Condition category
Not Applicable
Date applied
05/09/2012
Date assigned
10/09/2012
Last edited
27/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Prescribing errors occur in about half of hospital admissions. To reduce this, the government has recommended that all patients should receive a review from a pharmacist within 24 hours of admission to hospital. The medicines that the patient was taking before they came into hospital should be checked and compared against any hospital charts or other documentation. Currently hospitals in East of England achieve this only for 50% of patients. Expanding the pharmacy service to all patients would require a full seven-day service which is likely to be costly and may not be the best use of NHS resources. This study is designed to estimate the costs and effects of expanding the current pharmacy service in one teaching hospital.

Who can participate?
Adults, aged at least 18, admitted to one of the five adult medical wards with prescribed medicines.

What does the study involve?
Participants will be allocated to one of two groups. One group will receive usual care and the other group will be seen by a Pharmacist for a review of their medicines within 24 hours of their emergency admission. All participants will complete a short questionnaire. 3 months after discharge from hospital, the Research Assistant will write to the participants with a second questionnaire, as well as questions regarding their use of health or social services since their discharge. The length of stay in hospital, use of NHS resources, the level of medication errors and health-related quality of life will be compared between the two groups. Some participants will be randomly chosen to be invited to a discussion group regarding their experience of being in the study. Medical and Pharmacy staff who have had contact with the study will also be asked to join a discussion group regarding their experience of the study.

What are the possible benefits and risks of participating?
Participants may receive no direct benefit, but that their participation in this study may help to inform Pharmacists where best to concentrate their resources. Participants will need to complete some forms and that they will need to speak to a Researcher for 5-10 minutes. They may need to speak to a Pharmacist and the time taken can’t really be estimated. The risk regarding personal data is minimised, according to data protection laws, and this is fully explained to potential recruits.

Where is the study run from?
The study will be run from the Pharmacy department at Cambridge University Hospital. Participants will be recruited from one of five medical wards

When is the study starting and how long is it expected to run for?
The study started in July 2012 and will run until April 2013.

Who is funding the study?
NIHR Research for Patient Benefit Programme (UK).

Who is the main contact?
Miss Amanda Bale
amanda.bale@addenbrookes.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Amanda Bale

ORCID ID

Contact details

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
-
amanda.bale@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12437

Study information

Scientific title

Medicines reconciliation at the interface: a pilot randomised controlled trial to determine the costs and effects of a pharmacy provided service

Acronym

Study hypothesis

Prescribing errors have been estimated to occur within approximately fifty percent of hospital admissions. To reduce this, the government has recommended that all patients should receive a review from a pharmacist within 24 hrs following admission. The medicines that the patient was taking before they came into hospital should be checked and compared against any hospital charts or other documentation ("Medicines Reconciliation"). Currently hospitals in East of England achieve this only for 50% of patients. Expanding the pharmacy service to all patients would require a full seven day service which is likely to be costly and may not be the best use of NHS resources. This study is designed to estimate the costs and effects of expanding the current pharmacy service in one teaching hospital. Two hundred patients will be recruited to the study and randomised to either receive pharmacist service or usual care. The length of stay in hospital, use of NHS resources, the level of medication errors and health-related quality of life will be compared between the two groups 3 months post discharge. Additionally, patients, pharmacists and medical teams onwards which were involved in the pilot study will be invited for focus group discussion to review the study process and pharmacy service. Findings of this pilot and post study focus groups will inform the design of a definitive larger study.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12437

Ethics approval

Essex Reasearch Ethics Committee, 14/06/2012, ref: 12/EE/0143

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Health Services Research

Intervention

Medicines reconciliation versus medicines reconciliation within 24 hours of admisssion by the Study Pharmacist.
Followed up at 3 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Length of stay measured at discharge

Secondary outcome measures

1. Feasibility measured at end of study
2. Morbidity and mortality measured at 3 months
3. Patient satisfaction measured at 3 months
4. Quality of life measured at 3 months

Overall trial start date

04/07/2012

Overall trial end date

03/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult, aged at least 18 years of age
2. Admitted with prescribed medicines (at least one regular/OTC medication ) to one of the five adult medical wards.
3. Not received MR service from the pharmacy team as part of routine pharmaceutical input at the point of recruitment.
4. Identified from hospital computer system as being admitted within the previous 24 hours
5. Male or female participants

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 200; Description: 100 Control, 100 Intervention

Participant exclusion criteria

1. Elective patients receive MR via pre-admission clinics such as surgical pre admission assessment unit
2. Wards anticipated to close during the study period will be automatically excluded
3. Recruited patients readmitted during the course of the study

Recruitment start date

04/07/2012

Recruitment end date

03/04/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Children's Service
Box No 181
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

University/education

Website

http://www.cuh.org.uk/

Funders

Funder type

Government

Funder name

NIHR Research for Patient Benefit Programme (UK)

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

Publication citations

Additional files

Editorial Notes