Plain English Summary
Background and study aims
Older people take many different medicines. Anti-psychotics (powerful tranquilisers) can help to control behaviours – such as aggression – that occur in people with dementia and which may be difficult for carers to manage. However, because benefits are limited and anti-psychotics can cause significant harm, the Department of Health would like to reduce their levels of use by two-thirds. However, the sole focus on reducing anti-psychotics may simply shift prescribing to equally harmful, other mood-altering medicines (psychotropics), such as benzodiazepines (e.g. lorazepam). This study aims to assess the feasibility of a medication review combined with staff training in limiting the use of all psychotropics in care homes and consider if a larger study should be undertaken.
Who can participate?
Residents of a long-term care facility who have dementia and are receiving medication to treat behaviour that challenges
What does the study involve?
People with dementia undergo a medication review to support appropriate prescribing by an experienced specialist pharmacist. There is a follow-up at 6 months to assess the impact of the medication review. Care staff receive education and training to support them in managing challenging behaviour without medication.
What are the possible benefits and risks of participating?
People with dementia may benefit from by having unneeded medication stopped, reducing the risk of side effects. Care staff may benefit from training in the management of behavioural symptoms including using medication correctly. People with dementia may become distressed if medication is withdrawn and the other support mechanisms do not work. To reduce this risk, people with dementia with severe symptoms are excluded and the researchers work with the GP and care home staff.
Where is the study run from?
Aston University (UK)
When is the study starting and how long is it expected to run for?
January 2015 to June 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Ian Maidment
i.maidment@aston.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ian Maidment
ORCID ID
Contact details
Aston University
Birmingham
B4 7ET
United Kingdom
+44 (0)121 204 3002
i.maidment@aston.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
v8
Study information
Scientific title
Improving the management of behaviour that challenges associated with dementia in care homes: a pharmacy-health psychology intervention feasibility study
Acronym
MEDREV
Study hypothesis
This study aims to determine whether it is feasible to implement and measure the effectiveness of a combined pharmacy-health psychology intervention incorporating a medication review and staff training package to limit the prescription of psychotropics to manage behaviour that challenges in residential and nursing home residents.
Ethics approval
East Midlands (Nottingham 1) Research Ethics Committee, 15/09/2015, ref: 15/EM/3014
Study design
Mixed methods feasibility study with embedded qualitative arm
Primary study design
Observational
Secondary study design
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Dementia
Intervention
The study involves:
For people with dementia - a medication review to support appropriate prescribing by an experienced specialist pharmacist. Follow-up to assess the impact of the medication review
For care staff - 3-hour training session for care staff to support them in managing challenging behaviour without medication
Total follow-up period: 6 months
Intervention type
Mixed
Phase
Drug names
Primary outcome measures
Neuropsychiatric symptoms, assessed using the Neuropsychiatric Inventory (NPI). A specific nursing home version (NPI-MH) designed for interviewing professional care staff will be used. The decrease in the NPI-MH change score between baseline and 3 months will be the primary measure; it will also be collected at 6 weeks and 6 months. A decrease in 4 points, or more will be considered a clinically meaningful change in the NPI-NH.
Secondary outcome measures
Collected at baseline (before the medication review), 6 weeks and 3 and 6 months (unless stated):
1. Quality of life (QoL), measured using DEMQoL and EuroQoL EQ-5D (proxy versions). Participants may not be able to respond and to reduce any “proxy effect” caregivers will be requested to respond “as if” they were the person with dementia (EQ-5D only collected at baseline, 3 and 6 months; DEMQoL collected at all time points)
2. Cognitive test: standardised Mini-Mental State Examination (sMMSE) collected at baseline, 6 weeks and 3 months)
3. All prescribed medication
4. Costs: a modified version of the Client Services Receipt Inventory (CSRI) will be used to monitor levels of resource-use associated with the medication review (including preparation and recommendations) and the use of other NHS and PSS (Personal Social Services) resource-items e.g. medication utilisation, GP services and hospital visits/admissions. This will be completed by proxy. Only collected at baseline, 3 and 6 months
Overall trial start date
01/01/2015
Overall trial end date
30/06/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Receiving medication (including but not limited to medicines in British National Formulary [BNF] sections 4.1/4.2/4.3/4.11) to treat behaviour that challenges
2. Resident within a long-term care facility
3. Registered with a West Midlands GP (who has also agreed to participate)
4. Dementia confirmed (dementia register, documentation of relevant read codes, confirmation of diagnosis via communication from old age psychiatry, memory clinic or clinical psychologist)
5. Patient or personal consultee willing to provide consent/assent
6. A proxy informant (key worker or staff member with close working relationship) who can clearly communicate in English available
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
45
Participant exclusion criteria
1. Patient or personal consultee unable or unwilling to provide consent or lacks necessary English-language skills
2. On palliative care register, or has pathology requiring complex specialist medication
3. Risk of harm in line with Alzheimer Society guidance (guidelines published in 2011, currently being updated and therefore not available)
4. Severe mental illness (e.g. schizophrenia) where psychotropic treatment should be continued
Recruitment start date
01/02/2016
Recruitment end date
01/08/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Aston University
Aston Triangle
Birmingham
B7 4ET
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
1. Protocol published in: https://www.ncbi.nlm.nih.gov/pubmed/27009145, full detailed protocol on: www.aston.ac.uk/medrev
2. Planned publication of the results in high-impact peer reviewed journals
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
31/12/2017
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27009145