Plain English Summary
Background and study aims
Chronic obstructive pulmonary disease (COPD) is a group of lung conditions that cause breathing difficulties. Patients with lung disease often do not take their medications as prescribed (non-adherent) and can have poor inhaler technique. Community pharmacists may be able to improve patient medication adherence thus raising quality of life, reducing complications and reducing healthcare resource use and cost. The aim of this study is to measure the effect of pharmacist intervention on patients with COPD.
Who can participate?
Patients aged 40 and over with COPD
What does the study involve?
Participants are randomly allocated to either a group that receives the intervention or a group that does not receive the intervention (control group). The intervention group receive enhanced care that emphasizes lung disease management through the Medication Therapy Services (MTS) clinic. This involves medication review, patient education, a written COPD action plan, smoking cessation counselling, and referral to a community-based chronic disease self-management program. The control group receive usual care and an educational pamphlet that has information about COPD. Participants are followed up for 6 months to measure medication adherence, quality of life, inhaler technique, and healthcare resource and medication usage. After 6 months participants in the control group are offered the option to be referred to the MTS clinic to receive the detailed care intervention.
What are the possible benefits and risks of participating?
The methods and results from this study could be used to improve the care provided by community pharmacists in the real world. This would improve the health and quality of life of patients with COPD. The risks to participants should be minimal given the educational nature of the intervention. There may be negative emotional reactions or the feeling of being overwhelmed. Should participants suffer any effects from the study questionnaires or the educational session, pharmacists are instructed to allow rest and direct patients to counselling services where necessary.
Where is the study run from?
Respirology ambulatory care clinics at the Health Sciences Centre, and the MTS clinic at School of Pharmacy, Memorial University (Canada)
When is the study starting and how long is it expected to run for?
March 2017 to May 2019
Who is funding the study?
Health Research Foundation (Canada)
Who is the main contact?
1. Dr John Hawboldt
2. Dr Erin Davis
Trial website
Contact information
Type
Scientific
Primary contact
Dr John Hawboldt
ORCID ID
http://orcid.org/0000-0002-5219-5538
Contact details
School of Pharmacy
300 Prince Philip Drive
St. John's
A1B3V6
Canada
Type
Scientific
Additional contact
Dr Erin Davis
ORCID ID
Contact details
School of Pharmacy
300 Prince Philip Drive
St. John's
A1B3V6
Canada
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness of a Pharmacist-driven Intervention in COPD (EPIC2): a randomized controlled trial
Acronym
EPIC2
Study hypothesis
The pharmacist intervention will lead to improved adherence and more effective use of medication such as: better inhalation technique, and being prescribed more appropriate therapy for disease severity.
Ethics approval
The Newfoundland and Labrador Health Research Ethics Board, 01/06/2017, ref: 20180113
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Chronic Obstructive Pulmonary Disease (COPD)
Intervention
A random number list will be generated using Excel 2013 (Microsoft Corporation) and patients will be assigned to either intervention or control in a 1:1 ratio by the research assistant as they are recruited. Allocation concealment will be achieved using sequentially numbered, sealed, opaque envelopes containing the group assignments, opened sequentially when patients have consented to participating in the study.
The intervention group will receive an enhanced form of care that emphasizes COPD management through the Medication Therapy Services (MTS) clinic. The intervention involves 6 main strategies in addition to the COPD education pamphlet:
1. Medication review
2. Patient education
3. A written COPD action plan provided in collaboration with the respirologist if required
4. Provision of, or referral to, smoking cessation counseling (where applicable)
5. Referral to a community-based chronic disease self-management program
The control group will receive usual care and a COPD education pamphlet.
Patients will be followed up for 6 months. At the 6-month point, patients in the control group will be offered the option to be referred to the MTS clinic to receive the detailed care intervention.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Medication adherence, measured as the proportion of days covered (PDC) at baseline and 6 months
Secondary outcome measures
Measured at baseline and 6 months:
1. Quality of life, assessed by the St. George’s Respiratory Questionnaire (shorter version)
2. Medication inhalation technique, measured using a pharmacist-scored scale
3. Healthcare resource utilization (frequency of physician visits, hospitalizations, emergency department visits and pharmacy visits), reported by the patient at 6 months
4. Antibiotic and oral corticosteroid use for acute exacerbations of COPD (AECOPD), reported by the patient at 6 months
Overall trial start date
01/03/2017
Overall trial end date
30/05/2019
Reason abandoned
Eligibility
Participant inclusion criteria
1. Physician-diagnosed COPD
2. Age ≥40 years at trial enrollment
3. Ability to answer questionnaires in English
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 patients in each group
Participant exclusion criteria
1. Severe disease defined as a known Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) of <30%
2. A diagnosis of dementia or a prescription for cholinesterase inhibitors
3. A terminal illness
4. Participation in another clinical trial
5. Do not provide consent
Recruitment start date
01/06/2017
Recruitment end date
31/12/2018
Locations
Countries of recruitment
Canada
Trial participating centre
Respirology ambulatory care clinics at the Health Sciences Centre, and the MTS clinic at School of Pharmacy
Memorial University
St John's
A1B 3V6
Canada
Sponsor information
Organisation
The Health Research Foundation
Sponsor details
55 Metcalfe Street
Suite 1220
Ottawa
K1P 6L5
Canada
+1 (0)613 236 0455 EXT. 286
hscott@imc-mnc.ca
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Health Research Foundation
Alternative name(s)
Fondation pour la Recherche en Santé, HRF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Canada
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
IPD sharing statement
Directly identifiable information (e.g., name, personal health number) and indirectly identifying information (e.g., date of birth and place of residence) will be removed from information and replaced with a code. Only the principal investigator and research assistant will retain a list that links the participants’ code names with their actual name so data can be re-linked if necessary. This information is needed to be retained if for someone reason the trialists need to re-link the data. One of these situations could be the debriefing of participants. It will be necessary to retain this information so the trialists can contact them after the study is over. Another situation that perhaps requires retention of data is to assist internal and external audits that may be required of the research team by local research boards. This information will be stored securely in a locked cabinet in the principal investigators office and when stored electronically will be stored on an encrypted device. Consent from participants will be obtained in the respirology clinics.
Intention to publish date
01/05/2020
Participant level data
Other
Results - basic reporting
Publication summary