Condition category
Respiratory
Date applied
02/03/2016
Date assigned
04/03/2016
Last edited
17/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases which cause breathing difficulties. Patients with COPD often don't take their medications exactly as prescribed and have difficulty using their inhalers properly. Community pharmacists can help improve quality of life and overall health in these patients. We will study the effect that pharmacists can have on the health of patients with COPD. We hope to show that pharmacists can help improve the use of medications, inhaler technique and quality of life, and decrease health care costs and how many times COPD makes the patients sick.

Who can participate?
COPD patients, at least 40 years old

What does the study involve?
Participating pharmacies are randomly allocated to either provide the care they would normally offer on a daily basis, or to deliver an improved form of care that focuses on COPD management.

What are the possible benefits and risks of participating?
We hope to see an improvement in how well and how often people are remembering to take their medications, compared to before the study started. The only identified risks are the potential for the patient to feel overwhelmed during the data collection process.

Where is the study run from?
This study will take place in pharmacies in Newfoundland and Labrador (NL), Canada.

When is the study starting and how long is it expected to run for?
July 2015 to November 2017

Who is funding the study?
Health Research Foundation (Canada)

Who is the main contact?
1. Dr Erin Davis (emdavis@mun.ca)
2. Dr John Hawboldt (hawboldt@mun.ca)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Erin Davis

ORCID ID

http://orcid.org/0000-0002-4925-1447

Contact details

School of Pharmacy
Memorial University of Newfoundland
75 Tiffany Court
St. John’s
NL
A1A 0L1
Canada
+1 (0)709 777 7232
emdavis@mun.ca

Type

Scientific

Additional contact

Dr John Hawboldt

ORCID ID

Contact details

School of Pharmacy
Memorial University of Newfoundland
Health Sciences Centre
300 Prince Philip Parkway
St. John's
NL
A1B 3V6
Canada
+1 (0)709 777 8777
hawboldt@mun.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of a pharmacist-driven intervention in chronic obstructive pulmonary disease (EPIC): a pragmatic cluster randomized controlled trial

Acronym

EPIC

Study hypothesis

Community pharmacists can help improve health-related quality of life and overall outcomes in patients with chronic obstructive pulmonary disease (COPD) through a pharmacist-driven intervention on: medication adherence, inhaler technique, health-related quality of life, health care resource utilization, COPD exacerbations, and use of medications.

Ethics approval

Newfoundland and Labrador Health Research Ethics Board, 14/05/2015, approval number: 15 091

Study design

Pragmatic cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic obstructive pulmonary disease

Intervention

We will compare pharmacies delivering an improved form of care that focuses on COPD management with pharmacies providing the care they would normally offer on a daily basis.

Multifactorial pharmacist-led intervention on medication adherence, inhaler technique, health-related quality of life, health care resource utilization, COPD exacerbations, and use of medications. The intervention involves 6 main strategies:
1. Medication review
2. Patient education
3. A written COPD action plan provided in collaboration with their family physician
4. Patient referral to pulmonary rehabilitation in collaboration with their family physician
5. Provision of, or referral to, smoking cessation counseling (where applicable)
6. Referral to a community-based chronic disease self-management program

Intervention type

Other

Phase

Drug names

Primary outcome measures

Change from baseline to 6 months in medication adherence using the medication possession ratio (MPR) and the Morisky Medication Adherence Scale (MMAS-8)

Secondary outcome measures

1. Proportion of patients with a clinically significant change in adherence
2. Proportion of patients defined as having ‘good adherence’
3. Mean MPR between groups
4. Quality of life as measured by the St. George’s Respiratory Questionnaire
5. Medication inhalation technique using a pharmacist-scored checklist
6. Healthcare resource utilization
7. Antibiotic and oral corticosteroid use for COPD exacerbations
Measured at baseline and 6 months.

Overall trial start date

01/07/2015

Overall trial end date

01/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Physician-diagnosed COPD
2. Age ≥40 years at trial enrollment
3. Sufficient ability to answer questionnaires in English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

We will maintain a cluster size of 20 pharmacies (10 intervention and 10 control) we will aim to enroll 7 patients per pharmacy, or 140 patients total

Participant exclusion criteria

1. 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. Physician-diagnosed asthma
5. Participation in another clinical trial
6. If they do not provide consent

Recruitment start date

01/05/2016

Recruitment end date

01/05/2017

Locations

Countries of recruitment

Canada

Trial participating centre

Memorial University of Newfoundland
School of Pharmacy Memorial University of Newfoundland Health Sciences Centre
St. John's, Newfoundland
A1B 3V6
Canada

Sponsor information

Organisation

Memorial University of Newfoundland (Canada)

Sponsor details

School of Pharmacy
Memorial University of Newfoundland
Health Sciences Centre
300 Prince Philip Parkway
St. John's
NL
A1B 3V6
Canada
+1 (0)709 777 7232
emdavis@mun.ca

Sponsor type

University/education

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

There will be no publication restrictions, and publication of both the protocol and full project will be sought in peer-reviewed journals, the timeline for publication will be confirmed at a later date. The authors plan to hold stakeholder meetings to disseminate study results, as well as present the results at local and national conferences after completion of the study.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27737686

Publication citations

Additional files

Editorial Notes

17/10/2016: Publication reference added.