Decision-making and Decision Support Among Emerging Adults With First Episode Psychosis

NCT04373590 | Completed

• 1 other identifier: 24734
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the impact of an antipsychotic medication decision aid and interpersonal and cognitive factors, such as attachment style and motivation, on emerging adults' ability to engage in shared decision making regarding their medications.

Conditions

Early Psychosis

Outcome Measures

Primary Outcomes (8)

• Change in antipsychotics knowledge

  Scale to assess change in knowledge about antipsychotic medications over time (9 items)

  Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment )

• Decision-making self-efficacy

  Decision Self-Efficacy (DSE) scale to assess decision self-efficacy (11 items)

  Post appointment interview (1 day of the appointment )

• Decision-making attitudes

  Decision Attitude Scale (DAS) to assess decision-making attitudes (10 items)

  Post appointment interview (1 day of the appointment )

• Decisional Conflict

  Decisional Conflict Scale (DCS) to assess level of decisional conflict (15 items)

  Post appointment interview (1 day of the appointment )

• Shared decision making

  collaboRATE scale to assess level of shared decision making after an appointment (3 items)

  Post appointment interview (1 day of the appointment )

• Change in medication adherence

  Brief Adherence Rating Scale (BARS) to assess change in medication adherence over time (8 items)

  Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up .

• Change in service use

  Service Use and Resource Form for Monthly Items (SURF-M) scale to assess change in service use over time (66 items)

  Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up .

• Service engagement

  Service Engagement Scale (SES) to assess level of service engagement (14 items)

  Baseline (Pre-appointment interview )

Secondary Outcomes (7)

• Apathy

  Baseline (Pre-appointment interview )

• Attachment style

  Baseline (Pre-appointment interview )

• Working alliance

  Baseline (Pre-appointment interview )

• Trust

  Baseline (Pre-appointment interview )

• Cognitive functioning

  Baseline (Pre-appointment interview )

Study Arms (2)

Decision aid (DA)

EXPERIMENTAL

a one-page DA for use during the psychiatric consultation to help patients and clinicians discuss relevant treatment options pertaining to antipsychotics.

Behavioral: Decision aid

Treatment as usual (TAU)

NO INTERVENTION

Treatment as usual without the DA

Interventions

Decision aid BEHAVIORAL

The chosen intervention is a one-page DA developed by the first author, published and fully described elsewhere (Zisman-Ilani et al., 2017; Zisman et al., 2018) for use during the psychiatric consultation to help patients and clinicians discuss relevant treatment options pertaining to antipsychotics such as medication nonadherence and self-tapering. The DA format is a simple one-page table with rows containing frequently asked questions by patients about their treatment options and the benefits, risks, and implications of differing decisions. The columns display the treatment options available for the treatment decision in question: continuing, adjusting, or discontinuing antipsychotic medications.

Decision aid (DA)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 25 years
• Experiencing early psychosis, defined as psychosis lasting 18 months or less between the time when threshold symptom criteria were reached (as determined by the admitting CSC program assessor) and the date of CSC program enrollment
• Planning to attend a medication appointment with a participating CSC psychiatrist
• Ability to speak and understand English
• Ability to provide informed consent as assessed by research staff using procedures discussed by Carpenter et al. (2000) including a demonstrated understanding and recall of study procedures, rather than passive consent, and allowance of repetition of study procedures until there is understanding and recall.

You may not qualify if:

• Have a legal guardian
• Have identified co-occurring dementia, delirium, or intellectual disability that will likely affect their ability to provide informed consent or participate in the data collection procedures.

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Psychosis Education, Assessment, Care and Empowerment (PEACE)

Philadelphia, Pennsylvania, 19123, United States

Location

Related Publications (2)

• Zisman-Ilani Y, Shern D, Deegan P, Kreyenbuhl J, Dixon L, Drake R, Torrey W, Mishra M, Gorbenko K, Elwyn G. Continue, adjust, or stop antipsychotic medication: developing and user testing an encounter decision aid for people with first-episode and long-term psychosis. BMC Psychiatry. 2018 May 22;18(1):142. doi: 10.1186/s12888-018-1707-x.

  PMID: 29788933 RESULT

• Zisman-Ilani Y, Hurford I, Bowen A, Salzer M, Thomas EC. Evaluating the feasibility of a decision aid to promote shared decision making among young adults with first-episode psychosis: protocol for a pilot study. Pilot Feasibility Stud. 2021 Jan 11;7(1):22. doi: 10.1186/s40814-020-00757-0.

  PMID: 33431018 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization is accomplished using a HIPAA-compliant, Internet-based randomization service (studyrandomizer.com) using permuted blocks of 5. Patients and the participating psychiatrist are not blinded to the condition assigned to them; however, they are not given any explicit information on the DA. The psychiatrist was provided with the DA and received information about it as the DA is delivered by the psychiatrist for patients who are randomized to receive it. The RA who recruit and administer assessments to participants is not blinded to condition, except at baseline.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 4, 2020
• Study Start: February 27, 2019
• Primary Completion: August 12, 2020
• Study Completion: August 30, 2020
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)