Shared Decision Making for Antipsychotic Medications

New York State Psychiatric Institute

Status: Not yet enrolling

Conditions: Schizophreniform Disorders; Other Specified Schizophrenia Spectrum and Other Psychotic Disorder; Schizophrenia; Schizoaffective Disorder; Delusional Disorder

Treatments: Other: The Antipsychotic Medication Decision Aid (APM-DA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05416658

1R34MH128497-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

The Antipsychotic Medication Decision Aid (APM-DA) intervention clinics

Experimental group

Description:

Three pairs of comparable clinics (out of 22 clinics where OnTrackNY operates) based on the same region of the state and similar numbers of patients with similar demographic composition. One of each paired clinic is assigned to the intervention group by a blinded Co-I who will generate binary random variables.

Treatment:

Other: The Antipsychotic Medication Decision Aid (APM-DA)

Treatment As Usual (TAU) clinics

No Intervention group

Description:

The other clinic of each of the three pairs will be assigned to TAU.