Abstract
BackgroundYoung adults ages 18 to 25 with first episode psychosis (FEP) have an increased risk of discontinuation antipsychotic medications and psychiatric service disengagement that lead to symptom exacerbation and deterioration. We seek to (1) examine the feasibility, usability, and potential impact of a Shared Decision Making (SDM) Antipsychotic Medication Decision Aid (DA) on decision-making, adherence to the decision made, and service engagement among young adults with FEP and (2) understand the role of additional patient-level factors on SDM.MethodsA randomized controlled trial is being conducted in a coordinated specialty care community program for FEP in an urban setting. Eligible patients are randomly assigned to receive an intervention, the Antipsychotic Medication Decision Aid, or treatment as usual. Patients receive their assigned intervention before their medication appointment with the psychiatrist and complete four interviews: before the appointment (T0), after the appointment (T1), and at 3- and 6-month follow-ups (T2 and T3). The study staff and participating psychiatrists are not blinded to the intervention. The data are de-identified to maintain blinding during the analysis process. The primary aims are feasibility of intervention delivery and research procedures and preliminary impact of the intervention on SDM-related outcomes, medication adherence, and service engagement. As a secondary aim, we will explore the contribution of personality and motivation variables, clinical relationships, cognitive functioning, and mental-health-related stigma to SDM. If the sample size permits, we plan to conduct parametric tests such as independent-samples t tests at T1 to compare differences in SDM, adherence, and engagement scales. In the case of a small sample size, we will use non-parametric tests and descriptive statistics.DiscussionThis protocol outlines the methodology for a feasibility pilot comparing the effect of a novel SDM Antipsychotic Medication encounter DA with treatment as usual on SDM, medication adherence, and service engagement in FEP care. SDM is endorsed as a framework for use in FEP and antipsychotic pharmacotherapy, but its impact on adherence and health outcomes is unclear. Understanding the potential contribution of an SDM Antipsychotic Medication DA compared with usual care in psychosis pharmacotherapy is critical. The study will help answer several key questions new to SDM research, including the contribution of personality and clinical relationships to SDM in mental health and psychosis in particular. The study will serve to gather feasibility data to inform future studies and scale-up.Trial registrationEthics approval was obtained through Temple University’s institutional review board (IRB) and the City of Philadelphia’s Department of Public Health IRB. The study has been retrospectively registered with ClinicalTrials.gov as NCT04373590 on 29 April 2020. https://clinicaltrials.gov/ct2/show/NCT04373590?term=NCT04373590&draw=2&rank=1
Highlights
Young adults ages 18 to 25 with first episode psychosis (FEP) have an increased risk of discontinuation antipsychotic medications and psychiatric service disengagement that lead to symptom exacerbation and deterioration
(2021) 7:22 (Continued from previous page). This protocol outlines the methodology for a feasibility pilot comparing the effect of a novel Shared Decision Making (SDM) Antipsychotic Medication encounter Decision Aid (DA) with treatment as usual on SDM, medication adherence, and service engagement in FEP care
SDM is endorsed as a framework for use in FEP and antipsychotic pharmacotherapy, but its impact on adherence and health outcomes is unclear
Summary
Young adults ages 18 to 25 with first episode psychosis (FEP) have an increased risk of discontinuation antipsychotic medications and psychiatric service disengagement that lead to symptom exacerbation and deterioration. We identified one study about clinical decision-making (not an SDM) [25], and one study about preparation for SDM, where the intervention was provided by peers before the patient–clinician encounter and discussion but did not address a specific decision or medical condition [26]. These findings suggest that the literature on SDM for young adults with FEP is scarce and that no SDM intervention exists for use as part of medication management appointments
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