Nurse-led Medicines' Monitoring in Care Homes: a Process Evaluation
1 other identifier
observational
60
1 country
10
Brief Summary
Lay Summary: The investigators have shown in randomised controlled trials and observation studies that structured nurse-led medicines' monitoring using the WWADR Profile benefits patients, for example, by reducing pain and sedation and identifying high risk cardiovascular conditions. The investigators now aim to understand what is needed to sustain implementation of the WWADR Profile in routine practice and explore future directions. The participants of the investigators previous research, 5 newly recruited care homes, and stakeholders - care home managers, carers, healthcare professionals, and service users - will be asked to contribute interviews, observations and reflective diaries/ accounts. The investigators are interested in their experiences of medication use, medication management, adverse effects and barriers and facilitators of medicine monitoring, and how electronic devices can enhance nurse-led monitoring.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2017
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 22, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2018
CompletedResults Posted
Study results publicly available
June 24, 2020
CompletedJune 24, 2020
June 1, 2020
1.1 years
March 22, 2017
September 16, 2019
June 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Drug Reactions (ADRs) Treated
ADRs (adverse drug reactions) (as listed in the British National Formulary and manufacturers' datasheets) where actions are taken to correct the problem.
6 months
Secondary Outcomes (5)
Time for ADRe Administration (Including Interruptions) in Minutes
up to 1 hour
Number of Problems Identified Per Resident
up to 1 hour
Number of Changes to Care by Nurses Identified Per Resident
up to 4 weeks
Number of Pharmacist Recommendations for Prescription Review Per Resident
up to 4 weeks
Number of Drug Interactions Per Resident
up to 4 weeks
Study Arms (10)
Glangarnant Care Home
This is a 'before and after' observational study involving 10 care homes, listed below as groups. The investigators will observe the changes in detection and management of adverse drug reactions between usual care and with administration of the West Wales ADR Profile. Usual care will be provided before and during the intervention period.
Fieldbay Care Homes
All groups are having identical intervention, so the above text applies to all.
Neuadd Drymmau Care Home
As above
Monkstone House,
As above
Danygraig House
As above
Ty Coch
As above
Swn y mor
As above
Hengoed court
As above
Hengoed park
As above
Cefn Lodge care home
As above
Interventions
Nurse-led medicines' monitoring in care homes: a process evaluation of the impact and sustainability of the West Wales Adverse Drug Reaction (WWADR) Profile and pharmacist involvement
usual care
Eligibility Criteria
The investigators will work with healthcare professionals and service users involved in care homes in South West Wales. The target population for nurse-led medicines' monitoring is care home service users receiving at least one of: antipsychotics, anti-epileptics/ mood stabilisers, antidepressants, anxiolytics or hypnotics (benzodiazepines or Z drugs). Up to 3 service users per care home will be observed. Care homes will be invited to participate in the pilot work with pharmacists.
You may qualify if:
- Willing to use the WWADR monitoring Profile in routine practice
You may not qualify if:
- Resident at the care home and expected to continue to be for 1 year;
- Currently taking one of antipsychotics, anti-epileptics/ mood stabilisers, antidepres-sants, benzodiazepines, Z drugs;
- Diagnosis of dementia, or dementia related condition, recorded; permanent local authority funding for dementia care; permanent cognitive impairment, but no diagnosis in care home notes.
- Willing and able to give informed, signed consent themselves, or where capacity is lacking, a consultee who is willing to give advice
- Not well enough to participate, as screened by their nurses;
- Aged \<18;
- Receiving active palliative care.
- Professionals
- Involved in the provision of care for service users described above
- Willing to participate in the study
- Not involved with service users in care homes
- Unwilling to consent to participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swansea Universitylead
- Abertawe Bro Morgannwg University Health Boardcollaborator
Study Sites (10)
Llys Gywn Residential Home
Cardiff, Cardiff, Wales, CF33 4PN, United Kingdom
Monkstone House
Cardiff, Wales, CF36 3HU, United Kingdom
Danygraig House
Cardiff, Wales, CF36 5SR, United Kingdom
Neuadddrymmau care home
Swansea, Wales, SA10 6NR, United Kingdom
Cefnlodge Care Home
Swansea, Wales, SA10 6YR, United Kingdom
Swn-y-mor care home
Swansea, Wales, SA12 7PH, United Kingdom
Glangarnant care home
Swansea, Wales, SA18 1UF, United Kingdom
Fieldbay Ltd
Swansea, Wales, SA79LA, United Kingdom
Three Cliffs Care Home
Swansea, SA3 2HQ, United Kingdom
Glais Care Home
Swansea, SA79EN, United Kingdom
Related Publications (18)
Schork NJ. Personalized medicine: Time for one-person trials. Nature. 2015 Apr 30;520(7549):609-11. doi: 10.1038/520609a. No abstract available.
PMID: 25925459BACKGROUNDHakkarainen KM, Andersson Sundell K, Petzold M, Hagg S. Prevalence and perceived preventability of self-reported adverse drug events--a population-based survey of 7099 adults. PLoS One. 2013 Sep 4;8(9):e73166. doi: 10.1371/journal.pone.0073166. eCollection 2013.
