Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Matthew Boyd
ORCID ID
Contact details
School of Pharmacy
University Park
Nottingham
NG7 2RD
United Kingdom
+44 (0)115 9515061
matthew.boyd@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01635361
Protocol/serial number
12494
Study information
Scientific title
Understanding and appraising the New Medicine Service in the NHS in England
Acronym
Study hypothesis
About 25% medicines prescribed for longterm conditions are not taken as directed, and approximately 15% people receiving a new medicine take few, if any, doses. The New Medicines Service (NMS) is a community pharmacy service that started in England in October 2011 which involves the pharmacist providing additional support to patients starting a new medicine for some breathing problems (asthma & chronic obstructive pulmonary disease [COPD]), high blood pressure, adult onset diabetes or medicines which reduce blood clotting. It aims to improve the way patients take their medicines improving outcomes and reducing costs to the NHS.
Ethics approval
First MREC, 02/05/2012 ref: 12/WM/0096
Study design
Randomised interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
All diseases
Intervention
The effectiveness and cost effectiveness of the NMS will be assessed using a research study where some people will receive the NMS, and some wont, in order to look at the effect of the NMS on problems with their medicines, medicines taking and use of the NHS in general. Data will be collected in the East Midlands, South Yorkshire and London areas. 500 patients will be recruited from a range of different pharmacies and follow them up at 6, 10 and 26 weeks after starting their new medicine to assess effects on medicines taking behaviour, patients reported problems with medicines, referrals to their GP and use of NHS resources. The data gathered will be compared with that being collected routinely by all pharmacies in England to provide wider estimates of cost-effectiveness.
The study will also explore how the NMS service is being implemented by pharmacies. A sample of patients from the main study will be followed in more detail. This will involve recording the consultations with the pharmacist and also interviewing patients about their experience of the service. The patients GPs will be interviewed to investigate their views of the service. The trialists will also try to understand why people decline the invitation for the NMS.
Follow Up Length: 6 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Medicines adherence measured at 6, 10 and 26 weeks
Secondary outcome measures
1. Cost effectiveness measured at 6 months
2. Operation of the NMS measured 1 year from first recruited patient
3. Patients understanding of their medicines measured at 10 weeks
4. Pharmacovigilance measured 1 year from first recruited patient
5. Professional relationships measured 1 year from first recruited patient
6. Stakeholder experience measured 1 year from first recruited patient
Overall trial start date
16/07/2012
Overall trial end date
28/02/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. They are community dwelling patients eligible for NMS (i.e. aged from 14 years starting a new medicine for asthma/COPD, diabetes (Type 2), antiplatelets/anticoagulants or hypertension).
2. There is no upper age limit for providing the NMS hence there is no upper limit for patients taking part in the trial
3. They are able to understand patient/participant study documents
4. They are able and willing to provide informed assent/consent
5. The pharmacist will provide the patient with details of the study to in order to allow the patient to make an informed decision to take part into the study or not
6. Male and female participants
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 500; Description: The study requires 200 patients in each arm. The sample is calculated to allow for an attrition rate of 20%
Participant exclusion criteria
1. Younger patients who may not be able to understand the NMS service and/ or consenting procedure
2. Patients collecting a repeat prescription for a medicine for asthma/COPD, type 2 diabetes mellitus (T2DM), antiplatelets/anticoagulants or hypertension
3. Patients collecting a medicine where the only change from the previous medicine involves a dosage or formulation change only
4. Participants who are unable to understand patient/participant study documents
5. Participants who are unable and unwilling to provide assent/consent
Recruitment start date
16/07/2012
Recruitment end date
28/02/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Nottingham
Nottingham
NG7 2RD
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
School of Pharmacy
University Park
Nottingham
NG7 2RD
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) - Central Commissioning Facility (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24289059
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26647412
2017 cost effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/28776320
Publication citations
-
Protocol
Boyd M, Waring J, Barber N, Mehta R, Chuter A, Avery AJ, Salema NE, Davies J, Latif A, Tanajewski L, Elliott RA, Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England., Trials, 2013, 14, 411, doi: 10.1186/1745-6215-14-411.
-
Results
Elliott RA, Boyd MJ, Salema NE, Davies J, Barber N, Mehta RL, Tanajewski L, Waring J, Latif A, Gkountouras G, Avery AJ, Chuter A, Craig C, Supporting adherence for people starting a new medication for a long-term condition through community pharmacies: a pragmatic randomised controlled trial of the New Medicine Service, BMJ Qual Saf, 2015, doi: 10.1136/bmjqs-2015-004400.