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Not yet recruiting NCT05416658

Shared Decision Making for Antipsychotic Medications

No phase Interventional Schizophrenia Schizoaffective Disorder Schizophreniform Disorders Delusional Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Antipsychotic Medication Decision Aid (APM-DA).
Who it may be relevant to
Registry conditions: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Delusional Disorder. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Examining the Effectiveness of a Shared Decision Making Intervention for Antipsychotic Medications to Improve Engagement in Treatment for People Experiencing Early Psychosis

Overview

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.

Interventions

  • Other The Antipsychotic Medication Decision Aid (APM-DA)
    The APM-DA intervention is the first and only International Patient Decision Aid Standards (IPDAS) approved shared decision making (SDM) decision aid intervention for Antipsychotic Medication decisions in psychiatric visits. The APM-DA intervention developed by the research team addresses a common issue among psychiatric care providers and patients that lies in the heart of pharmacotherapy - taking, tapering or stopping APM. The APM-DA has a print format and can be used online as a PDF. It inclu

Primary outcome measures

  • The 9-item Shared Decision Making Questionnaire for Psychiatry (SDM-Q-9-Psy) (Primary) [Time frame: 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)]
  • Intent to Attend and Complete Treatment Scale (Primary) [Time frame: Change in OnTrackNY engagement from baseline (T0, measured at enrollment), after each post medication visit/s (Tnext), and at 3-month follow-up (T2 )]
  • Adherence Estimator (Primary) [Time frame: Change in Adherence Estimator from baseline (T0, measured at enrollment), after each post-visit/s (Tnext), and at 3-month follow-up (T2 )]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05416658 · 1R34MH128497-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