Shared Decision Making for Antipsychotic Medications

Not Applicable

Not yet recruiting

• Conditions: Schizophrenia; Delusional Disorder; Other Specified Schizophrenia Spectrum and Other Psychotic Disorder; Schizoaffective Disorder; Schizophreniform Disorders
• Interventions: Other: The Antipsychotic Medication Decision Aid (APM-DA)

• Registration Number: NCT05416658
• Lead Sponsor: New York State Psychiatric Institute

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.

Study Timeline

• Study First Submitted: 2022-06-03
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Study Start: 2026-01-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Antipsychotic Medication Decision Aid (APM-DA) intervention clinics	The Antipsychotic Medication Decision Aid (APM-DA)	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.

Primary Outcome Measures

Name	Time	Method
The 9-item Shared Decision Making Questionnaire for Psychiatry (SDM-Q-9-Psy) (Primary)	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)	The 9-item Shared Decision Making Questionnaire for Psychiatry (SDM-Q-9-Psy) is the only validated self-report measure for SDM in psychiatry/mental health. The SDM-Q-9-Psy includes 9 items ranging from 0 to 5, with higher scores indicating higher quality of the SDM process perceived by the patient. The SDM-Q-9-Psy will be first measured (baseline, T0) after the first medication visit and then after each medication visit throughout the study period, therefore there will be multiple post-visits or "Tnext".
Intent to Attend and Complete Treatment Scale (Primary)	Change in OnTrackNY engagement from baseline (T0, measured at enrollment), after each post medication visit/s (Tnext), and at 3-month follow-up (T2 )	The Intent to Attend and Complete Treatment are two items that are part of the EPINET Core Assessment Battery (CAB) "Medication Side Effects and Treatment Adherence" core domain to assess engagement in CSC program (OnTrackNY). The score ranges from 0 to 9 for each item, with higher scores indicating higher intent to attend and complete treatment. Changes in the Intent to Attend will be measured after each medication visit throughout the study period, therefore there will be multiple post-visits or "Tnext".
Adherence Estimator (Primary)	Change in Adherence Estimator from baseline (T0, measured at enrollment), after each post-visit/s (Tnext), and at 3-month follow-up (T2 )	The Adherence Estimator is a three-item measure relies on client self-report. The Adherence Estimator focuses on perceived concerns about medications, perceived need for medications, and perceived affordability of medications. The Adherence Estimator is scored by adding up the total number of points in each item and can range from 0 (Low risk for adherence problems) to 36 (High risk for adherence problems). Changes in the Adherence Estimator will be measured after each medication visit throughout the study period, therefore there will be multiple post-visits or "Tnext".