Contact information
Type
Scientific
Primary contact
Ms Julie Houghton
ORCID ID
Contact details
University of East Anglia
School of Pharmacy
Earlham Road
Norwich
NR4 7TJ
United Kingdom
J.Houghton@uea.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8221
Study information
Scientific title
Multi-professional clinical medication reviews in care homes for the elderly: a randomised controlled trial with cost effectiveness study
Acronym
CARE MED
Study hypothesis
To 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
Norfolk Research Ethics Committee approved on the 22nd February 2010 (ref: 09/H0310/96). Approval of amendment #1 given on the 4th October 2010.
Study design
Single centre 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
Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Intervention
The 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Number of falls, measured at 6 months prior to baseline (T0), T0 to 6 months (T1) and T1 to 6 months (T2)
Secondary outcome measures
Potentially inappropriate prescribing, measured at baseline, 6 months and 12 months
Overall trial start date
01/11/2010
Overall trial end date
31/07/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Care homes for older people (average age greater than 65 years)
2. Care homes which have been registered for at least 6 months
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned sample size: 824; UK sample size: 824
Participant exclusion criteria
1. 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
Recruitment start date
01/11/2010
Recruitment end date
31/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
Sponsor information
Organisation
University of East Anglia (UK)
Sponsor details
School of Pharmacy
Earlham Road
Norwich
NR4 7TJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0808-16065)
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
1. 2011 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/21974834
Publication citations
-
Study protocol
Desborough J, Houghton J, Wood J, Wright D, Holland R, Sach T, Ashwell S, Shaw V, Multi-professional clinical medication reviews in care homes for the elderly: study protocol for a randomised controlled trial with cost effectiveness analysis., Trials, 2011, 12, 218, doi: 10.1186/1745-6215-12-218.