Participants
All adult Māori patients (that is those who are not still at secondary school) who present to the emergency departments of North Shore, Waitakere, Middlemore and Northland hospitals who are able to give informed consent will be eligible for the study. Māori patients will be approached by a research team member while in hospital or within 48 hours of discharge. Patients who require an interpreter will be included in the study. Self-harm is defined as intentional self-poisoning or self-injury, irrespective of motivation. Self-poisoning includes the intentional ingestion of more than the prescribed amount of any drug, whether or not there is evidence that the act was intended to result in death. This also includes poisoning with non-ingestible substances (for example pesticides or carpet cleaner), overdoses of 'recreational drugs' and severe alcohol intoxication where the clinical staff consider such cases to be an act of intentional self-harm. Self-injury was defined as any injury that has been intentionally self-inflicted [
19]. We will assess the degree of suicidal intent by using a modified self report version of the Beck Suicide Intent Scale which we will use in the analysis to assess the impact suicidal intent on outcomes.
People will be excluded if they are aged under 17; are still at school; are unable to give informed consent to be part of the study, that is, if they are too mentally unwell (for example they are psychotic or hypomanic); if they are too physically unwell (for example, they are in a coma or with lowered level of consciousness); or if they are severely cognitively impaired.
Recruitment
Following a psychosocial assessment by a non-study mental health clinician, patients will be handed a card by non-study clinician which informs them that they will be approached to participate in a study about what happens after self-harm (Additional file
1). If patients do not want to be contacted they will be asked to inform one of the non-study staff. Eligibility for the study will be assessed by a research therapist reviewing the notes. Eligible patients will be randomised and then approached by the research clinician to explain the study and to request consent to participate.
The maximum delay between the psychosocial assessment and the attempt to obtain consent is four days to allow for weekends and public holidays when research staff are not available. In practice we aim to approach potential participants within 24 hours of their presentation to the hospital. The approach will occur either within the Emergency Department, in hospital if the person is admitted, or where necessary, by telephone after the patient is discharged. An interpreter will be made available to any person who requests one.
The powhiri model
Each iwi (tribe) throughout Aotearoa (New Zealand) practises their own variation of kawa (protocol) on their home marae (tribal meeting places). With this research there will be 132 Māori presenting to three DHB regions (Northland, Waitemata and Counties Manukau) from a number of iwi, not necessarily mana whenua (people of that region). Therefore, a powhiri (welcoming ceremony) process is the most appropriate method of engagement when Māori researchers and Māori participants come together.
Before the powhiri, the kawa is conveyed to the visitors so that they understand what is expected of them. Thus the kawa determines how both the hosts and visitors interact within the sacred boundaries of the marae. For the purposes of this research the marae may equate to the clinical setting, hauora, Māori organisation or local marae.
The conveying of the kawa for Te Ira Tangata is the first level of engagement and can be indicated through the sharing of information through a brief conversation and the information sheets.
Taki/Wero - Challenge
Before the powhiri can begin, the tangata whenua (researchers) must challenge the manuhiri (visitors - participants) to make sure of their intentions and ensure they have come in peace. If their intentions are friendly, the participants will accept the rautapu (a leaf or carved effigy) a symbolic offering of peace. Once the challenge is completed, the warriors will guide you on to the sacred ground of the marae, while the karanga or call of the women of the tribe welcomes you.
Te Ira Tangata will offer the rautapu in the form of a consent form if the participant accepts the peace offering they will sign and return the form to participate in the study.
Karanga - Call
Karanga refers to the ceremonial call of welcome. The start of the karanga indicates to a visitor that they are free to approach their hosts across the marae atea (sacred space directly in front of the meeting house). The call also clears a spiritual pathway for the ancestors of both visitor and host to meet and partake in the ceremonial uniqueness of the powhiri. The call acknowledges the ancestral spirits of the visitors before them. The karanga acknowledges who you are and why you have come, and invite you to stop and shed tears for those who have passed on.
This is the beginning of the 'Patient Support' process within Te Ira Tangata. Where the tangata whenua (research clinician and administrator) have already reviewed clinical notes, checked any management plans and whether they need updating, offered GP voucher, performed risk assessments, referrals in operations and any change of circumstances.
