Condition category
Not Applicable
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
11/01/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.uea.ac.uk/

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

  1. 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.

Additional files

Editorial Notes