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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
Sponsor:
Information provided by (Responsible Party):
Samuel Law, Focus Community Mental Health Team

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Schizophrenia Schizo Affective Disorder Bipolar I Disorder Other: Financial incentive Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Clinical status [ Time Frame: 18 months ]
    As assessed on the Brief Psychiatric Rating Scale -Expanded (BPRS-E), by the treating psychiatrist.

  3. 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.

  4. Number of involuntary and voluntary hospital admissions [ Time Frame: 18 months ]
    Any admission during the study

  5. Number of attempted and completed suicides [ Time Frame: 18 months ]
    Tracked by team

  6. Subjective satisfaction with medication [ Time Frame: 18 months ]
    Assessed by semi-structured interview

  7. Subjective quality of life measure [ Time Frame: 18 months ]
    Assessed by semi-structured interview

  8. Incidences of physical violence during the study [ Time Frame: 18 months ]
    Tracked by team

  9. Incidences of police arrests during the study [ Time Frame: 18 months ]
    Tracked by team

  10. Days spent incarcerated during the study [ Time Frame: 18 months ]
    Tracked by team

  11. 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

  12. Costs analyses [ Time Frame: 18 months ]
    cost effectiveness study by experts



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Samuel Law, MD; MPH 416-864-6060 ext 2415 laws@smh.ca
Contact: Arash Nakhost, MD; PhD 416-864-6060 ext 2836 nakhosta@smh.ca

Sponsors and Collaborators
Focus Community Mental Health Team

Publications of Results:
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Responsible Party: Samuel Law, Staff Psychiatrist, Focus Community Mental Health Team
ClinicalTrials.gov Identifier: NCT03192631     History of Changes
Other Study ID Numbers: #SMH-17-009
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samuel Law, Focus Community Mental Health Team:
financial incentive

Additional relevant MeSH terms:
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Disease
Schizophrenia
Mood Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders