Pharmacothérapie personnalisée utilisant la pharmacogénétique chez les vétérans (PGx)
Pharmacothérapie personnalisée utilisant la pharmacogénétique chez les vétérans cherchant un traitement pour la santé mentale
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.
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Natalie Ein, PhD
- Numéro de téléphone: 416-573-9047
- E-mail: natalie.ein@sjhc.london.on.ca
Lieux d'étude
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Ontario
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London, Ontario, Canada, N6C 0A7
- Recrutement
- MacDonald Franklin OSI Research and Innovation Centre
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Contact:
- Natalie Ein, PhD
- Numéro de téléphone: 416-573-9047
- E-mail: natalie.ein@sjhc.london.on.ca
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Mental Health Provider
Mental health provider's thoughts on pharmacogenetic testing for treatment planning and changes to treatment planning. |
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Expérimental: 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. |
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Aucune intervention: Patient without Pharmacogenetic Testing
For patient participants who opt-out to pharmacogenetic testing will be followed to see if treatment course is maintained. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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PHQ-9 - Patient Health Questionnaire 9
Délai: 5 minutes
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Objectifies degree of depression severity |
5 minutes
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GAD-7 - General Anxiety Disorder-7
Délai: 5 minutes
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Measures severity of anxiety |
5 minutes
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PCL-5 - Posttraumatic Stress Disorder Checklist - 5
Délai: 5 minutes
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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
Délai: 10 minutes
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A 45-item multiple-choice self-report inventory used to measure psychotherapy progress in adult patients |
10 minutes
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Pharmacological Side Effect Measure
Délai: 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
Délai: 10 minutes
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To determine trial and error attempts with pharmacological prescriptions in an attempt to minimize and/or control symptoms |
10 minutes
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 119245
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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