Understanding and Appraising the New Medicine Service in England (NMS)
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
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
London、英国
- Cambden, Barnet, Islington PCTs
-
Nottingham、英国
- Nottingham City PCT/Nottingham City Care
-
-
Notts
-
Nottingham、Notts、英国
- Nottinghamshire County PCT/ County Health Partnerships
-
-
South Yorkshire
-
Doncaster、South Yorkshire、英国
- Doncaster PCT
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：NMS
Patients in this arm will receive the full NMS service
|
The New Medicine Service is an intervention where patients prescribed a new medicine receive followup consultations with the pharmacist 7-14 days and 14-21 days after receiving the new prescription item
|
|
无干预：Current Practice
Patients in this arm will receive the normal advice with their new medicine as dictated by current professional practice
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Medicines adherence
大体时间：Change in adherence from 6 weeks to 10 weeks and 26 weeks
|
Patients will report medicines adherence using the service specified adherence question and against standard adherence scales
|
Change in adherence from 6 weeks to 10 weeks and 26 weeks
|
|
Cost effectiveness
大体时间：6 months
|
Patients will record all NHS resource use during the study period via a self completion diary to assess the impact on cost effectiveness up to 6 months post initiation.
|
6 months
|
|
Operation of the NMS
大体时间：1 year from first recruited patient
|
The investigators will qualitatively describe the operation of the NMS, the complexity and nature of resulting consultations in terms of patient engagement, advice-giving and support.
Additionally it will determine acceptability to stakeholders, reasons for success or lack of success, feasibility within the service delivery environment and generalisability and replicability across disease indications and community pharmacy settings
|
1 year from first recruited patient
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patients' understanding of their medicines
大体时间：10 weeks
|
The investigators will qualitatively evaluate patients' understanding of their medicines and the extent to which they are informed and supported in their medicines-related behaviour.
|
10 weeks
|
|
Pharmacovigilance
大体时间：1 year from first recruited patient
|
The investigators will qualitatively determine whether NMS encourages improved pharmacovigilance by community pharmacists and patients.
|
1 year from first recruited patient
|
|
Stakeholder experience
大体时间：1 year from first recruited patient
|
The investigators will qualitatively characterise patient (and/or carer) and professional experience.
|
1 year from first recruited patient
|
|
Professional relationships
大体时间：1 year from first recruited patient
|
The investigators will qualitatively explore inter-professional and patient-professional relationships.
|
1 year from first recruited patient
|
合作者和调查者
调查人员
- 研究主任：Anthony J Avery, DM、University of Nottingham
- 学习椅：Matthew J Boyd, PhD、University of Nottingham
- 学习椅：Rachel A Elliott, PhD、University of Nottingham
- 首席研究员：Nicholas Barber, PhD、University College, London
- 研究主任：Rajnikant Mehta, MSc、University of Nottingham
- 研究主任：Justin Waring, PhD、University of Warwick
- 研究主任：Antony Chuter、Patient Involvement representative
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.