퇴역군인의 약물유전학을 이용한 맞춤형 약물요법 (PGx)
정신 건강 치료를 원하는 퇴역군인에게 약물유전학을 사용한 맞춤형 약물요법
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Natalie Ein, PhD
- 전화번호: 416-573-9047
- 이메일: natalie.ein@sjhc.london.on.ca
연구 장소
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Ontario
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London, Ontario, 캐나다, N6C 0A7
- 모병
- MacDonald Franklin OSI Research and Innovation Centre
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연락하다:
- Natalie Ein, PhD
- 전화번호: 416-573-9047
- 이메일: natalie.ein@sjhc.london.on.ca
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
간섭 없음: Mental Health Provider
Mental health provider's thoughts on pharmacogenetic testing for treatment planning and changes to treatment planning. |
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실험적: 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. |
|
간섭 없음: Patient without Pharmacogenetic Testing
For patient participants who opt-out to pharmacogenetic testing will be followed to see if treatment course is maintained. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
PHQ-9 - Patient Health Questionnaire 9
기간: 5 minutes
|
Objectifies degree of depression severity |
5 minutes
|
|
GAD-7 - General Anxiety Disorder-7
기간: 5 minutes
|
Measures severity of anxiety |
5 minutes
|
|
PCL-5 - Posttraumatic Stress Disorder Checklist - 5
기간: 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
기간: 10 minutes
|
A 45-item multiple-choice self-report inventory used to measure psychotherapy progress in adult patients |
10 minutes
|
|
Pharmacological Side Effect Measure
기간: 10 minutes
|
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
기간: 10 minutes
|
To determine trial and error attempts with pharmacological prescriptions in an attempt to minimize and/or control symptoms |
10 minutes
|
공동 작업자 및 조사자
스폰서
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 119245
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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