Clinical trial NCT02768623: Evaluation of a Community Pharmacist Managed Asthma Consultation Service
Official title: Evaluation of a Community Pharmacist Managed Asthma Consultation Service
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncontrolled Asthma
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Asthma is one of the most common chronic health conditions, affecting 900,000 Ontarians, 2.4 million Canadians and over 300 million people worldwide. Unlike most other chronic diseases, asthma affects a significant proportion of children - an estimated 21% in Ontario. Asthma is also the leading cause of hospitalization for children in Canada and is a significant cause of school and work absenteeism. Though asthma is generally considered a chronic disease, it can be fatal in some instances - in 2009, an estimated 91 Ontarians died of this condition. Effective management of asthma can prevent exacerbation and more severe negative health consequences. In fact, estimates show that over 80% of the asthma-related deaths could be prevented through proper education. However, evidence also shows that over 55% of patients with moderate to severe asthma do not have their asthma symptoms under control, despite regular doctor visits. Less than a third (31%) of asthma patients report receiving an asthma action plan from their physicians, although such plans are associated with fewer ER visits, lower hospitalization rates and improved lung function. Hence, there is a clear opportunity to improve the management of asthma and reduce the incidence of related complications.

Given the scientific evidence of pharmacists effect on asthma management there is a strong rationale for introducing an asthma-specific pharmacist-led intervention for Ontarians suffering from this chronic disease. However, the implementation of such a program should be preceded by a pilot test to ensure that the program parameters are optimized to drive improved patient outcomes and maximum quality of service. The primary goals of this research project are to examine the impact of a pharmacist led asthma management intervention on patient health outcomes and to determine the optimum program structure to ensure quality of service delivery.

This study employs a mixed-methods study design. Investigators will begin with a cluster randomized controlled trial and end with exit interviews.This study will consist of a prospective, randomized controlled trial conducted in the community setting. A total of 12 pharmacies across the Greater Toronto Region will be recruited for this study. Each of these pharmacies will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. All data will be analyzed using statistical software. Significance level will be set at 0.05. Pharmacy level descriptive characteristics, including mean and standard deviation for the number of patients will be reported. There is a low perceived risk for this study; however, the investigators will take every precaution to ensure this study is conducted in an ethical manner, including protecting patient confidentiality and anonymity.


Eligibility criteria: Inclusion Criteria:

* Provided written consent
* Intending to refill all asthma-related prescriptions at the study pharmacy
* Diagnosed with asthma by a physician or nurse practitioner
* Taking inhaled corticosteroids for which the dose and/or medication has remained unchanged for at least 2 months
* 18 years of age or older
* Uncontrolled asthma (defined as in the past 4 weeks the patient has used their rescue medications 4 or more times in a given week and/or the patient has woken up in the night from their asthma in a given week).

Exclusion Criteria:

* Pregnant women
* Unable or unwilling to return to the pharmacy for scheduled visits
* Unable to speak English language well enough to communicate with the pharmacist and complete the questionnaires independently
* Terminal illness or poor prognosis (life expectancy less than 3 years)
* History of alcoholism or drug abuse
* Comorbidities/health issues:

  * Chronic obstructive pulmonary disorder (emphysema; chronic bronchitis)
  * Acute respiratory infection
  * Pulmonary fibrosis
  * Cancer (in the past 5 years preceding enrolment)
  * Organ transplantation
  * Dementia, cognitive impairment or other psychiatric disorder (Cognitive Impairments such as those found under the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) common Axis I and Axis II disorders
  * Any other health issue that may hinder performance on pulmonary function test
* Enrolled in an Employee Assistance Program for disease management within 6 months preceding the study enrolment date OR planning to enroll in the next 12 months
* Enrolled in another asthma management/clinical study OR planning to enroll in a similar study in the next 12 months
* Had a MedsCheck or MedsCheck Follow-Up done within the 3-month period preceding the anticipated date of the first study appointment
* Patients who do not wish their physician to be notified of their participation

Primary outcomes:
measure: Peak Expiratory Flow Rate (PEF)
timeFrame: Pharmacist will measure peak flow rate incrementally each month for 12 months total.
Secondary outcomes:
measure: Peak Flow Diary
timeFrame: Patients will measure their peak flow twice daily (morning and night) throughout the duration of the study (i.e., 12 months) with their peak flow meter. They will document their peak flow measurements in a diary.
measure: Asthma Control
timeFrame: Pharmacist will measure Asthma control twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
measure: The Medication Adherence Report Scale for Asthma
timeFrame: Pharmacist will measure Medication Adherence twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
measure: Health Care Service Usage Questionnaire
timeFrame: Pharmacist will measure Health Care Service Usage twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Pharmacist will measure Asthma related quality of life twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
measure: Heath and Work Performance Questionnaire
timeFrame: Pharmacist will measure health and work performance twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
measure: Asthma Self-Management Questionnaire
timeFrame: Pharmacist will measure Asthma self-management twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
measure: Asthma General Knowledge Questionnaire for Adults
timeFrame: Pharmacist will measure Asthma general knowledge twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
measure: Patient Satisfaction Questionnaire
timeFrame: The pharmacist will distribute this questionnaire to patients at the final appointment (12 months after baseline).
Other outcomes:
Locations:
Study officials:
affiliation: Ryerson University; Ontario Pharmacists Association
name: Zahava Rosenberg-Yunger, PhD
role: PRINCIPAL_INVESTIGATOR
References: