Mental Health Assessment and Prescribing by Alberta Pharmacists

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).

Full Title of Study: “Mental Health Assessment and Prescribing by Alberta Pharmacists (MAP-AP)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 31, 2022

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)

Interventions

  • Other: Patient Assessment
    • Recording participant scores from the combined PHQ-9/GAD-7/BC-CCI/SDS questionnaire tool completed by the participant & uf determined clinically relevant by the pharmacist partner: appearance, current mood, sleeping patterns, mental health, medical history, social history, family history, relationships with others, suicidal ideation, previous suicide attempts or hospitalizations, current employment status
  • Other: Collaboration and discussion with the patient’s physician
    • Pharmacist partner initiates discussion with physician re: treatment plan (as per CANMAT guidelines) for MDD and GAD, which may include referral to psychotherapy resources (i.e. psychologist).
  • Other: Prescription dose adjustment and/or prescribing adjunctive therapy
    • Prescribing action by pharmacist partner to achieve clinical response and/or remission of MDD and/or GAD and establish appropriate cognitive/functional status as per CAMAT guidelines
  • Other: Communication update with physician after participant contact
    • Pharmacist partner provides communication update with the patient’s family physician after each contact with the patient
  • Other: Medication Counselling and Educational Support
    • Pharmacist partner provides medication counselling and educational support in person during initial interview and follow up with patient
  • Other: Interim telephone follow-up
    • Interim telephone follow-up conducted by the pharmacist partner 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).
  • Other: Psychotherapy referral
    • Pharmacist partner collaborates with physician to arrange referral to psychologist/psychiatrist for psychotherapy
  • Other: Standard Pharmacist Care
    • Standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians)

Arms, Groups and Cohorts

  • Experimental: Intervention Group (Pharmacist Interventions)
    • 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 months 1, 3, and 6
  • Active Comparator: Control Group (Standard Pharmacist Care)
    • Patients randomized to the usual care groups will receive standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians) and physician care with no specific interventions for the duration of 6 months

Clinical Trial Outcome Measures

Primary Measures

  • Mean score difference in Patient Health Questionnaire 9-item (PHQ-9) score
    • Time Frame: 6 months
    • Mean score difference in PHQ-9 score from baseline to end of study between pharmacist intervention vs 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
    • Time Frame: 6 months
    • Mean score difference in GAD-7 score from baseline to end of study between pharmacist intervention vs 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 Measures

  • 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
    • Time Frame: 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 proportion of participants achieving clinically significant treatment response in Generalized Anxiety Disorder 7-item (GAD-7) score between pharmacist intervention vs. standard pharmacist care
    • Time Frame: 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 Major Depressive Disorder (MDD) to achieve Patient Health Questionnaire 9-item (PHQ-9) score <5
    • Time Frame: 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)
  • Difference in the proportion of participants with Generalized Anxiety Disorder (GAD) to achieve Generalized Anxiety Disorder 7-item (GAD-7) score <5
    • Time Frame: 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)
  • Difference in the proportion of participants with Major Depressive Disorder (MDD) and/or Generalized Anxiety Disorder (GAD) to achieve a British Columbia Cognitive Complaints Inventory (BC-CCI) score <5
    • Time Frame: 6 months
    • Difference in the proportion of participants with MDD and/or GAD to achieve BC-CCI score <5 between the pharmacist intervention and standard pharmacist care groups The BC-CCI consists of 6 items and scores reflect the severity of perceived cognitive difficulties; ranges from 0-18 (Scores: 0-4 broadly normal, 5-8 mild cognitive complaints, 9-14 moderate cognitive complaints, 15-18 Severe cognitive complaints)
  • Difference in the proportion of participants with Major Depressive Disorder (MDD) and/or Generalized Anxiety Disorder (GAD) to achieve Sheehan Disability Scale (SDS) score <5 on all subscales
    • Time Frame: 6 months
    • Difference in the proportion of participants with MDD and/or GAD to achieve SDS score <5 on all subscales between the pharmacist intervention and standard pharmacist care groups The SDS assess the severity of functional impairment in 3 domains: work/school, social, and family life. These 3 domains are measured using 10 point sub-scales that range from 0-10 and summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired); Any sub-scale indicating a score of >/= 5 are associated with significant functional impairment.
  • Percentage difference in self-reported safety concerns disclosed by participant to pharmacist partner, between pharmacist intervention and standard pharmacist care groups, during the study period.
    • Time Frame: 6 months
    • The participant discloses to the pharmacist partner at any time during the duration of study (or at time of withdrawal) 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) Withdrawal from Study

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Alberta
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yazid Al Hamarneh, BSc (Pharm), PhD, CDM, Principal Investigator, University of Alberta
  • Overall Contact(s)
    • Yazid Al Hamarneh, BSc (Pharm), PhD, CDM, (780) 492-9608, yazid.alhamarneh@ualberta.ca

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