Karakia - Blessing
Karakia are prayers that acknowledge a spiritual presence. When applied to a specific realm or occasion, each karakia would identify and acknowledge gods, demi gods and lesser spiritual deities so that nothing untoward should befall those involved. During a powhiri, the tangata whenua (people of the land) and manuhiri (visitors) often participate in karakia. This unites everyone present in body and spirit, and blesses the occasion. Once the karakia is completed, things begin to lighten up. It's time for the mihi and whaikorero, which amongst other things, talk about issues of the day and the reason for gathering.
Karakia is karakia in Te Ira Tangata and will be performed in appropriate sense for both the research clinician and the participant.
Mihi/Whaikorero - Greetings
The next phase of the powhiri involves the mihi and whaikorero, formal greetings exchanged between host and visitor. This phase is a very formal part of the powhiri. The hosts consider each visitor as sacred, according them all the rights that their position demands. As a visitor, you are expected to act in a dignified manner, for Māori accept your physical presence as representing all your ancestors. It is considered rude to show disinterest during these proceedings or talk over someone delivering their mihi. The exchange between research clinician and participant during PST forms the Mihi/Whaikorero.
There is a saying 'Ko te whaikorero, te kai a te Rangatira - Oratory is the food of Chiefs'. Today, as it was in former times, the arts of whaikorero and mihi are greatly revered. A good speaker will have both visitors and hosts in the palm of his hand, laughing or crying. A good research clinician will also be able to represent these skills during Te Ira Tangata.
Problem solving therapy has five steps including problem orientation, problem identification, generating solutions, making an action plan and reviewing the progress. As part of the problem orientation there will be an acknowledgement of:
III.
the reason for the gathering
This can form the cultural assessment process investigating a person's cultural identity profile. Using these outcomes a person's identity profile and sense of belonging will inform one of the 'problems' to be solved within the therapy.
Waiata - Song
The singing of waiata or song usually follows each mihi and whaikorero (formal greetings exchanged between host and visitor). Today waiata are sung in many languages and for many different reasons. Visitors that sing of their homeland or in their native tongue are said to bestow their hosts with the voice and sound of their ancestors. This is considered a great gift and honour.
At the end of the first PST session there is an opportunity for the participant to identify problems (list), chose one problem to work on, define the problem and generate a solution. When they leave the session they will be able to work on this and bring back progress to the next session.
Koha - Gift
Koha is the traditional act of gifting. In the powhiri (welcoming ceremony) the presentation of koha follows directly after the last speaker has finished their mihi (formal greetings) and waiata (song). The gifting of koha is a very dignified act.
In appreciation for participant contributions a gift will be given on the completion of the rating scales at baseline, 3 month follow up and 12 month follow up. This is a mark of reciprocity from the study to the participant.
Hongi - Coming together
The next stage of the powhiri, the hongi (pressing of noses), the ha or breath of life is exchanged and intermingled. Through the exchange of this physical greeting, you are no longer considered manuhiri (visitor) but rather tangata whenua, one of the people of the land. The hongi is also a sign of life symbolising the action of Tane's breath of life to humans. By this action the life force is permanently established and the spiritual and physical bodies become a living entity.
This symbolises the end of the therapy, participants have had their mauri (life force) restored, rejuvenated and supported.
Hakari - Feast
Hakari is the act of ritual feasting that traditionally applied to the eating of cooked food. Symbolically, the hakari recognises the transition from the spiritual realm of the powhiri back into the physical world where food is shared.
At the completion of patient support and each of the PST sessions participants will be offered food and drink.
Poroporoaki - Farewell
Poroporoaki, or speeches of farewell, are reserved for the final part of the powhiri but are by no means the least important part of the process. The poroporoaki is the act of farewell and the return of mana (esteem and authority) to the host people. This is operationalised by the writing and sharing of a final discharge letter to other people involved in the participants care.
Intervention group
Māori randomised to the experimental group (Te Ira Tangata) who give their consent will be offered the following by the self harm team:
1.
Patient support for up to two weeks. This will consist of one or two face-to-face or telephone sessions depending on patient preference and feasibility over the two week period following the participant's discharge from hospital. These sessions will involve obtaining the discharge plan developed by the assessing clinicians, checking that the patient understands it, identifying potential barriers to implementation of the plan and assisting the patient to follow through with the plan. In other words, the primary aim of patient support will be to ensure patients do not "fall through the cracks". The research clinicians will be expected to liaise with the mental health crisis and community mental health teams; alcohol and drug services; primary care and non health services. Each patient support session will include a risk assessment asking about thoughts and plans for self harm. If a patient is identified as being at risk of self harm the risk management protocol will be followed.
