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临床试验/NCT04907669
NCT04907669已完成不适用

An Implementation Study of Suicide Risk Management Among Discharged Psychiatric Patients Based on Brief Contact Interventions and Sequential Multiple Assignment Randomized Trial

Shenzhen Kangning Hospital1 个研究点 分布在 1 个国家目标入组 498 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
498
试验地点
1
主要终点
The trajectory of suicide ideation from baseline to 12 months after discharge

研究概览

简要总结

The post-discharge suicide risk among psychiatric patients is significantly higher than it among patients with other diseases and general population. The brief contact interventions (BCIs) are recommended to decrease the risk in areas with limited mental health service resource like China, however the best frequency to implement BCIs is unknown. This implementation study aims to 1) to develop an intervention strategy against post-discharge suicide based on BCIs for Chinese psychiatric patients; 2) to determine the best frequency of BCIs based on Sequential Multiple Assignment Randomized Trial; 3) to evaluate the effectiveness of the intervention strategy and explore its implementability based on the Implementation Outcome Framework (IOF). Based on the community-based participatory research (CBPR) approach, this study will invite psychiatric patients and family members, psychiatrist and nurses, community mental health workers and social workers as the community team to develop a post-discharge suicide intervention strategy. The study will recruit patients with psychotic symptoms and with major depressive disorder discharged from Shenzhen Kangning Hospital (SKH) in a Sequential Multiple Assignment Randomized Trial (SMART) to determine the best frequency for implementing BCIs and to evaluate the effectiveness. Participants will be randomized into two intervention groups to receive BCIs at different frequencies. Follow-ups to evaluate participants' suicide risk are scheduled at 1, 3, 6 and 12 months after discharge. The re-randomization will be applied at 3 months after discharge. With the Intent-to-treat (ITT) approach, generalized estimating equation (GEE) and survival analysis (SA) will be applied to compare the effectiveness among groups and to explore factors associated with suicide risk. Meanwhile, this study will collect qualitative and quantitative information on implementation and service outcomes from the community team.

详细描述

This is a mixed-methods study with two stages. The first stage is to develop the intervention strategy by individual in-depth and focus groups interviews; and the second stage is to implement the strategy and evaluate the implementation quantitatively by a randomized trial and qualitatively by focus group interviews.

  1. The community-based participatory research The investigators aim to recruit discharged psychiatric patients and their lay health care supporters (LHSs) who are usually their family members, psychiatrists and nurses, psycho-crisis intervention team members, community mental health workers and mental health social workers as the community team that will provide a Chinese context under the community-based participatory research (CBPR) framework. In specific, the framework would help this study: explore the feasibility of implementing BCIs against suicide risk after discharge, understand the needs for suicide risk management after discharge from related health care service providers and acceptors, integrate suicide risk management experiences from the community, discuss, develop, and revise the intervention strategy with the community.

The investigators categorize the community team into three sub-groups, the patients-LHSs group, the clinic mental health service provider group (psychiatrists and nurses, and psycho-crisis intervention team members), and the community mental health service provider group (community mental health workers and mental health social workers).

1.1 Intervention development The investigators will conduct three focus group interviews in each sub-group and ten to fifteen cases of individual in-depth interview with the community to avoid bias in focus groups and to protect privacy related to personal experience in suicide and suicide intervention. The themes include: 1) key points in suicide risk management after discharge, 2) how to develop BCIs content and delivery BCIs appropriately and feasibly to increase social connectedness and social support, 3) how to improve compliance to treatment and increase subsequent visits after discharge. There will be scheduled meetings with the community to discuss and revise the intervention strategy before implementation.

1.2 Implementation evaluation Based on IOF, the investigators will conduct three focus group interviews in each sub-group to explore 1) patients' and LHSs' attitudes, acceptability, and understanding of the strategy, 2) the clinic and community mental health service providers' willingness, feasibility and sustainability to implement the strategy, 3) the effectiveness, efficiency, equity, safety and timeliness of the strategy and whether it is patient-centered.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

After recruitment and the baseline survey, we will assign participants into Group 1 and Group 2 by block randomization in R program. At the check point in the SMART trial, we will re-assign participants into Group 1a, Group 1b, Group 1c, Group 2a, Group 2b, and Group 2c based on their suicide risk by simple randomization in R program. The allocation ratio in randomization will be 1:1. The randomization will be performed by a statistician in the research team. Patients, LHSs, nurses who perform recruitment and baseline survey, the statistician who performs randomization, and investigators who perform follow-ups will be blinded to the assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For patients in the SMART trial and qualitative interviews
  • Being 18 years and above;
  • Being diagnosed with psychotic symptoms or MDD;
  • Having received in-patient care for three days or more;
  • Living in Shenzhen and having no plan to leave Shenzhen in the following 12 months after discharge;
  • Being able to read text messages, answer phone calls on mobile phones, use WeChat or any application on smart phones.
  • For lay health care supporters (LHSs) in qualitative interviews
  • Being 18 years and above;
  • Being without any diagnosis of mental disorder;
  • Being the lay health care supporter in the family;
  • Living in Shenzhen and having no plan to leave Shenzhen in the following 12 months after discharge;
  • Being able to read text messages, answer phone calls on mobile phones, use WeChat or any application on smart phones.
  • For the clinic and community mental health service providers in qualitative interviews
  • Being 18 years and above;
  • Having practiced in mental health service at least for 12 months.

排除标准

  • for patients in the SMART trial and qualitative interviews
  • Unable to provide written consent due to any cognitive problems.
  • Being discharged by the patient's or LHSs' demand against medical advice.
  • With no ID, no stable residence nor any source of income.

研究组 & 干预措施

Group 1a

Experimental

After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 1, participants will receive brief contact intervention (BCI) monthly. If participants' suicide risk increased at 3 months after discharge, they will be re-randomized into Group 1a and Group 1b to receive BCIs weekly (Group 1a) and bi-weekly (Group 1b).

干预措施: Brief contact intervention (Other)

Group 1b

Experimental

After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 1, participants will receive brief contact intervention (BCI) monthly. If participants' suicide risk increased at 3 months after discharge, they will be re-randomized to receive BCIs weekly (Group 1a) and bi-weekly (Group 1b).

干预措施: Brief contact intervention (Other)

Group 1c

Experimental

After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 1, participants will receive brief contact intervention (BCI) monthly. If participants' suicide risk decreased or did not change, they will remain receiving BCIs monthly as Group 1c.

干预措施: Brief contact intervention (Other)

Group 2a

Experimental

After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 2, participants will receive brief contact intervention (BCI) weekly. If the suicide risk increased or did not change, they will remain receiving BCIs weekly as Group 2a.

干预措施: Brief contact intervention (Other)

Group 2b

Experimental

After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 2, participants will receive brief contact intervention (BCI) weekly. If the suicide risk decreased, they will be re-randomized to receive BCIs monthly (Group 2b) and bi-weekly (Group 2c).

干预措施: Brief contact intervention (Other)

Group 2c

Experimental

After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 2, participants will receive brief contact intervention (BCI) weekly. If the suicide risk decreased, they will be re-randomized to receive BCIs monthly (Group 2b) and bi-weekly (Group 2c).

干预措施: Brief contact intervention (Other)

结局指标

主要结局

The trajectory of suicide ideation from baseline to 12 months after discharge

时间窗: It will be evaluated at 12 months after discharge.

This study will use the Beck Suicide Ideation Scale-Chinese Version (BSI-CV) to assess participants' suicide ideation. The BSI-CV includes 19 items, and each item scores from 0 to 2 with a total score ranging from 0 to 38, and a higher score indicates a higher level of suicide ideation. The total score's trajectory from baseline to 12 months after discharge will be recorded and compared.

The trajectory of suicide ideation from baseline to three months after discharge

时间窗: It will be evaluated at three months after discharge.

This study will use the Beck Suicide Ideation Scale-Chinese Version (BSI-CV) to assess participants' suicide ideation. The BSI-CV includes 19 items, and each item scores from 0 to 2 with a total score ranging from 0 to 38, and a higher score indicates a higher level of suicide ideation. The total score's trajectory from baseline to three months after discharge will be recorded and compared.

次要结局

  • The trajectory of social support from baseline to three months after discharge(It will be evaluated at one month after discharge.)
  • The trajectory of social support from baseline to 12 months after discharge(It will be evaluated at 12 months after discharge.)
  • The trajectory of social connectedness from baseline to 12 months after discharge(It will be evaluated at 12 months after discharge.)
  • The trajectory of suicide ideation from three months after discharge to 12 months after discharge(It will be evaluated at 12 months after discharge.)
  • The trajectory of social connectedness from baseline to three month after discharge(It will be evaluated at three months after discharge.)

研究者

发起方
Shenzhen Kangning Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fengsu Hou

Research Associate Professor

Shenzhen Kangning Hospital

研究点 (1)

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