Project Summary
Shared decision making (SDM) is a process that involves open discussion between patient and clinician with
the goal of improving treatment engagement and quality of care. Cumulative research as well as the recent
edition of the American Psychiatric Association Practice Guideline for the Treatment of Patients with
Schizophrenia recognize the need for SDM when making decisions about antipsychotic medication (APM) and
identify the lack of SDM in psychiatric care as a factor contributing to inconsistent APM use. The high rates of
premature treatment discontinuation and inconsistent use of APM among individuals with first episode
psychosis (FEP), who are at high risk for relapse and clinical deterioration, make SDM a public health priority.
SDM is considered by the NIMH to be a framework within a coordinated specialty care (CSC) treatment model
for FEP to improve care and engagement. Yet, to date, there is a gap between recommendations for using
SDM and its actual use in psychiatric visits. In addition, evidence-based SDM interventions for APM decisions
in psychiatry, especially in early psychosis care, are lacking, and the mechanism of SDM is yet to be defined.
To fill these gaps, our project provides the first evidence-based SDM intervention for making decisions about
APM within a FEP CSC treatment model. We will further develop our existing SDM intervention for psychosis,
the Antipsychotic Medication Decision Aid (APM-DA), which was developed according to the highest
International Patient Decision Aid Standards (IPDAS) and quality criteria. We hypothesize that the use of the
APM-DA intervention in psychiatric visits focused on APM management for FEP will improve SDM targets
(trust in the clinician, active participation in APM decisions, knowledge of APM and FEP), which will produce
improved SDM proximal (level of SDM, program engagement, consistent use of APM) and distal outcomes
(positive recovery attitudes, less severe symptoms over time, fewer ED visits and hospitalizations). This pilot
effectiveness trial has two aims. In Aim 1, we will develop a delivery protocol and training materials for using
the APM-DA in psychiatric visits in a large CSC program, OnTrackNY. Step 1 involves a qualitative formative
study to develop the protocol and training materials (25 interviews), and Step 2 involves an open pilot trial of
the protocol and training materials for final refinement with 20 patient participants. In Aim 2, we will conduct a
cluster RCT at 6 CSC clinics with 120 patient participants (60 in each arm) to test potential mechanism/targets
and impact of the APM-DA intervention compared with treatment as usual. Successful completion will result in
an evidence-based SDM intervention that addresses an NIMH strategic goal to improve the quality of APM
management for individuals with psychosis. Upon completion, a larger APM-DA clinical trial will be conducted
via a subsequent R01.
