rise by £119); lower clozapine compliance (service user costs rise by £509

for each point increase on the 5 point frequency of forgetting scale (never, occasionally, 1-2 times per

month, 1-2 times per week, every day); time taking clozapine (service use costs rise by £565 for every

one point increase on the 3 point scale (<1 year / 1-2 years / >2 years); living in sheltered

accommodation (raises service utilisation costs by £743 compared to someone not living in sheltered

accommodation) (Table 3, row 5).

Costs of clinic provision

The human resources used in each clinic, and associated costs are shown in Table 5. Costs per clinic

per annum ranged from about £1000 to £22,000, depending on the number of hours open and the

skill mix of staff. MDT clinics in which doctors worked with pharmacists and nurses (A,B,C) incurred

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higher costs of provision. Average (per patient) costs per annum ranged from £80 to £750 and were

higher in some sole nurse clinics than in MDT clinics due to small patient lists.

TABLE 5 GOES HERE

DISCUSSION

Community clozapine services in one mental health trust in Britain have two service delivery models:

a doctor-led /MDT team, with pharmacist and nurse or health care assistant, in three clinics, and a

sole nurse, without a doctor or pharmacist routinely in attendance, in the remaining four. The study

investigated whether differences in delivery model were associated with differences in patient

wellbeing, functioning and self efficacy, quality of care, use of other services and costs.

There were a few differences between the patients attending the two models, with those managed

by the MDT being slightly older and more likely to have a diagnosis of hypertension than those

managed by sole nurses. Since clinics served local areas, demographic differences are likely to be a

reflection of variability in the characteristics of the populations of clinic catchment areas. The gender

mix and age distribution in a recent study of outpatient clozapine prescribing in Canada was similar to

this British sample, suggesting it is representative (Alessi-Severini et al. 2013).

Although the patients in the MDT clinics self reported better health, wellbeing, functioning and self

efficacy were not associated with clinic model after controlling for other background factors. Scores

on these indicators were instead associated with patient characteristics. Wellbeing was reduced

significantly by a diagnosis of depression and recreational drug use, and independence in daily living

was lower in people who lived alone and who had left school at a lower age. As might be

anticipated, self efficacy, which is an indicator of self management (Bentall 2010), was lower for

people having a higher alcohol intake, depression and less formal education. However, processes of

care also had an effect; higher frequency of clinic appointments, and reporting that caffeine intake

was monitored by clinic staff (a possible indicator of health professional attention), was associated

with higher self efficacy.

Patients managed by the sole nurse clinics reported waiting less time in clinic, possibly reflecting the

smaller number of patients treated in these clinics. Patients treated in the doctor-led / MDT clinics

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were more likely to have their temperatures monitored at routine visits and receive six-monthly

ECGs, but there was no difference between the models in reported provision of other checks and

tests (including BP, weight, smoking and alcohol consumption) recommended by NICE guidelines

(NICE 2009). The overall satisfaction indicator used in the study (a shortened version of a validated

instrument) showed no significant difference between models.

Patients in the sole nurse clinics reported significantly more use of community psychiatric nurses

(outside the clozapine clinic) over a three month period. The reason for this is not known, but may

reflect the referring practices of the nurses running the clozapine clinics. Also, there was a tendency

for patients in the nurse- led clinics to report more outpatient visits to psychiatrists, so it is possible

that access to the doctor in the MDT clinic substituted for specialist care. Across the whole sample,

higher service utilisation costs were associated with having more co-morbidities, lower self efficacy

and compliance, and living in sheltered accommodation, but not with clinic model.

The patient lists of the doctor-led/MDT clinics tended to be larger than in the sole nurse clinics (mean

42 vs. 16), but variability existed within models. The total costs of running doctor - led /MDT clinics

was higher than that of sole nurse clinics, reflecting the expense of the larger team of more highly

trained professionals in that model. However, the average cost per patient varied across clinics and

were not necessarily lower for sole nurse services. Economies of scale were realised by clinics serving

larger numbers of patients, which was usually those staffed by MDTs. Other studies have also shown

that the direct costs of schizophrenia care can vary markedly between centres (Haro et al. 1998).

Limitations

The study has several limitations. Most data were gathered through patient responses to a single

questionnaire survey, and rely on self report. Although the local patient representation organisation

contributed to the development of the survey instrument, ensuring it was user – friendly, and

participants were assisted in completing it by a researcher who attended each clinic, it is possible that

recall errors and other biases could have occurred. The overall participation rate was 35% and varied

between clinics, and the absolute numbers responding from smaller clinics was very small. Hence, it

is not known how representative the sample is of the whole population of patients attending the

clozapine clinics in the study area, or more widely. The observational cross sectional design

prohibited an analysis of changes in health outcomes. Many factors in the lives of people with TRS

may affect their wellbeing and functioning, making it difficult to identify the contribution of different

elements, and in particular the influence of model of provision.

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CONCLUSIONS

Delivery of care by multidisciplinary teams to people with chronic conditions is generally considered

to be the ideal service delivery model because division of labour increases efficiency and patients

benefit from the specific skills of different professionals (Wagner 2000). In this respect, the doctor-

led/ MDT teams in three clozapine clinics in the study reflect good practice. The findings indicate

that patients attending such clinics were more likely to receive some of the routine tests

recommended by NICE guidelines than patients monitored in sole nurse clinics. The delivery of

services by sole nurses in the other four clinics, however, reflects the local population distribution

and the smaller number of patients in the areas they serve. A team approach in such localities is

unlikely to be an economic proposition, but ongoing multidisciplinary support for sole nurses may

help ensure all guidelines are followed.

The findings show that specialist nurses working on their own can effectively provide clozapine

monitoring services, but that the lack of direct access to doctors in such clinics may increase

demands on outpatient psychiatric consultations and use of mental health nurses in the community.

This is consistent with other research that has concluded that nurses, when compared to doctors,

tend to refer more ( Sharples et al. 2002; Reynolds et al. 2000), even if there are few differences in

patient outcomes and processes of care (Laurent et al. 2004). In general, nurses have been found to

provide cost effective care (Goryakin et al. 2011), and clinic costs per patient in this study in two of

the larger sole nurse clinics (D, F) were largely comparable to those in the more efficient doctor-led

clinics (A, B). Other research has identified potential barriers to the successful substitution of

doctors by nurses, including lack of appropriate staff training, professional demarcations, poor

strategic planning and human resource management (Sibbald et al. 2004), but each of these had

been successfully addressed in the study area making sole nurse clinics an accepted, and respected,

model of clozapine service delivery. Interviews with staff in the MDT clinics (reported elsewhere),

however, indicated some ambiguities and blurring of boundaries between health professional roles,

suggesting scope for evaluating the service delivery systems (Sutton et al, in press).

Future service planning will need to balance the delivery of high quality patient-centred care with

the realisation of economies of scale and scope to contain costs. Recent developments in the

pharmacy profession enable pharmacist to offer new services that have normally been associated

with doctors and nurses, including prescribing and supporting people with long term conditions

(Smee 2007; Richardson & Polluck 2010). More research is needed on the patient outcomes and

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costs that incorporate consideration of optimal clinic size, as well as team configurations. This study

suggests that roles and responsibilities held by staff in community clozapine clinics are flexible, and

that there is scope to explore alternative delivery arrangements so that cost-effective models of care

can be identified.

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Table 1: Data collected in the questionnaire

Domain Instrument / DetailsBackground socio demographic and health information

Age; gender; ethnicity; age left full time education ; employment status; living arrangements; how supported they felt by network of friends / relatives; length of time with mental health problems; time taking clozapine; co-morbidities; number of prescribed medicines; overall health (rated 1 = worst possible to 10= best possible),

Health related behaviours

Self reported alcohol intake, smoking status, use of recreational drugs, exercise and physical activity, height and weight (for BMI), whether they slept in the day (yes/no).

Concordance Concordance, which is important for its effect on the likelihood of relapse (Sarez 2004; Mitchell & Selmes 2007), was measured by the self reported number of clinic appointments forgotten in the last 3 months, and how often clozapine doses were forgotten (5 point scale, never to always).

Wellbeing Warwick and Edinburgh Mental Health Wellbeing Scale (WEMWBS); 14 statements about feelings and thoughts (e.g. I have been feeling confident; I have been feeling interested in new things) scored on a 5 point scale (1 = none of the time to 5 = all of the time), summed across items and mean calculated (Tennant et al. 2007).

Functional status Eight item Instrumental Activities of Daily Living (IADL) scale covering activities such as using the phone, laundry and shopping (Lawton & Brady 1969). Responses to each item are transformed to a 100-point scale, and item scores summed to give a range of 800 (full functional competence) to 0 (no functioning).

Self efficacy Self efficacy was assessed by adapting three items from the Stanford self efficacy scale (ability to : keep symptoms from interfering with what they want to do; manage their mental health condition to reduce the need to see doctor / health care professional outside of clozapine clinic; manage mental health status by means other than medication), each scored on a 10 point visual analogue scale (1= not at all confident to 10= totally confident), from which the mean was calculated (Lorig et al. 1996; Lorig et al. 2001).

Quality of care Process measures (as reported by users): waiting time in clinic; time with health care professionals; frequency of clinic appointments; monitoring of temperature/ BP/ pulse/ weight/ blood/ caffeine intake (at each clinic visit), and ECG (six monthly), according to guidelines (NICE 2009).

Satisfaction with care

Selected items from the Verona Service Satisfaction Scale – European version (VSSS-EU), a validated instrument for evaluating mental health services. Items are scored on a 5 point scale (1 = terrible to 5 = excellent), summed and a mean value calculated. Sixteen of the 63 VSSS-EU items were incorporated: the overall satisfaction and access dimensions (3 and 2 items respectively) and individual items from the information, professional skills and behaviours, efficacy, interventions and relative involvement dimensions (Ruggieri et al. 2006a; Ruggieri et al. 2006b).

Use of other services

The Client Service Receipt Inventory (CSRI) (Chisholm & Knapp 2006), which is widely used with people with mental health disorders was adapted. To assist participants, the names of some local services were used (e.g. hostels, crisis houses). Respondents were asked to self report use, over the previous 3 months of: hospital inpatient (general and psychiatric wards and alcohol units); hospital outpatient (including psychiatrist, crisis team, A&E); community services (day centres, learning disability and other community teams; contacts with health professionals, including general practitioner (GP), district nurse, community psychiatric nurses, care coordinator, physiotherapist, occupational therapist, dietician, pharmacist, counsellor). They were also asked about frequency of help received at home (e.g. with cooking and cleaning), and provider (formal /paid care worker vs. informal relative or friend).

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Table 2: Characteristics of participants: comparison of sole nurse and doctor-led MDT clinics

Variable Units Doctor-led/ MDT clinics Sole nurse clinics Signific-ance: pN n % N n %

Gender Male 38 25 65.8 28 21 75.0 0.421*Ethnicity White British 38 35 92.1 28 22 78.6 0.153 +Education: age left full time education

<=1637

19 51.328

15 53.6 0.673^17 - 18 7 18.9 7 25Over 18 11 29.7 6 21.4

EmploymentStatus (vs. not in employment)

Full time

37

2 5.4

28

0 - 0.420*Part time 6 16.2 2 7.14Voluntary 7 13.5 4 14.3Seeking 2 5.4 3 10.7

Living situation Alone (vs. with others): Yes 38 14 36.8 28 14 50 0.285*Accommodation Sheltered (vs. independent) Yes 36 8 22.2 28 2 7.14 0.165 +Co-morbidities Hypertension (Yes) 38 10 26.3 28 2 7.14 0.046

