Effectiveness of a pharmacist-driven intervention in chronic obstructive pulmonary disease
| ISRCTN | ISRCTN78138190 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78138190 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/03/2016
- Registration date
- 04/03/2016
- Last edited
- 29/04/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Respiratory
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)
Contact information
Scientific
School of Pharmacy, Memorial University of Newfoundland
75 Tiffany Court
St. John’s, NL
A1A 0L1
Canada
 ORCID ID |
0000-0002-4925-1447 |
|---|---|
| Phone | +1 (0)709 777 7232 |
| emdavis@mun.ca |
Scientific
School of Pharmacy
Memorial University of Newfoundland
Health Sciences Centre
300 Prince Philip Parkway
St. John's, NL
A1B 3V6
Canada
| Phone | +1 (0)709 777 8777 |
|---|---|
| hawboldt@mun.ca |
Study information
| Study design | Pragmatic cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effectiveness of a pharmacist-driven intervention in chronic obstructive pulmonary disease (EPIC): a pragmatic cluster randomized controlled trial |
| Study 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(s) | Newfoundland and Labrador Health Research Ethics Board, 14/05/2015, approval number: 15 091 |
| 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 |
| Primary outcome measure | 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 study start date | 01/07/2015 |
| Overall study end date | 01/11/2017 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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 inclusion criteria | 1. Physician-diagnosed COPD 2. Age ≥40 years at trial enrollment 3. Sufficient ability to answer questionnaires in English |
| 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
Study participating centre
Memorial University of Newfoundland
Health Sciences Centre
St. John's, Newfoundland
A1B 3V6
Canada
Sponsor information
University/education
School of Pharmacy
Memorial University of Newfoundland
Health Sciences Centre
300 Prince Philip Parkway
St. John's, NL
A1B 3V6
Canada
| Phone | +1 (0)709 777 7232 |
|---|---|
| emdavis@mun.ca | |
"ROR" |
https://ror.org/04haebc03 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Fondation pour la Recherche en Santé, HRF
- Location
- Canada
Results and Publications
| Intention to publish date | 01/11/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/10/2016 | Yes | No |
Editorial Notes
29/04/2019: The study was stopped due to participant recruitment issues.
18/10/2017: Internal review.
17/10/2016: Publication reference added.
