Mental Health Assessment and Prescribing by Alberta Pharmacists

Major Depressive Disorder Clinical Trial

— MAP-AP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04410575
• Other study ID #: REB ID Pro00093776
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Generalized Anxiety Disorder
• Major Depressive Disorder
• Pharmacist-Patient Relations

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