Introduction

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Deliberate self harm is a serious clinical problem in England and Wales, accounting for 140 000 hospital presentations a year.¹ About 15-23% of patients will be seen for treatment of a subsequent episode of deliberate self harm within a year. ^{2 3} About 4% of those who harm themselves die by suicide within 5-10 years.⁴

Evidence on how best to manage patients in primary care who have deliberately harmed themselves is lacking.⁵ We examined the effectiveness of an intervention based in primary care, aimed at reducing the incidence of repeated deliberate self harm. The intervention comprised a letter from the general practitioner inviting the patient to make an appointment to consult, and guidelines on assessing and managing patients for the general practitioner to use in any subsequent consultation.

	Methods

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Protocol
Recruitment of practicesIn total, 49 practices were allocated to the intervention arm and 49 to the control arm (figure). The practices are based in the areas covered by the Avon, Wiltshire, and Somerset Health Authorities.

View larger version (51K): [in this window] [in a new window]   Practice and patient recruitment

Recruitment of patientsWe identified patients eligible for inclusion in the trial from a case register for deliberate self harm. Recruitment data were collected on a weekly basis from the records of the hospitals' accident and emergency departments between 26 May 1997 and 29 February 1999.

ExclusionsWe excluded cases of alcohol (taken alone) and illicit drug overdose, except where the casualty officer felt that the purpose of the act was self harm or suicide. We excluded patients who were under 16, of no fixed abode, or imprisoned; who had requested that nobody was to be informed of the episode or had harmed themselves deliberately in response to a psychotic hallucination or delusion; or whose episode of deliberate self harm was managed entirely in primary care.

InterventionIf an episode of deliberate self harm was the patient's first within the trial period, their general practitioner was sent a letter informing them of the incident, a letter to forward to the patient (at their discretion) inviting them to make an appointment for a consultation, and a copy of guidelines for the management of deliberate self harm, which were developed for the trial (see bmj.com).⁶ The general practitioners were asked to insert the guidelines into the patient's notes so that they were available for use during consultation.

Usual careApart from the Royal United Hospital, Bath (which had a specialist nurse), the hospitals from which patients were recruited had no specialist services for patients who deliberately harm themselves.

Primary and secondary outcomesThe primary outcome measure for the trial was a repeat episode of deliberate self harm in the 12 months after the index episode. Secondary outcomes were the time (days) to the first repeat episode and the number of repeats.

Sample size calculationWe needed 1920 patients to detect a reduction of five percentage points (from 15% to 10%) in the rate of repeat deliberate self harm in 12 months (giving 80% power, 5% significance level, and 40% inflation to allow for the cluster randomisation).

Data analyses
For the primary analysis, which compared the intervention and control groups on an intention to treat basis, we carried out a logistic regression analysis with repeat episodes of deliberate self harm within 12 months of the index event as the outcome variable. This analysis controlled for practice size (two categories) and quartile of rates of deliberate self harm by practice at baseline and allowed for clustering by practice, using random effects logistic regression.

We used a Poisson regression analysis to compare the intervention and control groups in terms of differences in the number of repeat episodes. We used Cox's proportional hazards regression for time (in days) to first repeat episode. Clustering was taken into account for both of these (intention to treat) analyses. Further regression analyses adjusted for factors with large baseline differences across randomisation groups.

	Results

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In total, 2084 potentially eligible patients were identified over the 21 month period of recruitment. We excluded 152 of these (figure).

Patient characteristics (table 1) were comparable for the participating and non-participating practices. Although the control group had fewer training practices than the intervention group, other practice characteristics were reasonably well balanced between the trial arms (see bmj.com).

Patient characteristics in the intervention and control groups differed for a recent recorded episode of deliberate self harm, general practice Townsend score (weighted by the number of patients recruited from each practice), and hospital attended for the index episode (table 1). The Royal United Hospital in Bath contributed more patients to the control group than in the intervention group (table 1).

Primary analysis
The proportion of participants who had a repeat episode of deliberate self harm within 12 months of the index episode was only slightly but not significantly higher in the intervention group (table 2). The results were not noticeably different when we adjusted for clustering. The observed degree of clustering would have led to an inflation factor of 11% rather than the 40% that was estimated in the sample size calculation.

