Improving the management of behaviour that challenges associated with dementia in care homes: testing the feasibility of a combined pharmacy-health psychology intervention

ISRCTN ISRCTN58330068
DOI https://doi.org/10.1186/ISRCTN58330068
Secondary identifying numbers v8
Submission date
30/12/2015
Registration date
05/10/2017
Last edited
08/11/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 People with dementia may become distressed if medication is withdrawn and the other support mechanisms do not work.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

Study website

Contact information

Dr Ian Maidment
Scientific

Aston University
Birmingham
B4 7ET
United Kingdom

Phone +44 (0)121 204 3002
Email i.maidment@aston.ac.uk

Study information

Study designMixed methods feasibility study with embedded qualitative arm
Primary study designObservational
Secondary study design
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleImproving the management of behaviour that challenges associated with dementia in care homes: a pharmacy-health psychology intervention feasibility study
Study acronymMEDREV
Study objectivesThis 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(s)East Midlands (Nottingham 1) Research Ethics Committee, 15/09/2015, ref: 15/EM/3014
Health condition(s) or problem(s) studiedDementia
InterventionThe 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 typeMixed
Primary outcome measureNeuropsychiatric 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 measuresCollected 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 study start date01/01/2015
Completion date30/06/2017

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants45
Total final enrolment34
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/02/2016
Date of final enrolment01/08/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Aston University
Aston Triangle
Birmingham
B7 4ET
United Kingdom

Sponsor information

Aston University
University/education

Aston Triangle
Birmingham
B4 7ET
England
United Kingdom

ROR logo "ROR" https://ror.org/05j0ve876

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination plan1. Protocol published in: https://www.ncbi.nlm.nih.gov/pubmed/27009145, full detailed protocol on: https://www.aston.ac.uk/medrev
2. Planned publication of the results in high-impact peer reviewed journals
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 23/03/2016 Yes No
Results article results 19/10/2018 10/09/2019 Yes No
Results article 02/03/2020 08/11/2023 Yes No

Editorial Notes

08/11/2023: Publication reference added.
10/09/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.