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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Department of Health, United Kingdom
University College, London
University of Warwick
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01635361
First received: June 19, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Asthma
Pulmonary Disease, Chronic Obstructive
Diabetes Mellitus, Type 2
Hypertension
Blood Coagulation
Other: New Medicine Service

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Understanding and Appraising the New Medicine Service in England

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Medicines adherence [ Time Frame: Change in adherence from 6 weeks to 10 weeks and 26 weeks ] [ Designated as safety issue: No ]
    Patients will report medicines adherence using the service specified adherence question and against standard adherence scales

  • Cost effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Patients' understanding of their medicines [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The investigators will qualitatively characterise patient (and/or carer) and professional experience.

  • Professional relationships [ Time Frame: 1 year from first recruited patient ] [ Designated as safety issue: No ]
    The investigators will qualitatively explore inter-professional and patient-professional relationships.


Estimated Enrollment: 500
Study Start Date: August 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635361

Locations
United Kingdom
Nottinghamshire County PCT/ County Health Partnerships
Nottingham, Notts, United Kingdom
Doncaster PCT
Doncaster, South Yorkshire, United Kingdom
Cambden, Barnet, Islington PCTs
London, United Kingdom
Nottingham City PCT/Nottingham City Care
Nottingham, United Kingdom
Sponsors and Collaborators
University of Nottingham
Department of Health, United Kingdom
University College, London
University of Warwick
Investigators
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
  More Information

Additional Information:
No publications provided by University of Nottingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01635361     History of Changes
Other Study ID Numbers: 12024
Study First Received: June 19, 2012
Last Updated: January 14, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Department of Health
United Kingdom: National Institute for Health Research

Additional relevant MeSH terms:
Asthma
Chronic Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014