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
About this trial
This is an interventional other trial for Schizophrenia focused on measuring financial incentive
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.
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
NCT ID
NCT03192631
First Posted
June 15, 2017
Last Updated
June 18, 2017
Sponsor
Focus Community Mental Health Team
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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