Evaluation of a Community Pharmacist Managed Asthma Consultation Service

NCT ID: NCT02768623

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2018-04-16

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.

Conditions

Uncontrolled Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control Group

Patients in the control group will receive standard, dispensing services they currently receive from pharmacists. Control group pharmacists will continue to provide these services in accordance with the standards of practice adopted by the Ontario College of Pharmacists. They will not provide either of the 3 intervention components outlined above. Should a control group patient request additional information and/or services, the pharmacist will comply and provide these as deemed necessary for the particular patient. This could include the full range of educational and drug therapy optimization services outlined for the intervention group. If this occurs then the pharmacists will document all services provided in order for the research team to account for this in the analysis.

Group Type: ACTIVE_COMPARATOR

Pharmacist Intervention (when requested by patient)

Intervention Type: OTHER

Intervention Group

Pharmacists in the intervention group will provide patients with a comprehensive disease management program for asthma. The 3 major components of pharmacists' intervention are outlined below. The services delivered will be customized based on each patient's case.

1. Medication review and drug therapy optimization

2. Patient education

3. Improving patient adherence

Group Type: EXPERIMENTAL

Pharmacist led Asthma Management

Intervention Type: OTHER

Interventions

Pharmacist led Asthma Management

Intervention Type: OTHER

Pharmacist Intervention (when requested by patient)

Intervention Type: OTHER

Other Intervention Names

Pharmacist Asthma Intervention

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zahava Rosenberg-Yunger

OTHER

Sponsor Role: lead

Responsible Party

Zahava Rosenberg-Yunger

Dr. Rosenberg-Yunger

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zahava Rosenberg-Yunger, PhD

Role: PRINCIPAL_INVESTIGATOR

Ryerson University; Ontario Pharmacists Association

Other Identifiers

RyersonU1

Identifier Type: -

Identifier Source: org_study_id