Abstract
Keywords
Introduction
Community treatment orders
Since November 2008, supervised community treatment orders (CTOs) have been used to legally require patients to adhere to treatment in the community in England and Wales [Department of Health, 2007]. CTOs can only be applied after an initial period of detention in hospital but afford compulsory treatment in a less restrictive environment than in-patient care. Requirements or ‘conditions’ of the CTO may focus on aspects of treatment and risk management, including restrictions regarding place of residence. A further statuary condition is that the patient must meet with a Second Opinion Appointed Doctor (SOAD) for authorization of medication treatment within a given timeframe (usually 1 month). If the person fails to comply with the conditions of the CTO, they can be ‘recalled’ to hospital for up to 72 hours. The ability to recall a patient to hospital is generally seen to be the primary power of a CTO. If the patient continues to refuse treatment the CTO is ‘revoked’ and the patient is then detained in hospital under a hospital treatment order once more. Although the UK government anticipated that 450 people in England and Wales would be subject to a CTO in the first year of legislation, the actual figure was approximately 4000 people, and this resulted in a shortage of SOADs [Care Quality Commission, 2010; Gould, 2009]. The background, legislation, and clinical application of the CTO in England and Wales has been described elsewhere [Brookes and Brindle, 2010; Macpherson et al. 2010; Taylor, 2010b].
Efficacy and ethnicity
The high uptake of CTOs occurred despite the fact that neither of the two randomized controlled trials (RCTs) of CTOs in North America provided definitive evidence of efficacy [Steadman et al. 2001; Swartz et al. 1999] and both have methodological concerns [Swartz and Swanson, 2004; O’Reilly and Bishop, 2001; Szmukler and Hotopf, 2001]. A Cochrane review estimated that 85 people would need to receive a CTO in order to avoid one admission and that 238 people would need to receive a CTO in order to avoid one arrest [Kisely et al. 2005]. A third RCT is currently being conducted in England [Burns et al. 2008] and, hopefully, this will provide useful information relevant to the UK setting. This is pertinent as international generalizability for the efficacy of CTO is complicated by the widely differing clinical criteria and legal jurisdiction. Generalization of findings from international RCTs is complicated by the substantial differences in the structure and function of community services [Lambert et al. 2009]. Further, in the UK, there are concerns regarding institutional racism in psychiatry [McKenzie and Bhui, 2007] and patients of black ethnic origin are reported to be subject to more frequent re-admissions [Burnett et al. 1999] with a higher rate of compulsory detention [Morgan et al. 2005; Bhui et al. 2003]. Although differences in illness course and duration, acuity of presentation, insight, attitudes to treatment and family and social support [Fearon et al. 2006; Morgan et al. 2006] may be explanatory factors, it remains to be seen whether this difference by ethnic group holds true for CTO use.
Medication
In practice, probably the most common condition of a CTO is to compel the patient to continue with medication for symptom control and relapse prevention, particularly when insight into the need for continuing treatment is suboptimal. In Australia, a strong link has been identified in the use of CTOs combined with antipsychotic long-acting injections (LAIs), which are used to overcome covert medication nonadherence [Lambert et al. 2009; Patel et al. 2009; Patel and David, 2005]. In the USA, LAIs are more commonly used for patients of black than white ethnic origin [Shi et al. 2007; Valenstein et al. 2001] but this pattern is less evident in the UK [Connolly and David, 2008; Lloyd and Moodley, 1992; Chen et al. 1991]. Our objective was to quantify how CTOs were used in the first year of legislation, with particular regard to medication prescribing, in a prospectively ascertained cohort. The aims were: (i) to identify patient characteristics, including ethnicity, for those commenced on a CTO; (ii) to identify the nature of psychotropic medication prescribing at CTO initiation; (iii) to measure time taken for SOAD certification. It was hypothesized that patients with schizophrenia would have higher than average rates of LAI use as compared with national prescribing data [Barnes et al. 2009] but that there would be no ethnic bias.
Method
Design
Baseline data are presented for a 1-year prospective observational cohort study with systematic inclusion sampling of all patients initiated on a CTO within a large mental health trust in the first year (3 November 2008 to 31 October 2009) of CTO legislation in England and Wales.
