Understanding and Appraising the New Medicine Service in England

Study Overview
=================
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

Official Title
-----------------
Understanding and Appraising the New Medicine Service in England

Conditions
-----------------
Asthma, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Type 2, Hypertension, Blood Coagulation

Intervention / Treatment
-----------------
* Other: New Medicine Service


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NMS<br>Patients in this arm will receive the full NMS service | Other: New Medicine Service<br>* 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<br>|
| No Intervention: Current Practice<br>Patients in this arm will receive the normal advice with their new medicine as dictated by current professional practice | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medicines adherence | 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 | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' understanding of their medicines | 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 | The investigators will qualitatively determine whether NMS encourages improved pharmacovigilance by community pharmacists and patients. | 1 year from first recruited patient | 
| Stakeholder experience | The investigators will qualitatively characterise patient (and/or carer) and professional experience. | 1 year from first recruited patient | 
| Professional relationships | The investigators will qualitatively explore inter-professional and patient-professional relationships. | 1 year from first recruited patient |