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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Generalized Anxiety Disorder; Major Depressive Disorder; Pharmacist-Patient Relations
• Intervention / Treatment: Other: Standard Pharmacist Care; Other: Reviewed Questionnaire tool results with participant; Other: Patient Clinical Assessment; Other: Psychotherapy Referral; Other: Pharmacist initiated interim telephone follow-up with participant; Other: Communication update with physician after participant contact; Other: Medication Counselling and Educational Support; Other: Non-medication Counselling; Other: Identification of drug interaction; Other: Identification of drug adverse effect; Other: Identification of severe deterioration; Other: Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing; Other: Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribing

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)

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yazid Al Hamarneh, BSc (Pharm), PhD, CDM; Phone Number: (780) 492-9608; Email: Yazid.Alhamarneh@ualberta.ca
• Study Contact Backup: Name: Matthew Chow, BSc Pharm, PharmD; Phone Number: (587) 999-0778; Email: mchow1@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2R3
      • Recruiting
      • University of Alberta
      • Contact: Yazid Al Hamarneh, BSc (Pharm), PhD, CDM; Phone Number: (780) 492-9608; Email: Yazid.Alhamarneh@ualberta.ca
      • Contact: Matthew Chow, BScPharm, PharmD; Phone Number: (587)999-0778; Email: mchow1@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions); Participants enrolled in the intervention group will receive pharmacist interventions, in addition to standard care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians), at enrollment (month 0) and at 1, 3, and 6 month in-person follow-up appointments	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
Active Comparator: Control Group (Standard Pharmacist Care); Patients randomized to the usual care group will receive standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians) and physician care, at enrollment (month 0) with no specific interventions for the duration of 6 months, until the 6 month in-person follow-up appointment	Other: Standard Pharmacist Care; Standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Yazid Al Hamarneh, BSc (Pharm), PhD, CDM, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Estimated): September 22, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Mental Health; Generalized Anxiety Disorder; Intervention; Major Depressive Disorder; Pharmacist; Prescribing; Expanded Scope
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders; Depressive Disorder, Major
• Other Study ID Numbers: REB ID Pro00093776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No