Clinical trial NCT04410575: Mental Health Assessment and Prescribing by Alberta Pharmacists
Official title: Mental Health Assessment and Prescribing by Alberta Pharmacists (MAP-AP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Generalized Anxiety Disorder
Pharmacist-Patient Relations
Keywords: Pharmacist
Prescribing
Major Depressive Disorder
Generalized Anxiety Disorder
Mental Health
Intervention
Expanded Scope
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center randomized control trial evaluating the mean difference in depression and anxiety score with patients with major depressive disorder (MDD) and/or generalized anxiety disorder (GAD) by pharmacists with prescribing \& management interventions in comparison to pharmacist management per standard pharmacist care.
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Mean score difference in Patient Health Questionnaire 9-item (PHQ-9) score
timeFrame: 6 months
measure: Mean score difference in Generalized Anxiety Disorder 7-item (GAD-7) score
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: Difference in the proportion of participants with Major Depressive Disorder (MDD) to achieve Patient Health Questionnaire 9-item (PHQ-9) score <5
timeFrame: 6 months
measure: Difference in the proportion of participants with Generalized Anxiety Disorder (GAD) to achieve Generalized Anxiety Disorder 7-item (GAD-7) score <5
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Yazid Al Hamarneh, BSc (Pharm), PhD, CDM
role: PRINCIPAL_INVESTIGATOR
References: