Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-27 @ 10:07 PM
Study NCT ID:
NCT01635361
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2012-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding and Appraising the New Medicine Service in England
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 504}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2012-06-19', 'studyFirstSubmitQcDate': '2012-07-03', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medicines adherence', 'timeFrame': 'Change in adherence from 6 weeks to 10 weeks and 26 weeks', 'description': 'Patients will report medicines adherence using the service specified adherence question and against standard adherence scales'}, {'measure': 'Cost effectiveness', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Operation of the NMS', 'timeFrame': '1 year from first recruited patient', 'description': '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'}], 'secondaryOutcomes': [{'measure': "Patients' understanding of their medicines", 'timeFrame': '10 weeks', 'description': "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."}, {'measure': 'Pharmacovigilance', 'timeFrame': '1 year from first recruited patient', 'description': 'The investigators will qualitatively determine whether NMS encourages improved pharmacovigilance by community pharmacists and patients.'}, {'measure': 'Stakeholder experience', 'timeFrame': '1 year from first recruited patient', 'description': 'The investigators will qualitatively characterise patient (and/or carer) and professional experience.'}, {'measure': 'Professional relationships', 'timeFrame': '1 year from first recruited patient', 'description': 'The investigators will qualitatively explore inter-professional and patient-professional relationships.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma', 'Pulmonary Disease, Chronic Obstructive', 'Diabetes Mellitus, Type 2', 'Hypertension', 'Blood Coagulation']}, 'referencesModule': {'references': [{'pmid': '31732700', 'type': 'DERIVED', 'citation': "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': '28776320', 'type': 'DERIVED', 'citation': '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': '26647412', 'type': 'DERIVED', 'citation': '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': '24289059', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.NMSevaluation.org.uk', 'label': 'NMS Study homepage'}]}, 'descriptionModule': {'briefSummary': "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).\n\nThe 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.\n\nThe 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.\n\nThe 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community dwelling patients eligible for NMS (aged from 14 years starting a new medicine for asthma/COPD, diabetes (Type 2), antiplatelet/anticoagulation or hypertension).\n\nExclusion Criteria:\n\n* Patients collecting a repeat prescription for a medicine (i.e. not new) for asthma/COPD, type 2 diabetes mellitus (T2DM), antiplatelets/anticoagulants or hypertension\n* Patients collecting a medicine where the only change from the previous medicine involves a dosage or formulation change only\n* Participants who are unable to understand patient/participant study documents\n* Participants who are unable and unwilling to provide written consent / assent'}, 'identificationModule': {'nctId': 'NCT01635361', 'acronym': 'NMS', 'briefTitle': 'Understanding and Appraising the New Medicine Service in England', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'Understanding and Appraising the New Medicine Service in England', 'orgStudyIdInfo': {'id': '12024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NMS', 'description': 'Patients in this arm will receive the full NMS service', 'interventionNames': ['Other: New Medicine Service']}, {'type': 'NO_INTERVENTION', 'label': 'Current Practice', 'description': 'Patients in this arm will receive the normal advice with their new medicine as dictated by current professional practice'}], 'interventions': [{'name': 'New Medicine Service', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['NMS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'state': 'Notts', 'country': 'United Kingdom', 'facility': 'Nottinghamshire County PCT/ County Health Partnerships', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'city': 'Doncaster', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Doncaster PCT', 'geoPoint': {'lat': 53.52285, 'lon': -1.13116}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Cambden, Barnet, Islington PCTs', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham City PCT/Nottingham City Care', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Matthew J Boyd, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Nottingham'}, {'name': 'Rachel A Elliott, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Nottingham'}, {'name': 'Anthony J Avery, DM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Nottingham'}, {'name': 'Nicholas Barber, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College, London'}, {'name': 'Rajnikant Mehta, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Nottingham'}, {'name': 'Justin Waring, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Warwick'}, {'name': 'Antony Chuter', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Patient Involvement representative'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Health, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'University College, London', 'class': 'OTHER'}, {'name': 'University of Warwick', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}