ISRCTN ISRCTN23949491
DOI https://doi.org/10.1186/ISRCTN23949491
Secondary identifying numbers 12437
Submission date
05/09/2012
Registration date
10/09/2012
Last edited
07/06/2017
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

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

Contact information

Miss Amanda Bale
Scientific

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Email amanda.bale@addenbrookes.nhs.uk

Study information

Study designRandomised interventional trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMedicines reconciliation at the interface: a pilot randomised controlled trial to determine the costs and effects of a pharmacy provided service
Study hypothesisPrescribing 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(s)Essex Reasearch Ethics Committee, 14/06/2012, ref: 12/EE/0143
ConditionHealth Services Research
InterventionMedicines reconciliation versus medicines reconciliation within 24 hours of admisssion by the Study Pharmacist.
Followed up at 3 months.
Intervention typeOther
Primary outcome measureLength of stay measured at discharge
Secondary outcome measures1. 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 study start date04/07/2012
Overall study end date03/04/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsUK Sample Size: 200; Description: 100 Control, 100 Intervention
Participant inclusion criteria1. 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 exclusion criteria1. 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 date04/07/2012
Recruitment end date03/04/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
University/education

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

Website http://www.cuh.org.uk/
ROR logo "ROR" https://ror.org/04v54gj93

Funders

Funder type

Government

NIHR Research for Patient Benefit Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 16/03/2017 Yes No

Editorial Notes

07/06/2017: Publication reference added