Shared Decision Making for Antipsychotic Medications

Sponsor
New York State Psychiatric Institute
Study ID
NCT05416658
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • The Antipsychotic Medication Decision Aid (APM-DA) — OTHER
    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 includes a concise table describing what each option involves, its benefits, risks, and strategies to reduce risks. The intervention was developed in co-production with various stakeholders (patients, clinicians, service leadership, family members, researchers). Additional intervention materials are an evidence document to support the information and an APM side effects table.

Study Details

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.

Key Dates

First listed
Jun 13, 2022
Start date
Jan 1, 2027
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: The Antipsychotic Medication Decision Aid (APM-DA) intervention clinics
    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.
  • No Intervention: Treatment As Usual (TAU) clinics
    The other clinic of each of the three pairs will be assigned to TAU.

Primary Outcome Measure

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) ]

Central Contacts

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