Evaluation of the New Medicine Service

ISRCTN	ISRCTN23560818
DOI	https://doi.org/10.1186/ISRCTN23560818
ClinicalTrials.gov number	NCT01635361
Secondary identifying numbers	12494

Submission date: 05/07/2012
Registration date: 05/07/2012
Last edited: 27/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Matthew Boyd
Scientific

School of Pharmacy
University Park
Nottingham
NG7 2RD
United Kingdom

Phone	+44 (0)115 9515061
Email	matthew.boyd@nottingham.ac.uk

Study information

Study design	Randomised interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Understanding and appraising the New Medicine Service in the NHS in England
Study objectives	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(s)	First MREC, 02/05/2012 ref: 12/WM/0096
Health condition(s) or problem(s) studied	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
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 study start date	16/07/2012
Completion date	28/02/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	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%
Key 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
Key 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
Date of first enrolment	16/07/2012
Date of final enrolment	28/02/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Nottingham

Nottingham
NG7 2RD
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

School of Pharmacy
University Park
Nottingham
NG7 2RD
England
United Kingdom

Website	http://www.nottingham.ac.uk/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Government

National Institute for Health Research (NIHR) - Central Commissioning Facility (UK)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/12/2013		Yes	No
Results article	10-week follow-up	01/10/2016		Yes	No
Results article	cost effectiveness results	01/12/2017		Yes	No
Results article	26-week follow-up	15/11/2019	27/10/2022	Yes	No

Editorial Notes

27/10/2022: Publication reference added.
09/08/2017: Publication reference added.
10/04/2013: The overall trial end date was changed from 31/03/2013 to 28/02/2014