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

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ClinicalTrials.gov Identifier: NCT01635361
Recruitment Status : Completed
First Posted : July 9, 2012
Last Update Posted : May 28, 2015
Sponsor:
Collaborators:
Department of Health, United Kingdom
University College, London
University of Warwick
Information provided by (Responsible Party):
University of Nottingham

Tracking Information
First Submitted Date  ICMJE June 19, 2012
First Posted Date  ICMJE July 9, 2012
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2012)
  • 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
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2012)
  • 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.
  • Pharmacovigilance [ Time Frame: 1 year from first recruited patient ]
    The investigators will qualitatively determine whether NMS encourages improved pharmacovigilance by community pharmacists and patients.
  • Stakeholder experience [ Time Frame: 1 year from first recruited patient ]
    The investigators will qualitatively characterise patient (and/or carer) and professional experience.
  • Professional relationships [ Time Frame: 1 year from first recruited patient ]
    The investigators will qualitatively explore inter-professional and patient-professional relationships.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Understanding and Appraising the New Medicine Service in England
Official Title  ICMJE Understanding and Appraising the New Medicine Service in England
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Asthma
  • Pulmonary Disease, Chronic Obstructive
  • Diabetes Mellitus, Type 2
  • Hypertension
  • Blood Coagulation
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: NMS
    Patients in this arm will receive the full NMS service
    Intervention: Other: New Medicine Service
  • No Intervention: Current Practice
    Patients in this arm will receive the normal advice with their new medicine as dictated by current professional practice
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2015)
504
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2012)
500
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01635361
Other Study ID Numbers  ICMJE 12024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Nottingham
Study Sponsor  ICMJE University of Nottingham
Collaborators  ICMJE
  • Department of Health, United Kingdom
  • University College, London
  • University of Warwick
Investigators  ICMJE
Study Chair: Matthew J Boyd, PhD University of Nottingham
Study Chair: Rachel A Elliott, PhD University of Nottingham
Study Director: Anthony J Avery, DM 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
PRS Account University of Nottingham
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP