Daily Delivery and Supervision of Psychotropic Medication for High-Risk Patients With Severe/Persistent Mental Illness

NCT03766503 | Completed

• 1 other identifier: H2016:321
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence

Keywords

Medication adherence; Severe and persistent mental illness

Outcome Measures

Primary Outcomes (1)

• Patient Self-Report Measure (Client Coercion Survey)

  The questionnaire asks about the client's perceptions of care which will help measure the effectiveness of the study's recovery intervention (Daily Dispensing program) by evaluating patient response to the program through this self-reported measure. The measure is composed of three subscales: Perceived Coercion (items scored as False=1; True/Don't Know=0); Negative Pressures (items scored as False=1; True/Don't Know=0; except item 12 is reverse scored); Voice (items scored as False=1; True/Don't Know=0; except item 13 which is reverse scored). The Perceived Coercion subscale ranges from 0 (minimum score) to 5 (maximum score) and lower values reflect better outcomes; the Negative Pressures subscale ranges from 0 (minimum score) to 6 (maximum score) and higher values reflect better outcomes; the Voice subscale ranges from 0 (minimum score) to 3 (maximum score) and lower values reflect better outcomes. The subscales will not be combined to compute a total score.

  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 (2)

• Stakeholder survey

  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.

• Client Satisfaction Measure

  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.

Study Arms (1)

Intervention

OTHER

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.

Other: Daily

Interventions

Daily OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead
• Winnipeg Regional Health Authority: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Canada

Location

Related Publications (9)

• Emsley R, Oosthuizen P, Koen L, Niehaus D, Martinez L. Comparison of treatment response in second-episode versus first-episode schizophrenia. J Clin Psychopharmacol. 2013 Feb;33(1):80-3. doi: 10.1097/JCP.0b013e31827bfcc1.

  PMID: 23277247 BACKGROUND

• Goeree R, Farahati F, Burke N, Blackhouse G, O'Reilly D, Pyne J, Tarride JE. The economic burden of schizophrenia in Canada in 2004. Curr Med Res Opin. 2005 Dec;21(12):2017-28. doi: 10.1185/030079905X75087.

  PMID: 16368053 BACKGROUND

• Keers R, Ullrich S, Destavola BL, Coid JW. Association of violence with emergence of persecutory delusions in untreated schizophrenia. Am J Psychiatry. 2014 Mar;171(3):332-9. doi: 10.1176/appi.ajp.2013.13010134.

  PMID: 24220644 BACKGROUND

• Patel MX, de Zoysa N, Bernadt M, Bindman J, David AS. Are depot antipsychotics more coercive than tablets? The patient's perspective. J Psychopharmacol. 2010 Oct;24(10):1483-9. doi: 10.1177/0269881109103133. Epub 2009 Mar 20.

  PMID: 19304865 BACKGROUND

• Patel MX, de Zoysa N, Bernadt M, David AS. A cross-sectional study of patients' perspectives on adherence to antipsychotic medication: depot versus oral. J Clin Psychiatry. 2008 Oct;69(10):1548-56. doi: 10.4088/jcp.v69n1004. Epub 2008 Sep 23.

  PMID: 19192437 BACKGROUND

• Rossler W, Salize HJ, van Os J, Riecher-Rossler A. Size of burden of schizophrenia and psychotic disorders. Eur Neuropsychopharmacol. 2005 Aug;15(4):399-409. doi: 10.1016/j.euroneuro.2005.04.009.

  PMID: 15925493 BACKGROUND

• Schooler NR. Relapse prevention and recovery in the treatment of schizophrenia. J Clin Psychiatry. 2006;67 Suppl 5:19-23.

  PMID: 16822093 BACKGROUND

• Thornicroft G, Brohan E, Rose D, Sartorius N, Leese M; INDIGO Study Group. Global pattern of experienced and anticipated discrimination against people with schizophrenia: a cross-sectional survey. Lancet. 2009 Jan 31;373(9661):408-15. doi: 10.1016/S0140-6736(08)61817-6. Epub 2009 Jan 21.

  PMID: 19162314 BACKGROUND

• Angermeyer MC, Matschinger H. The stereotype of schizophrenia and its impact on discrimination against people with schizophrenia: results from a representative survey in Germany. Schizophr Bull. 2004;30(4):1049-61. doi: 10.1093/oxfordjournals.schbul.a007120.

  PMID: 15954207 RESULT

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jeffrey Waldman, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: December 6, 2018
• Study Start: October 15, 2016
• Primary Completion: December 30, 2018
• Study Completion: February 11, 2019
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be collected over a span of 12 months and be retained for seven years.
• Access Criteria: Only authorized project staff will have access to patient medical information. Aggregate data will be made available for sharing with other organizations.

Locations

CA (1)