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

University of Alberta

Status: Enrolling

Conditions: Major Depressive Disorder; Pharmacist-Patient Relations; Generalized Anxiety Disorder

Treatments: Other: Psychotherapy Referral; Other: Pharmacist initiated interim telephone follow-up with participant; Other: Identification of drug interaction; Other: Identification of drug adverse effect; Other: Reviewed Questionnaire tool results with participant; Other: Standard Pharmacist Care; Other: Identification of severe deterioration; Other: Patient Clinical Assessment; Other: Communication update with physician after participant contact; 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; Other: Medication Counselling and Educational Support; Other: Non-medication Counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT04410575

REB ID Pro00093776

Details and patient eligibility

About

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).

Full 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)

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

Experimental group

Description:

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

Treatment:

Other: Non-medication Counselling

Other: Medication Counselling and Educational Support

Other: Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribing

Other: Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing

Other: Communication update with physician after participant contact

Other: Patient Clinical Assessment

Other: Identification of severe deterioration

Other: Standard Pharmacist Care

Other: Reviewed Questionnaire tool results with participant

Other: Identification of drug adverse effect

Other: Identification of drug interaction

Other: Pharmacist initiated interim telephone follow-up with participant

Other: Psychotherapy Referral

Control Group (Standard Pharmacist Care)

Active Comparator group

Description:

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

Treatment:

Other: Non-medication Counselling

Other: Medication Counselling and Educational Support

Other: Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing

Other: Identification of severe deterioration

Other: Standard Pharmacist Care

Other: Identification of drug adverse effect

Other: Identification of drug interaction