Understanding and Appraising the New Medicine Service in England (NMS)
27 de mayo de 2015 actualizado por: 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
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
504
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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London, Reino Unido
- Cambden, Barnet, Islington PCTs
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Nottingham, Reino Unido
- Nottingham City PCT/Nottingham City Care
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Notts
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Nottingham, Notts, Reino Unido
- Nottinghamshire County PCT/ County Health Partnerships
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South Yorkshire
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Doncaster, South Yorkshire, Reino Unido
- Doncaster PCT
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
14 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: NMS
Patients in this arm will receive the full NMS service
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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
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Sin intervención: Current Practice
Patients in this arm will receive the normal advice with their new medicine as dictated by current professional practice
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Medicines adherence
Periodo de tiempo: Change in adherence from 6 weeks to 10 weeks and 26 weeks
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Patients will report medicines adherence using the service specified adherence question and against standard adherence scales
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Change in adherence from 6 weeks to 10 weeks and 26 weeks
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Cost effectiveness
Periodo de tiempo: 6 months
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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.
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6 months
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Operation of the NMS
Periodo de tiempo: 1 year from first recruited patient
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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
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1 year from first recruited patient
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patients' understanding of their medicines
Periodo de tiempo: 10 weeks
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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.
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10 weeks
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Pharmacovigilance
Periodo de tiempo: 1 year from first recruited patient
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The investigators will qualitatively determine whether NMS encourages improved pharmacovigilance by community pharmacists and patients.
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1 year from first recruited patient
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Stakeholder experience
Periodo de tiempo: 1 year from first recruited patient
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The investigators will qualitatively characterise patient (and/or carer) and professional experience.
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1 year from first recruited patient
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Professional relationships
Periodo de tiempo: 1 year from first recruited patient
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The investigators will qualitatively explore inter-professional and patient-professional relationships.
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1 year from first recruited patient
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Anthony J Avery, DM, University of Nottingham
- Silla de estudio: Matthew J Boyd, PhD, University of Nottingham
- Silla de estudio: Rachel A Elliott, PhD, University of Nottingham
- Investigador principal: Nicholas Barber, PhD, University College, London
- Director de estudio: Rajnikant Mehta, MSc, University of Nottingham
- Director de estudio: Justin Waring, PhD, University of Warwick
- Director de estudio: Antony Chuter, Patient Involvement representative
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2012
Finalización primaria (Actual)
1 de abril de 2014
Finalización del estudio (Actual)
1 de abril de 2014
Fechas de registro del estudio
Enviado por primera vez
19 de junio de 2012
Primero enviado que cumplió con los criterios de control de calidad
3 de julio de 2012
Publicado por primera vez (Estimar)
9 de julio de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
28 de mayo de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
27 de mayo de 2015
Última verificación
1 de mayo de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12024
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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