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临床试验/NCT07130500
NCT07130500Enrolling By Invitation不适用

Can Financial Incentives Improve Medication Adherence and Patient Outcomes After Involuntary Hospitalization?

Stanford University5 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年1月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,000
试验地点
5
主要终点
Adherence to antipsychotic medication

研究概览

简要总结

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.

详细描述

The investigators seek to understand the effectiveness of financial incentives at reducing medication non-adherence and costly involuntary hospitalizations for individuals with acute mental health needs. The focus will be on patients diagnosed with schizophrenia, schizoaffective disorder, and/or bipolar disorder who have recent experiences with involuntary hospitalization and possibly a co-occurring substance use disorder. This population has been documented to have particularly high healthcare expenditures and mortality, as well as incidence of criminal charges. Partnering with UPMC Western Psychiatric Hospital (WPH), Pittsburgh Mercy, and the Allegheny County Department of Human Services (ACDHS), the investigators will run a randomized controlled trial (RCT) where the treatment group is offered financial incentives for long-acting injectable (LAI) versions of the antipsychotic and substance use disorder medications they need. If effective, financial incentives for LAIs can be a scalable tool for addressing a range of costly problems facing the whole country.

Investigators will enroll eligible individuals at discharge from involuntary hospitalization at WPH, in WPH outpatient clinics, and in the field with Pittsburgh Mercy's community treatment teams. Eligible individuals will be those who have a diagnosis of schizophrenia, schizoaffective disorder, and/or bipolar disorder, who were involuntary hospitalized within the last year or who are deemed by ACDHS models to be at high risk of involuntary hospitalization, and whose prescribed medication has an LAI formulation. Investigators will hire and train a research team to enroll patients in the study, randomize patients into treatment and control groups, and work with their physicians to keep track of who is taking up LAIs and who needs to receive the incentives. Each participant will experience a study duration of 12 months.

The primary hypotheses are that financial incentives for LAIs can increase medication adherence in this particularly hard-to-treat population and (2) increased medication adherence will decrease the incidence of involuntary hospitalization. Additional hypotheses, based on ongoing research in Allegheny County (Emanuel, Welle, and Bolotnyy, 2025), are that criminal charges and mortality will also decline if medication adherence improves and there will be improvements in housing stability, employment, subjective well being, relationships with others, and attitudes towards long-acting injections and the healthcare system.

Outcomes will be measured using ACDHS administrative data, including Medicaid claims and prescription refill records, death and Medical Examiner records, county court records, utilization data for homeless shelters in Allegheny County, and employment and income data from Pennsylvania's Department of Labor and Industry. Additionally, study participants will be surveyed every month during the study period and 6 months and 12 months after the end of the study. Surveys will collect information on participants' subjective wellbeing, the quality of their relationships, as well as their attitudes towards long-acting injections and the healthcare system. Outcomes will be measured and effects assessed at the end of the study period for all participants and after the follow-up survey data are collected. Priebe et al. (2013) and Noordraven et al. (2017) work with patients with a baseline adherence rate of 70-80%; the comparable adherence rate in our setting is 52%.

Randomization Plan

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Financial Incentives for Medication Adherence

Experimental

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

干预措施: Financial incentives for adherence to long-acting injectable medication (Behavioral)

Standard of Care

Active Comparator

Receives standard outpatient care and survey incentives only.

干预措施: Standard of care with monthly surveys (Behavioral)

结局指标

主要结局

Adherence to antipsychotic medication

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

Proportion of days covered by medication

Involuntary hospitalization

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

Binary indicator for whether or not individual was involuntarily hospitalized

次要结局

  • Child welfare involvement(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • 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.)
  • Total behavioral health medical costs(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.)
  • Inpatient utilization(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Total medical costs(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Index of criminal justice outcomes(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Involuntary hospitalization petition rate(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Mental health crisis service utilization(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Violent crime charges(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Mortality(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Quarterly earnings(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Enrollment in public assistance program: SSI(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Subjective well-being and attitudes(Assessed through monthly surveys over the course of 12 months of study enrollment for each patient; for follow-up, assessed at 6 months and 12 months after study completion.)
  • Hospital critical incidents(From start of study to end of study for all participants; for follow-up, for 12 months after end of study for all participants.)
  • Homeless system utilization(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Index of employment outcomes(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Quarterly employment(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Enrollment in public assistance program: SNAP(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Enrollment in public assistance program: TANF(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)
  • Enrollment in public assistance program: public housing(From start of study to end of study 12 months later; for follow-up, for 12 months after end of study.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Valentin Bolotnyy

Kleinheinz Fellow

Stanford University

研究点 (5)

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