Clinical trial NCT05416658: Shared Decision Making for Antipsychotic Medications
Official title: Examining the Effectiveness of a Shared Decision Making Intervention for Antipsychotic Medications to Improve Engagement in Treatment for People Experiencing Early Psychosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Delusional Disorder
Other Specified Schizophrenia Spectrum and Other Psychotic Disorder
Keywords: Shared decision making
psychosis
schizophrenia
antipsychotic
medication
intervention
decision aid
coordinated specialty care (CSC)
randomized controlled trial (RCT)
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Temple University
First posted: 2022-06-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to provide an evidence-based shared decision making intervention for antipsychotic medications, the Antipsychotic Medication Decision Aid (APM-DA), for individuals experiencing early psychosis and provide, for the first time, an understanding of the shared decision making mechanism of action.

Detailed description: The investigators will conduct a cluster RCT of the APM-DA intervention at 6 OnTrackNY clinics, with 3 clinics implementing APM-DA as part of their psychiatric visits and 3 randomized to serve as control offering treatment as usual (TAU). The planned sample size is 120 OnTrackNY clients with first episode psychosis (FEP). This real-world pilot cluster RCT will assess the feasibility of the APM-DA intervention in FEP care, providing the first evidence for the effectiveness of the APM-DA compared with TAU and understanding of the SDM intervention's mechanism of action.

Eligibility criteria: Inclusion Criteria:

* Ages 18 to 30 who have experienced nonaffective psychosis with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, other specified/unspecified schizophrenia spectrum and other psychotic disorders (ICD-10-CM Diagnosis Code F20.x)
* Current/past experiences with antipsychotic medications (APM; e.g., currently taking any antipsychotic medication, stopped taking, or considering stopping).
* Receive FEP treatment in one of OnTrackNY clinics/sites randomized to intervention or treatment as usual (TAU) - Willing to participate in research interviews after each APM visit during the study period (3 months)

Exclusion Criteria:

* Unable to provide informed consent
* No experience with APM
* Not fluent (speaking, reading, writing) in English

Primary outcomes:
measure: The 9-item Shared Decision Making Questionnaire for Psychiatry (SDM-Q-9-Psy) (Primary)
timeFrame: Change in SDM from baseline (T0, measured after the first medication visit) to the next post medication visit/s (Tnext) and up to a period of 3 months follow-up (T2)
measure: Intent to Attend and Complete Treatment Scale (Primary)
timeFrame: Change in OnTrackNY engagement from baseline (T0, measured at enrollment), after each post medication visit/s (Tnext), and at 3-month follow-up (T2 )
measure: Adherence Estimator (Primary)
timeFrame: Change in Adherence Estimator from baseline (T0, measured at enrollment), after each post-visit/s (Tnext), and at 3-month follow-up (T2 )
Secondary outcomes:
Other outcomes:
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