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Clinical Trials/NCT04373590
NCT04373590
Completed
N/A

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

Temple University1 site in 1 country18 target enrollmentFebruary 27, 2019
ConditionsEarly Psychosis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Early Psychosis
Sponsor
Temple University
Enrollment
18
Locations
1
Primary Endpoint
Change in service use
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
February 27, 2019
End Date
August 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yaara Zisman Ilani

Assistant Professor

Temple University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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)

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)

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)

Service engagement

Time Frame: Baseline (Pre-appointment interview )

Service Engagement Scale (SES) to assess level of service engagement (14 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 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 attitudes

Time Frame: Post appointment interview (1 day of the appointment )

Decision Attitude Scale (DAS) to assess decision-making attitudes (10 items)

Secondary Outcomes

  • 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 ))

Study Sites (1)

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