Condition category
Not Applicable
Date applied
11/11/2016
Date assigned
21/11/2016
Last edited
11/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

www.ipu.ie

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/01/2018: The summary of the results of the NMS pilot is published on pages 24-28 of the IPU Review December 2017: http://ipu.ie/wp-content/uploads/2017/12/IPU-Review-DEC2017-JAN2018.pdf 30/01/2017: Ethical approval information added.