Setting
This study was conducted in the South London and Maudsley (SLAM) NHS Foundation Trust in London, UK. The Trust serves a local population of 1.1 million and the proportion of people of black ethnic origin (the largest ethnic minority group) for the four local boroughs is as follows: Lambeth (25.8%), Southwark (25.9%), Lewisham (23.5%) and Croydon (13.3%) [Office for National Statistics, 2001]. During the first 6 months of the sampling period there were 667 acute inpatient beds, for which the average length of inpatient stay was 53 days and the ‘trimmed’ (for admissions of duration 3–90 days) mean length of stay was 28 days. Acute inpatient bed occupancy levels were 97% including patients on leave and 83% excluding patients on leave. Acute inpatient care is led by inpatient consultants and not community consultants. The Trust also includes specialist tertiary referral inpatient facilities (e.g. national psychosis unit) and forensic wards. This study was approved as a Trust-wide audit by the SLAM clinical audit and effectiveness committee. Ethical approval was not required and this was confirmed by the local research ethics committee.
Participants
Systematic consecutive sampling was conducted for all patients commenced on a CTO between 3 November 2008 (CTO legislation introduction in England and Wales) and 31 October 2009 whose CTO was registered at one of the five Mental Health Act offices within the Trust. Only the first CTO for each patient was included. There were no exclusion criteria.
Variables
A pro forma for data extraction at baseline was designed to enhance reliability and included the following variables.
Sample characteristics
Sociodemographic variables included gender, date of birth, marital status, employment status, and ethnicity which was categorized using standard format from census data [Office for National Statistics, 2001]. Primary psychiatric diagnosis at CTO initiation was recorded as documented by clinicians (ICD-10) [World Health Organization, 1992].
Mental Health Act status
Date of CTO initiation, reasons for CTO (protection of patient’s own safety, health or others), preceding/parent section (sections 3, 37 or 25a) and CTO specified conditions were noted.
Medication
Psychotropic medication prescribed at the time of CTO initiation (drug name and dose), history of previous clozapine (ever) use, and history of previous antipsychotic LAI (ever) use were recorded. SOAD assessment for use of psychotropic medication including date of SOAD (CTO11) form within first 6 months, medication approved and reasons for lack of SOAD form were also noted.
Data extraction
The primary sources of data included the Mental Health Act office registers, source legal CTO documents, prescription charts and electronic patient records including medication details, contemporary clinical notes and summaries. A baseline data pro forma was completed by clinical research staff.
Analysis
Statistical analyses with SPSS software included baseline descriptive analyses. Age at CTO initiation was calculated and categorized according to ‘Count me in’ census categories [Care Quality Commission, 2009]. Conditions stated on CTO were coded according to commonly occurring themes (as outlined in Table 3). Current antipsychotic medication was categorized according to class and formulation and antipsychotic polypharmacy was noted. Doses for antipsychotics were converted into percentage of maximum dose licensed according the British National Formulary (%BNF) [Royal Pharmaceutical Society of Great Britain, 2008]. Completion of SOAD certification was categorized according to time of completion and reason for lack of completion within 6 months (as outlined in Table 3).
Results
Sample characteristics
Sample characteristics.
LAI, long-acting injection.
CTO use and ethnicity
Variation in CTO use by London borough and ethnicity.
Statutory reasons and conditions
CTO statutory reasons, conditions and medication.
Medication
At time of CTO initiation, 193 patients (99%) were prescribed an antipsychotic, and first-generation (typical) antipsychotic LAIs were most commonly used (see Table 3). Regarding antipsychotic doses, the mean %BNF was 61.6% (SD 37.1, range 2.5– 183.3%). Of the total sample 7.2% had antipsychotic (combined) doses exceeding 100% BNF limits and 9.7% were prescribed two antipsychotics. The most commonly prescribed LAIs were risperidone LAI, pipothiazine palmitate and flupenthixol decanoate. Of those with a diagnosis of schizophrenia, 88/138 (63.8%) were prescribed an LAI.
SOAD involvement
Only 136 (69.7%) patients received SOAD certification within 6 months (see Table 3). Completion rates of SOAD certification within the required timeframe (usually 1 month) did not improve over the study duration: Q1, 16/64 (25.0%); Q2, 9/62 (14.5%); Q3, 3/39 (7.7%); Q4, 1/30 (3.3%); total, 29/195 (14.9%). The mean time from CTO onset to SOAD certification was 66.6 days (SD 40.8, range 1–175 days, N = 136); for those with a standard 1 month time requirement the mean was 67.4 days (SD 41.4, range 1–175 days, N = 120).
