Dataset Information

Sequential multiple assignment randomised trial of a brief contact intervention for suicide risk management among discharged psychiatric patients: an implementation study protocol.

ABSTRACT:

Introduction

The postdischarge suicide risk among psychiatric patients is significantly higher than it is among patients with other diseases and general population. The brief contact interventions (BCIs) are recommended to decrease suicide risk in areas with limited mental health service resources like China. This study aims to develop a postdischarge suicide intervention strategy based on BCIs and evaluate its implementability under the implementation outcome framework.

Methods and analysis

This study will invite psychiatric patients and family members, clinical and community mental health service providers as the community team to develop a postdischarge suicide intervention strategy. The study will recruit 312 patients with psychotic symptoms and 312 patients with major depressive disorder discharged from Shenzhen Kangning Hospital (SKH) in a Sequential Multiple Assignment Randomised Trial. Participants will be initially randomised into two intervention groups to receive BCIs monthly and weekly, and they will be rerandomised into three intervention groups to receive BCIs monthly, biweekly and weekly at 3 months after discharge according to the change of their suicide risk. Follow-ups are scheduled at 1, 3, 6 and 12 months after discharge. With the intention-to-treat approach, generalised estimating equation and survival analysis will be applied. This study will also collect qualitative and quantitative information on implementation and service outcomes from the community team.

Ethics/dissemination

This study has received ethical approval from the Ethics Committee Review Board of SKH. All participants will provide written informed consent prior to enrolment. The findings of the study will be disseminated through peer-reviewed scientific journals, conference presentations. A project report will be submitted to the National Natural Science Foundation of China as the concluding report of this funded project, and to the mental health authorities in the Shenzhen to refine and apply evidence-based and pragmatic interventions into health systems for postdischarge suicide prevention.

Trial registration number

NCT04907669.

SUBMITTER: Liu H

PROVIDER: S-EPMC8628333 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Research indicates that maintaining contact either via letter or postcard with at-risk adults following discharge from care services after a suicide attempt (SA) can reduce reattempt risk. Pilot studies have demonstrated that interventions using mobile health (mHealth) technologies are feasible in a suicide prevention setting.The aim of this study was to report three cases of patients recruited in the Suicide Intervention Assisted by Messages (SIAM) study to describe how a mobile intervention may influence follow-up.SIAM is a 2-year, multicenter randomized controlled trial conducted by the Brest University Hospital, France. Participants in the intervention group receive SIAM text messages 48 hours after discharge, then at day 8 and day 15, and months 1, 2, 3, 4, 5, and 6. The study includes participants aged 18 years or older, who have attended a participating hospital for an SA, and have been discharged from the emergency department (ED) or a psychiatric unit (PU) for a stay of less than 7 days. Eligible participants are randomized between the SIAM intervention messages and a control group. In this study, we present three cases from the ongoing SIAM study that demonstrate the capability of a mobile-based brief contact intervention for triggering patient-initiated contact with a crisis support team at various time points throughout the mobile-based follow-up period.Out of the 244 patients recruited in the SIAM randomized controlled trial, three cases were selected to illustrate the impact of mHealth on suicide risk management. Participants initiated contact with the emergency crisis support service after receiving text messages up to 6 months following discharge from the hospital. Contact was initiated immediately following receipt of a text message or up to 6 days following a message.This text message-based brief contact intervention has demonstrated the potential to reconnect suicidal individuals with crisis support services while they are experiencing suicidal ideation as well as in a period after receiving messages. As follow-up phone calls over an extended period of time may not be feasible, this intervention has the potential to offer simple technological support for individuals following discharge from the ED.ClinicalTrials.gov NCT02106949; https://clinicaltrials.gov/ct2/show/NCT02106949 (Archived by WebCite at http://www.webcitation.org/6wMtAFL49).

