Condition category
Not Applicable
Date applied
15/10/2015
Date assigned
19/10/2015
Last edited
24/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Omitted medication doses, that is prescribed medicine that has not been given to a patient at the time that their next dose is due, are commonly seen in UK hospitals. These omitted doses can and do lead to harm for patients, particularly if medicines involved are ‘critical’ in that they require timely and regular administration to be effective, such as antibiotics and drugs to treat epilepsy. The aim of this study is to find out whether introducing a pharmacy technician to support nurse drug administration rounds in a NHS hospital in England can reduce the number of omitted doses when compared to wards where this technician support is not provided.

Who can participate?
Registered pharmacy technicians, medical staff and nursing stuff working in participating hospital wards.

What does the study involve?
Four pairs of medical, surgical and/or specialty wards are randomly selected to take part, and one ward within each pair is randomly selected to receive pharmacy technician support. The study hospital uses electronic recording of prescribing and drug administration, and the data used to compare the number of omitted doses and number of doses due to be given to patients on the wards. Trained pharmacy technicians visit the chosen wards on weekdays over 1 month to help them administer and document drug administration. The proportion of omitted doses as well as dose omissions involving ‘critical’ medicines are then compared between the wards with technician support and those without to see if they are reduced. Pharmacy staff, medical staff and nurses involved in the study are also asked their views on how well they think the added support works and if they can suggest any improvements to support possible wider roll-out in the future.

What are the possible benefits and risks of participating?
Whilst there are no direct benefits to health care staff who participate in this study, they may be given the opportunity to reflect on their own practice to identify new ways to work more closely with other health care professionals to deliver integrated patient care.

Where is the study run from?
Salford Royal NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
October 2015 to September 2016

Who is funding the study?
United Kingdom Clinical Pharmacy Association (UKCPA) and Pharmacy Research UK (PRUK)

Who is the main contact?
Dr Richard Keers

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Keers

ORCID ID

http://orcid.org/0000-0001-7854-8154

Contact details

Room 1.185
Stopford Building
Manchester Pharmacy School
Oxford Road
The University of Manchester
Manchester
M13 9PL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2

Study information

Scientific title

Evaluation of pharmacy TECHnician supported MEDication administration rounds (TECHMED) on reducing omitted doses: a randomised controlled trial and process evaluation in a university teaching hospital.

Acronym

TECHMED

Study hypothesis

The aim of this research study is to conduct a randomised controlled trial (RCT) to evaluate the effect of introducing pharmacy TECHnician supported MEDication administration rounds (TECHMED) to reduce the frequency of omitted doses at a NHS hospital in England.

Ethics approval

The University of Manchester: University Research Ethics Committee 2, 26/11/2015, ref: 1550

Study design

Single-centre randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Omitted doses of medications occurring on inpatient hospital wards.

Intervention

This randomised controlled trial involves a control and intervention arm and will be divided into three phases – pre-intervention/baseline, intervention (where intervention wards receive the TECHMED intervention but the control wards do not) and post-intervention. The pre- and post-intervention phases will involve no TECHMED support on the intervention or control wards, and will last 1 month with the intervention phase also lasting 1 month.

Trained pharmacy technicians already employed by the study hospital will perform the TECHMED intervention. These trained technicians will accompany nursing staff on medication administration rounds on weekdays during a 1 month intervention period.

During the medicines administration rounds, pharmacy technicians will accompany nurses and directly support them during this process, helping to source medications and solve medicines administration challenges to promote timely and safe administration of medicines.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Rate of all omitted doses, measured using extracted prescribing and medicines administration data from electronic inpatient record systems at the study hospital. Data will be extracted following completion of each 1 month phase of the study.

Secondary outcome measures

1. Rate of preventable omitted doses (PrOD)
2. Rate of all omitted doses of critical list medications
3. Rate of preventable omitted doses of critical list medications

Overall trial start date

01/10/2015

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Techmed RCT:
1. AFC Band 4/5 professionally registered pharmacy technicians employed by the study hospital who were interested in delivering the TECHMED service and who have drug accuracy checking qualifications and experience of ward work
2. Wards with similar characteristics suitable for randomisation who are interested in taking part, with senior nursing and individual ward manager approval
3. All regular and stat scheduled doses of medication to be given via any route of administration on the chosen study wards.

Process evaluation:
1. AFC Band 4/5 pharmacy technicians responsible for delivering TECHMED services
2. Professionally registered nursing staff of any grade employed by hospital site predominantly on the intervention wards who work directly with TECHMED pharmacy technicians to deliver the service
3. Professionally registered medical, nursing and pharmacy staff of any grade/level of experience employed on the intervention ward(s) who have experienced indirect contact with TECHMED components (e.g. dispensary staff receiving new orders from TECHMED technicians, ward based nursing/medical/pharmacy staff who respond to queries raised by the technicians/nurses)

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

20-30 for process evaluation interviews, 12 technicians to deliver TECHMED intervention

Participant exclusion criteria

Techmed RCT:
1. Inpatient wards which cannot be paired and therefore pooled in the randomisation sampling process (e.g. single units with no similar ward like intensive care, medical admissions)
2. Outpatient environments within study hospital
3. Any inpatient wards which do not utilise electronic prescribing and drug administration systems
4. Pharmacy technicians who are not AFC pay scale band 4/5 or not employed by study hospital
5. Pharmacy technicians without drug accuracy checking qualifications and prior experience of ward work
6. Pharmacy technicians not professionally registered with General Pharmaceutical Council (GPhC)
7. When required PRN doses of medication on the study wards

Process evaluation:
1. Staff not employed on the intervention ward(s)
2. University students (e.g. nursing students)
3. Patients and their relatives/friends/representatives
4. Health care support staff such as physiotherapists, dieticians, SALT, social workers, ward clerks, support workers, occupational therapists, phlebotomists (i.e. not pharmacy/nursing/medical)

Recruitment start date

01/12/2015

Recruitment end date

31/05/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

The University of Manchester, Faculty of MHS Administration

Sponsor details

3.53 Simon Building
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

United Kingdom Clinical Pharmacy Association (UKCPA) and Pharmacy Research UK (PRUK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Planned publication of at least two open access articles relating to this project
2. Planned presentation of findings in at least 2 abstracts at academic/professional conferences during the 2017 season

Intention to publish date

31/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.