DementiaNCT03110471
Nurse-led Medicines' Monitoring in Care Homes: a Process Evaluation
An observational study of Dementia, run by Swansea University at 10 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Dementia
- What is being tested?
- West Wales Adverse Drug Reaction (WWADR) Profile
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- 1 Mar 2017to 30 Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Providing residential or nursing care or both to >4 service users meeting inclusion criteria below.
- Willing to use the WWADR monitoring Profile in routine practice
- 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
- Involved in the provision of care for service users described above
- Willing to participate in the study
Who cannot join
- <5 residents meet the inclusion criteria Unwilling or unable to volunteer to undertake nurse-led medicines' monitoring
- • Not well enough to participate, as screened by their nurses;
- Aged <18;
- Receiving active palliative care.
- Professionals
- Not involved with service users in care homes
- Unwilling to consent to participation
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Llys Gywn Residential Home
Cardiff, Cardiff, Wales, CF33 4PN
Monkstone House
Cardiff, Wales, CF36 3HU
Danygraig House
Cardiff, Wales, CF36 5SR
Neuadddrymmau care home
Swansea, Wales, SA10 6NR
Cefnlodge Care Home
Swansea, Wales, SA10 6YR
Swn-y-mor care home
Swansea, Wales, SA12 7PH
Glangarnant care home
Swansea, Wales, SA18 1UF
Fieldbay Ltd
Swansea, Wales, SA79LA
Three Cliffs Care Home
Swansea, SA3 2HQ
Glais Care Home
Swansea, SA79EN
About this study
Official title: 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
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.
Read the detailed description
Background:
Between 1 in 4 and 1 in 25 people benefit from their prescribed medicines (Schork 2015). However, adverse drug reactions (ADRs, known as side effects) occur in 7.8% (7.2-8.4%) patients in community (or ambulatory) care (Hakkarainen et al 2013). Most of these are preventable (Hakkarainen et al 2013, NICE 2015). Adverse drug events (ADE), which include ADRs and under-prescribing, and medicines' mismanagement are responsible for 8% of healthcare spend in the USA, $213bn (Aitkin \& Valkova 2013) and 9.5% of direct costs in Sweden.
The West Wales ADR Profiles for medicines' monitoring has improved quality of care by reducing the prescription of mental health medicines and identifying and addressing previously unsuspected adverse effects, such as coupled beats and severe hypertension (Jordan 2002, et al 2002), infections (Gabe el al 2014), chest pain and valproate-induced pancreatitis (Jones et al 2016), and, in care homes, drug-induced Parkinson's (Jordan et al 2014), pain, nausea and behaviour problems (Jordan et al 2015). The investigators now need to know how the intervention can embed in practice and governance frameworks, and benefit from pharmacist involvement and new monitoring devices.
Aims and objectives:
The investigators aim to explore
- What is needed to sustain implementation of the WWADR Profile in routine practice
- How it might be enhanced by a) pharmacist involvement and b) digitisation and new monitoring technology c) new profiles in other areas, such as respiratory medicine, pain control, falls.
Research Design A qualitative process evaluation and audit of interest
Duration 9 months from approval date
Location Care homes in Abertawe Bro Morgannwg University Health Board U.K.
The investigators have received full approval from the West Wales Research Ethics Committee,Committee (reference 16/WA/038, IRAS ID 213050), to carry out this study. Written informed consent will be sought for all interviews, observations (service users and nurses), and reviews of reflective diaries or accounts. Copies of the consent forms will be placed in service users' records or given to the interviewees, as appropriate, and stored by the research team in a locked cabinet in a locked office. Participants or their consultees will be free to withdraw or retract their data at any time. Swansea University are the study sponsors and provide indemnity cover.
Recruitment All 5 care homes from the previous trial (Jordan et al 2015) and 5 new care homes have opted to participate.
Methods:
The investigators will use interviews, observations and reflective diaries/ accounts with the participants of 5 previous research sites, and 5 newly recruited care homes.
The investigators propose to explore 2 additions to nurse-led medicines' monitoring:
- Cluster pharmacist or study pharmacist review completed Profiles in a pilot
- Combining administration with the Multiparametric sensor systems (Yang et al 2015) or electronic version of the Profiles in an audit of interest.