Secondary analyses
Although more repeat episodes of deliberate self harm and fewer days to first repeat episode were seen in the intervention group than in the control group, Poisson and Cox regression analyses showed that these differences were not significant (table 2). When we also adjusted for the practice's training status, previous recorded episodes of deliberate self harm, Townsend score, and hospital attended by the patient, no appreciable impact on the result for the primary outcome was seen (odds ratio 1.14, 0.88 to 1.50).

Subgroup analyses
Subgroup analyses, agreed on before the trial began, showed that the intervention effect did not differ by sex (interaction P=0.51) or method of deliberate self harm (interaction P=0.64). A similar analysis showed that the treatment effect differed depending on whether or not the patient had a previous recorded episode of deliberate self harm (interaction P=0.017). The odds ratio for the effect of intervention in patients with a history of deliberate self harm was 0.57 (0.33 to 0.98), indicating a beneficial effect, and in those with no history was 1.32 (1.02 to 1.70), indicating a harmful effect.

Analyses of process data
Information about contact with the patient (letter, consultation, or both) was obtained from questionnaires completed by general practitioners for 1383 (72%) patients. Of 612 patients in the intervention group for whom the relevant information was provided, 352 (58%) had been sent the letter inviting them to make an appointment for a consultation. General practitioners in the control group had initiated contact with only 97/642 (15.1%) patients.

	Discussion

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The development of guidelines to be given to general practitioners had to rely largely on existing opinion on best practice and on research on the assessment and management of problems known to be associated with deliberate self harm. In line with evidence from the literature that was available when we planned the study, the guidelines included information relevant to local circumstances and acted as a patient specific reminder. They were not disseminated with an active educational intervention.² Deliberate self harm is a relatively rare event for each general practitionerthe mean annual number of patients recruited per general practitioner was about three in our study. It was thought unlikely that all general practitioners in the intervention arm could be attracted to attend specific educational sessions. Furthermore, a recent study using a practice based educational programme for depressiona much more common disorderfailed to change doctors' behaviour appreciably.⁷ Our guidelines probably enhanced the routine primary care of deliberate self harm because general practitioners have relatively little formal training in its management.

Though only a short delay occurred between the index episode and the general practitioner receiving the letter and guidelines, many patients had already consulted their general practitioner. This delay may be critical when we consider the increased risk of repeat episodes in the weeks immediately after the index event; in one study more than 10% of patients who deliberately harmed themselves again did so within one week of the index episode.⁸ Nevertheless, more general practitioners in the intervention group had initiated contact with their patients in response to the index episode of deliberate self harm than in the control group. All general practitioners in the intervention arm received copies of the guidelines at the outset of the trial and once a patient who deliberately harmed himself or herself had been identified. Receipt of the guidelines for previous patients may have influenced the management of "early attending" patients, even if the general practitioner had not received the guidelines and letter for that particular patient.

Our trial was pragmatic; the obstacles to its potential success were those that would arise if such a system was introduced in the service setting. Nevertheless, the implementation of the intervention showed that a more efficient form of communication with general practitioners is needed. An intervention aimed at reducing the incidence of repeat episodes of deliberate self harm must be initiated within one or two days of the index episode, because of the rate of repetition in this period and because help from general practitioners may already have been sought. Although the letter seems to have had little effect in instigating face to face contact between patients and general practitioners, this may have been because of the delay in sending it to patients. Where the letter did not result in patients contacting their general practitioner in the short term, their awareness of the interest shown by their general practitioner may have led them to seek help in future.

Conclusion
The lack of benefit from the intervention evaluated in this trial leaves open the question of the most effective management in general practice of patients with self harm. The role of the general practitioner in the aftercare of patients who deliberately harm themselves is important, as more than half of these patients receive no psychiatric follow up. The high proportion of patients who make contact with general practitioners after an episode of deliberate self harm suggests that more research is needed on how best to manage such patients in primary care to reduce the incidence of repeated episodes.