NCT04410575

Mental Health Assessment and Prescribing by Alberta Pharmacists

Mental Health Assessment and Prescribing by Alberta Pharmacists (MAP-AP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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)

Conditions

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Pharmacist-Patient Relations

Interventions

Type	Name	Description
OTHER	Standard Pharmacist Care	Standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians)
OTHER	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
OTHER	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
OTHER	Psychotherapy Referral	Pharmacist initiates collaboration with physician to arrange referral for psychotherapy, including: psychologist, social worker, counsellor, psychiatrist
OTHER	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)
OTHER	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
OTHER	Medication Counselling and Educational Support	Pharmacist provides medication related counselling and educational support to participant
OTHER	Non-medication Counselling	Pharmacist provides non-medication related counselling and educational support to participant
OTHER	Identification of drug interaction	Pharmacist identification of drug interaction related to medication for major depressive disorder and/or generalized anxiety
OTHER	Identification of drug adverse effect	Pharmacist identification of adverse effect related to medication for major depressive disorder and/or generalized anxiety
OTHER	Identification of severe deterioration	Pharmacist identification of participant severe deterioration (i.e. suicide attempt)
OTHER	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
OTHER	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

Timeline

• Start date: 2023-03-22
• Primary completion: 2025-03-31
• Completion: 2025-05-31
• First posted: 2020-06-01
• Last updated: 2025-07-04

Locations

1 site across 1 country: Canada