Understanding and Appraising the New Medicine Service in England (NMS)
|ClinicalTrials.gov Identifier: NCT01635361|
Recruitment Status : Completed
First Posted : July 9, 2012
Last Update Posted : May 28, 2015
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
|Condition or disease||Intervention/treatment||Phase|
|Asthma Pulmonary Disease, Chronic Obstructive Diabetes Mellitus, Type 2 Hypertension Blood Coagulation||Other: New Medicine Service||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||504 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Understanding and Appraising the New Medicine Service in England|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Patients in this arm will receive the full NMS service
Other: New Medicine 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
No Intervention: Current Practice
Patients in this arm will receive the normal advice with their new medicine as dictated by current professional practice
- Medicines adherence [ Time Frame: 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
- Cost effectiveness [ Time Frame: 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.
- Operation of the NMS [ Time Frame: 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
- Patients' understanding of their medicines [ Time Frame: 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.
- Pharmacovigilance [ Time Frame: 1 year from first recruited patient ]The investigators will qualitatively determine whether NMS encourages improved pharmacovigilance by community pharmacists and patients.
- Stakeholder experience [ Time Frame: 1 year from first recruited patient ]The investigators will qualitatively characterise patient (and/or carer) and professional experience.
- Professional relationships [ Time Frame: 1 year from first recruited patient ]The investigators will qualitatively explore inter-professional and patient-professional relationships.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635361
|Nottinghamshire County PCT/ County Health Partnerships|
|Nottingham, Notts, United Kingdom|
|Doncaster, South Yorkshire, United Kingdom|
|Cambden, Barnet, Islington PCTs|
|London, United Kingdom|
|Nottingham City PCT/Nottingham City Care|
|Nottingham, United Kingdom|
|Study Chair:||Matthew J Boyd, PhD||University of Nottingham|
|Study Chair:||Rachel A Elliott, PhD||University of Nottingham|
|Study Director:||Anthony J Avery, DM||University of Nottingham|
|Principal Investigator:||Nicholas Barber, PhD||University College, London|
|Study Director:||Rajnikant Mehta, MSc||University of Nottingham|
|Study Director:||Justin Waring, PhD||University of Warwick|
|Study Director:||Antony Chuter||Patient Involvement representative|