Clinical trial NCT03766503: Daily Delivery and Supervision of Psychotropic Medication for High-Risk Patients With Severe/Persistent Mental Illness
Official title: Daily Delivery and Supervision of Psychotropic Medication for High-Risk Patients With Severe and Persistent Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Keywords: Medication adherence
Severe and persistent mental illness
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Winnipeg Regional Health Authority
First posted: 2018-12-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The main study intervention is the daily witnessing of participants while they self-administer their medications by trained pharmacy staff to ensure compliance. The staff in question will be provided by Leila pharmacy and will in addition provide support so that individuals can transition back into living independently through reminders to attend regularly scheduled medical appointments and counseling on correct use of prescribed medications.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The main study intervention is the daily witnessing of participant self-administration of medications by trained pharmacy staff to ensure compliance. The staff in question will be provided by Leila pharmacy and will in addition provide support so that individuals can transition back into living independently through reminders to attend regularly scheduled medical appointments and counseling on correct use of prescribed medications.

Detailed description: The program is designed to serve individuals with severe and persistent mental illnesses who have been repeatedly hospitalized, are repeat users of community crisis services, or are frequently in contact with the criminal justice system. There are several objectives of this new approach. First, the investigators believe that these patients are invested in working with the daily dispensing program to stay well, but individual factors related to their personal background or symptoms of their illness contribute to frequent non-adherence to medications. Non-adherence to medications then leads to behaviour that results in frequent use of very expensive services such as the criminal justice system, acute care hospital beds, and crisis services. Working collaboratively with the patient to improve adherence to medications in partnership with a private pharmacy that absorbs costs of the program is a less coercive model than injectable medications, which is the current standard for working with this population. In addition, oral medications are much less expensive than the newer injectable antipsychotics and the costs of running a "depot clinic" where the injectable medications are provided. At this time, there has been no effective program to ensure compliance with oral medications in the published literature.

The primary purpose of this study is to evaluate the effectiveness of this new model for decreasing the harmful effects of relapses to psychosis resulting from non-adherence to medications. Specifically, the investigators plan to examine whether or not this program results in less use of crisis services, acute care hospitalization and less contact with the criminal justice system. The investigators plan to evaluate client response through a self-reported measure and to assess client satisfaction by conducting participant satisfaction survey for the program. Key stakeholders will be engaged during the process (e.g., community mental health workers, probation officers, pharmacists) to gather information and suggestions regarding the daily dispensing program. Based on feedback from clients and stakeholders, the investigators will then aim to implement improvements to the process to optimize its effectiveness.

Eligibility criteria: Inclusion Criteria:

* Individuals currently enrolled in the new daily dispensing program
* Individuals with severe and persistent mental illnesses
* Individuals who have been repeatedly hospitalized, are repeat users of community crisis services, or are in frequently in contact with the criminal justice system
* Individuals who are involved in the Forensics program.

Exclusion Criteria:

* Individuals who are not currently in the Forensics program
* Individuals who are part of the daily dispensing program, but are not Forensic outpatients

Primary outcomes:
measure: Patient Self-Report Measure (Client Coercion Survey)
timeFrame: This study will employ a crossover design where data is collected for 12 months during the study and compared to baseline data retrieved for 12 months for each patient before enrollment into the project.
Secondary outcomes:
measure: Stakeholder survey
timeFrame: This study will employ a crossover design where data is collected for 12 months during the study and compared to baseline data retrieved for 12 months for each patient before enrollment into the project.
measure: Client Satisfaction Measure
timeFrame: This study will employ a crossover design where data is collected for 12 months during the study and compared to baseline data retrieved for 12 months for each patient before enrollment into the project.
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
Study officials:
affiliation: University of Manitoba
name: Jeffrey Waldman, MD
role: PRINCIPAL_INVESTIGATOR
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