Decision-making and Decision Support Among Emerging Adults With First Episode Psychosis

Early Psychosis Clinical Trial

Official title:

Mental Healthcare Decision-Making and Decision Support Among Emerging Adults Enrolled in Coordinated Specialty Care for Early Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04373590
• Other study ID #: 24734
• Status: Completed
• Phase: N/A
• Start date: February 27, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: February 2021
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 30, 2020
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Early Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Psychosis Education, Assessment, Care and Empowerment (PEACE)	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zisman-Ilani Y, Shern D, Deegan P, Kreyenbuhl J, Dixon L, Drake R, Torrey W, Mishra M, Gorbenko K, Elwyn G. Continue, adjust, or stop antipsychotic medication: developing and user testing an encounter decision aid for people with first-episode and long-te — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in antipsychotics knowledge	Scale to assess change in knowledge about antipsychotic medications over time (9 items)	Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment )
Primary	Decision-making self-efficacy	Decision Self-Efficacy (DSE) scale to assess decision self-efficacy (11 items)	Post appointment interview (1 day of the appointment )
Primary	Decision-making attitudes	Decision Attitude Scale (DAS) to assess decision-making attitudes (10 items)	Post appointment interview (1 day of the appointment )
Primary	Decisional Conflict	Decisional Conflict Scale (DCS) to assess level of decisional conflict (15 items)	Post appointment interview (1 day of the appointment )
Primary	Shared decision making	collaboRATE scale to assess level of shared decision making after an appointment (3 items)	Post appointment interview (1 day of the appointment )
Primary	Change in medication adherence	Brief Adherence Rating Scale (BARS) to assess change in medication adherence over time (8 items)	Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up .
Primary	Change in service use	Service Use and Resource Form for Monthly Items (SURF-M) scale to assess change in service use over time (66 items)	Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up .
Primary	Service engagement	Service Engagement Scale (SES) to assess level of service engagement (14 items)	Baseline (Pre-appointment interview )
Secondary	Apathy	Marin Apathy Evaluation Scale to assess apathy (18 items)	Baseline (Pre-appointment interview )
Secondary	Attachment style	Experiences in Close Relationships-Revised (ECR-R) Questionnaire to assess attachment style (36 items)	Baseline (Pre-appointment interview )
Secondary	Working alliance	Working Alliance Inventory (WAI) to assess alliance (36)	Baseline (Pre-appointment interview )
Secondary	Trust	Trust in the Medical Profession Scale to assess level of trust in the clinician (11 items)	Baseline (Pre-appointment interview )
Secondary	Cognitive functioning	Brief Assessment of Cognition in Schizophrenia (BACS) - a battery to assess aspects of cognition such as verbal memory and attention.	Baseline (Pre-appointment interview )
Secondary	Insight	Birchwood Insight Scale to assess insight to the illness (8 items)	Baseline (Pre-appointment interview )
Secondary	Self-stigma	Internalized Stigma of Mental Illness (ISMI) Scale - Brief Version, to assess mental health self-stigma (10 items)	Baseline (Pre-appointment interview )