Multi-professional clinical medication reviews in care homes for the elderly

ISRCTN ISRCTN90761620
DOI https://doi.org/10.1186/ISRCTN90761620
Secondary identifying numbers 8221
Submission date
21/10/2010
Registration date
21/10/2010
Last edited
01/10/2018
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

Ms Julie Houghton
Scientific

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

Email J.Houghton@uea.ac.uk

Study information

Study designSingle centre randomised 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 titleMulti-professional clinical medication reviews in care homes for the elderly: a randomised controlled trial with cost effectiveness study
Study acronymCARE MED
Study objectivesTo determine whether a multi-professional clinical medication review leads to a reduction in falls and potentially inappropriate prescribing in care homes for the elderly. Thirty care homes will be recruited and randomised into two groups: the control group will receive usual care and the intervention group will receive two multi-professional clinical medication reviews.
Ethics approval(s)Norfolk Research Ethics Committee approved on the 22nd February 2010 (ref: 09/H0310/96). Approval of amendment #1 given on the 4th October 2010.
Health condition(s) or problem(s) studiedTopic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
InterventionThe intervention group will receive two multi-professional clinical medication reviews at baseline and 6 months, with follow-up for a further 6 months. Residents' medications will be reviewed by pharmacist, pharmacy technician, GP and care home staff. Agreed action plan will be implemented by the medicines management team. The control group (15 care homes) will receive usual care (support they currently receive from the NHS), with data collection at baseline and 12 months. Both control and intervention homes are in the study for a total of 12 months.
Intervention typeOther
Primary outcome measureNumber of falls, measured at 6 months prior to baseline (T0), T0 to 6 months (T1) and T1 to 6 months (T2)
Secondary outcome measuresPotentially inappropriate prescribing, measured at baseline, 6 months and 12 months
Overall study start date01/11/2010
Completion date31/07/2011

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsPlanned sample size: 824; UK sample size: 824
Key inclusion criteria1. Care homes for older people (average age greater than 65 years)
2. Care homes which have been registered for at least 6 months
Key exclusion criteria1. Care homes specifically for people with dementia
2. Care homes specifically for people with learning difficulties
3. Care homes specifically for people with sensory impairment
4. Care homes specifically for people with mental health problems
5. Care homes specifically for people with physical disabilities
6. Care homes specifically for people with alcohol dependence
7. Care homes which have received a medication review service from the PCT in the last six months
8. Residents who self-medicate
Date of first enrolment01/11/2010
Date of final enrolment31/07/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Sponsor information

University of East Anglia (UK)
University/education

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

Website http://www.uea.ac.uk/
ROR logo "ROR" https://ror.org/026k5mg93

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0808-16065)

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?
Protocol article study protocol 05/10/2011 Yes No
Abstract results results presented at British Geriatrics Society Spring Meeting 01/10/2014 No No

Editorial Notes

01/10/2018: Publication reference added.