Clinical trial NCT01635361: Understanding and Appraising the New Medicine Service in England
Official title: Understanding and Appraising the New Medicine Service in England
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Pulmonary Disease, Chronic Obstructive
Diabetes Mellitus, Type 2
Hypertension
Blood Coagulation
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Department of Health, United Kingdom
name: University College, London
name: University of Warwick
First posted: 2012-07-09
Enrollment: 504
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: About 25% medicines prescribed for long term conditions are not taken as directed, and approximately 15% people receiving a new medicine take few, if any, doses. The New Medicine 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 \& 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 National Health Service (NHS).

The investigators will assess the effectiveness and cost effectiveness of the NMS using a research study where some people will receive the NMS, and some won't, so The investigators can 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.

The investigators will recruit 500 patients from a range of different pharmacies and follow them up at six, ten and twenty six weeks after starting their new medicine to assess effects on medicines taking behaviour, patients' reported problems with medicines, referrals to their General Practitioner (GP) and use of NHS resources. The investigators will compare the data gathered from this study with that being collected routinely by all pharmacies in England to provide wider estimates of cost effectiveness.

The investigators 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 investigators will interview the patients GP to investigate their views of the service. The investigators will also try to understand why people decline the invitation for the NMS


Eligibility criteria: Inclusion Criteria:

* Community dwelling patients eligible for NMS (aged from 14 years starting a new medicine for asthma/COPD, diabetes (Type 2), antiplatelet/anticoagulation or hypertension).

Exclusion Criteria:

* Patients collecting a repeat prescription for a medicine (i.e. not new) for asthma/COPD, type 2 diabetes mellitus (T2DM), antiplatelets/anticoagulants or hypertension
* Patients collecting a medicine where the only change from the previous medicine involves a dosage or formulation change only
* Participants who are unable to understand patient/participant study documents
* Participants who are unable and unwilling to provide written consent / assent

Primary outcomes:
measure: Medicines adherence
timeFrame: Change in adherence from 6 weeks to 10 weeks and 26 weeks
measure: Cost effectiveness
timeFrame: 6 months
measure: Operation of the NMS
timeFrame: 1 year from first recruited patient
Secondary outcomes:
measure: Patients' understanding of their medicines
timeFrame: 10 weeks
measure: Pharmacovigilance
timeFrame: 1 year from first recruited patient
measure: Stakeholder experience
timeFrame: 1 year from first recruited patient
measure: Professional relationships
timeFrame: 1 year from first recruited patient
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottinghamshire County PCT/ County Health Partnerships
state: Notts
city: Doncaster
country: United Kingdom
facility: Doncaster PCT
state: South Yorkshire
city: London
country: United Kingdom
facility: Cambden, Barnet, Islington PCTs
city: Nottingham
country: United Kingdom
facility: Nottingham City PCT/Nottingham City Care
Study officials:
affiliation: University of Nottingham
name: Matthew J Boyd, PhD
role: STUDY_CHAIR
affiliation: University of Nottingham
name: Rachel A Elliott, PhD
role: STUDY_CHAIR
affiliation: University of Nottingham
name: Anthony J Avery, DM
role: STUDY_DIRECTOR
affiliation: University College, London
name: Nicholas Barber, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Rajnikant Mehta, MSc
role: STUDY_DIRECTOR
affiliation: University of Warwick
name: Justin Waring, PhD
role: STUDY_DIRECTOR
affiliation: Patient Involvement representative
name: Antony Chuter
role: STUDY_DIRECTOR
References:
citation: Elliott RA, Boyd MJ, Tanajewski L, Barber N, Gkountouras G, Avery AJ, Mehta R, Davies JE, Salema NE, Craig C, Latif A, Waring J, Chuter A. 'New Medicine Service': supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial. BMJ Qual Saf. 2020 Apr;29(4):286-295. doi: 10.1136/bmjqs-2018-009177. Epub 2019 Nov 15.
citation: Elliott RA, Tanajewski L, Gkountouras G, Avery AJ, Barber N, Mehta R, Boyd MJ, Latif A, Chuter A, Waring J. Cost Effectiveness of Support for People Starting a New Medication for a Long-Term Condition Through Community Pharmacies: An Economic Evaluation of the New Medicine Service (NMS) Compared with Normal Practice. Pharmacoeconomics. 2017 Dec;35(12):1237-1255. doi: 10.1007/s40273-017-0554-9.
citation: 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. 2016 Oct;25(10):747-58. doi: 10.1136/bmjqs-2015-004400. Epub 2015 Dec 8.
citation: 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 Dec 1;14:411. doi: 10.1186/1745-6215-14-411.