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).
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
13
Standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians)
Pharmacist reviews results of the patient-administered PHQ-9 and/or GAD-7 questionnaire tool, at the scheduled follow-up appointment
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
University of Alberta
Edmonton, Alberta, Canada
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)
Time frame: 6 months
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)
Time frame: 6 months
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)
Time frame: 6 months
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)
Time frame: 6 months
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Pharmacist initiates collaboration with physician to arrange referral for psychotherapy, including: psychologist, social worker, counsellor, psychiatrist
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)
Pharmacist provides communication update (fax or electronic charting) with the participant's physician after contact with the participant
Pharmacist provides medication related counselling and educational support to participant
Pharmacist provides non-medication related counselling and educational support to participant
Pharmacist identification of drug interaction related to medication for major depressive disorder and/or generalized anxiety
Pharmacist identification of adverse effect related to medication for major depressive disorder and/or generalized anxiety
Pharmacist identification of participant severe deterioration (i.e. suicide attempt)
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 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
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)
Time frame: 6 months
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)
Time frame: 6 months
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
Time frame: 6 months