Data Handling- All data will be anonymised immediately, and kept strictly confidential. Participants and care homes will be assigned study numbers, and personal names will only appear on consent forms. A file linking care homes' names and addresses to study numbers will be stored in a password protected file on a password protected computer in a locked office used only by the PI. Service users' ages, sex, medicines and medical conditions will be recorded. Professionals' roles and length of service will be recorded. Data will be managed in accordance with the Data Protection Act 1998, the Caldicott Guardian, the Research Governance Framework for Health \& Care Research Wales, and the Research Ethics' Committee. Study documents will be stored in locked filing cabinets in a locked office for sole use of the PI. All study data will be anonymised before being entered into electronic files, which will be stored on pass-word protected computers for sole use of the researchers.
Consent- Prospective service user participants will be approached by their nurses. onsent to participation will be obtained by a qualified member of staff who is aware of the Mental Capacity Act 2005. For those without capacity to consent, as this is not a CTIMP, their consultees will be approached for advice regarding involvement. For many participants the consultee is a relative in regular contact; however, some service users have no regular visitors, and rely on professional support. Information sheets (in English and Welsh) and verbal information will be offered and potential participants will be given at least a week to decide whether to be observed or interviewed. Residents (or their family or consultees) to be observed will be asked to sign consent to non-participant observation and review of case notes.
Service users' and carers' views will be obtained as part of this project.
Anticipated outcome: The enhanced Profiles will offer a measure of care quality that matters to service users for example, pain, sedation, food and fluid intake and a sustainable strategy to improve care quality by: a) regular systematic review and transfer of information to pharmacists and prescribers (Francis 2013, Andrews and Butler 2014, Older People's Commissioner 2014, Flynn 2015); b) integration with NHS services e.g. contacts with prescribers, GPs, dentists and opticians; c) pharmacist reviews to optimise medication regimens for participants.
Outcomes to be reported:
Number and nature of problems addressed (including prescription changes)and understanding of any changes needed to optimise clinical gain and sustain implementation.
- Conditions
- Dementia
- Being tested
- West Wales Adverse Drug Reaction (WWADR) Profile, usual care
- Keywords
- Cognitive impairment, antipsychotics, antidepressants
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
West Wales Adverse Drug Reaction (WWADR) ProfileBehavioural
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 careBehavioural
usual care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile; Behavioral: usual care | |
| Fieldbay Care Homes | All groups are having identical intervention, so the above text applies to all. Receives: Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile; Behavioral: usual care | |
| Neuadd Drymmau Care Home | As above Receives: Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile; Behavioral: usual care | |
| Monkstone House, | As above Receives: Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile; Behavioral: usual care | |
| Danygraig House | As above Receives: Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile; Behavioral: usual care | |
| Ty Coch | As above Receives: Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile; Behavioral: usual care | |
| Swn y mor | As above Receives: Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile; Behavioral: usual care | |
| Hengoed court | As above Receives: Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile; Behavioral: usual care | |
| Hengoed park | As above Receives: Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile; Behavioral: usual care | |
| Cefn Lodge care home | As above Receives: Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile; Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Time for ADRe Administration (Including Interruptions) in Minutes
Assessed by researchers observing resident/ care-giver interaction.
Measured: up to 1 hour
Number of Problems Identified Per Resident
Signs and symptoms of prescribed medicines as listed as undesirable effects in manufacturers' Summaries of Product Characteristics.
Measured: up to 1 hour
Number of Changes to Care by Nurses Identified Per Resident
Measures taken to alleviate signs and symptoms of prescribed medicines as listed as undesirable effects in manufacturers' Summaries of Product Characteristics.
Measured: up to 4 weeks
Number of Pharmacist Recommendations for Prescription Review Per Resident
Recommendations to optimise prescription regimens. These included specific points to review or change.
Measured: up to 4 weeks
Number of Drug Interactions Per Resident
Regimen entered into the BNF drug interactions checker, and number of interactions flagged up were used for this outcome measure.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 Mar 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- Abertawe Bro Morgannwg University Health Board
- Responsible party
- Principal investigator, Professor Sue Jordon, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110471
- Sponsor's protocol ID
- SwanseaUCHHS
- Status last verified
- Jun 2020
- First submitted
- 22 Mar 2017
- Last updated
- 24 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data, will not be shared \& participants not identified. The investigators aim to publish the outcomes in 2018. Swansea university website.
Publications
Schork NJ. Personalized medicine: Time for one-person trials. Nature. 2015 Apr 30;520(7549):609-11. doi: 10.1038/520609a. No abstract available.
PubMed 25925459Hakkarainen 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.
