Examining the effectiveness of a shared decision making intervention for antipsychotic medications to improve engagement in treatment for people experiencing early psychosis

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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.