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View larger version:In a new windowDownload as PowerPoint SlideFig 1 The AID trial profileView this table:View PopupView InlineTable 1 Baseline characteristics of included patients with recent suicide attempt during 2007 to 2010. Values are number (percentage) unless otherwise stated Service use in the intervention groupThe service offered in the AID-intervention was flexible, with a median of 9 (interquartile range (IQR) 6-12) home consultations including cafe visits, 1 (0-3) attendances to healthcare services, 12 (7-21) phone calls to patients and relatives, and 2.5 (0-5) and 5 (0 to 8) phone calls to healthcare and social services, respectively. The median number of text messages sent was 17 (IQR 8 to 30). In total, 91 crisis interventions were provided. These interventions included phone calls when severe suicidal ideation or impulses were present and emergency calls when either somatic or psychiatric admission was requested. Five patients did not receive the allocated intervention because they withdrew from the study.Primary outcomeDuring the 12 months’ follow-up, we found that 20/123 (16%) patients in the intervention group had been registered in hospital records with subsequent attempts, compared with 13/120 (11%) in the control group (odds ratio (OR) 1.60, 95% confidence interval 0.76 to 3.38; P=0.22 (table 2?). Adjusting the primary analysis with the use of antidepressants at baseline did not markedly alter the results (1.67, 0.78 to 3.58; P=0.19). Our analysis suggested no association between antidepressants and allocation (P=0.48).View this table:View PopupView InlineTable 2 Number of patients with subsequent suicide attempt at one year follow-up, by source of data on new events and by subgroup. Values are number of patients with one or more new events/number in group with available data (percentage) unless otherwise statedBy contrast, self reported data on new events showed 11/95 (12%) in the intervention group versus 13/74 (18%) in the control group (OR 0.61, 95% confidence interval 0.26 to 1.46; P=0.27; table 2). Seven patients (four in the intervention group versus three in standard care) were identified with a subsequent suicide attempt in the hospital records although the patients themselves had reported none. Correspondingly, nine patients (one in the intervention group versus eight in standard care) themselves reported subsequent attempts that were not listed in the hospital records. Analysis of missing self reported data based on baseline information about relevant risk factors (sex, age, unemployment, suicide attempts prior to index attempt, prior psychiatric admission, and alcohol consumption at index attempt) assumed data were missing at random. By imputing missing data on the self reported outcome as described above we estimated 15/123 (12%) in the intervention group and 23/120 (19%) in the control group (OR=0.69, 95% confidence interval 0.34 to 1.43; P=0.32; table 2).We identified two deaths due to causes other than suicide; one in the intervention group and one in the control group. One patient died by suicide in the intervention group within two weeks of the index attempt.Combining the self reported outcome with the hospital records in post-hoc analyses did not markedly alter results (OR=0.97; 95% confidence interval 0.50 to 1.89; P=0.93).Additional analyses using attendance to healthcare services as the outcome did not show more health care contacts by participants in the intervention compared with the standard group (OR=0.57 95% confidence interval 0.29 to 1.14; P=0.11). Similarly, attendance to social services was similar between in the two groups (1.01, 0.61 to 1.68; P=0.96).Subgroup analysisA separate subgroup analysis conducted by age group showed no impact of age on estimated effects of the intervention (table 2). Subgroup analyses by sex and by diagnoses of mild to moderate depression and personality disorders did not obtain differences in effects.DiscussionPrincipal findingsThis pragmatic, randomised controlled clinical trial investigated the effect of assertive outreach as a preventive treatment strategy for patients with a recent suicide attempt. The trial did not find any significant difference in repetition rates between the group receiving the intervention and the group receiving standard treatment. We noted a difference between register data and self reported data for subsequent suicide attempts, especially in the control group. The AID trial has contributed to international research by investigating an assertive approach demanded by experts and clinicians.Strengths and weaknesses of the trialA strength of the trial was the randomised design and high methodological quality, associated with a low risk of bias.29 The robustness was increased by a relatively large sample size and use of detailed register data to ensure that no patients were lost to follow-up. The frequency of assertive consultations and service use suggest that patients accepted the experimental intervention by adhering to the approach. The study covered a heterogeneous population, including patients with alcohol and substance abuse problems, and those diagnosed with borderline personality disorder and various other diagnoses. Both these groups are at high risk,12 33 often with limited or already rejected treatment opportunities. The trial population was therefore similar to that seen in clinical reality, leading to high external validity of the study. Since patients diagnosed with schizophrenia spectrum disorders were excluded, the findings do not apply to these patients, but they do apply to other groups of high risk patients without psychosis.The lack of a manual based approach for the AID intervention and the presence of various kinds of after-treatment modalities in both study groups makes replication less feasible and could affect the internal validity. Marked distinctions between the standard and intervention approaches were the assertiveness, the accessibility, and the active assistance of patients to scheduled appointments in the intervention group; these parts were all thought to be substantially relevant for this patient group.18 23 24 25 The standard treatment offered by the Centre of Excellence in Suicide Prevention Copenhagen improved during the study period and is judged to be after-treatment of good quality. As the AID intervention was an add-on, the standard