Condition category
Not Applicable
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
14/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Jenny Kelly

ORCID ID

Contact details

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

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 measures

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

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

http://www.uea.ac.uk/

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

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23243818

Publication citations

Additional files

Editorial Notes

14/07/2016: Publication reference added