Decision-making and Decision Support Among Emerging Adults With First Episode Psychosis
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|ClinicalTrials.gov Identifier: NCT04373590|
Recruitment Status : Completed
First Posted : May 4, 2020
Last Update Posted : February 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Early Psychosis||Behavioral: Decision aid||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||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.|
|Official Title:||Mental Healthcare Decision-Making and Decision Support Among Emerging Adults Enrolled in Coordinated Specialty Care for Early Psychosis|
|Actual Study Start Date :||February 27, 2019|
|Actual Primary Completion Date :||August 12, 2020|
|Actual Study Completion Date :||August 30, 2020|
Experimental: Decision aid (DA)
a one-page DA for use during the psychiatric consultation to help patients and clinicians discuss relevant treatment options pertaining to antipsychotics.
Behavioral: Decision aid
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.
No Intervention: Treatment as usual (TAU)
Treatment as usual without the DA
- Change in antipsychotics knowledge [ 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)
- Decision-making self-efficacy [ Time Frame: Post appointment interview (1 day of the appointment ) ]Decision Self-Efficacy (DSE) scale to assess decision self-efficacy (11 items)
- Decision-making attitudes [ Time Frame: Post appointment interview (1 day of the appointment ) ]Decision Attitude Scale (DAS) to assess decision-making attitudes (10 items)
- Decisional Conflict [ Time Frame: Post appointment interview (1 day of the appointment ) ]Decisional Conflict Scale (DCS) to assess level of decisional conflict (15 items)
- Shared decision making [ Time Frame: Post appointment interview (1 day of the appointment ) ]collaboRATE scale to assess level of shared decision making after an appointment (3 items)
- Change in medication adherence [ 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)
- Change in service use [ 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)
- Service engagement [ Time Frame: Baseline (Pre-appointment interview ) ]Service Engagement Scale (SES) to assess level of service engagement (14 items)
- Apathy [ Time Frame: Baseline (Pre-appointment interview ) ]Marin Apathy Evaluation Scale to assess apathy (18 items)
- Attachment style [ Time Frame: Baseline (Pre-appointment interview ) ]Experiences in Close Relationships-Revised (ECR-R) Questionnaire to assess attachment style (36 items)
- Working alliance [ Time Frame: Baseline (Pre-appointment interview ) ]Working Alliance Inventory (WAI) to assess alliance (36)
- Trust [ Time Frame: Baseline (Pre-appointment interview ) ]Trust in the Medical Profession Scale to assess level of trust in the clinician (11 items)
- Cognitive functioning [ 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.
- Insight [ Time Frame: Baseline (Pre-appointment interview ) ]Birchwood Insight Scale to assess insight to the illness (8 items)
- Self-stigma [ Time Frame: Baseline (Pre-appointment interview ) ]Internalized Stigma of Mental Illness (ISMI) Scale - Brief Version, to assess mental health self-stigma (10 items)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373590
|United States, Pennsylvania|
|Psychosis Education, Assessment, Care and Empowerment (PEACE)|
|Philadelphia, Pennsylvania, United States, 19123|