Shared Decision Making for Antipsychotic Medications
Examining the Effectiveness of a Shared Decision Making Intervention for Antipsychotic Medications to Improve Engagement in Treatment for People Experiencing Early Psychosis
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Jan 2027
Shorter than P25 for not_applicable schizophrenia
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
Study Completion
Last participant's last visit for all outcomes
June 30, 2027
March 30, 2026
March 1, 2026
6 months
June 3, 2022
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The 9-item Shared Decision Making Questionnaire for Psychiatry (SDM-Q-9-Psy) (Primary)
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".
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)
Intent to Attend and Complete Treatment Scale (Primary)
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".
Change in OnTrackNY engagement from baseline (T0, measured at enrollment), after each post medication visit/s (Tnext), and at 3-month follow-up (T2 )
Adherence Estimator (Primary)
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".
Change in Adherence Estimator from baseline (T0, measured at enrollment), after each post-visit/s (Tnext), and at 3-month follow-up (T2 )
Study Arms (2)
The Antipsychotic Medication Decision Aid (APM-DA) intervention clinics
EXPERIMENTALThree 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.
Treatment As Usual (TAU) clinics
NO INTERVENTIONThe other clinic of each of the three pairs will be assigned to TAU.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Unable to provide informed consent
- No experience with APM
- Not fluent (speaking, reading, writing) in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New York State Psychiatric Institutelead
- Temple Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Edna L. Edison Professor of Psychiatry
Study Record Dates
First Submitted
June 3, 2022
First Posted
June 13, 2022
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Descriptive and raw data will be submitted on an annual basis. Unpublished de-identified data will be shared within one year after project completion, or when the data are published, whichever is earlier.
- Access Criteria
- Data and materials will be made available for research to investigators working under a Federal Wide Assurance who meet security measures and data use agreement criteria associated with public repositories, including the National Database for Clinical Trials related to Mental Illness (NDCT) and the NIMH Database of Cognitive Training and Remediation Studies (DoCTRS).
Findings from this study will be presented to research peers, clinicians, and the public through Presentations at Scientific Meetings, Regional Research or Educational Meetings, Newsletters and Social Media and Peer-Reviewed Publications. Those events will occur during or at the conclusion of the study.