Understanding and Appraising the New Medicine Service in England

NCT ID: NCT01635361

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-04-30

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NMS

Patients in this arm will receive the full NMS service

Group Type EXPERIMENTAL

New Medicine Service

Intervention Type 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

Current Practice

Patients in this arm will receive the normal advice with their new medicine as dictated by current professional practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Health, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role collaborator

University of Warwick

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew J Boyd, PhD

Role: STUDY_CHAIR

University of Nottingham

Rachel A Elliott, PhD

Role: STUDY_CHAIR

University of Nottingham

Anthony J Avery, DM

Role: STUDY_DIRECTOR

University of Nottingham

Nicholas Barber, PhD

Role: PRINCIPAL_INVESTIGATOR

University College, London

Rajnikant Mehta, MSc

Role: STUDY_DIRECTOR

University of Nottingham

Justin Waring, PhD

Role: STUDY_DIRECTOR

University of Warwick

Antony Chuter

Role: STUDY_DIRECTOR

Patient Involvement representative

Locations

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Nottinghamshire County PCT/ County Health Partnerships

Nottingham, Notts, United Kingdom

Site Status

Doncaster PCT

Doncaster, South Yorkshire, United Kingdom

Site Status

Cambden, Barnet, Islington PCTs

London, , United Kingdom

Site Status

Nottingham City PCT/Nottingham City Care

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31732700 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28776320 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26647412 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24289059 (View on PubMed)

Related Links

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Other Identifiers

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12024

Identifier Type: -

Identifier Source: org_study_id

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