Back to resultsShared Decision Making for Antipsychotic Medications
Primary Purpose
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The Antipsychotic Medication Decision Aid (APM-DA)
Sponsored by
About this trial
This is an interventional health services research trial for Schizophrenia focused on measuring Shared decision making, psychosis, schizophrenia, antipsychotic, medication, intervention, decision aid, coordinated specialty care (CSC), randomized controlled trial (RCT)
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Unable to provide informed consent
- No experience with APM
- Not fluent (speaking, reading, writing) in English
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
The Antipsychotic Medication Decision Aid (APM-DA) intervention clinics
Treatment As Usual (TAU) clinics
Arm Description
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.
The other clinic of each of the three pairs will be assigned to TAU.
Outcomes
Primary Outcome Measures
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".
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".
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".
Secondary Outcome Measures
Full Information
NCT ID
NCT05416658
First Posted
June 3, 2022
Last Updated
July 3, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
Temple University, Feinstein Institutes for Medical Research, The Zucker Hillside Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05416658
Brief Title
Shared Decision Making for Antipsychotic Medications
Official Title
Examining the Effectiveness of a Shared Decision Making Intervention for Antipsychotic Medications to Improve Engagement in Treatment for People Experiencing Early Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Temple University, Feinstein Institutes for Medical Research, The Zucker Hillside Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The investigators will conduct a cluster RCT of the APM-DA intervention at 6 OnTrackNY clinics, with 3 clinics implementing APM-DA as part of their psychiatric visits and 3 randomized to serve as control offering treatment as usual (TAU). The planned sample size is 120 OnTrackNY clients with first episode psychosis (FEP). This real-world pilot cluster RCT will assess the feasibility of the APM-DA intervention in FEP care, providing the first evidence for the effectiveness of the APM-DA compared with TAU and understanding of the SDM intervention's mechanism of action.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Delusional Disorder, Other Specified Schizophrenia Spectrum and Other Psychotic Disorder
Keywords
Shared decision making, psychosis, schizophrenia, antipsychotic, medication, intervention, decision aid, coordinated specialty care (CSC), randomized controlled trial (RCT)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The Antipsychotic Medication Decision Aid (APM-DA) intervention clinics
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual (TAU) clinics
Arm Type
No Intervention
Arm Description
The other clinic of each of the three pairs will be assigned to TAU.
Intervention Type
Other
Intervention Name(s)
The Antipsychotic Medication Decision Aid (APM-DA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The 9-item Shared Decision Making Questionnaire for Psychiatry (SDM-Q-9-Psy) (Primary)
Description
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".
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)
Title
Intent to Attend and Complete Treatment Scale (Primary)
Description
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".
Time Frame
Change in OnTrackNY engagement from baseline (T0, measured at enrollment), after each post medication visit/s (Tnext), and at 3-month follow-up (T2 )
Title
Adherence Estimator (Primary)
Description
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".
Time Frame
Change in Adherence Estimator from baseline (T0, measured at enrollment), after each post-visit/s (Tnext), and at 3-month follow-up (T2 )
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Unable to provide informed consent
No experience with APM
Not fluent (speaking, reading, writing) in English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Dixon, MD, MPH
Phone
646-774-8420
Email
lisa.dixon@nyspi.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yaara Zisman-llani, MA, PhD
Phone
215-204-8726
Email
yaara@temple.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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).
Learn more about this trial
Shared Decision Making for Antipsychotic Medications
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