Discussion
Strengths, weaknesses and principal findings
This is the largest reported study on CTOs in England and Wales to date and comprised all 195 patients commenced on a CTO within the first year of legislation in a large mental health trust. A key strength of this study is that it used a systematic sampling strategy which included all patients, thus avoiding sampling bias. Weaknesses of this study include lack of detail regarding education, length of contact with psychiatric services, number of prior psychiatric hospital admissions (compulsory or voluntary) and duration of index admission (leading to CTO) and lack of a matched comparison group. We did not aim to definitively address the question of whether or not CTOs are beneficial or efficacious, which requires an RCT [Burns and Dawson, 2009; Churchill et al. 2007]; rather, we aimed to investigate how CTOs are being used with particular regard to medication use. Key findings included the considerable variability in CTO use across the four boroughs which the Trust serves. Over half of the patients were of black ethnic origin which is more than twice that suggested by the population census data for the four boroughs (13.3–25.9%) [Office for National Statistics, 2001]. Further, common CTO conditions included clinical assessment, medication adherence, specified place of residence and access to residence. Investigation of psychotropic medication revealed that 99% were prescribed an antipsychotic and 63.8% of those with schizophrenia on a CTO were prescribed an LAI. The majority was clozapine naïve and this was higher than anticipated but possibly reflects poor adherence by this patient population obviating the use of clozapine due to the requirement for weekly blood tests. A clinically important minority was prescribed two antipsychotics and 7.2% had (combined) antipsychotic doses exceeding 100%BNF dose limits. Only 14.9% of patients had timely medication SOAD certification.
CTO use and ethnicity
Reasons for the geographical variation in CTO use might reflect varying attitudes and beliefs of clinical staff regarding CTOs, perhaps stemming from the lack of definitive evidence of efficacy of CTOs, and lack of belief that the individual patient will comply with treatment despite the legal sanction. This may be further exacerbated by differences between inpatient and community consultant psychiatrists for the same patient and also influenced by additional services including home treatment and assertive outreach teams. Also, use of CTOs for patients of black ethnic origin appears to be more than twice that suggested by the population census data [Office for National Statistics, 2001] for the locality served by the Trust. However, this can probably be largely explained by rates of hospital detention for ethnic minorities [Eaton, 2010; Audini and Lelliott, 2002]. For this Trust, 43% of patients on acute inpatient wards were of black ethnic origin using ‘Count me in’ census data [Care Quality Commission, 2009] for the Trust, 50.2% of all patients detained with a section 3 hospital order were of black ethnic origin using Trust Mental Health Act data (April 2007–March 2008) and local antipsychotic prescribing data for inpatient wards showed almost identical proportions of ethnic diversity [Connolly and Taylor, 2008]. Hence, there does not appear to be any ethnic bias in the application of CTOs over and above the factors leading to ethnic differences in the current use of the Mental Health Act for hospital detention orders as shown by our nonsignificant finding (black ethnic origin: CTO, 52.3%; section 3, 50.2%). However, as with the early report on CTO use in Birmingham and Solihull [Evans et al. 2010], we lack the data necessary to demonstrate this using statistical modelling or more rigorously still, by comparing groups of differing ethnicities matched for illness severity and course. Future studies should quantify rates of CTO renewal, revocation, voluntary hospital admissions and with regard to differences by ethnic group.
Conditions
Conditions should only be applied to a CTO which are necessary for enabling treatment or for safety [Department of Health, 2008] and should be practical and enforceable. If the condition cannot be enforced or monitored then, critically, should the patient be at risk of being recalled to hospital for breach of that specific condition? Recall should be invoked only if it is deemed a proportionate action to the identified level of risk associated with the breach of the condition [Department of Health, 2008]. The Code of Practice highlights that conditions might include ‘where the patient is to live, and avoidance of known risk factors or high-risk situations relevant to the patient’s mental disorder’ [Department of Health, 2008]. We wonder how many patients will be recalled to hospital specifically because a condition regarding place of residence (applicable to over half of our sample) has not been upheld, or a urine drug screen sample has not been consistently provided. Further, it is stated that conditions should only minimally restrict the patient’s liberty while being consistent with achieving their purpose [Department of Health, 2008]. Requiring access to a patient’s home is intrusive and may not be consistent with the ‘least restrictive principle’ governing compulsory treatment, as is suggested by the use of this condition for almost a third of our sample. Further monitoring of conditions, particularly regarding place of residence, seems appropriate and should include subsequent alterations to the conditions (after CTO initiation) for which there are no current additional checks in place. Also, the process by which a responsible clinician and approved mental health practitioner formulate the conditions to be imposed is in need of more consideration and structure by policymakers. This should also anticipate how these conditions might be challenged by the patient, potentially at the point of CTO renewal if not earlier.
