Understanding and Appraising the New Medicine Service in England (NMS)

May 27, 2015 updated by: University of Nottingham

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

504

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Cambden, Barnet, Islington PCTs
      • Nottingham, United Kingdom
        • Nottingham City PCT/Nottingham City Care
    • Notts
      • Nottingham, Notts, United Kingdom
        • Nottinghamshire County PCT/ County Health Partnerships
    • South Yorkshire
      • Doncaster, South Yorkshire, United Kingdom
        • Doncaster PCT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NMS
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change in adherence from 6 weeks to 10 weeks and 26 weeks
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.
6 months
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
1 year from first recruited patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 weeks
Pharmacovigilance
Time Frame: 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
Time Frame: 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
Time Frame: 1 year from first recruited patient
The investigators will qualitatively explore inter-professional and patient-professional relationships.
1 year from first recruited patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

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

Investigators

  • Study Director: Anthony J Avery, DM, University of Nottingham
  • Study Chair: Matthew J Boyd, PhD, University of Nottingham
  • Study Chair: Rachel A Elliott, PhD, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 19, 2012

First Submitted That Met QC Criteria

July 3, 2012

First Posted (Estimate)

July 9, 2012

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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