Project description:IntroductionEffective, brief, low-cost interventions for suicide attempt survivors are essential to saving lives and achieving the goals of the National Strategy for Suicide Prevention and Zero Suicide. This study aims to examine the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP) in averting suicide reattempts in the United States healthcare system, its psychological mechanisms as predicted by the Interpersonal Theory of Suicide, and the potential implementation costs, barriers and facilitators for delivering it.Methods and analysisThis study is a hybrid type 1 effectiveness-implementation randomised controlled trial (RCT). ASSIP is delivered at three outpatient mental healthcare clinics in New York State. Participant referral sites include three local hospitals with inpatient and comprehensive psychiatric emergency services, and outpatient mental health clinics. Participants include 400 adults who have had a recent suicide attempt. All are randomised to 'Zero Suicide-Usual Care plus ASSIP' or 'Zero Suicide-Usual Care'. Randomisation is stratified by sex and whether the index attempt is a first suicide attempt or not. Participants complete assessments at baseline, 6 weeks, and 3, 6, 12 and, 18 months. The primary outcome is the time from randomisation to the first suicide reattempt. Prior to the RCT, a 23-person open trial took place, in which 13 participants received 'Zero Suicide-Usual Care plus ASSIP' and 14 completed the first follow-up time point.Ethics and disseminationThis study is overseen by the University of Rochester, with single Institutional Review Board (#3353) reliance agreements from Nathan Kline Institute (#1561697) and SUNY Upstate Medical University (#1647538). It has an established Data and Safety Monitoring Board. Results will be published in peer-reviewed academic journals, presented at scientific conferences, and communicated to referral organisations. Clinics considering ASSIP may use a stakeholder report generated by this study, including incremental cost-effectiveness data from the provider point of view.Trial registration numberNCT03894462.

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Project description:BackgroundSuicide prevention is currently a national health priority in Canada. Emergency departments (EDs) are critical settings for suicide prevention, and in our local psychiatric ED at the Centre for Addiction and Mental Health, we plan to embed an app-based tool called the Hope app to support suicide safety planning intervention. The app is free and available on app stores, and usability tests have been completed. As a next step to embed this new tool into the routine clinical workflow, research is needed to assess determinants of and design strategies for implementation with the end goal of routinization.ObjectiveThe purpose of this 2-phased research is to implement the app in the routine clinical workflow in our local psychiatric ED. The specific objectives are as follows: (1) understanding ED clinicians' perceptions and experience of implementing the app in routine practice and identifying barriers to and facilitators of implementation (phase 1) and (2) using findings and outputs from phase 1 and collaborating with service users, families, and ED clinicians to co-design implementation strategies for the app (phase 2).MethodsWe will use an integrated knowledge translation approach throughout this project. In phase 1, we will conduct interviews with ED clinicians to identify implementation determinants using a behavior change framework. In phase 2, a co-design team comprising clinicians, ED service users, and families will design implementation strategies that align with the determinants identified in phase 1.ResultsThis protocol presents detailed information about the entire structure of the 2-phased research project. Ethics approval for conducting the qualitative descriptive study (phase 1) has been obtained, and the recruitment and data collection processes will be completed no later than December 2023. Ethics approval for phase 2 is underway.ConclusionsInvolving multiple knowledge user groups early in the research and decision-making process is crucial for successful implementation. Although co-designing is commonly practiced during innovation development, there is often a misconception that the responsibility for implementing what has been designed falls on others. This research aims to fill this methodological gap in the health informatics literature. By the end of this project, we will have developed theory-informed implementation strategies to support Centre for Addiction and Mental Health ED clinicians in adopting the Hope app to complete safety planning intervention. These strategies, guided by a behavior change framework, will target clinicians' behavior change and seamlessly integrate the app into the routine clinical workflow. In addition, this research project will provide recommendations on how to involve multiple knowledge user groups and offer insights into how the methodology used can be adapted to other areas within the health informatics literature.International registered report identifier (irrid)PRR1-10.2196/50643.

