NCT01635361

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
504

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

June 19, 2012

Last Update Submit

May 27, 2015

Conditions

AsthmaPulmonary Disease, Chronic ObstructiveDiabetes Mellitus, Type 2HypertensionBlood Coagulation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Patients' understanding of their medicines

    10 weeks

  • Pharmacovigilance

    1 year from first recruited patient

  • Stakeholder experience

    1 year from first recruited patient

  • Professional relationships

    1 year from first recruited patient

Study Arms (2)

NMS

EXPERIMENTAL

Patients in this arm will receive the full NMS service

Other: New Medicine Service

Current Practice

NO INTERVENTION

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

Interventions

New Medicine ServiceOTHER

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

NMS

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Community dwelling patients eligible for NMS (aged from 14 years starting a new medicine for asthma/COPD, diabetes (Type 2), antiplatelet/anticoagulation or hypertension).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Nottinghamshire County PCT/ County Health Partnerships

Nottingham, Notts, United Kingdom

Location

Doncaster PCT

Doncaster, South Yorkshire, United Kingdom

Location

Cambden, Barnet, Islington PCTs

London, United Kingdom

Location

Nottingham City PCT/Nottingham City Care

Nottingham, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 31732700DERIVED

  • 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.

    PMID: 28776320DERIVED

  • 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.

    PMID: 26647412DERIVED

  • 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.

    PMID: 24289059DERIVED

Related Links

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic ObstructiveDiabetes Mellitus, Type 2HypertensionThrombosis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesEmbolism and Thrombosis

Study Officials

  • Matthew J Boyd, PhD

    University of Nottingham

    STUDY CHAIR

  • Rachel A Elliott, PhD

    University of Nottingham

    STUDY CHAIR

  • Anthony J Avery, DM

    University of Nottingham

    STUDY DIRECTOR

  • Nicholas Barber, PhD

    University College, London

    PRINCIPAL INVESTIGATOR

  • Rajnikant Mehta, MSc

    University of Nottingham

    STUDY DIRECTOR

  • Justin Waring, PhD

    University of Warwick

    STUDY DIRECTOR

  • Antony Chuter

    Patient Involvement representative

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

July 9, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

GB(4)