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

27. maj 2015 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

504

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • London, Det Forenede Kongerige
        • Cambden, Barnet, Islington PCTs
      • Nottingham, Det Forenede Kongerige
        • Nottingham City PCT/Nottingham City Care
    • Notts
      • Nottingham, Notts, Det Forenede Kongerige
        • Nottinghamshire County PCT/ County Health Partnerships
    • South Yorkshire
      • Doncaster, South Yorkshire, Det Forenede Kongerige
        • Doncaster PCT

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

14 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: NMS
Patients in this arm will receive the full NMS service
Andet: 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
Ingen indgriben: Current Practice
Patients in this arm will receive the normal advice with their new medicine as dictated by current professional practice

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medicines adherence
Tidsramme: 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
Change in adherence from 6 weeks to 10 weeks and 26 weeks
Cost effectiveness
Tidsramme: 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.
6 months
Operation of the NMS
Tidsramme: 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
1 year from first recruited patient

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patients' understanding of their medicines
Tidsramme: 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.
10 weeks
Pharmacovigilance
Tidsramme: 1 year from first recruited patient
The investigators will qualitatively determine whether NMS encourages improved pharmacovigilance by community pharmacists and patients.
1 year from first recruited patient
Stakeholder experience
Tidsramme: 1 year from first recruited patient
The investigators will qualitatively characterise patient (and/or carer) and professional experience.
1 year from first recruited patient
Professional relationships
Tidsramme: 1 year from first recruited patient
The investigators will qualitatively explore inter-professional and patient-professional relationships.
1 year from first recruited patient

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Nottingham

Samarbejdspartnere

University College, London
University of Warwick
Department of Health, United Kingdom

Efterforskere

  • Studieleder: Anthony J Avery, DM, University of Nottingham
  • Studiestol: Matthew J Boyd, PhD, University of Nottingham
  • Studiestol: Rachel A Elliott, PhD, University of Nottingham
  • Ledende efterforsker: Nicholas Barber, PhD, University College, London
  • Studieleder: Rajnikant Mehta, MSc, University of Nottingham
  • Studieleder: Justin Waring, PhD, University of Warwick
  • Studieleder: Antony Chuter, Patient Involvement representative

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2012

Primær færdiggørelse (Faktiske)

1. april 2014

Studieafslutning (Faktiske)

1. april 2014

Datoer for studieregistrering

Først indsendt

19. juni 2012

Først indsendt, der opfyldte QC-kriterier

3. juli 2012

Først opslået (Skøn)

9. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12024

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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