Gepersonaliseerde farmacotherapie met behulp van farmacogenetica bij veteranen (PGx)
Gepersonaliseerde farmacotherapie met behulp van farmacogenetica bij veteranen die behandeling zoeken voor de geestelijke gezondheid
This study is an observational clinical trial aimed at to evaluate the use of pharmacogenetic testing (PGx) for mental health treatment in members and Veterans of the CAF and RCMP patient population as well as the attitudes of both St. Joseph's OSI Clinic Psychiatrists and patients towards PGx. Both OSI Clinic Psychiatrists participants and patient participants will be administered a brief demographic survey in addition to a survey examining their views on, and current knowledge of PGx. Patient participants will have an opportunity to opt-in to or opt-out of receiving PGx. For patient participants who opt-in to PGx (PGx-guided treatment group), a report summarizing the PGx results will be sent to each patient participants' respective OSI Clinic Psychiatrist, alongside a questionnaire that captures the OSI Clinic Psychiatrist participant's treatment planning and changes to treatment planning. Where applicable, past treatment data from patient participants acquired at the St. Joseph's OSI Clinic will be used to identify the number of prior medication changes. Patient participants who opt-out of PGx but continue to receive pharmacologic care at the St. Joseph's OSI Clinic will act as a standard care comparator treatment group. Patient participant's outcomes including PTSD, depression and anxiety severity, and medication-related side effects, will be assessed until the patient participant is discharged from the OSI Clinic or after 24 weeks, whichever comes first. All patient participants, regardless of their study treatment group, will have their symptomatology collected via standard care data collection protocol (Client Reported Outcomes Monitoring Information System (CROMIS) and electronic medical records (EMR)); a self-report assessing the presence of side effects will be completed via Lawson REDCap. OSI Clinic Psychiatrist participants and patient participants will be asked to complete a virtual exit interview at the end of their participation.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Natalie Ein, PhD
- Telefoonnummer: 416-573-9047
- E-mail: natalie.ein@sjhc.london.on.ca
Studie Locaties
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Ontario
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London, Ontario, Canada, N6C 0A7
- Werving
- MacDonald Franklin OSI Research and Innovation Centre
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Contact:
- Natalie Ein, PhD
- Telefoonnummer: 416-573-9047
- E-mail: natalie.ein@sjhc.london.on.ca
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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Provider participant:
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Are at least 18 years of age;
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Speak and write English;
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Currently working as an OSI Clinic Psychiatrist at the London St. Joseph's OSI Clinic.
- Psychiatrist with an active caseload of patients being treated for OSIs.
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Patient participant:
- Veteran (patient) CAF or RCMP member;
- Are at least 18 years of age;
- Are a current patient at the London St. Joseph's OSI Clinic;
- Current diagnosis of an OSI;
- Speak and write English;
- Consents to the use of CROMIS data for the purpose of this study; and
- Consents to the use of prior OSI Clinic data for research purposes (if you have been a patient at the OSI Clinic prior to this study, the research team will use past OSI Clinic data to observe changes over time).
Exclusion Criteria:
- Participants (provider or patients) who are unable to, or do not, provide informed consent for participation.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Mental Health Provider
Mental health provider's thoughts on pharmacogenetic testing for treatment planning and changes to treatment planning. |
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Experimenteel: Patient with Pharmacogenetic Testing
For patient participants who opt-in to pharmacogenetic testing, a report summarizing the pharmacogenetic testing results will be sent to each patient participants' respective mental health provider. |
Genetic test to determine individual genetic compatibility with multiple pharmaceutical drug classes to determine best outcomes for prescription drug treatment. |
|
Geen tussenkomst: Patient without Pharmacogenetic Testing
For patient participants who opt-out to pharmacogenetic testing will be followed to see if treatment course is maintained. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
PHQ-9 - Patient Health Questionnaire 9
Tijdsspanne: 5 minutes
|
Objectifies degree of depression severity |
5 minutes
|
|
GAD-7 - General Anxiety Disorder-7
Tijdsspanne: 5 minutes
|
Measures severity of anxiety |
5 minutes
|
|
PCL-5 - Posttraumatic Stress Disorder Checklist - 5
Tijdsspanne: 5 minutes
|
A 20-item self-report tool that corresponds to the 20 symptoms listed in the DSM-V |
5 minutes
|
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OQ-45 - Outcome Questionnaire 45
Tijdsspanne: 10 minutes
|
A 45-item multiple-choice self-report inventory used to measure psychotherapy progress in adult patients |
10 minutes
|
|
Pharmacological Side Effect Measure
Tijdsspanne: 10 minutes
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To determine if the participant is experiencing any new or worsening or continuing side effects related to prescription medications |
10 minutes
|
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Electronic Medical Record Extraction Measure
Tijdsspanne: 10 minutes
|
To determine trial and error attempts with pharmacological prescriptions in an attempt to minimize and/or control symptoms |
10 minutes
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 119245
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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