Financial Incentives to Improve Acceptance of Antipsychotic Injections
Financial Incentives to Improve Acceptance and Adherence to Depot Injection Anti-psychotic Medication in Treatment Avoidant and Non-adherent Patients - a Pilot Study
研究概览
详细说明
Background: Medication adherence in patients with schizophrenia is a major challenge. For those who do come into contact with treatment services, various clinical and psychosocial approaches to improve antipsychotic medication adherence have been studied but none is very successful. People with severe psychotic illness often have poor insight into their illness, and lack competence for treatment decisions, making them very vulnerable to frequent illness relapses due to inadequate or lack of treatment. Furthermore, to compel them to receive treatment out of concerns for their own and others' safety and welfare, they are often subjected to involuntary hospitalization and community based treatments, by means such as Community Treatment Orders (CTO). Under the authority of CTO, patients need to take medication or they will be forcefully brought to the hospital for assessment and or hospitalization. There is concern for the coercive nature of these means that may harm these patients' relationship to the psychiatric system, and overall quality of life. There is well found concern for potential violation of the ethical principle of "do no harm", particularly when less coercive, easy to understand alternatives - such as financial incentives to take medication - have not been well explored. This study aims to assess financial incentive as a promoter of medication adherence in the most medication resistant patient population.
Methods: In a randomized cross-over study, the investogators will study medication adherence by focusing exclusively on a form of medication that is accurately measureable - the long-acting injectable antipsychotic medication. Participants will be recruited from the 160 patients who are currently enrolled at the St. Michael Hospital's Assertive Community Treatment team (FOCUS). Any patient who has had less than 75% adherence rate of his/her injectable antipsychotic depot medication in the last 4 months will be recruited. There are estimated 20-30 patients who would meet the inclusion criteria. Ten patients will be randomly assigned to each arm of the cross-over study. The treatment A arm would be offered the intervention of a $15 incentive to take the injectable medication. The treatment B arm would be treatment as usual as per FOCUS services. Each phase of the cross-over study would last 9 months - i.e. the cross-over would take place after 9 months. The primary outcome will be depot medication adherence levels, comparing the adherence rates in the treatment as usual phase. The secondary outcomes will be global clinical improvement, number of voluntary and involuntary hospital admissions and Emergency Room visits, number of police and justice system encounters, number of attempted and completed suicides, incidents of physical violence, number of days spent in work/education/rehabilitation programs, subjective quality of life and satisfaction with medication. The investigators will also study the cost effectiveness of offering financial incentives.
Discussion: The pilot study aims to provide new evidence on the effectiveness and cost effectiveness of offering financial incentives as an alternative to existing coercive approaches to improving medication adherence for patients with severe psychotic disorders. If found effective, and the benefits outweigh the risks, the potential to expand the practice, under strict ethical considerations and monitoring, at a larger policy and as an optional, available service improvement tool, is anticipated to be large. This will be the first known Canadian study on the subject.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Samuel Law, MD; MPH
- 电话号码:2415 416-864-6060
- 邮箱:laws@smh.ca
研究联系人备份
- 姓名:Arash Nakhost, MD; PhD
- 电话号码:2836 416-864-6060
- 邮箱:nakhosta@smh.ca
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- The inclusion criteria are the following: 1) an established psychiatric diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder according to DSM-V; 2) part of the FOCUS team for at least 4 months; 3) between 18 and 65 years of age; 4) capacity to give informed consent to participate in the study; 5) be prescribed depot antipsychotic medications more than 4 months; 6) poor adherence to anti-psychotic medication, i.e. receiving less than 75% of their prescribed depot medication in the defined period of last 4 months (some patients may eventually accept depot after repeated efforts by clinicians, but the 4-month timeframe allows precise calculation of their adherence rate); and 7) team consensus on history of failure of other general methods available to the team to ensure adherence to medication (e.g. repeated psychoeducation, case meetings, family persuasion, offering of at-home depot administration, etc.); and 8) established incapacity for treatment decision.
Exclusion Criteria:
- Exclusion criteria are: 1) established learning disorder; 2) inability to give informed consent for the study; and 3) established incapacity for treatment decision.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:with financial incentive
Patients randomized to this arm will start with receiving the financial incentive.
Cross-over after 9 months to treatment as usual.
|
Incentive of $15 Canadian
|
无干预:treatment as usual
Patients randomized to this arm will start with receiving treatment as usual, cross-over after 9 months to incentive arm.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Adherence to depot injection
大体时间:18 months
|
The primary outcome is adherence to depot medication during the 18-month study period.
Adherence will be measured, objectively, as the percentage of prescribed depot injections actually taken.
|
18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The time 'delayed' in taking depot
大体时间:18 months
|
The percentage of the prescribed time interval that has elapsed before the depot is taken
|
18 months
|
Clinical status
大体时间:18 months
|
As assessed on the Brief Psychiatric Rating Scale -Expanded (BPRS-E), by the treating psychiatrist.
|
18 months
|
Psychosocial status
大体时间:18 months
|
As assessed by the Multnomah Community Ability Scale, by the primary clinician at the beginning and end of the study.
|
18 months
|
Number of involuntary and voluntary hospital admissions
大体时间:18 months
|
Any admission during the study
|
18 months
|
Number of attempted and completed suicides
大体时间:18 months
|
Tracked by team
|
18 months
|
Subjective satisfaction with medication
大体时间:18 months
|
Assessed by semi-structured interview
|
18 months
|
Subjective quality of life measure
大体时间:18 months
|
Assessed by semi-structured interview
|
18 months
|
Incidences of physical violence during the study
大体时间:18 months
|
Tracked by team
|
18 months
|
Incidences of police arrests during the study
大体时间:18 months
|
Tracked by team
|
18 months
|
Days spent incarcerated during the study
大体时间:18 months
|
Tracked by team
|
18 months
|
Qualitative feedback from the teams on all aspects of their experiences with the study at the beginning and end of study
大体时间:18 months
|
Conducted by researcher in focus group
|
18 months
|
Costs analyses
大体时间:18 months
|
cost effectiveness study by experts
|
18 months
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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