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Financial Incentives to Improve Acceptance of Antipsychotic Injections

Primary Purpose

Schizophrenia, Schizo Affective Disorder, Bipolar I Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Financial incentive
Sponsored by
Focus Community Mental Health Team
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia focused on measuring financial incentive

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    with financial incentive

    treatment as usual

    Arm Description

    Patients randomized to this arm will start with receiving the financial incentive. Cross-over after 9 months to treatment as usual.

    Patients randomized to this arm will start with receiving treatment as usual, cross-over after 9 months to incentive arm.

    Outcomes

    Primary Outcome Measures

    Adherence to depot injection
    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

    The time 'delayed' in taking depot
    The percentage of the prescribed time interval that has elapsed before the depot is taken
    Clinical status
    As assessed on the Brief Psychiatric Rating Scale -Expanded (BPRS-E), by the treating psychiatrist.
    Psychosocial status
    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
    Any admission during the study
    Number of attempted and completed suicides
    Tracked by team
    Subjective satisfaction with medication
    Assessed by semi-structured interview
    Subjective quality of life measure
    Assessed by semi-structured interview
    Incidences of physical violence during the study
    Tracked by team
    Incidences of police arrests during the study
    Tracked by team
    Days spent incarcerated during the study
    Tracked by team
    Qualitative feedback from the teams on all aspects of their experiences with the study at the beginning and end of study
    Conducted by researcher in focus group
    Costs analyses
    cost effectiveness study by experts

    Full Information

    First Posted
    June 15, 2017
    Last Updated
    June 18, 2017
    Sponsor
    Focus Community Mental Health Team
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03192631
    Brief Title
    Financial Incentives to Improve Acceptance of Antipsychotic Injections
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2017 (Anticipated)
    Primary Completion Date
    December 31, 2019 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Focus Community Mental Health Team

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Schizo Affective Disorder, Bipolar I Disorder
    Keywords
    financial incentive

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Cross-over study of 20 patients randomized to two arms, 9 month before cross-over.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    with financial incentive
    Arm Type
    Experimental
    Arm Description
    Patients randomized to this arm will start with receiving the financial incentive. Cross-over after 9 months to treatment as usual.
    Arm Title
    treatment as usual
    Arm Type
    No Intervention
    Arm Description
    Patients randomized to this arm will start with receiving treatment as usual, cross-over after 9 months to incentive arm.
    Intervention Type
    Other
    Intervention Name(s)
    Financial incentive
    Intervention Description
    Incentive of $15 Canadian
    Primary Outcome Measure Information:
    Title
    Adherence to depot injection
    Description
    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.
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    The time 'delayed' in taking depot
    Description
    The percentage of the prescribed time interval that has elapsed before the depot is taken
    Time Frame
    18 months
    Title
    Clinical status
    Description
    As assessed on the Brief Psychiatric Rating Scale -Expanded (BPRS-E), by the treating psychiatrist.
    Time Frame
    18 months
    Title
    Psychosocial status
    Description
    As assessed by the Multnomah Community Ability Scale, by the primary clinician at the beginning and end of the study.
    Time Frame
    18 months
    Title
    Number of involuntary and voluntary hospital admissions
    Description
    Any admission during the study
    Time Frame
    18 months
    Title
    Number of attempted and completed suicides
    Description
    Tracked by team
    Time Frame
    18 months
    Title
    Subjective satisfaction with medication
    Description
    Assessed by semi-structured interview
    Time Frame
    18 months
    Title
    Subjective quality of life measure
    Description
    Assessed by semi-structured interview
    Time Frame
    18 months
    Title
    Incidences of physical violence during the study
    Description
    Tracked by team
    Time Frame
    18 months
    Title
    Incidences of police arrests during the study
    Description
    Tracked by team
    Time Frame
    18 months
    Title
    Days spent incarcerated during the study
    Description
    Tracked by team
    Time Frame
    18 months
    Title
    Qualitative feedback from the teams on all aspects of their experiences with the study at the beginning and end of study
    Description
    Conducted by researcher in focus group
    Time Frame
    18 months
    Title
    Costs analyses
    Description
    cost effectiveness study by experts
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Samuel Law, MD; MPH
    Phone
    416-864-6060
    Ext
    2415
    Email
    laws@smh.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arash Nakhost, MD; PhD
    Phone
    416-864-6060
    Ext
    2836
    Email
    nakhosta@smh.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19785727
    Citation
    Priebe S, Burton A, Ashby D, Ashcroft R, Burns T, David A, Eldridge S, Firn M, Knapp M, McCabe R. Financial incentives to improve adherence to anti-psychotic maintenance medication in non-adherent patients - a cluster randomised controlled trial (FIAT). BMC Psychiatry. 2009 Sep 28;9:61. doi: 10.1186/1471-244X-9-61.
    Results Reference
    result

    Learn more about this trial

    Financial Incentives to Improve Acceptance of Antipsychotic Injections

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