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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04410575
Other study ID # REB ID Pro00093776
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 22, 2023
Est. completion date December 30, 2024

Study information

Verified date January 2024
Source University of Alberta
Contact Yazid Al Hamarneh, BSc (Pharm), PhD, CDM
Phone (780) 492-9608
Email yazid.alhamarneh@ualberta.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a clinical trial evaluating the experimental intervention of enhanced pharmacist care by pharmacists with additional prescribing authorization (APA) in Alberta, for patients newly diagnosed with Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD).


Description:

Primary objective -To evaluate the effect of enhanced pharmacist care possible by community pharmacists with APA in comparison with usual care (standard pharmacist care and physician care) for patients with MDD and/or GAD initiated on pharmacotherapy, with focus on interventions that include: i) monitoring (lab ordering and interpretation, clinical monitoring of MDD and GAD) ii) patient education iii) referral facilitation (in collaboration with prescribing physician) iv) prescribing (dose adjustment and the addition of adjunctive medication) Secondary objectives - To evaluate the effect of APA pharmacist interventions on: i)Clinical: - The rate of achieving clinical response and remission of MDD and/or GAD compared to usual care (using PHQ-9/GAD-7) - Change in the mean PHQ-9 and GAD-7 score - Cognitive and functional impairment related to MDD and/or GAD - The occurrence of relapse of depression and/or anxiety - The proportion of patients receiving appropriate and optimized depression and anxiety medication - Patient complaints and/or experiences of medication-related side effects during treatment for MDD and/or GAD (i.e. GI intolerance, dizziness, weight gain) ii) Process: - The impact of the interventions on patient satisfaction and quality of life impact (Patient survey) - Assure sustainability by exploring enabling (i.e. pharmacist reimbursement framework) and potential barrier forces (i.e. pharmacist training in managing patients with MDD and GAD)


Recruitment information / eligibility

Status Recruiting
Enrollment 94
Est. completion date December 30, 2024
Est. primary completion date September 22, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Adults (= 18 years of age) newly diagnosed with MDD and/or GAD, including: - Patients starting on medications for the management of adults with MDD - Patients starting on medications for the management of GAD Exclusion Criteria: - Pregnancy - Non-Alberta residents - Unwilling or unable to participate in regular follow-up visits - Unwilling to participate/sign consent form - =2 suicide attempts per year - Severe, psychotic, and catatonic depression - History of and/or current substance abuse, intoxication, addiction or withdrawal - Patients diagnosed with comorbid anxiety disorders other than GAD, including: panic -disorder, agoraphobia, specific phobia, social anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder - Patients diagnosed with comorbid depressive disorder other than MDD, including: depressive disorder due to another medical condition (e.g. hypothyroidism, MS, OSA, -Parkinsons, stroke, TBI, Vitamin B12 insufficiency, Huntington disease, adrenal insufficiency, mononucleosis, systemic lupus erythematosus), adjustment disorder with depressed mood - Patients diagnosed with concurrent ADHD, bipolar disorder, schizophrenia and schizoaffective disorder

Study Design


Intervention

Other:
Standard Pharmacist Care
Standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians)
Reviewed Questionnaire tool results with participant
Pharmacist reviews results of the patient-administered PHQ-9 and/or GAD-7 questionnaire tool, at the scheduled follow-up appointment
Patient Clinical Assessment
Pharmacist conducts clinical assessment of the participant's major depressive disorder and/or generalized anxiety, which can include: appearance, current mood, sleeping patterns, mental health, medical history, social history, family history, relationship with others, suicidal ideation, previous suicide attempts or hospitalizations, current employment status
Psychotherapy Referral
Pharmacist initiates collaboration with physician to arrange referral for psychotherapy, including: psychologist, social worker, counsellor, psychiatrist
Pharmacist initiated interim telephone follow-up with participant
Interim telephone follow-up conducted by the pharmacist since the last in-person follow-up & a minimum of 1-2 weeks after the last in-person follow-up that involved a dose adjustment, prescribing of adjunctive medication, or discontinuation of therapy (Note: a telephone follow-up does not replace the scheduled in-person follow-up)
Communication update with physician after participant contact
Pharmacist provides communication update (fax or electronic charting) with the participant's physician after contact with the participant
Medication Counselling and Educational Support
Pharmacist provides medication related counselling and educational support to participant
Non-medication Counselling
Pharmacist provides non-medication related counselling and educational support to participant
Identification of drug interaction
Pharmacist identification of drug interaction related to medication for major depressive disorder and/or generalized anxiety
Identification of drug adverse effect
Pharmacist identification of adverse effect related to medication for major depressive disorder and/or generalized anxiety
Identification of severe deterioration
Pharmacist identification of participant severe deterioration (i.e. suicide attempt)
Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing
Pharmacist collaborates, discusses, and makes recommendations to physician re: treatment plan for MDD and/or GAD (as per CANMAT guidelines), which can include: medication dose adjustment, change to alternative medication, add-on, or deprescribing
Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribing
Pharmacist initiated alteration to treatment plan for MDD and/or GAD (as per CANMAT guidelines), which can include: medication dose adjustment, change to alternative medication, add-on, or deprescribing

