Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Financial Incentives to Improve Acceptance of Antipsychotic Injections

18. června 2017 aktualizováno: Samuel Law, Focus Community Mental Health Team

Financial Incentives to Improve Acceptance and Adherence to Depot Injection Anti-psychotic Medication in Treatment Avoidant and Non-adherent Patients - a Pilot Study

There is a lack of incentive approach for patients who suffer from schizophrenia yet lack the insight to accept treatment. Most existing approaches involve coercion and involuntary hospitalizations. This study will explore whether patients with poor insight and lacking in competence for treatment decisions will improve their acceptance and adherence of depot injection antipsychotic medication if a financial incentive is offered. Ethical considerations are also explored for this innovative pilot study

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Očekávaný)

20

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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
Žádný zásah: treatment as usual
Patients randomized to this arm will start with receiving treatment as usual, cross-over after 9 months to incentive arm.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Adherence to depot injection
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The time 'delayed' in taking depot
Časové okno: 18 months
The percentage of the prescribed time interval that has elapsed before the depot is taken
18 months
Clinical status
Časové okno: 18 months
As assessed on the Brief Psychiatric Rating Scale -Expanded (BPRS-E), by the treating psychiatrist.
18 months
Psychosocial status
Časové okno: 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
Časové okno: 18 months
Any admission during the study
18 months
Number of attempted and completed suicides
Časové okno: 18 months
Tracked by team
18 months
Subjective satisfaction with medication
Časové okno: 18 months
Assessed by semi-structured interview
18 months
Subjective quality of life measure
Časové okno: 18 months
Assessed by semi-structured interview
18 months
Incidences of physical violence during the study
Časové okno: 18 months
Tracked by team
18 months
Incidences of police arrests during the study
Časové okno: 18 months
Tracked by team
18 months
Days spent incarcerated during the study
Časové okno: 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
Časové okno: 18 months
Conducted by researcher in focus group
18 months
Costs analyses
Časové okno: 18 months
cost effectiveness study by experts
18 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Očekávaný)

1. července 2017

Primární dokončení (Očekávaný)

31. prosince 2019

Dokončení studie (Očekávaný)

31. prosince 2021

Termíny zápisu do studia

První předloženo

15. června 2017

První předloženo, které splnilo kritéria kontroly kvality

18. června 2017

První zveřejněno (Aktuální)

20. června 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. června 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. června 2017

Naposledy ověřeno

1. června 2017

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • #SMH-17-009

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

3
Předplatit