Nurse-led medication monitoring for patients with dementia and adverse events
| ISRCTN | ISRCTN48133332 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48133332 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/04/2013
- Registration date
- 15/07/2013
- Last edited
- 16/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
It is important to improve the quality of care for people with dementia through person-centred care and reduction in inappropriate use of medications. Most side effects to long-term medicines could be improved by regularly looking for it in patients. We suggest to introduce this using the West Wales Adverse Drug Reaction (ADR) Profile for Mental Health medicines. This comprises of a checklist of questions, and observations (including weight and blood pressure), based on the known side effects of mental health medicines. The first section can be passed to the prescriber, with problems highlighted, while the health promotion section is passed to nurses or carers with suggestions for actions. Guidelines are supplied. The aim if this study is to find out if observing the medications given, improves clinical outcome. The ADR Profile is already available in the public domain, will be used in the care home as an education package
Who can participate?
This study aims to recruit 50 patients with dementia, or a dementia subtype, living in care homes. At enrolment, participants must be taking at least one of antipsychotic, antidepressant or anti-epileptic medicines.
What does the study involve?
Five care homes will use the West Wales (ADR) profile with 10 patients each at different intervals. Care home staff will complete the ADR profile during usual care. This will involve observing or questioning patients and seeking information from medical records. Care home staff will complete short assessments at each interval. Information will be taken from the patients notes for evidence of medication monitoring, problems identified, actions taken, and outcomes. Staff will be asked to provide some feedback at the end of the project during short interviews.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. However, there should be benefits to future service users with dementia receiving at least one of the targeted medications. We foresee no physical or emotional risks to participants.
Where is the study run from?
The study has been set up by Swansea University in collaboration with West Wales Organisation for Rigorous Trials in Health and Social Care, UK.
When is the study starting and how long is it expected to run for?
Recruitment of participants starts in April 2013. Participants will be enrolled on the study for a period of up to seven months.
Who is funding the study?
Funding has been provided by Wales School for Primary Care Research (WSPCR), Cardiff, UK.
Who is the main contact?
Dr Susan Jordan, s.e.jordan@swansea.ac.uk
Dr Marie Gabe, m.gabe@swansea.ac.uk
Contact information
Scientific
College of Human and Health Sciences
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom
| Phone | +44 1792 518541 |
|---|---|
| s.e.jordan@swansea.ac.uk |
Study information
| Study design | Stepped-wedge cluster RCT of nurse-led medication monitoring in 5 care homes at monthly intervals. Randomisation performed by West Wales Organisation for Rigorous Trials in Health and Social Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Nurse-led medication monitoring using the West Wales Adverse Drug Reaction (WWADR) for patients with dementia in care homes in South West Wales: a feasibility study for a stepped wedge trial |
| Study acronym | WWADR |
| Study hypothesis | We hypothesise that structured nurse-led medication monitoring using the West Wales Adverse Drug Reaction (ADR) for mental health, alongside usual care, will help detect previously unsuspected ADR-related problems for residents in care homes. Jordan S., Knight J., Pointon D. 2004 Monitoring Adverse Drug Reactions: Scales, Profiles and Checklists. International Nursing Review. 51, 208-221 |
| Ethics approval(s) | The South West Wales Research Ethics Committee, 10 April 2013, ref: 13/WA/0067 |
| Condition | Dementia, including dementia subtypes |
| Intervention | Staff in the care home, who are responsible for patient care, will use the West Wales Adverse Drug Reaction Profile for mental health between 1-5 times for each participant. Supporting scales will be completed at the discretion of the clinical staff. |
| Intervention type | Other |
| Primary outcome measure | Problems found and actions taken at each step in the trial. Each step is separated by one month and data will be collected using the ADR profile and case note review. |
| Secondary outcome measures | This project will be used to develop a feasibility study to assess: 1. Rates of recruitment, retention, compliance and cross-over 2. Feasibility of reporting changes in documentation for: 2.1. Amelioration of problems found using the profile 2.2. Problems found and actions taken using the profile 2.3. Medication review or changes 2.4. Patients with different severity of illness 3. Develop clinical endpoints for a full trial, such as measures to capture changes in patients functioning 4. Calculate intra-cluster correlation coefficient (ICC), and any time delay to patient benefits 5. Explore the basis for cost-effectiveness analysis 6. Report views of care home staff on the WWADR profile for mental health medicines |
| Overall study start date | 01/04/2013 |
| Overall study end date | 28/02/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 50 |
| Participant inclusion criteria | 1. Resident at the care home 2. Diagnosed with dementia or dementia subtypes 3. Currently taking at least one of: antipsychotic or anti-epileptic or antidepressant medicine 4. Willing and be able to give informed, signed consent themselves, or if capacity is lacking, guardian or representative willing to give consent to access the patient records |
| Participant exclusion criteria | 1. Not be well enough to participate, as screened by their nurses 2. Those aged 18 or under |
| Recruitment start date | 01/04/2013 |
| Recruitment end date | 28/02/2014 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
SA2 8PP
United Kingdom
Sponsor information
University/education
c/o Ceri Jones
Department of Research and Innovation
Singleton Park
Swansea
SA2 8PP
Wales
United Kingdom
"ROR" |
https://ror.org/053fq8t95 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 13/10/2015 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/10/2015: Publication reference added.