N Mean Std dev N Mean Std dev pAge Years 38 44.92 12.428 28 38.71 11.065 0.040#Social support 1 (unsupported) – 5(supported) 35 4.4 0.723 26 4.35 0.745 0.792#

N Median Range N Median Range p*Years with mental illness

< 1yr; 2-5yr; 5-10yr; 11-15yr; >15yr

38 11-15 <2-5 to >15

28 5-10 <2-5 to >15

0.102^

Years taking clozapine <1yr; 1-2yr; >2yr 38 >2 <1 to >2 28 >2 1-2 to >2 0.642^Number of medicines (includes clozapine)

1; 2 - 3; 4 - 5; >5 37 4-5 1 to >5 28 4-5 1 to >5 0.411^

Self reported health VAS: 1 - 10 (best) 38 7.43 2.060 27 6.43 1.974 0.052#Health behaviours Smoke: Yes 37 21 55.3 28 16 57.1 0.879*

Recreational drugs: Yes 38 1 2.63 28 3 10.7 0.304+Overweight/ obese, BMI > 25 33 22 65.7 27 21 77.8 0.342*Exercise < once per week 38 4 10.5 28 4 14.3 0.714+Exceed weekly alcohol recommendations

38 3 7.9 27 5 18.5 0.260+

Sleep during day: Yes 38 16 42.1 28 11 39.3 0.818*Concordance > 1 clinic appointment missed

last 3 months37 2 5.4 28 3 10.7 0.430^

Ever vs. never forget taking clozapine

38 12 31.6 28 11 39.3 0.600*

Statistical tests: * Chi square; + Fishers Exact; ^ Mann Whitney U; #Unpaired t tests$Weekly alcohol recommendations: Women:>14;Men: >21 units~ No significant difference (p>.05) between models in reported prevalence (overall %) of coronary heart disease (4.5%), diabetes (15.2%), asthma (19.7%), alcohol/ substance abuse (13.6%), depression (50.0%), anxiety (48.5%), no co-morbidities (27.3%).

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Table 3: Factors associated with wellbeing, functioning, satisfaction and service utilisation costs*

Response variable NR2

Explanatory variables Fitted parameter

95% C I p*

WEMWBS(Wellbeing)Mean Score (1 low -5)

N = 65R2 = 0.208

Constant 3.483 3.258 to 3.709 <0.001Depression (yes) -.462 -.778 to -.145 0.005Use drugs (yes) -.913 -1.571 to -.255 0.007

IADL(Instrumental Activities of Daily Living)(0 low -800)

N = 65R2 = 0.324

Constant 101.512 84.628 to 118.397 <0.001Live alone (yes) -15.110 -24.793 to - 5.427 0.003Educated > 18 yrs 16.584 5.502 to 27.667 0.004Diabetes (yes) -17.889 -31.396 to - 4.382 0.01Asthma (yes) 14.540 2.179 to 26.900 0.022

Self – EfficacyMean Score (1 low -10)

N = 64R2 = 0..377

Constant 5.812 4.264 to 7.360 <0.001Alcohol units/week -.052 -.089 to -.015 0.007Depression -1.671 -2.635 to - .706 0.001Frequency of clinic appointments

.630 .164 to 1.096 0.009

Educated <=16 yrs -1.124 -2.382 to -.179 0.021Asked about caffeine in clinic

.961 .152 to 1.770 0.021

VSSS-EU (16 itemclinic satisfaction)Mean value (1 low -5)

N = 65R2 = 0.176

Constant 3.974 3.690 to 4.258 <0.001Clinic waiting time -.008 -.014 to -.002 0.009Have ECG (yes) .370 .075 to .665 0.015

Total cost per patient over 3 months

N = 64R2 = 0.193

Constant -519 -2152 to 1114 0.527Asthma (yes) 1048.8 513 to 1584.5 <0.001How often forget to take clozapine?

