Mental Health Assessment and Prescribing by Alberta Pharmacists

Not Applicable

Recruiting

• Conditions: Major Depressive Disorder; Generalized Anxiety Disorder; Pharmacist-Patient Relations
• Interventions: Other: Standard Pharmacist Care; Other: Reviewed Questionnaire tool results with participant; Other: Medication Counselling and Educational Support; Other: Patient Clinical Assessment; Other: Non-medication Counselling; Other: Psychotherapy Referral; Other: Pharmacist initiated interim telephone follow-up with participant; Other: Identification of drug adverse effect; Other: Communication update with physician after participant contact; Other: Identification of drug interaction; 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

• Registration Number: NCT04410575
• Lead Sponsor: University of Alberta

Brief 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)

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-01
• Study Start: 2023-03-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-09-22
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)	Pharmacist initiated interim telephone follow-up with participant	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
Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)	Reviewed Questionnaire tool results with participant	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
Control Group (Standard Pharmacist Care)	Identification of drug adverse effect	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
Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)	Identification of drug interaction	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
Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)	Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing	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
Control Group (Standard Pharmacist Care)	Medication Counselling and Educational Support	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
Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)	Patient Clinical Assessment	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
Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)	Psychotherapy Referral	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
Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)	Communication update with physician after participant contact	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
Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)	Standard Pharmacist Care	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
Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)	Identification of drug adverse effect	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
Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)	Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribing	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
Control Group (Standard Pharmacist Care)	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
Control Group (Standard Pharmacist Care)	Non-medication Counselling	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
Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)	Medication Counselling and Educational Support	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
Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)	Non-medication Counselling	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
Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)	Identification of severe deterioration	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
Control Group (Standard Pharmacist Care)	Identification of severe deterioration	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
Control Group (Standard Pharmacist Care)	Identification of drug interaction	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
Control Group (Standard Pharmacist Care)	Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing	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

Primary Outcome Measures

Name	Time	Method
Mean score difference in Patient Health Questionnaire 9-item (PHQ-9) score	6 months	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)
Mean score difference in Generalized Anxiety Disorder 7-item (GAD-7) score	6 months	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)

Secondary Outcome Measures

Name	Time	Method
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	6 months	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)
Difference in the proportion of participants with Major Depressive Disorder (MDD) to achieve Patient Health Questionnaire 9-item (PHQ-9) score <5	6 months	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)
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.	6 months	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
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	6 months	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)
Difference in the proportion of participants with Generalized Anxiety Disorder (GAD) to achieve Generalized Anxiety Disorder 7-item (GAD-7) score <5	6 months	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)

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada