Effectiveness of a pharmacist intervention in patients with lung disease
| ISRCTN | ISRCTN32281812 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32281812 |
| Protocol serial number | N/A |
| Sponsor | The Health Research Foundation |
| Funder | Health Research Foundation |
- Submission date
- 16/05/2017
- Registration date
- 17/05/2017
- Last edited
- 14/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
School of Pharmacy
300 Prince Philip Drive
St. John's
A1B3V6
Canada
 ORCID ID |
0000-0002-5219-5538 |
|---|
Scientific
School of Pharmacy
300 Prince Philip Drive
St. John's
A1B3V6
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effectiveness of a Pharmacist-driven Intervention in COPD (EPIC2): a randomized controlled trial |
| Study acronym | EPIC2 |
| Study objectives | 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(s) | The Newfoundland and Labrador Health Research Ethics Board, 01/06/2017, ref: 20180113 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Medication adherence, measured as the proportion of days covered (PDC) at baseline and 6 months |
| Key secondary outcome measure(s) |
Measured at baseline and 6 months: |
| Completion date | 30/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Physician-diagnosed COPD 2. Age ≥40 years at trial enrollment 3. Ability to answer questionnaires in English |
| Key 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 |
| Date of first enrolment | 01/06/2017 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- Canada
Study participating centre
St John's
A1B 3V6
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 06/12/2017 | 14/10/2022 | No | No |
Additional files
- ISRCTN32281812_PROTOCOL_06Dec17.pdf
- Protocol file
Editorial Notes
14/10/2022: Protocol uploaded (not peer reviewed).
10/01/2022: The intention to publish date has been changed from 01/12/2021 to 01/12/2022.
18/05/2021: The intention to publish date was changed from 01/05/2021 to 01/12/2021.
04/11/2020: The intention to publish date was changed from 01/05/2020 to 01/05/2021.
25/01/2018: Ethics approval information added.