treatment was also offered to patients in the intervention group, thus avoiding risk of bias. Although the study groups were located in different settings, contamination of standard treatment cannot be excluded. Different motivational factors might explain the lack of a difference between the groups in attendance of health and social services. During the study period, the Danish government’s requirements for receiving sick leave benefits included mandatory frequent contact with social services; if citizens did not attend scheduled appointments, they risked losing their sick leave benefits. Also, social services often require medical documentation in order to issue sick leave benefits. Figures of attendance to health and social services in the control group do not show whether patients were adherent to service requirements.The significantly higher proportion of patients prescribed antidepressants at baseline in the intervention group could constitute a source of bias. These patients might represent a group with more severe mental illness who might also be more difficult to prevent from subsequent suicidal behaviour.18 On the other hand, patients already receiving drug treatment might, arguably, be less depressed than those not receiving pharmacotherapy.18 20 However, the analysis adjusting for this potential confounder found no indication of bias.The relatively wide age range of the study population, which included teenagers and older people as well as people of both sexes, could be considered a potential limitation owing to the varied needs and help seeking behaviours of different groups. However, our subgroup analyses showed no effect of age or sex on the findings. The recorded rate of subsequent suicide attempts among males was slightly higher in the intervention group than in the standard group, which might give rise to speculation that males in the standard group were less inclined to seek help, leading to detection bias. However, the difference in rates between the groups was not significant.We expected that adherence to the AID intervention would reduce subsequent suicide attempts. However, we also expected that the intervention would encourage participants to seek contact more frequently, which could have increased the likelihood that subsequent attempts were reported. The higher repetition rate shown in the hospital records might suggest that patients in the intervention arm, after subsequent attempts, called the AID manager, who then provided emergency arrangements. The weakening of differences in effect when self reported information was added to the analysis adds to this argument.10The power calculation, in which we estimated a repetition risk of 30% in the standard group and 15% in the intervention group, could be judged to be too optimistic. The calculation relied on rates recorded in past European studies13 34 but might not have been powered to detect smaller differences such as those present in this trial.There was disagreement between the two data sources over the number of suicide attempts. The clinical decision to classify a self inflicted episode as a suicide attempt corresponding to a diagnosis in hospital records is often not consistent. Also, in the acute phase of treating the trauma, diagnoses from emergency departments do not always reflect the suicidal dimension of the event,3 unless the risk of suicide is ongoing. The WHO definition of suicide attempt used in this trial also leaves room for interpretation; although a blinded external evaluation committee examined doubtful cases in detail, a small number of false positives was unavoidable, especially since the medical records in some cases provided limited information. The dissonance in number of suicide attempts between the two data sources could also have been due to differences between the groups in the participants’ perception of their own need or attitudinal barriers—for example, the wish to handle problems alone, which is related to lower tendency for help seeking behaviours.35 36 37 Furthermore, some patients might not be completely truthful about subsequent suicide attempts in order to perform well when interviewed by the researcher, hence a risk of performance bias. On the other hand, patients who reported subsequent attempts but had no hospital record of such an event might have preferred to avoid hospital contact, because they feared being registered and potentially stigmatised later on. These factors reflect a risk in this trial of detection bias related to both underestimation and overestimation.The multiple imputations indicated a potential underestimation based on self reported data.29 However, given that suicidal patients tend to display a lack of treatment seeking behaviour, self reported data might actually have a higher validity than register data.Restrictions by the Danish Data Protection Agency did not allow analysis of information on patients who refused to participate in the trial. Because the inclusion criteria were pragmatic, we did not expect this to affect the external validity.Previous studies have recommended a structured risk assessment as an important tool in suicide prevention.22 Although suicidal behaviour was routinely addressed as a pivotal point of all consultations in the AID intervention, no formal risk assessment tool was used besides the development of crisis intervention plans and individual psychoeducation.Comparison with other studiesThe result of the present trial are similar to those presented in reviews of psychosocial interventions in general.18 19 20 However, a study of a similar intervention by Hvid and colleagues did find an effect.27 The differences in baseline characteristics between that trial and the AID trial suggest that our study included more patients with previous suicide attempts and former psychiatric contacts. The study populations might have differed, therefore, in severity of mental illness. However, Hvid and colleagues did not provide information on diagnosis, and data on service use were only provided for the intervention group. Interestingly, both trials used same inclusion and exclusion criteria and were conducted within a few years and a radius of 5 km. The most likely explanation for the difference in effects seems to be type one error, or that the standard treatment offered in the previous study was less intensive. Standard treatment in the previous study mainly consisted of standard care in general practice, whereas the current study was able to offer an enhanced treatment through the Centre of Excellence during the AID trial.Baseline characteristics of the current sample resembled populations in international studies; for instance, three quarters of those who attempted suicide were women,6 one quarter were of younger age (<20 years),8 9 38 and overdose was the most frequent method.6 16 Based on post-hoc analysis, the combined repetition rates based on medical records and self reported data were estimated to be 17% for the intervention group and 18 % in the standard, respectively, which corresponded to repetition rates previously outlined in international reviews.10 11 12Possible explanations and implications for clinicians and policymakersAlthough experts, clinicians, and patients have called for an assertive approach to suicide prevention, we did not find evidence to recommend such a strategy. However, the complexity of suicidal behaviour might not be addressed adequately by accompanying patients to after-treatment if waiting lists are extensive, or if the treatment modalities are not evidence-based. By comparison with other settings, the standard treatment in our trial was of good quality, and this could affect the external validity. However, the repetition rate among recipients of standard treatment was still very high. We do not believe, therefore, that the threshold for improvements has been reached. It would have been appropriate and interesting to rate patients on relevant suicidal scales (for example, for depressive symptoms, substance abuse, and self efficacy) at baseline and follow-up, to detect any difference in secondary outcomes in relation to treatment modalities.Extensive information is available on risk factors for suicidal behaviour,6 10 39 but less is known about recommendations for psychosocial treatment.19 20 Evidence of benefit has been shown for cognitive behaviour therapy21 22 and for psychosocial treatment within a family context for adolescents.40 However, this evidence relates to specific subgroups and has yet to be replicated in heterogeneous populations.A remarkable relative difference was noted between the number of registered and self reported repeated suicide attempts among patients in the standard treatment. Suicide attempts are probably under recorded in general.1 5 6 However, it is worrisome that these people did not seek help despite being enrolled in an ongoing treatment programme. The estimate of multiple imputations on self reported data suggested that there could be even more patients with subsequent unrecorded events in both groups. The long term consequences of untreated deliberate self harm are unknown, but are certainly a potential risk factor.Patients attempting suicide constitute a heterogeneous group, differing in age, life conditions, and risk factors. Prevention strategies targeting repeated suicide attempts need to address most of the raised risk factors by providing crisis intervention, being assertive and accessible, and at the same time offering individually shaped support. The AID intervention aimed to incorporate all these essential elements and yet failed to reduce the repetition frequency in a large, representative sample. Future research could target subgroups with even more specialised therapeutic interventions, such as specialised cognitive behavioural therapy, or could focus on primary prevention strategies addressing risk and vulnerability before the first suicide attempt.What is already known on this topicSuicide attempt is often associated with subsequent suicidal behaviour, but patients can be difficult to engage in after-treatmentA previous study with limited power suggested that assertive and motivational consultations could reduce the rate of repeated suicide attemptsWhat this study addsThis randomised clinical trial did not find evidence to recommend an assertive intervention over standard care for patients after suicide attemptPatients allocated to the intervention were more likely than controls to be hospitalised and treated for subsequent suicide attemptsPatients were compliant with the interventionNotesCite this as: BMJ 2012;345:e4972FootnotesWe thank all included patients and relatives, intervention staff Agnete Birktoft and Hanne Frandsen, all collaborating partners in intensive units both somatic and psychiatric, Centre of Excellency in Suicide Prevention, social services, external psychiatrists, and psychologists. We thank the investigators Hvid and Wang for their collaboration.Contributors: MN was primary investigator. BM and MN developed the research protocol, designed the study, acquired funding, carried out the intervention, and gathered data. FA was administrative collaborator and consulting physician for the research assistant. FA, AE, and MN were the blinded external evaluation committee. BM and JK constructed the database and conducted the statistical analysis. All authors contributed to writing and revising the manuscript. BM and MN are guarantors.Funding: The study received funding from the Ministry of Health and Internal Affairs, Denmark, the National Board of Social Services, an independent subdivision of The Ministry of Social Affairs and Integration, TrygFonden, and Aase og Ejnar Danielsens Foundation.Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: the study received funding from the Ministry of Health and Internal Affairs, Denmark, the National Board of Social Services, an independent subdivision of The Ministry of Social Affairs and Integration, TrygFonden, and Aase og Ejnar Danielsens Foundation; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.Ethical approval: The trial was approved by the Danish Ethic Committee (journal number KF-01 271146) and by the Danish Data Protection Agency (journal number 2011-41-6398). All participating patients gave written informed consent.Data sharing: No additional data available.This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.References?WHO. Suicide rates per 100?000 by country, year and sex. 2009. www.who.int/mental_health/prevention/suicide_rates/en.?Krug EG, Mercy JA, Dahlberg LL, Zwi AB. The world report on violence and health. Lancet2002;360:1083-8.OpenUrlCrossRefMedlineWeb of Science?Nordentoft M, Sogaard M. Registration, psychiatric evaluation and adherence to psychiatric treatment after suicide attempt. 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