PMID: 24023828BACKGROUNDNICE Medicines and Prescribing Centre (UK). Medicines Optimisation: The Safe and Effective Use of Medicines to Enable the Best Possible Outcomes. Manchester: National Institute for Health and Care Excellence (NICE); 2015 Mar. Available from http://www.ncbi.nlm.nih.gov/books/NBK305021/
PMID: 26180890BACKGROUNDAitken M. & Valkova S. (2013). Avoidable costs in US Healthcare. IMS Institute for Healthcare Informatics, Parsippany, NJ, USA
BACKGROUNDJordan S. Managing adverse drug reactions: an orphan task. J Adv Nurs. 2002 Jun;38(5):437-48. doi: 10.1046/j.1365-2648.2002.02205.x.
PMID: 12028277BACKGROUNDJordan S, Tunnicliffe C, Sykes A. Minimizing side-effects: the clinical impact of nurse-administered 'side-effect' checklists. J Adv Nurs. 2002 Jan;37(2):155-65. doi: 10.1046/j.1365-2648.2002.02064.x.
PMID: 11851783BACKGROUNDGabe ME, Murphy F, Davies GA, Russell IT, Jordan S. Medication monitoring in a nurse-led respiratory outpatient clinic: pragmatic randomised trial of the West Wales Adverse Drug Reaction Profile. PLoS One. 2014 May 5;9(5):e96682. doi: 10.1371/journal.pone.0096682. eCollection 2014.
PMID: 24798210BACKGROUNDJones R, Moyle C, Jordan S. Nurse-led medicines monitoring: a study examining the effects of the West Wales Adverse Drug Reaction Profile. Nurs Stand. 2016 Nov 30;31(14):42-53. doi: 10.7748/ns.2016.e10447.
PMID: 27902153BACKGROUNDJordan S, Gabe M, Newson L, Snelgrove S, Panes G, Picek A, Russell IT, Dennis M. Medication monitoring for people with dementia in care homes: the feasibility and clinical impact of nurse-led monitoring. ScientificWorldJournal. 2014 Feb 23;2014:843621. doi: 10.1155/2014/843621. eCollection 2014.
PMID: 24707218BACKGROUNDJordan S, Gabe-Walters ME, Watkins A, Humphreys I, Newson L, Snelgrove S, Dennis MS. Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial. PLoS One. 2015 Oct 13;10(10):e0140203. doi: 10.1371/journal.pone.0140203. eCollection 2015.
PMID: 26461064BACKGROUNDYang S, Chen YC, Nicolini L, Pasupathy P, Sacks J, Su B, Yang R, Sanchez D, Chang YF, Wang P, Schnyer D, Neikirk D, Lu N. "Cut-and-Paste" Manufacture of Multiparametric Epidermal Sensor Systems. Adv Mater. 2015 Nov 4;27(41):6423-30. doi: 10.1002/adma.201502386. Epub 2015 Sep 23.
PMID: 26398335BACKGROUNDFrancis, R. (2013) Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. London: The Stationery office. http://www.midstaffspublicinquiry.com/report.
BACKGROUNDAndrews J, Butler M. Trusted to Care: An independent Review of the Princess of Wales Hospital and Neath Port Talbot Hospital at Abertawe Bro Morgannwg University Health Board People, Dementia Services Development Centre, the People Organisation. 2014. Available at: http://wales.gov.uk/docs/dhss/publications/140512trustedtocareen.pdf
BACKGROUNDFlynn M. 2015 In Search of Accountability. Welsh Government, Cardiff, OGL Crown copyright 2015 WG25658 ISBN 978 1 4734 4027 2
BACKGROUNDOlder People's Commissioner for Wales. A Place to Call Home. Older people's Commissioner for Wales, Cardiff. 2014. Available at: http://www.olderpeoplewales.com/Libraries/Uploads/A_Place_to_Call_Home_-_A_Review_into_the_Quality_of_Life_and_Care_of_Older_People_living_in_Care_Homes_in_Wales.sflb.ashx
BACKGROUNDJordan S, Knight J, Pointon D. Monitoring adverse drug reactions: scales, profiles, and checklists. Int Nurs Rev. 2004 Dec;51(4):208-21. doi: 10.1111/j.1466-7657.2004.00251.x.
PMID: 15530161BACKGROUNDJordan S, Banner T, Gabe-Walters M, Mikhail JM, Round J, Snelgrove S, Storey M, Wilson D, Hughes D; Medicines Management Group. Nurse-led medicines' monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the adverse drug reaction (ADRe) profile for mental health medicines. BMJ Open. 2018 Sep 28;8(9):e023377. doi: 10.1136/bmjopen-2018-023377.
PMID: 30269073BACKGROUNDJordan S, Banner T, Gabe-Walters M, Mikhail JM, Panes G, Round J, Snelgrove S, Storey M, Hughes D; Medicines' Management Group, Swansea University. Nurse-led medicines' monitoring in care homes, implementing the Adverse Drug Reaction (ADRe) Profile improvement initiative for mental health medicines: An observational and interview study. PLoS One. 2019 Sep 11;14(9):e0220885. doi: 10.1371/journal.pone.0220885. eCollection 2019.
PMID: 31509537RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- sue jordan
- Organization
- swansea university
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof Susan Jordan
Study Record Dates
First Submitted
March 22, 2017
First Posted
April 12, 2017
Study Start
March 1, 2017
Primary Completion
March 30, 2018
Study Completion
March 30, 2018
Last Updated
June 24, 2020
Results First Posted
June 24, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share
Individual participant data, will not be shared \& participants not identified. The investigators aim to publish the outcomes in 2018. Swansea university website.