2.
Postcard contact for one year. Eight postcards will be sent in sealed envelopes in months 1,2,3,4,6,8,10 and 12 after the index episode. The cards will contain a short message stating that we hope things are going well and inviting them to write us a note if they wish to (Additional file
2). Each envelope will contain a return stamped addressed envelope.
3.
Problem solving therapy. This will consist of four to six sessions in the four weeks after the participant's index presentation to hospital for self harm. Research clinicians will assess the participant's eligibility for brief problem solving therapy prior to and at the initial patient support session. Patients may be ineligible for brief PST if they are already receiving psychotherapy (for example if they are receiving Dialectical Behaviour Therapy), if brief PST would contradict their management plan, if they live or are moving out of area, if they are in prison or if there is a risk of harm to the research clinician. The problem solving therapy we will use in the treatment package will be conducted with individual patients and is based on the model originally defined by D'Zurilla and Goldfried [
21]. PST sessions will aim to teach the person to recognise and identify current problems and will provide them with a structured approach to problem solving. A clinician manual and a participant workbook will be used by the research team to guide the structure of PST sessions. Sessions will be audiotaped.
4.
Improved access to primary care. We will encourage participants to attend their GP for a physical health check paying particular attention to cardiovascular risk factors especially alcohol and smoking. We will use GP vouchers to facilitate these visits.
5.
A risk management strategy. The teams will also pilot a risk management strategy around the management of suicidal patients. This will consist of a checklist for patient support to ensure that key tasks are completed and questions asked. Secondly the research team will meet once a week to discuss adverse events defined as repeat episodes of self harm, hospital re presentation for any reason and suicides. A record will be kept of these discussions, including any changes to process as a result of these discussions, and circulated to the team in the form of a "risk bulletin". The research team will also receive training in crew resource management.
6.
Cultural assessment. We have two aims here, the first is to increase the number of people who receive cultural services after self harm. From our previous study we found that the input of Maori services after self harm was very rare. The second aim will be to complete a cultural assessment on everyone paying particular attention to the sense of belonging and feelings around ethnicity. Problems with sense of belonging will be included in the problem solving checklist for patients.
Control group
Māori patients randomised to the control group who give their consent will receive treatment as usual and will be asked to complete a consent form and questionnaires at baseline, and questionnaires and telephone interviews at three months and one year. Treatment as usual following self harm varies and may involve referrals to multi-disciplinary teams for psychiatric or psychological intervention, referrals to crisis teams and/or recommendations for engagement with community alcohol and drug treatment centres. The discharge plan may include referrals to more than one health care provider, or may consist solely of referral back to the patient's General Practitioner.
Treatment as usual assessment
Treatment as usual for all participants will be assessed by self report using a written questionnaire and telephone interview by a research assistant blind to treatment allocation; a review of DHB records; and by using the National minimum dataset from the Ministry of Health Information Directory to record hospital contacts and contact with mental health services.
Outcome measures (Table 1)
Primary
| | | |
Hopelessness | Beck Hopelessness Scale (BHS)[ 22] | Scores below 9 on the BHS. Best predictor of subsequent self harm. Scores on a range of 0 to 20 with higher scores indicating greater hopelessness. | Entry, three and twelve months |
Secondary
| | | |
Hospital repetition of self harm | | Data on hospital contacts from participating DHB's and the New Zealand Health Information Service National Minimum Dataset | Three and twelve months |
Depression and anxiety | Hospital Anxiety and Depression Scale (HADS)[ 23] | Self report scale. Scores of 10 and above on the anxiety and depression sub scales indicate clinically significant symptoms. | Baseline, three and twelve months. |
Health status | | A generic health-related quality of life index that can be related to costs. | Baseline, three and twelve months. |
Self report repetition of self-harm | | Self report assessed by telephone interviewer blind to allocation | Three and twelve months |
Social functioning | | A generic measure of functional health and well being | Baseline, three and twelve months |
Sense of belonging | Sense of belonging instrument (SOBI) [ 26] | Self report scale on sense of belonging to a community and ethnicity | Baseline, three and twelve months |
Cultural identity | Cultural identity profile [ 27] | Produces four indicators of cultural identity, a secure, positive, notional or compromised identity | Baseline, three and twelve months |
Seriousness of suicide attempt | Self rated objective part of the Beck Suicide Intent Scale (BSIS)[ 28] | Self report scale indicating the degree of suicidal intent of the self harm episode | Baseline |
Costs following index attempt | Health service use, costs of attending care, cost of medication and time off work | Self report assessed by telephone interviewer blind to allocation | Three and twelve months |
Intervention study
The primary outcome measure is the proportion of subjects who score below nine on the Beck Hopelessness Scale after one year (see sample size section for explanation).
