Plain English Summary
Background and study aims
Medicines play a crucial role in maintaining health, managing long term health conditions and curing disease. One aspect of optimising the use of medication is 'medications adherence', patients taking their medication as prescribed, or seeking support if they have questions or concerns. Estimates vary, but non-adherence is common. Non-adherence impacts patients health. It is also wasteful to the NHS. In England, the estimated cost to the NHS from wasted medication in primary care is £300 million per year. Other credible estimates calculate the full opportunity cost to the NHS at many times this amount. A wide range of factors affect adherence. These include forgetting, missing windows of opportunity and intentional non-adherence. Lots of help is already in place. for example, advice from pharmacists and GPs or reminder charts. An area where there may be new things to do is to close the gap between people’s good intentions (to take their medications) and their actions (not doing so). A proven concept from a range of settings is to encourage people to self-commit to achieve a particular goal. In addition, to use simple messages to motivate people to take their medication or to seek advice or help if they have concerns. The aim of this study is to test a simple and non-enforceable commitment device designed to help close the gap between someone's good intention to take their medication as prescribed, and their actions of non-adherence.
Who can participate?
Patients that have agreed to participate in an existing NHS Medicine service and have been prescribed a medicine to treat a long-term condition for the first time.
What does the study involve?
In a pharmacy, shortly after receiving a new course of medication for a long term condition, a participant may be invited by the pharmacist to sign a sticker. This is a commitment to take their medication as prescribed, or to seek advice if they have questions. The patient is then invited to attach this to their medications package, as a reminder of this good intention every time they see the package. The participant is randomly selected to receive one of three stickers. One sticker contains the aforementioned commitment to take the medication and message to seek advice if the participant has any questions (sticker A). A another sticker contains these messages and, in addition, another message reminding the patient that the NHS spends £300 million every year on wasted medication (sticker B). A third sticker (sticker C) has the same message as A but with an additional message reminding the patient that not taking medication can harm their health. Some participants do not receive a sticker, but are instead allocated to the control group and they receive their usual service. The sticker is tested as part of a small change to an existing NHS service, called the New Medicines Service and investigates if accompanying wording on the sticker - about the cost to the NHS from wasted medication or about the benefits to the patient’s own health - can further encourage adherence. At two weeks and again at four weeks after the start of the study, the patient speaks on the phone to their pharmacist to receive verbal advice about their medication. For example, the pharmacist may help with side effects. At these discussions, the pharmacist asks a few short questions about how the patient is getting on with taking their medication. This research uses this information - self-reported by patients - to measure if the new sticker has an effect.
What are the possible benefits and risks of participating?
The benefit of taking part in the study may be in helping the participating patient who wants to take their medication to be motivated to take it; or for patients who have queries or concerns to feel motivated to speak to their GP or pharmacist. We have not identified any risks of taking part in the study.
Where is the study run from?
All Boots UK pharmacies in London, UK
When is the study starting and how long is it expected to run for?
July 2015 to December 2015
Who is funding the study?
UK Department of Health (UK)
Who is the main contact?
1. Mr Daniel Berry
2. Ms Laura Freeman
Trial website
Contact information
Type
Public
Primary contact
Mr Daniel Berry
ORCID ID
Contact details
Department of Health
79 Whitehall
London
SW1A 21NS
United Kingdom
Type
Public
Additional contact
Ms Laura Freeman
ORCID ID
http://orcid.org/0000-0001-6212-7961
Contact details
Department of Health
79 Whitehall
London
SW1A 2NS
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC 15/WM/0225
Study information
Scientific title
Inviting patients to make a commitment to take their medication as prescribed, as a way to increase medications adherence: a cluster randomised controlled trial
Acronym
Study hypothesis
A wide range of psychological factors affect 'adherence': i.e. whether patients take their medications as prescribed. These include simply forgetting, missing windows of opportunity, and intentional non-adherence. An under-explored area in medication adherence research is the use of behavioural insights. This term covers disciplines that draw from behavioural economics and other sciences. Behavioural insights can help to close the gap between people’s good intentions (in this case, to take their medications) and their actions (not doing so). A proven concept from a range of settings is the use of a ‘commitment device’ to help bridge this intentions-to-actions gap.
The hypothesis is therefore that a simple and non-enforceable commitment device may help close the gap between someone's good intention to take their medication as prescribed, and their actions of non-adherence.
Ethics approval
NRES Research Ethics Committee, 26/06/2015, ref: 15/WM/0225
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Medications adherence
Intervention
11,292 patients who have already agreed to participate in a NHS service to support patients to take their medications will be randomly assigned as follows:
A: To be invited to sign a sticker committing to take their medication as prescribed, or to seek advice if they have any concern. The patients may then attach this to their medications package.
B: To be invited to sign a sticker as at A, but with an additional message reminding the patient that the NHS spends £300 million every year on wasted medication
C: To be invited to sign a sticker as at A, but with an additional message reminding the patient that not taking medication can harm their health
D: To receive the usual service (this is the control group)
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Whether the patient takes their medication as prescribed. This is measured by the patent self-reporting this to the pharmacist. This research uses common set of questions about adherence, called the Morisky scale. These are the four questions:
1. Do you ever forget to take your medicine? Yes/No
2. Are you careless at times about taking your medicine? Yes/No
3. Sometimes if you feel worse when you take the medicine, do you stop taking it? Yes/No
4. When you feel better do you sometimes stop taking your medicine? Yes/No
Secondary outcome measures
N/A
Overall trial start date
20/07/2015
Overall trial end date
31/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients who have already consented to participate in an existing NHS service, called the New Medicines Service
2. Patients who are prescribed a medicine to treat a long-term condition for the first time
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
11,292
Participant exclusion criteria
1. Anyone who has opted to not participate in the NHS New Medicine service
2. Any patients who opt-out from the trial component of the Service
Recruitment start date
20/07/2015
Recruitment end date
30/11/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Boots UK
All Boots UK pharmacies in London, UK.
London
-
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
79 Whitehall
London
SW1A 2NS
United Kingdom
Sponsor type
Government
Website
https://www.gov.uk/government/organisations/department-of-health
Funders
Funder type
Government
Funder name
UK Department of Health
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Peer reviewed journal and dissemination through the NHS
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list