Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7288
Study information
Scientific title
A non-randomised process of care case-controlled study of an individualised service to improve medicine administration to adults with dysphagia
Acronym
DYS-MED
Study hypothesis
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
Ethics approval
Essex 2 Research Ethics Committee (REC) approved on the 16th January 2009 (ref: 08/H0302/153)
Study design
Non-randomised interventional and observational process of care case-controlled study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Age and ageing
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Whether the introduction of individualised medicine administration guides reduce the number of medication errors.
Secondary outcome measures
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.
Overall trial start date
01/07/2010
Overall trial end date
01/11/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
Planned Sample Size: 360; UK Sample Size: 360
Participant exclusion criteria
Unable to communicate in English
Recruitment start date
01/07/2010
Recruitment end date
01/11/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Pharmacy
Norwich
NR4 7TJ
United Kingdom
Sponsor information
Organisation
University of East Anglia (UK)
Sponsor details
School of Medicine
Earlham Road
Norwich
NR4 7TJ
United Kingdom
-
research.acad@uea.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23243818