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NCT Number: NCT01635361

Understanding and Appraising the New Medicine Service in England

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

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Key information

Conditions

Asthma Blood Coagulation Bronchial Diseases Cardiovascular Diseases Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Embolism and Thrombosis Endocrine System Diseases Glucose Metabolism Disorders Hypersensitivity Hypersensitivity, Immediate Hypertension Immune System Diseases Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Thrombosis Vascular Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nottinghamshire County PCT/ County Health Partnerships, Nottingham, Notts, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

New Medicine Service

Other

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

Primary outcomes

  1. 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

  2. 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.

  3. 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

Secondary outcomes

  1. 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.

  2. Pharmacovigilance

    Time frame: 1 year from first recruited patient

    The investigators will qualitatively determine whether NMS encourages improved pharmacovigilance by community pharmacists and patients.

  3. Stakeholder experience

    Time frame: 1 year from first recruited patient

    The investigators will qualitatively characterise patient (and/or carer) and professional experience.

  4. Professional relationships

    Time frame: 1 year from first recruited patient

    The investigators will qualitatively explore inter-professional and patient-professional relationships.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Department of Health, United Kingdom
  • University College, London
  • University of Warwick

Registry information

Acronym: NMS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 9, 2012
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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