Will an individualised service improve medicine administration to adults with dysphagia - a pilot study?

ISRCTN	ISRCTN77708631
DOI	https://doi.org/10.1186/ISRCTN77708631
Secondary identifying numbers	7288

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 14/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Jenny Kelly
Scientific

School of Pharmacy
University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Study information

Study design	Non-randomised interventional and observational process of care case-controlled study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A non-randomised process of care case-controlled study of an individualised service to improve medicine administration to adults with dysphagia
Study acronym	DYS-MED
Study objectives	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(s)	Essex 2 Research Ethics Committee (REC) approved on the 16th January 2009 (ref: 08/H0302/153)
Health condition(s) or problem(s) studied	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
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 study start date	01/07/2010
Completion date	01/11/2010

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target number of participants	Planned Sample Size: 360; UK Sample Size: 360
Key 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
Key exclusion criteria	Unable to communicate in English
Date of first enrolment	01/07/2010
Date of final enrolment	01/11/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Pharmacy

Norwich
NR4 7TJ
United Kingdom

Sponsor information

University of East Anglia (UK)
University/education

School of Medicine
Earlham Road
Norwich
NR4 7TJ
England
United Kingdom

Email	research.acad@uea.ac.uk
Website	http://www.uea.ac.uk/
"ROR"	https://ror.org/026k5mg93

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2012		Yes	No

Editorial Notes

14/07/2016: Publication reference added