Condition category
Not Applicable
Date applied
05/07/2012
Date assigned
05/07/2012
Last edited
09/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.nmsevaluation.org.uk

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 won’t, 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 measures

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

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

http://www.nottingham.ac.uk/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

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