Mental Healthcare Decision-Making and Decision Support Among Emerging Adults Enrolled in Coordinated Specialty Care for Early Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in service use
研究概览
简要总结
The purpose of this study is to evaluate the impact of an antipsychotic medication decision aid and interpersonal and cognitive factors, such as attachment style and motivation, on emerging adults' ability to engage in shared decision making regarding their medications.
详细描述
The long-term occupational, social, and economic outcomes associated with psychosis make it an urgent public health problem. Coordinated specialty care (CSC) is now the gold standard for early psychosis, demonstrating positive clinical and functional effects in the short-term, and longer-term reduced hospitalization rates. These services include an array of treatment options, including psychotropic medications, individual psychotherapy, family education, and support, and occupational therapy and supported employment/education.
While a shorter period between psychosis onset and receipt of appropriate care is associated with better outcomes, emerging adults often experience significant delays before receiving treatment, and a large percentage disengage from services once they are commenced. Decisional conflict about treatment options (i.e., feeling conflicted about which option to choose) and interpersonal factors such as attachment style and trust in health providers can contribute to decision delay and discontinuance of chosen options. Decision support tools (e.g., decision aids), have been shown to reduce decisional conflict as well as improve service engagement. A requisite step in expanding the array of decision support tools available to emerging adults experiencing early psychosis is to better understand their decision-making ability, capacity, and motivation to engage in decision making and how these relate to their engagement in CSC.
It is well recognized that individuals who are being prescribed antipsychotic medications often face decisional conflict about their treatment options. An especially controversial decision is whether individuals should continue taking medication at the same dose or adjust the dose whilst monitoring their symptoms. This dilemma is the result of some uncertainty about the appropriate treatment strategy for long-term management of psychosis. The present project focuses on evaluating the feasibility and effectiveness of the use of a decision aid for making decisions about antipsychotic medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
Randomization is accomplished using a HIPAA-compliant, Internet-based randomization service (studyrandomizer.com) using permuted blocks of 5. Patients and the participating psychiatrist are not blinded to the condition assigned to them; however, they are not given any explicit information on the DA. The psychiatrist was provided with the DA and received information about it as the DA is delivered by the psychiatrist for patients who are randomized to receive it. The RA who recruit and administer assessments to participants is not blinded to condition, except at baseline.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 25 years
- •Experiencing early psychosis, defined as psychosis lasting 18 months or less between the time when threshold symptom criteria were reached (as determined by the admitting CSC program assessor) and the date of CSC program enrollment
- •Planning to attend a medication appointment with a participating CSC psychiatrist
- •Ability to speak and understand English
- •Ability to provide informed consent as assessed by research staff using procedures discussed by Carpenter et al. (2000) including a demonstrated understanding and recall of study procedures, rather than passive consent, and allowance of repetition of study procedures until there is understanding and recall.
排除标准
- •Have a legal guardian
- •Have identified co-occurring dementia, delirium, or intellectual disability that will likely affect their ability to provide informed consent or participate in the data collection procedures.
结局指标
主要结局
Change in service use
时间窗: Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up .
Service Use and Resource Form for Monthly Items (SURF-M) scale to assess change in service use over time (66 items)
Decision-making self-efficacy
时间窗: Post appointment interview (1 day of the appointment )
Decision Self-Efficacy (DSE) scale to assess decision self-efficacy (11 items)
Change in medication adherence
时间窗: Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up .
Brief Adherence Rating Scale (BARS) to assess change in medication adherence over time (8 items)
Service engagement
时间窗: Baseline (Pre-appointment interview )
Service Engagement Scale (SES) to assess level of service engagement (14 items)
Decisional Conflict
时间窗: Post appointment interview (1 day of the appointment )
Decisional Conflict Scale (DCS) to assess level of decisional conflict (15 items)
Shared decision making
时间窗: Post appointment interview (1 day of the appointment )
collaboRATE scale to assess level of shared decision making after an appointment (3 items)
Change in antipsychotics knowledge
时间窗: Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment )
Scale to assess change in knowledge about antipsychotic medications over time (9 items)
Decision-making attitudes
时间窗: Post appointment interview (1 day of the appointment )
Decision Attitude Scale (DAS) to assess decision-making attitudes (10 items)
次要结局
- Attachment style(Baseline (Pre-appointment interview ))
- Apathy(Baseline (Pre-appointment interview ))
- Insight(Baseline (Pre-appointment interview ))
- Working alliance(Baseline (Pre-appointment interview ))
- Cognitive functioning(Baseline (Pre-appointment interview ))
- Self-stigma(Baseline (Pre-appointment interview ))
- Trust(Baseline (Pre-appointment interview ))
研究者
Yaara Zisman Ilani
Assistant Professor
Temple University