Effectiveness of a pharmacist intervention in patients with lung disease

ISRCTN ISRCTN32281812
DOI https://doi.org/10.1186/ISRCTN32281812
Secondary identifying numbers N/A
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr John Hawboldt
Scientific

School of Pharmacy
300 Prince Philip Drive
St. John's
A1B3V6
Canada

ORCiD logoORCID ID 0000-0002-5219-5538
Dr Erin Davis
Scientific

School of Pharmacy
300 Prince Philip Drive
St. John's
A1B3V6
Canada

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEffectiveness of a Pharmacist-driven Intervention in COPD (EPIC2): a randomized controlled trial
Study acronymEPIC2
Study objectivesThe 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) studiedChronic Obstructive Pulmonary Disease (COPD)
InterventionA 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 typeOther
Primary outcome measureMedication adherence, measured as the proportion of days covered (PDC) at baseline and 6 months
Secondary outcome measuresMeasured 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 study start date01/03/2017
Completion date30/05/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100 patients in each group
Key inclusion criteria1. Physician-diagnosed COPD
2. Age ≥40 years at trial enrollment
3. Ability to answer questionnaires in English
Key exclusion criteria1. 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 enrolment01/06/2017
Date of final enrolment31/12/2018

Locations

Countries of recruitment

  • Canada

Study 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

The Health Research Foundation
Research organisation

55 Metcalfe Street, Suite 1220
Ottawa
K1P 6L5
Canada

Phone +1 (0)613 236 0455 EXT. 286
Email hscott@imc-mnc.ca
Website http://www.hrf-frs.com/home
ROR logo "ROR" https://ror.org/00hg4tf86

Funders

Funder type

Research organisation

Health Research Foundation
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 date01/12/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal
IPD sharing planDirectly 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?
Protocol file 06/12/2017 14/10/2022 No No

Additional files

ISRCTN32281812_PROTOCOL_06Dec17.pdf

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.