Randomised controlled trial and economic evaluation of domiciliary medication review by pharmacists in Norfolk & Suffolk

ISRCTN	ISRCTN06813178
DOI	https://doi.org/10.1186/ISRCTN06813178
Protocol serial number	G106/991
Sponsor	Medical Research Council (MRC) (UK)
Funders	NHS Eastern Region R&D (reference number: HSR/1199/2) (UK), Medical Research Council (reference number: G106/991) (UK), Norfolk Health Authority (no reference number allocated) (UK), Norfolk Social Services (no reference number allocated) (UK), Suffolk Social Services (no reference number allocated) (UK), Pharmacy Practice Unit, UEA (no reference number allocated) (UK)

Submission date: 11/02/2003
Registration date: 11/02/2003
Last edited: 07/09/2009

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

Dr Richard Holland
Scientific

School of Medicine
Health Policy & Practice
University of East Anglia
Norfolk
Norwich
NR4 7TJ
United Kingdom

Phone	+44 (0)1603 593574
Email	r.holland@uea.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	The HOMER trial
Study objectives	To determine whether domiciliary medication review leads to reductions in emergency hospital admissions and an improvement in quality of life compared to standard care among elderly subjects (80 years old and over).
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Not Applicable
Intervention	Two groups: Control group received standard care (whatever that entails). Intervention group are referred to a review pharmacist. The review pharmacist will complete a standard medication review form and will then arrange a home visit at a time when they can meet the patient and any carers helping them with their drugs. The home visit will include a brief assessment of their ability to self-medicate and an assessment of drug compliance. The review pharmacist will, where appropriate: a. Educate the patient/carer b. Remove out-of-date drugs (with the patient's consent) c. Feedback to the GP possible drug reactions/interactions d. Feedback to the local pharmacist the need for a compliance aid. One follow-up visit will occur at 6-8 weeks post-recruitment to allow reinforcement of the original advice.
Intervention type	Other
Primary outcome measure(s)	Total number of emergency hospital admissions by 6-months
Key secondary outcome measure(s)	1. Total number of emergency hospital admissions by 3 months 2. Hospital/nursing/residential home admissions for respite care by 3 & 6 months 3. Admissions to nursing/residential care for long-term care by 3 & 6 months 4. Deaths by 3 & 6 months 5. Self-assessed quality of life at 3 & 6 months (using EQ-5D) 6. Average medication costs at 6 months
Completion date	31/12/2004

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	850
Key inclusion criteria	1. Discharged after an emergency hospital admission 2. 80 years and over 3. Prescribed two or more daily medications 4. Living in own home or warden controlled accommodation 5. Norfolk or Suffolk resident
Key exclusion criteria	Living in a residential or nursing home.
Date of first enrolment	01/01/2001
Date of final enrolment	31/12/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

School of Medicine

Norwich
NR4 7TJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/02/2005		Yes	No