Medication
Our finding of 88/138 (63.8%) of those with schizophrenia on a CTO being prescribed an LAI is double that reported by Barnes and colleagues who highlighted that in the UK, LAI use for patients with schizophrenia is 35% on acute wards, 36% for assertive outreach team cases, 28% on forensic wards [Barnes et al. 2009]. In 2002 in the state of Victoria, Australia, just under half of those with schizophrenia on CTOs were prescribed an LAI [Lambert et al. 2009]. Thus far, there has been no definitive evidence to suggest the use of a CTO with an LAI is more beneficial, in terms of long-term outcomes, than either an LAI alone or a CTO with an oral antipsychotic. Moreover the alleged superior long-term benefits in relapse prevention of LAIs over oral antipsychotics lack definitive evidence [Leucht et al. 2011; Rosenheck et al. 2011; Patel et al. 2009] although a large cohort study favoured depot antipsychotics over their equivalent oral preparations [Tiihonen et al. 2011]. That said, the CTO may grant access to treating the patient with an LAI and also provide sufficient time to establish a regular injection routine. In turn this allows patients a better chance of establishing some control over their illness and, with it, a measure of improved insight [Lambert et al. 2009]. This study also found that high-dose (>100%BNF) antipsychotic prescribing and polyantipsychotic use is evident for patients on CTOs, although to a lesser extent than that reported for other UK samples [Tungaraza et al. 2010; Paton et al. 2008], despite guidelines to the contrary [Langan and Shajahan, 2010; Taylor, 2010a; National Institute for Clinical Excellence, 2009]. Compelling any patient to have potentially dangerous or even fatal high doses of medication is extremely problematic. Indeed, a study of 93,300 patients treated with antipsychotics and 186,600 matched controls found that high doses (>300 mg chlorpromazine equivalent) of first- and second-generation antipsychotics were associated with increased rates of sudden cardiac death [Ray et al. 2009]. Thus, whilst it is probable that the requirement for a SOAD to sanction treatment plans has already reduced the potential number on a CTO who would otherwise have been prescribed high doses, more needs to be done regarding prescribing monitoring for this patient group.
SOAD certification
SOAD certification involves an important safeguard for CTOs but this is subject to delay in our sample as highlighted by the low rate of SOAD certification within the specified timeframe (14.9%). This is probably in keeping with national trends and is undoubtedly due to higher than anticipated rates of CTO use across England and Wales. This may be further compounded by some patients failing to attend at the scheduled time but as this was not consistently documented, we were unable to accurately take this into account for this study. Owing to the debated legality of community treatment orders without completed SOAD certification, a temporary measure of using emergency treatment orders (section 64) was instigated but this has proved unpopular and is arguably also unlawful in this specific context. Until the shortage of SOADs is resolved, we are likely to continue facing the problem that many patients are being required to take medication that has not been approved nor had full legal process. As the system further adjusts to cope with the new Mental Health Act, it is hoped that several of these early problems for CTOs can be resolved.
Contributions
MXP designed the study, conducted the analyses, drafted the article and takes responsibility for the integrity of the data and the accuracy of the data analysis. JM, MKB, JG and KB contributed to the data collection, analyses, and interpretation. JB, FH, DT, GS, TL and ASD contributed to the data analysis and interpretation. All authors were involved in the drafting of this article and approved the final published version.
Footnotes
Funding
The authors acknowledge support from the Department of Health via the National Institute for Health Research (NIHR) Specialist Biomedical Research Centre for Mental Health award to South London and Maudsley NHS Foundation Trust (SLAM) and the Institute of Psychiatry at King’s College London.
Conflict of interest statement
MXP and ASD have been reimbursed for attendance at scientific conferences and have received fees for lecturing and/or consultancy from Janssen-Cilag and Eli-Lilly, and investigator-initiated grants and have previously worked on two clinical drug trials for Janssen-Cilag. DT has received consultancies fees, lecturing honoraria and/or research funding from AstraZeneca, Janssen-Cilag, Servier, Sanofi-Aventis, Lundbeck, Bristol-Myers Squibb, Novartis, Eli Lilly and Wyeth. TL has consulted to and received educational and research grants from Eli Lilly and Janssen-Cilag.