Plain English Summary
Background and study aims
Between 30% and 50% of prescribed medicines are not taken as recommended. This means that a lot of medicines are wasted or are not as effective as they could be. This study is looking at patients who have been prescribed a new medicine by their doctor for a specific condition and trying to understand why they take their new medicine as recommended (treatment adherence). All patients who get medicines from their community pharmacist receive counseling on how to take their medicines when they collect the prescription. The aim of this study is to find out whether additional counseling with a pharmacist about medication use can help improve treatment adherence.
Who can participate?
Adults who have been prescribed a new medicine for asthma, lung conditions, type 2 diabetes, high blood pressure, anti-clotting medications, medications to lower cholesterol or long-term pain.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive a telephone call from the pharmacist after 7-14 days or are asked to come back to the pharmacy and the pharmacist asks some questions about how they are getting on with their new medicine, find out if theyyou are having problems and give information and support as needed. After one month, the pharmacist again make contact, either over the phone or when the participant comes in to collect their next prescription, to ask some further questions about how patients are getting on with their medicine. Those in the second group only receive contact from the pharmacist after one month, either over the phone or when they come in to collect their next prescription.
What are the possible benefits and risks of participating?
Participants who take part in the counseling program benefit from having extra contact from their community pharmacist which may help them better understand their new medicine. There are no notable risks involved with participating.
Where is the study run from?
The study is run by the Irish Pharmacy Union and takes place in 50 community pharmacies in Ireland (Ireland)
When is the study starting and how long is it expected to run for?
November 2016 to April 2017
Who is funding the study?
1. Pfizer Healthcare Ireland (Ireland)
2. Irish Pharmacy Union (Ireland)
Who is the main contact?
1. Ms Pamela Logan (public)
pamela.logan@ipu.ie
2. Dr Gerry Molloy (scientific)
gerry.molloy@nuigalway.ie
3. Ms Sinead McCool (scientific)
sineadmccoolmpsi@gmail.com
Trial website
Contact information
Type
Public
Primary contact
Ms Pamela Logan
ORCID ID
Contact details
Irish Pharmacy Union
Butterfield Avenue
Rathfarnham
Dublin
Dublin 14
Ireland
+353 14936401
pamela.logan@ipu.ie
Type
Scientific
Additional contact
Dr Gerry Molloy
ORCID ID
Contact details
1037 Arts Millennium Building Extension (AMBE)
School of Psychology
National University of Ireland
Galway
-
Ireland
+353 91 495123
gerry.molloy@nuigalway.ie
Type
Scientific
Additional contact
Ms Sinead McCool
ORCID ID
Contact details
Irish Pharmacy Union
Butterfield Avenue
Rathfarnham
Dublin
Dublin 14
Ireland
+353 87 6380375
sineadmccoolmpsi@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IPU1
Study information
Scientific title
IPU New Medicine Service Pilot: a randomised control pilot to explore the operation of the NMS, the complexity and nature of consultations and determine acceptability to stakeholders
Acronym
Study hypothesis
The aim of this study is to:
1. Explore the operation of the NMS, in particular the complexity and nature of resulting consultations in terms of patient engagement, age range, advice-giving and support
2. Determine acceptability to stakeholders, reasons for success or lack of success and feasibility within the service delivery environment
Ethics approval
National University of Ireland (NUI) Galway Research Ethics Committee, 27/01/2017, ref: 16-Dec-17
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
See additional files
Condition
Long-term medication
Intervention
Patients presenting with a new prescription for a medicine within one of the identified conditions will be asked if they wish to participate in a pilot service. They will be informed that this will either involve:
1. A telephone or face-to-face consultation within 7-14 days followed by a short survey after one month; or
2. A short survey after one month.
The patient will be asked to sign a consent form. The pharmacist will input the patient details into the Pharmapod platform (a web-based platform that will collate data from pharmacies and anonymise and aggregate) and Pharmapod will randomly allocate the patient to the active (NMS service) or control arm (current practice service). Patient selection would not be dependent on disease area. Adherence will be measured by the collection of the patient’s prescription over 3 months. Patients will have an option to opt out of the study at any time.
Those patients who have been selected for the NMS service will receive a telephone or face-to-face consultation within 7-14 days and will be asked a number of questions to find out if they are having any problems with their medicine. The patients in the control arm will not receive this consultation.
After one month, all patients who consented to participate, and who were allocated either the NMS service or the current practice service, will be asked to complete a survey, either face-to-face or by telephone. The survey will consist of the Morisky Eight Item Medication Adherence Scale (MMAS-8).
The pharmacist will input all data collected from the consultation and survey into the Pharmapod platform along with data on prescription collection over a 3-month period. A selection of anonymised and aggregated reports will be produced by Pharmapod to evaluate the pilot. Pharmacists will also be required to complete an online survey to determine acceptability of the service, the reasons for success or lack of success and the feasibility within the service delivery environment.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Acceptability of the NMS service to pharmacists is measured using a pharmacist survey created for the purpose of this study at the end of the pilot (after 3 months).
Secondary outcome measures
Patient adherence levels are measured by reviewing how often the patient collects their prescription from the pharmacy over a 3-month period.
Overall trial start date
06/11/2016
Overall trial end date
30/04/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged 18 years and older
2. Presenting with a new prescription for a medicine within one of the identified conditions/therapy areas
3. Living independently at home
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
1. Under 18 years of age
2. Living in care home or residential home
3. Using compliance aid or involved in any other adherence programme
4. Under the care of psychiatric services
5. Unable to participate in the study due to language difficulties
Recruitment start date
25/01/2017
Recruitment end date
17/02/2017
Locations
Countries of recruitment
Ireland
Trial participating centre
Irish Pharmacy Union
Butterfield Avenue
Rathfarnham
Dublin
14
Ireland
Sponsor information
Organisation
Irish Pharmacy Union
Sponsor details
Butterfield Avenue
Rathfarnham
Dublin
D14E126
Ireland
+353 14936401
pamela.logan@ipu.ie
Sponsor type
Other
Website
Funders
Funder type
Industry
Funder name
Pfizer Healthcare Ireland
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Irish Pharmacy Union
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of the study results in a report which will be sent to all community pharmacies and Department of Health officials.
IPS Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Ms Pamela Logan (pamela.logan@ipu.ie)
Intention to publish date
30/05/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN12674490_PIS_15Nov16_V1.docx Uploaded 21/11/2016