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| Name | Class |
|---|---|
| University of Calgary | OTHER |
| Shared Health Manitoba | UNKNOWN |
| Winnipeg Regional Health Authority | OTHER |
| Health Sciences Centre, Winnipeg, Manitoba |
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Investigate the feasibility and utility of implementing pharmacogenetic testing for adults (aged 18 and older) seeking care for mental illness in Manitoba.
Background and Rationale: Pharmacogenomic (PGx) testing utilizes genetic information as a surrogate marker of a person's ability to process and react to drugs. This information can be used to inform medication selection and dosing, reducing the number of trials needed to choose a suitable medicine. For Manitoba healthcare providers, the only access to psychiatric PGx testing is through commercial providers, costing patients $200 to $2,300. To the best of our knowledge, no study in Manitoba has previously evaluated the feasibility of PGx testing in adult patients seeking care for mental illness.
RESEARCH OBJECTIVES: We aim to investigate the feasibility and utility of implementing PGx testing in Manitoba for adult patients seeking care for mental illness.
Primary Outcome and Measures: Feasibility will be measured along four dimensions:
Secondary Outcomes and Measures:
Expected Outcomes: The findings from the proposed study will inform policymakers and facilitate decision-making and priority-setting related to implementing PGx-based psychotropic prescribing policies in Manitoba](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacogenetic Testing | Experimental | Pharmacogenetic testing panel (CYP2C19, CYP2D6, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP4F2, DPYD, HLA-A, HLA-B, NUDT15, SLCO1B1, TPMT, VKORC1, 2C Cluster, UGT1A1) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacogenetic Testing | Diagnostic Test | Participants will donate a 1ml (one-fifth of a teaspoon) sample of saliva. DNA extracted from the saliva sample will be used for genotyping. Genotyping results will be translated into an interpretative clinical report using evidence-based software (Sequence2Script) and delivered to the treating physician for use in their clinical decision-making. The report will contain genotyping results, predicted phenotype, and evidence-based drug selection and dosing recommendations relevant to the patient's current and future care. |
| Measure | Description | Time Frame |
|---|---|---|
| Testing Acceptibility | Acceptability will be measured via a four-item patient satisfaction survey three months after the testing and a two-item clinician satisfaction survey after discharge. Responses will be recorded on a five-point Likert scale (1 = very dissatisfied to 5 = very satisfied). | 3 months after after baseline. |
| Implementation Practicality | Practicality will be measured by the mean and median testing turnaround time (i.e., test ordering to return of results). | Up to 3 Months |
| Implementation Feasibility | Implementation will be measured using a two-item clinician self-report questionnaire that asks about using testing results in the prescribing decision-making process. These will be Yes/No questions, with more "yes" responses indicating higher usefulness and interest in using the test in clinical practice. | Patient discharge date [within 3 months of baseline]. |
| Test Demands | Demand will be measured by the total number of referrals to the study and by a one-item clinician self-report questionnaire asking about intent to use the testing in the future. Responses will be recorded on a five-point Likert scale (1 = very unlikely to 5 = very likely). | Patient discharge date [within 3 months of baseline]. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Scale (CGI) - Severity | 1 = normal, 7 = among the most extremely ill | Baseline |
| Clinical Global Impression Scale (CGI) - Improvement | Assesses the overall change in the patient's condition compared to baseline, on a 7-point scale (1 = very much improved, 7 = very much worse). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdullah Al Maruf, BPharm, MPharm, PhD | Contact | 204-318-2575 | abdullah.maruf@umanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Abdullah Al Maruf, PhD, M.Pharm., B.Pharm | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shared Health Facilities | Not yet recruiting | Winnipeg | Manitoba | R3C 3H8 | Canada |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D000092862 | Psychological Well-Being |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000071185 | Pharmacogenomic Testing |
| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| OTHER |
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|
| 3 months after baseline. |
| Brief Psychiatric Rating Scale (BPRS) | The rater enters a number for each symptom construct, ranging from 1 (not present) to 7 (extremely severe). | Baseline and patient discharge date, within 3 months. |
| DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult | This adult version of the measure consists of 23 questions that assess 13 psychiatric domains, including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use. Each item on the measure is rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day). | Baseline and 3 months after baseline. |
| General Anxiety Disorder-7 (GAD-7) | This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety | Baseline and 3 months after baseline. |
| Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 asks patients about the frequency with which they have experienced certain symptoms over the past two weeks, using a four-point scale (0 = "not at all" to 3 = "nearly every day"). The total score, ranging from 0 to 27, indicates the severity of depression, with higher scores suggesting more severe symptoms. Scoring: 0-4: Minimal or no symptoms 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20 or higher: Severe depression | Baseline and 3 months after baseline. |
| Altman Self-Rating Mania Scale (ASRM) - Adult | Each item on the measure is rated on a 5-point scale (i.e., 1 to 5) with the response categories having different anchors depending on the item. The ASRM score range from 5 to 25 with higher scores indicating greater severity of manic symptoms. | Baseline and 3 months after baseline. |
| The Early Psychosis Screener (EPS-26) | The EPS-26 consists of 26 questions that assess for symptoms and experiences associated with psychosis. A higher score on the EPS-26 suggests a greater likelihood of being at risk for psychosis. | Baseline and 3 months after baseline. |
| Frequency, Intensity, Burden of Side Effects Rating (FIBSER) | It measures three dimensions: the frequency of side effects, the intensity of these side effects, and the burden they impose on daily functioning. Each dimension is rated on a Likert scale, ranging from 0 to 6, where higher scores indicate greater severity and difficulty caused by side effects. | Baseline (if applicable) and 3 months after baseline. |
| Healthcare Utlization | Changes in healthcare utilization (including inpatient length of stay) will be measured using a ten-item patient self-report mental health resource use questionnaire, medical charts, and administrative data records six months before and after the participant enrolled in the study. | 1 year |
| University of Manitoba College of Pharmacy | Recruiting | Winnipeg | Manitoba | R3E 0T5 | Canada |
|
| D019967 |
| Schizophrenia Spectrum and Other Psychotic Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |