Mental Health Assessment and Prescribing by Alberta Pharmacists (MAP-AP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Mean score difference in Patient Health Questionnaire 9-item (PHQ-9) score
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Stratified randomization of participants via blocking factor to either pharmacist intervention or standard pharmacist care groups.
Participants will be assigned a unique identifier number & group allocation for the duration of their participation in the study (also recorded by the pharmacy partner to ensure consistency in the delivery of pharmacist interventions described by the participant's group allocation.
The participant is sent a secured electronic link (to the contact number or email they provided in the written consent form) of the electronic version of the PHQ-9/GAD-7 questionnaire tool to complete.
The study data (from the participant's electronic questionnaire tool results) will be sent directly to a centralized & secured website/spreadsheet to ensure allocation concealment for the investigational team. The participant will report their score to the pharmacist participant through an electronic recording platform
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention Group (Standard Pharmacist Care + 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 1, 3, and 6 month in-person follow-up appointments
干预措施: Non-medication Counselling (Other)
Intervention Group (Standard Pharmacist Care + 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 1, 3, and 6 month in-person follow-up appointments
干预措施: Identification of drug interaction (Other)
Intervention Group (Standard Pharmacist Care + 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 1, 3, and 6 month in-person follow-up appointments
干预措施: Identification of drug adverse effect (Other)
Intervention Group (Standard Pharmacist Care + 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 1, 3, and 6 month in-person follow-up appointments
干预措施: Identification of severe deterioration (Other)
Control Group (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
干预措施: Identification of severe deterioration (Other)
Intervention Group (Standard Pharmacist Care + 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 1, 3, and 6 month in-person follow-up appointments
干预措施: Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing (Other)
Intervention Group (Standard Pharmacist Care + 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 1, 3, and 6 month in-person follow-up appointments
干预措施: Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribing (Other)
Control Group (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
干预措施: Standard Pharmacist Care (Other)
Control Group (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
干预措施: Medication Counselling and Educational Support (Other)
Control Group (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
干预措施: Non-medication Counselling (Other)
Control Group (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
干预措施: Identification of drug interaction (Other)
Control Group (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
干预措施: Identification of drug adverse effect (Other)
Intervention Group (Standard Pharmacist Care + 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 1, 3, and 6 month in-person follow-up appointments
干预措施: Medication Counselling and Educational Support (Other)
Intervention Group (Standard Pharmacist Care + 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 1, 3, and 6 month in-person follow-up appointments
干预措施: Standard Pharmacist Care (Other)
Intervention Group (Standard Pharmacist Care + 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 1, 3, and 6 month in-person follow-up appointments
干预措施: Reviewed Questionnaire tool results with participant (Other)
Intervention Group (Standard Pharmacist Care + 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 1, 3, and 6 month in-person follow-up appointments
干预措施: Patient Clinical Assessment (Other)
Intervention Group (Standard Pharmacist Care + 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 1, 3, and 6 month in-person follow-up appointments
干预措施: Psychotherapy Referral (Other)
Intervention Group (Standard Pharmacist Care + 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 1, 3, and 6 month in-person follow-up appointments
干预措施: Pharmacist initiated interim telephone follow-up with participant (Other)
Intervention Group (Standard Pharmacist Care + 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 1, 3, and 6 month in-person follow-up appointments
干预措施: Communication update with physician after participant contact (Other)
Control Group (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
干预措施: Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing (Other)
结局指标
主要结局
Mean score difference in Patient Health Questionnaire 9-item (PHQ-9) score
时间窗: 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
时间窗: 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)
次要结局
- 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)
- Difference in the proportion of participants with Major Depressive Disorder (MDD) to achieve Patient Health Questionnaire 9-item (PHQ-9) score <5(6 months)
- 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)
- 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)
- Difference in the proportion of participants with Generalized Anxiety Disorder (GAD) to achieve Generalized Anxiety Disorder 7-item (GAD-7) score <5(6 months)