Condition category
Mental and Behavioural Disorders
Date applied
30/12/2015
Date assigned
05/10/2017
Last edited
13/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 People with dementia may become distressed if medication is withdrawn and the other support mechanisms do not work.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

http://www.aston.ac.uk/medrev/

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

Sponsor information

Organisation

Aston University

Sponsor details

Aston Triangle
Birmingham
B4 7ET
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes