Psychosis Education, Assessment, Care and Empowerment (PEACE)
Philadelphia, Pennsylvania, 19123, United States
NCT Number: NCT04373590
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.
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Notify Me18 year–25 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19123, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The chosen intervention is a one-page DA developed by the first author, published and fully described elsewhere (Zisman-Ilani et al., 2017; Zisman et al., 2018) for use during the psychiatric consultation to help patients and clinicians discuss relevant treatment options pertaining to antipsychotics such as medication nonadherence and self-tapering. The DA format is a simple one-page table with rows containing frequently asked questions by patients about their treatment options and the benefits, risks, and implications of differing decisions. The columns display the treatment options available for the treatment decision in question: continuing, adjusting, or discontinuing antipsychotic medications.
Time frame: 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)
Time frame: Post appointment interview (1 day of the appointment )
Decision Self-Efficacy (DSE) scale to assess decision self-efficacy (11 items)
Time frame: Post appointment interview (1 day of the appointment )
Decision Attitude Scale (DAS) to assess decision-making attitudes (10 items)
Time frame: Post appointment interview (1 day of the appointment )
Decisional Conflict Scale (DCS) to assess level of decisional conflict (15 items)
Time frame: Post appointment interview (1 day of the appointment )
collaboRATE scale to assess level of shared decision making after an appointment (3 items)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (Pre-appointment interview )
Service Engagement Scale (SES) to assess level of service engagement (14 items)
Time frame: Baseline (Pre-appointment interview )
Marin Apathy Evaluation Scale to assess apathy (18 items)
Time frame: Baseline (Pre-appointment interview )
Experiences in Close Relationships-Revised (ECR-R) Questionnaire to assess attachment style (36 items)
Time frame: Baseline (Pre-appointment interview )
Working Alliance Inventory (WAI) to assess alliance (36)
Time frame: Baseline (Pre-appointment interview )
Trust in the Medical Profession Scale to assess level of trust in the clinician (11 items)
Time frame: Baseline (Pre-appointment interview )
Brief Assessment of Cognition in Schizophrenia (BACS) - a battery to assess aspects of cognition such as verbal memory and attention.
Time frame: Baseline (Pre-appointment interview )
Birchwood Insight Scale to assess insight to the illness (8 items)
Time frame: Baseline (Pre-appointment interview )
Internalized Stigma of Mental Illness (ISMI) Scale - Brief Version, to assess mental health self-stigma (10 items)
Temple University
Other
Mental Healthcare Decision-Making and Decision Support Among Emerging Adults Enrolled in Coordinated Specialty Care for Early Psychosis
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