509 221.6 to 796.4 0.001

Alcohol / substance dependence (yes)

930.8 285.2 to 1576.4 0.006

CHD (yes) 1234 242.6 to 2225.3 0.016Self- efficacy -118.8 -219 to -18.7 0.021Time taking clozapine 564.7 89.9 to 1039.6 0.021Independent living -742.7 -1377.7 to -107.7 0.023

* The regression models tested for the impact of clinic model (explanatory variable), controlling for: user socio-demographic characteristics (age, gender, ethnicity, live alone (or with others), accommodation (independent or sheltered), home help (yes/no), in employment (vs. not), age leaving full time education); health status (having vs. not) hypertension/ CHD/ diabetes/ asthma/ alcohol or substance dependence/ depression/ anxiety/ sleep during the day, number of medications, caffeine units per day, alcohol units per week, recreational drug use (yes/no), smoking status (yes/no), length of time with mental illness, length of time on clozapine), and processes of care (frequency of clozapine clinic appointments, waiting time at clozapine clinic, whether or not tests and procedures performed (FBC/ BP/ pulse/ weight/ temperature/ ECG/ clinic staff monitor caffeine). Cost model additionally included wellbeing (WEMWBS), service satisfaction (16 item VSSS-EU), self efficacy and IADL scores.

Results show reduced form models. Sample sizes are reduced by missing data in some models.R2 values show the proportion of variability in the dependent variable that is explained by the model.

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Indicators* Units Doctor- led/ MDT clinics Sole nurse clinics Signif-icance

pN Mean Std dev N Mean Std dev

VSSS-EU 16 item mean satisfaction

Range 1 worst - 5 best

38 3.99 0.67 28 4.07 0.48 0.622#

VSSS-EU 3 item overall satisfaction domain mean

Range 1 worst – 5 best

38 4.06 0.69 28 4.23 0.58 0.309#

Waiting times in clinics

Minutes 38 32.37 24.62 28 12.59 11.29 <0.001#

Consultation times Minutes 38 20.29 16.064 28 15.75 11.719 0.900#n % n %

Routine testing (vs. not)$

Temperature (each clinic visit)

38 35 92.1 28 19 67.9 0.021*

ECG (6 monthly) 38 31 81.6 27 14 51.9 0.015*Median Range Median Range

Appointment frequency~

Weekly/fort-nightly/monthly

38 Fortnightly Weekly-monthly

28 Monthly Weekly-monthly

0.008^

Table 4: Quality of care: comparison of models

Statistical tests: * Chi square;^ Mann Whitney U; # Unpaired t test$- No significant difference (p>.05) between models in testing (vs. not) at each clinic visit of blood (overall 99% tested); BP (99%); pulse (85%); weight (99%); asking about caffeine intake (84%) ~ Clinic E only opens once per month, whilst other clinics are weekly

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Table 5: Human resource costs of clozapine clinics (£,2009)

CLINIC MODEL Doctor-led/MDT Sole nurseCLINIC A B C D E F GClinic hoursper week

3 2 2 3 2 hours per

month

2 2

No. clozapine patients on list

62 45 18 21 12 20 11

Professionals Doctor Pharmacist

NursePhlebotomist

DoctorPharmacist

HCAReceptionist

DoctorPharmacist

NurseReceptionist

Nurse Nurse Nurse Nurse

Costs of human resources, per clinic session

£420.00 £215.50 £259.50 £119.25 £79.50 £79.50 £98.75

Costs of human resources, per annum

£21,840 £11,206 £13,494 £6,201 £954 £4,134 £5,135

Average cost per patient per annum*

£352.33 £249.00 £749.70 £295.33 £79.50 £206.70 £466.80

HCA: Health care assistant

Unit costs per hour: Doctor £162; Pharmacist £108; Nurse £72; HCA £28; Phlebotomist £42; Receptionist (shared with other clinics) £7.50 (Curtis 2009)

* Costs for clinics C – G do not include the doctor time spent reading blood tests (conducted within clinics A and B) of approximately £30 - £75 per patient per year (based on 3 minutes per test, and depending on frequency of testing).

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