Locations

Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean score difference in Patient Health Questionnaire 9-item (PHQ-9) score Mean score difference in PHQ-9 score from baseline to end of study between intervention (pharmacist intervention + standard pharmacist care) group vs control (standard pharmacist care) group;
PHQ-9 scores reflect depression severity, ranges from 0-27 (Scores: 0-4 none/minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe)
6 months
Primary Mean score difference in Generalized Anxiety Disorder 7-item (GAD-7) score Mean score difference in GAD-7 score from baseline to end of study between intervention (pharmacist intervention + standard pharmacist care) group vs control (standard pharmacist care) group;
GAD-7 scores reflect anxiety severity; Ranges from 0-21 (Scores: 0-4 none/minimal. 5-9 mild, 10-14 moderate, 15-21 severe)
6 months
Secondary Difference in proportion of participants achieving clinically significant treatment response in Patient Health Questionnaire 9-item (PHQ-9) score between pharmacist intervention vs. standard pharmacist care Clinically significant treatment response for the PHQ-9 is defined as a reduction in PHQ-9 score by at least 50% from baseline;
PHQ-9 Scores reflect depression severity, ranges from 0-27 (Scores: 0-4 none/minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe)
6 months
Secondary Difference in proportion of participants achieving clinically significant treatment response in Generalized Anxiety Disorder 7-item (GAD-7) score between pharmacist intervention vs. standard pharmacist care Clinically significant treatment response for the GAD-7 is defined as a reduction in GAD-7 score by at least 50% from baseline;
GAD-7 scores reflect anxiety severity; Ranges from 0-21 (Scores: 0-4 none/minimal. 5-9 mild, 10-14 moderate, 15-21 severe)
6 months
Secondary Difference in the proportion of participants with Major Depressive Disorder (MDD) to achieve Patient Health Questionnaire 9-item (PHQ-9) score <5 Difference in the proportion of participants with MDD to achieve PHQ-9 score <5 (i.e. remission/no depression) between the pharmacist intervention and standard pharmacist care groups
PHQ-9 scores reflect depression severity; Ranges from 0-27 (Scores: 0-4 none/minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe)
6 months
Secondary Difference in the proportion of participants with Generalized Anxiety Disorder (GAD) to achieve Generalized Anxiety Disorder 7-item (GAD-7) score <5 Difference in the proportion of participants with GAD to achieve GAD-7 score <5 (i.e. remission/no anxiety) between the pharmacist intervention and standard pharmacist care groups;
GAD-7 scores reflect anxiety severity; Ranges from 0-21 (Scores: 0-4 none/minimal. 5-9 mild, 10-14 moderate, 15-21 severe)
6 months
Secondary Percentage difference in self-reported safety concerns disclosed by participant to pharmacist partner, between intervention (pharmacist intervention + standard pharmacist care) and control (standard pharmacist care) study groups, during the study period. The participant discloses to the pharmacist partner at any time during the duration of study, events that fit the description of a safety concern and measured via frequency of occurrence.
Safety concerns include:
1) Adverse Medication Effects 2) Suicide Ideation/attempt, 3) Causing withdrawal from Study
6 months
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