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ISRCTN
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ISRCTN77708631
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ClinicalTrials.gov identifier
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Public title
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Will an individualised service improve medicine administration to adults with dysphagia - a pilot study?
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Scientific title
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A non-randomised process of care case-controlled study of an individualised service to improve medicine administration to adults with dysphagia
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Acronym
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DYS-MED
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Serial number at source
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7288
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Study hypothesis
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To estimate:
1. The likely effect of a dedicated pharmacist's introduction of individualised medicine administration guides (I-MAGs) on nurses' clinical practice and medicine administration error (MAE) rate (primary outcome measure)
2. The likely effect of the introduction of I-MAGs on patients' health-related quality-of-life, post-discharge adherence and hospitalisation (secondary outcome measures)
3. Whether randomisation for such a trial should occur at ward or hospital level
4. The most efficient method of patient recruitment, the likely 'drop out' rate, the best outcome measures, and the feasibility of a full cost-effectiveness analysis
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Lay summary
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Ethics approval
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Essex 2 Research Ethics Committee (REC) approved on the 16th January 2009 (ref: 08/H0302/153)
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Study design
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Non-randomised interventional and observational process of care case-controlled study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Age and ageing
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Participants - inclusion criteria
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1. Patients with dysphagia
2. Based in three Care of the Elderly wards and one Stroke unit at the Norfolk and Norwich University Hospital
3. Consent to take part
4. Taking medication
5. Registered nurses working on the same four wards who consent to take part
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Participants - exclusion criteria
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Unable to communicate in English
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Anticipated start date
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01/07/2010
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Anticipated end date
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01/11/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned Sample Size: 360; UK Sample Size: 360
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Interventions
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Whilst an inpatient the intervention patient group will receive their medicines as prescribed by the doctors caring for them in the normal way. A pharmacist, employed for the purposes of the study, will develop an individualised medicine administration guide for each patient which will be used by the nurses administering medicines to those patients to guide appropriate preparation and administration. Prior to discharge the pharmacist employed for the project will adapt the individualised medicine administration guide to reflect the medcines the patient is to be discharged on, and will teach the patient how to use it. Copies will also be sent to the patient's GP and local community pharmacist.
The control group will not have these individualised medicine administration guides.
Both groups will be followed up for six months after discharge from hospital and will be asked to complete four questionnaires on discharge, six weeks and six months post discharge.
The primary outcome measure for the study is a decrease in medicine administration errors by the nurses administering medicines to patients in the intervention and control groups. The nurses will be given a questionnaire about aspect of medicine administration at the begining of the study and 16 will be observed administering medicines to patients on the four wards involed, i.e. the two intervention and two contiol wards. After six months the questionnaire will be re-administered and 16 medicine adminisration rounds will be observed.
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Primary outcome measure(s)
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Whether the introduction of individualised medicine administration guides reduce the number of medication errors.
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Secondary outcome measure(s)
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The likely effect of the introduction of individualised medicine administration guides on health related quality of life measures, patient satisfaction with information and pharmaceutical care and medicine adherence. These will be measured at patient discharge, six weeks and six months after discharge.
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
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Trial website
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Publications
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Contact name
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Mrs
Jenny
Kelly
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Address
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School of Pharmacy
University of East Anglia
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City/town
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Norwich
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Zip/Postcode
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NR4 7TJ
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Country
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United Kingdom
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Sponsor
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University of East Anglia (UK)
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Address
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School of Medicine
Earlham Road
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City/town
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Norwich
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Zip/Postcode
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NR4 7TJ
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Country
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United Kingdom
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Email
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research.acad@uea.ac.uk
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Sponsor website:
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http://www.uea.ac.uk/
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Date applied
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29/04/2010
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Last edited
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30/04/2010
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Date ISRCTN assigned
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29/04/2010
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