Medication AdherenceNCT03766503
Daily Delivery and Supervision of Psychotropic Medication for High-Risk Patients With Severe/Persistent Mental Illness
A study testing Daily in people with Medication Adherence, run by University of Manitoba at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2016to 11 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals who are not currently in the Forensics program
- Individuals who are part of the daily dispensing program, but are not Forensic outpatients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Daily Delivery and Supervision of Psychotropic Medication for High-Risk Patients With Severe and Persistent Mental Illness
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.
Read the 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.
- Conditions
- Medication Adherence
- Being tested
- Daily
- Keywords
- Medication adherence, Severe and persistent mental illness
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DailyOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The researchers will engage key stakeholders during the project (e.g., community mental health workers, psychiatrists, pharmacists) to gather information and suggestions regarding the Daily Dispensing program. Based on feedback stakeholders, the researchers will then aim to implement improvements to the program to optimize its effectiveness. The survey uses a 5 point Likert scale and items are scored from 1 to 5 (and the negative questions items 8, 10, 12 are reverse scored) with lower scores indicating better outcomes. The scale contains 11 items that can be summed (items: 3-12, 15) - the maximum score for this scale is 55 (5 x 11 items) and the minimum score is 11 (1 x 11 items). The Stakeholder Survey has no subscales. The survey also features 7 descriptive items (items: 1, 2, 13, 14, 16-19) and these will be reported.
Measured: 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
The survey measures clients' satisfaction regarding program and consists of several domains but no real subscales: accessibility, availability of resources, continuity of care, outcome of care, humanness of program staff, information gathering, information giving, pleasantness of surroundings, competence of staff, and quality of program. The survey was further modified by the Daily Dispensing team. The survey uses a 5 point Likert scale and items are scored from 1 to 5 with lower scores indicating better outcomes. There are no reverse scored items. The scale contains 26 items that can be summed - the maximum score for the Client Satisfaction Scale is 130 (5 x 26 items) and the minimum score is 26 (1 x 26 items). Items 27-29 are descriptive and these will be reported.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start15 Oct 2016
- Primary completion30 Dec 2018
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Winnipeg Regional Health Authority
- Responsible party
- Sponsor
- Investigators
- Jeffrey Waldman, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766503
- Sponsor's protocol ID
- H2016:321
- Status last verified
- Jun 2020
- First submitted
- 3 May 2018
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All patient personal health information: Personal Health Information Number (PHIN), name and date of birth will be stored in a secured database (REDCAP) for the duration of the project. Analysis will be done on aggregate data only stripped from personal health identifiers. Database will be archived in REDCAP with access only by authorized individuals.
Publications
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.
PubMed 23277247Goeree 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.
PubMed 16368053Keers 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.
PubMed 24220644Patel 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.
PubMed 19304865Patel 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.
PubMed 19192437Rossler 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.
PubMed 15925493Schooler NR. Relapse prevention and recovery in the treatment of schizophrenia. J Clin Psychiatry. 2006;67 Suppl 5:19-23.
PubMed 16822093Thornicroft 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.
PubMed 19162314Angermeyer 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.
PubMed 15954207
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Delivery and Supervision of Psychotropic Medication for High-Risk Patients With Severe and Persistent Mental Illness
- ClinicalTrials.gov ID
- NCT03766503
- Acronym / sponsor ID
- H2016:321
- Conditions
- Medication Adherence
- Keywords
- Medication adherence, Severe and persistent mental illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Winnipeg Regional Health Authority
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: DailyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals who are not currently in the Forensics program
- Individuals who are part of the daily dispensing program, but are not Forensic outpatients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DailyThe 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 | Intervention |
Primary outcome
Patient Self-Report Measure (Client Coercion Survey)
Time frame: 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.
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.
2 secondary outcomes
Stakeholder survey
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Background: PubMed 23277247Emsley 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.
- Background: PubMed 16368053Goeree 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.
- Background: PubMed 24220644Keers 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.
- Background: PubMed 19304865Patel 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.
- Background: PubMed 19192437Patel 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.
- Background: PubMed 15925493Rossler 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.
- Background: PubMed 16822093Schooler NR. Relapse prevention and recovery in the treatment of schizophrenia. J Clin Psychiatry. 2006;67 Suppl 5:19-23.
- Background: PubMed 19162314Thornicroft 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.
- Results publication: PubMed 15954207Angermeyer 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.
- Individual participant dataSharing planned: Yes. All patient personal health information: Personal Health Information Number (PHIN), name and date of birth will be stored in a secured database (REDCAP) for the duration of the project. Analysis will be done on aggregate data only stripped from personal health identifiers. Database will be archived in REDCAP with access only by authorized individuals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Waldman, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily in people with Medication Adherence, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Self-Report Measure (Client Coercion Survey) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03766503, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.