Overview
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)
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