Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization

NCT07130500 | Enrolling By Invitation

• 1 other identifier: 76061
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 5

Brief Summary

This study is a randomized controlled trial evaluating the impact of financial incentives on medication adherence among individuals with schizophrenia, schizoaffective disorder, or bipolar disorder and/or co-occurring substance use disorder who are recently discharged from involuntary hospitalization or are at high risk of future involuntary hospitalization. Participants will be randomized to receive financial incentives for adherence to long-acting injectable medications or to a control group.

Conditions

Schizophrenia Disorder; Schizoaffective Disorder; Bipolar Disorder (BD); Substance Use Disorder (SUD)

Keywords

LAI; adherence; incentives; involuntary hospitalization; involuntary commitment; long-acting injectables; antipsychotics; Medicaid

Outcome Measures

Primary Outcomes (2)

• Adherence to antipsychotic medication

  Proportion of days covered by medication

  From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.

• Involuntary hospitalization

  Binary indicator for whether or not individual was involuntarily hospitalized

  From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.

Secondary Outcomes (24)

• Adherence to MOUD where indicated among participants with OUD diagnosis

  From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.

• Adherence to MAUD where indicated among participants with AUD diagnosis

  From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.

• Number of mental health outpatient appointments attended

  From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.

• Number of injectable medications received

  From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.

• Number of emergency room visits

  From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.

Study Arms (2)

Financial Incentives for Medication Adherence

EXPERIMENTAL

Receives financial incentives for each LAI administered and increasing bonus for consecutive adherence.

Behavioral: Financial incentives for adherence to long-acting injectable medication

Standard of Care

ACTIVE COMPARATOR

Receives standard outpatient care and survey incentives only.

Behavioral: Standard of care with monthly surveys

Interventions

Financial incentives for adherence to long-acting injectable medication BEHAVIORAL

This intervention is a randomized controlled trial where patients in the treatment group are offered financial incentives for taking long-acting injectable (LAI) versions of the antipsychotic and substance use disorder medications they need and the control group receives the status quo standard of care.

Financial Incentives for Medication Adherence

Standard of care with monthly surveys BEHAVIORAL

Receives standard outpatient care and incentives for completing monthly surveys.

Standard of Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia, schizoaffective disorder, and/or bipolar disorder
• Recent (within 12 months) involuntary hospitalization or high risk of future hospitalization
• Eligible for medication (antipsychotic or SUD-related) with an LAI formulation
• Allegheny County, PA resident
• Receiving or assigned to treatment at clinics participating in this study

You may not qualify if:

• Lack of injectable formulation for prescribed medication
• Aged under 18 or 65 or older

Sponsors & Collaborators

• Stanford University: lead
• University of Pittsburgh Medical Center: collaborator
• Arnold Ventures: collaborator
• Allegheny County Department of Human Services: collaborator
• Pittsburgh Mercy: collaborator
• Stanford Impact Labs: collaborator
• Federal Reserve Bank of New York: collaborator

Study Sites (5)

Pittsburgh Mercy

Pittsburgh, Pennsylvania, 15203, United States

Location

UPMC Franklin Building

Pittsburgh, Pennsylvania, 15203, United States

Location

UPMC Bellefield Towers

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Oxford Building

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Western Psychiatric Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• Stanford Impact Labs Project Page

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Substance-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Antoine Douaihy, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Valentin Bolotnyy, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kleinheinz Fellow

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 19, 2025
• Study Start: March 9, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)