Effectiveness and Implementation of a Clinician Decision Support System to Prevent Suicidal Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 2
- 主要终点
- Suicide attempt
研究概览
简要总结
The primary aim of this project are to evaluate a comprehensive, practice-ready, and deployment-focused strategy for improving the prediction and prevention of suicide attempts among a sample of 4,000 patients presenting to an ED with a psychiatric concern. The first aim is to evaluate the effects of providing information about risk of patient suicidal behavior to ED clinicians. The investigators hypothesize that patients randomly assigned to have their clinician receive their risk score will have a lower rate of suicide attempts during 6-month follow-up and that this effect will be mediated by changes in clinician decision-making.
详细描述
This study is designed to test the effects of providing emergency department (ED) clinicians with enhanced information about their patients' risk of a suicide attempt in the 6-months after leaving the ED. The study will be conducted in five EDs. The primary study will be conducted in four EDs within Mass General Brigham (MGB): Massachusetts General Hospital (MGH), MGB-Salem, Brigham and Women's Hospital (BWH), and Brigham and Women's Faulkner Hospital (BWFH). The investigators propose to enroll 4,000 participants over the study period and to provide the treating clinician with a risk score for a randomly selected half of those 4,000 participants. The primary outcome will be rate of suicide attempts over the next 6-months. It is anticipated that provision of this risk score will change clinician decision-making, leading clinicians to be more likely to hospitalize high-risk patients and less likely to hospitalize low-risk patients. A smaller (N=250) pilot implementation study has been added in a new non-MGB ED at Cambridge Health Alliance (CHA).
The primary study will enroll 4,000 patients presenting to the ED at MGH MGB-Salem, BWH, and BWFH. Study inclusion criteria include presentation to the ED, adult status (≥18 years-old), and ability to provide an email address.
Exclusion criteria include the presence of any factor that impairs an individual's ability to comprehend and effectively participate in the study, including an inability to speak or write English fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior. These broad inclusion criteria maximize the clinical applicability of results while the exclusion criteria ensure the ethical principle of respect for persons.
According to prior studies in the MGB system, investigators anticipate the MGB sample will be about 73% White/European American, 9% African-American, 4% Asian American, and the remainder of other or mixed ethnicity. The implementation study will enroll 250 patients presenting to the ED at CHA and will have the same inclusion/exclusion criteria as the primary study. Based on recent numbers reported in the CHA 2021 Annual Report, it is anticipated that the CHA sample will be about 37% White/European American, 16% African- American, 9% Asian American, and the remainder of other or mixed ethnicity.
Study Research Assistants (RAs) will use well-established protocols of reviewing patients presenting to the ED, where investigators have been conducting IRB approved research on the prediction of suicidal behavior for >15 years. RAs will first consult potentially eligible patients' assigned clinician to obtain their permission to approach the patient to briefly describe the study and ask if they are interested in learning more about it. Only those patients determined to meet the inclusion/exclusion criteria will be approached. To further ensure communication between the research and clinical team, investigators will give a presentation about the study to the ED clinical teams before starting recruitment and at regular intervals throughout the award period. RAs will obtain written informed consent from participants (using REDCap, described below) while in the ED, and administer a baseline self-report assessment battery (on an iPad). Contact information (including the full name, phone number, and if available, email address for both the participant and a collateral contact for emergency situations) will be collected via secure REDCap data collection surveys at baseline, and with participants' permission, select health data (e.g., readmission for a suicide attempt over the next 6 months) will be extracted from the EHR (and stored in a de-identified database). Participants will receive an email-based survey to assess the receipt of treatment and the presence of a suicide attempt at 1-month and 6-months after their ED visit. Participants will receive financial incentives for each survey completed.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult status (≥18 years-old);
- •Willing to provide an email address;
- •Presentation at the APS
排除标准
- •Inability to understand the study procedures and provide informed consent such as those with gross cognitive impairment (including florid psychosis), intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior
- •Decisions about inclusion/exclusion criteria will be made by the emergency department providers on duty at the time. These broad inclusion criteria maximize the clinical applicability of obtained results while the exclusion criteria ensure the ethical principle of respect for persons.
研究组 & 干预措施
Experimental
Investigators will use previously developed EHR-derived machine- learning-based model to generate predicted probability risk scores of 1-month suicide attempt for each patient. The EHR-derived risk score will be combined with the patient self-report data (initially from the 20-question screener) to generate composite predicted risk scores (based on the most updated ML model developed by investigators via the ensemble ML Super Learner [SL] method) for the patient within minutes of the patient completing the self-report survey. Risk scores will be provided to the clinician while the patient is in the ED. This feedback includes information about the patient's relative risk compared to other psychiatric patients seen in the ED and the risk factors contributing to this level of risk.
干预措施: Clinician Decision Support Tool (Diagnostic Test)
Control
Patient's clinician is not given Clinician Decision Support Tool (care as usual)
结局指标
主要结局
Suicide attempt
时间窗: 6-months
The primary endpoint is the occurrence (0,1) of a suicide attempt during the 6 months following randomization. The outcome will be measured as a single binary variable, indicating whether a participant experienced at least one suicide attempt during the follow-up period. This outcome will be ascertained using participant self-report and EHR documentation. Self-reported suicide attempts will be assessed using questions from the Self-Injurious Thoughts and Behaviors Interview (SITBI), a widely used measure of suicidal thoughts and behaviors with strong reliability and validity and one of the measures recommended in the PhenX Toolkit. EHR review will further identify documented suicide attempts during follow-up. Information from both sources will be used to determine a single outcome value for each participant. The singular outcome measure is the occurrence of at least one suicide attempt during follow-up (Yes/No; 0,1) as identified by either source (self-report or EHR).
次要结局
- Suicide attempt(1-month)
研究者
Matthew K. Nock, PhD
Research Scientist
Massachusetts General Hospital