Secondary outcomes are:
1.
The proportion of subjects who repeat self harm by presenting to hospital at three months and one year after their index attempt.
2.
Self reported repetition of self harm at three months and one year, assessed with a telephone questionnaire and a written questionnaire
3.
Hopelessness measured by the Beck Hopelessness Scale at baseline, three months and one year
4.
Anxiety and depression measured by the Hospital Anxiety and Depression Scale at baseline, three months and one year
6.
Overall mortality (that is suicide deaths plus other causes of death) and suicide deaths at three months, one year, five years and ten years
7.
Health service use at three months, one year, five years and ten years, assessed by a telephone questionnaire and interrogation of DHB and Ministry Of Health Information Directorate records
Outcome measures will be collected in several different ways.
Self report or self rating
Ratings scales will be by self rating. Self report will be to a researcher blind to the treatment allocation by a semi structured telephone interview which asks about repetition, health service use and economic measures (see attached copy of questionnaire).
DHB records
we will inspect these for episodes of repetition and health service use.
we will inspect these for health service use (both general and mental health), repetition and for mortality data. (It is necessary to look at national data on these measures as we found in our previous trial that at least 50% of people who self harm change address over twelve months often outside the DHB where they presented).
Self report by structured interview
Information for the economic analysis and self report of repetition will be gathered by telephone interview at three months and one year after the index attempt (Additional file
3). Telephone interviewers will be blind to the allocation of subjects. Blinding will be tested by asking the interviewers to nominate which group the subject was enrolled in. The economic analysis will also use a brief measure of quality of life the EQ-5D and interviewers will ask about health service use; costs associated with this; time off work; time off work for family to care for the participant; changes in benefit; changes in occupation; and drug use and cost. Participants will have the option of completing these measures in a face to face interview if, for example, they do not have a phone.
Process evaluation
A process evaluation will explore the implementation, receipt and context of the intervention with a view to helping understand the results in accordance with the Medical Research Council's guidelines [
29] on assessing complex interventions. This will describe the processes in the intervention and control groups, provide information about the contexts in which the treatments are delivered and supply information about the experience of being part of the trial. The process evaluation is described in Table
2 below. The self-harm teams will also receive weekly supervision, the main themes of which we will incorporate into the process evaluation.
Table 2
Process evaluation in Te Ira Tangata
Programme documentation and observation (to assess fidelity, dose and reach) | Number of sessions of patient support Number of PST sessions Completion of PST Audiotaping of PST sessions Examination of written client PST research records Number of clients where sense of belonging addressed in PST Use of GP voucher Number of postcards sent Summary of discussions around adverse events Proportion of clients who received the interventions in each centre Proportion of clients not contactable after presentation to hospital |
Structured interviews (to assess barriers, facilitators and suggestions for improvement) | Interview research clinicians re barriers and facilitators to the interventions plus suggestions for improvement Interview purposive sample of patients re what helped and what did not help plus suggestions for improvement Twelve month telephone interview of all patients what helped and what did not help Interview GP's who saw clients through GP voucher to assess their perception of the intervention and suggestions for improvement Interview focus group of staff in mental health and cultural services re barriers and facilitators to interventions plus suggestions for improvement |
Process evaluation analysis
Numerical data will be entered into the Clinical Trials Research Unit web based data entry system specifically designed for this study. Information from the examination of patient notes and audiotapes will be used to assess the adherence of therapists to the manual in a 10% random sample of those who completed problem solving therapy. Data from structured interviews and focus groups will be analysed for emergent themes using NVIVO.