Financial Incentives to Improve Acceptance of Antipsychotic Injections
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|ClinicalTrials.gov Identifier: NCT03192631|
Recruitment Status : Not yet recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizo Affective Disorder Bipolar I Disorder||Other: Financial incentive||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Cross-over study of 20 patients randomized to two arms, 9 month before cross-over.|
|Masking:||None (Open Label)|
|Official Title:||Financial Incentives to Improve Acceptance and Adherence to Depot Injection Anti-psychotic Medication in Treatment Avoidant and Non-adherent Patients - a Pilot Study|
|Estimated Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: with financial incentive
Patients randomized to this arm will start with receiving the financial incentive. Cross-over after 9 months to treatment as usual.
Other: Financial incentive
Incentive of $15 Canadian
No Intervention: treatment as usual
Patients randomized to this arm will start with receiving treatment as usual, cross-over after 9 months to incentive arm.
- Adherence to depot injection [ Time Frame: 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.
- The time 'delayed' in taking depot [ Time Frame: 18 months ]The percentage of the prescribed time interval that has elapsed before the depot is taken
- Clinical status [ Time Frame: 18 months ]As assessed on the Brief Psychiatric Rating Scale -Expanded (BPRS-E), by the treating psychiatrist.
- Psychosocial status [ Time Frame: 18 months ]As assessed by the Multnomah Community Ability Scale, by the primary clinician at the beginning and end of the study.
- Number of involuntary and voluntary hospital admissions [ Time Frame: 18 months ]Any admission during the study
- Number of attempted and completed suicides [ Time Frame: 18 months ]Tracked by team
- Subjective satisfaction with medication [ Time Frame: 18 months ]Assessed by semi-structured interview
- Subjective quality of life measure [ Time Frame: 18 months ]Assessed by semi-structured interview
- Incidences of physical violence during the study [ Time Frame: 18 months ]Tracked by team
- Incidences of police arrests during the study [ Time Frame: 18 months ]Tracked by team
- Days spent incarcerated during the study [ Time Frame: 18 months ]Tracked by team
- Qualitative feedback from the teams on all aspects of their experiences with the study at the beginning and end of study [ Time Frame: 18 months ]Conducted by researcher in focus group
- Costs analyses [ Time Frame: 18 months ]cost effectiveness study by experts
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192631
|Contact: Samuel Law, MD; MPH||416-864-6060 ext email@example.com|
|Contact: Arash Nakhost, MD; PhD||416-864-6060 ext firstname.lastname@example.org|