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Project description:ObjectivesFamily caregivers of people with dementia (FC-of-PWD) suffer from a high level of stress and depressive symptoms, which usually require different interventions at different stages. Although some standalone interventions such as behavioural activation (BA) and mindfulness practice (MP) have been shown to be potentially effective at reducing depressive symptoms, the best sequence and combination of these interventions for caregivers are unknown. This study aims to develop and identify a two-stage adaptive intervention with prespecified rules guiding whether, how or when to offer different interventions initially/over time to reduce depressive symptoms in FG-of-PWD.MethodsA sequential multiple assignment randomised trial design will be adopted. 272 FG-of-PWD with mild to moderate depressive symptoms will be recruited from the community. Four two-stage, embedded adaptive interventions involving BA and MP of different sequences and dosages (eg, 8 weeks of BA followed by booster sessions for responders and 8 weeks of MP for non-responders) will be assigned to the participants following a set of decision rules. The primary outcomes will be depressive symptoms (measured using the Patient Health Questionnaire-9), assessed after the second stage of the intervention. Other outcomes, such as positive aspects of caregiving (measured using the Positive Aspects of Caregiving Scale), sleep quality (measured using the Pittsburgh Sleep Quality Index) and time points will also be assessed. The analyses will follow the intention-to-treat principle. Several process indicators (eg, engagement in meaningful activities and level of mindfulness) will also be assessed. The findings will have strong implications for the further development of psychosocial adaptive interventions to reduce depressive symptoms among FC-of-PWD.Ethics and disseminationThis study has received ethical approval from the Human Research Ethics Committee at The Hong Kong Polytechnic University (HSEARS20211223001). The findings will be presented at academic conferences and submitted to peer-reviewed journals for publication.Trial registration numberNCT05634317.

Project description:BackgroundWe investigated whether a volitional helpsheet (VHS), a brief psychological intervention, could reduce repeat self-harm in the 6 months following a suicide attempt.MethodsWe did a prospective, single-site, randomised controlled trial. Patients admitted to a hospital in Edinburgh, UK, after a suicide attempt were deemed eligible for the study if they were over the age of 16 years, had a self-reported history of self-harm, were fluent in English, were medically fit to interview, and were not participating in other research studies within the hospital. Eligible patients were randomly assigned (1:1), via web-based randomisation, to receive either VHS plus usual treatment (intervention group) or only treatment as usual (control group). Randomisation was stratified by sex and self-reported past self-harm history. The Information Services Division of the National Health Service (NHS-ISD) staff and those extracting data from medical notes were masked to the study group the participant was allocated to. Clinical staff working within the hospital were also masked to participants' randomisation status. There were three primary outcomes: the proportion of paticipants who re-presented to hospital with self-harm during the 6-month follow-up period; the number of times a participant re-presented to hospital with self-harm during the 6-month follow-up period; and cost-effectiveness of the VHS as measured by estimated incremental cost per self-harm event averted. Primary outcomes were analysed in all randomised patients. Follow-up data collection was extracted from the Information Services Division of the NHS and from patient medical records. The trial is registered with International Standard Randomised Controlled Trial Number Registry, number ISRCTN99488269.FindingsBetween May 9, 2012, and Feb 24, 2014, we assessed 1308 people for eligibility. Of these, 259 patients were randomly assigned to the intervention group and 259 to the control group. We obtained complete follow-up data on 512 (99%) of 518 patients (five participants were lost to follow-up in the intervention group and one in the control group). 11 patients assigned to the intervention group did not complete the VHS in hospital. Overall, the intervention did not affect the number of people who re-presented with self-harm (67 [26%] of 254 patients in the intervention group vs 71 [28%] of 258 patients in the control group, odds ratio [OR] 0·90, 95% CI 0·58-1·39, p=0·63). The intervention had no effect on the number of re-presentations per patient (mean 0·67 [SD 2·55] re-presentations for the intervention group vs 0·85 [2·79] for the control group, incident rate ratio [IRR] 1·65, 95% CI 0·74-3·67, p=0·21). Mean total costs per person for NHS hospital services in the VHS intervention group over the 6 months were £513 versus £561 in the control group but this difference was not significant (95% CI-£353 to £257, p=0·76). Three patients died by suicide in the 6 months following their index suicide attempt (one in the intervention group and two in the control group). There were no reported unintended effects or adverse events in either group.InterpretationFor the primary outcomes, there were no significant differences between groups. Although the VHS had no overall effect, post-hoc analyses suggest VHS might be effective in reducing the number of self-harm repetitions following a suicide attempt in people who complete the helpsheet and who have been previously admitted to hospital with self-harm. This is the first study to investigate the usefulness of the VHS to reduce self-harm among those who have attempted suicide. These subgroup findings require replication. The potential use of the VHS in those who self-harm for different motives requires further exploration.FundingChief Scientist Office (CZH/4/704).

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