PubMed 24023828NICE 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/
PubMed 26180890Aitken M. & Valkova S. (2013). Avoidable costs in US Healthcare. IMS Institute for Healthcare Informatics, Parsippany, NJ, USA
Jordan 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.
PubMed 12028277Jordan 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.
PubMed 11851783Gabe 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.
PubMed 24798210Jones 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.
PubMed 27902153Jordan 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.
PubMed 24707218Jordan 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.
PubMed 26461064Yang 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.
PubMed 26398335Francis, R. (2013) Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. London: The Stationery office. http://www.midstaffspublicinquiry.com/report.
Andrews 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
Flynn M. 2015 In Search of Accountability. Welsh Government, Cardiff, OGL Crown copyright 2015 WG25658 ISBN 978 1 4734 4027 2
Older 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03110471
- Acronym / sponsor ID
- SwanseaUCHHS
- Conditions
- Dementia
- Keywords
- Cognitive impairment, antipsychotics, antidepressants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- Abertawe Bro Morgannwg University Health Board
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 24 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Between 1 in 4 and 1 in 25 people benefit from their prescribed medicines (Schork 2015). However, adverse drug reactions (ADRs, known as side effects) occur in 7.8% (7.2-8.4%) patients in community (or ambulatory) care (Hakkarainen et al 2013). Most of these are preventable (Hakkarainen et al 2013, NICE 2015). Adverse drug events (ADE), which include ADRs and under-prescribing, and medicines' mismanagement are responsible for 8% of healthcare spend in the USA, $213bn (Aitkin \& Valkova 2013) and 9.5% of direct costs in Sweden.
The West Wales ADR Profiles for medicines' monitoring has improved quality of care by reducing the prescription of mental health medicines and identifying and addressing previously unsuspected adverse effects, such as coupled beats and severe hypertension (Jordan 2002, et al 2002), infections (Gabe el al 2014), chest pain and valproate-induced pancreatitis (Jones et al 2016), and, in care homes, drug-induced Parkinson's (Jordan et al 2014), pain, nausea and behaviour problems (Jordan et al 2015). The investigators now need to know how the intervention can embed in practice and governance frameworks, and benefit from pharmacist involvement and new monitoring devices.
Aims and objectives:
The investigators aim to explore
- What is needed to sustain implementation of the WWADR Profile in routine practice
- How it might be enhanced by a) pharmacist involvement and b) digitisation and new monitoring technology c) new profiles in other areas, such as respiratory medicine, pain control, falls.
Research Design A qualitative process evaluation and audit of interest
Duration 9 months from approval date
Location Care homes in Abertawe Bro Morgannwg University Health Board U.K.
The investigators have received full approval from the West Wales Research Ethics Committee,Committee (reference 16/WA/038, IRAS ID 213050), to carry out this study. Written informed consent will be sought for all interviews, observations (service users and nurses), and reviews of reflective diaries or accounts. Copies of the consent forms will be placed in service users' records or given to the interviewees, as appropriate, and stored by the research team in a locked cabinet in a locked office. Participants or their consultees will be free to withdraw or retract their data at any time. Swansea University are the study sponsors and provide indemnity cover.
Recruitment All 5 care homes from the previous trial (Jordan et al 2015) and 5 new care homes have opted to participate.
Methods:
The investigators will use interviews, observations and reflective diaries/ accounts with the participants of 5 previous research sites, and 5 newly recruited care homes.
The investigators propose to explore 2 additions to nurse-led medicines' monitoring:
- Cluster pharmacist or study pharmacist review completed Profiles in a pilot
- Combining administration with the Multiparametric sensor systems (Yang et al 2015) or electronic version of the Profiles in an audit of interest.
Data Handling- All data will be anonymised immediately, and kept strictly confidential. Participants and care homes will be assigned study numbers, and personal names will only appear on consent forms. A file linking care homes' names and addresses to study numbers will be stored in a password protected file on a password protected computer in a locked office used only by the PI. Service users' ages, sex, medicines and medical conditions will be recorded. Professionals' roles and length of service will be recorded. Data will be managed in accordance with the Data Protection Act 1998, the Caldicott Guardian, the Research Governance Framework for Health \& Care Research Wales, and the Research Ethics' Committee. Study documents will be stored in locked filing cabinets in a locked office for sole use of the PI. All study data will be anonymised before being entered into electronic files, which will be stored on pass-word protected computers for sole use of the researchers.
Consent- Prospective service user participants will be approached by their nurses. onsent to participation will be obtained by a qualified member of staff who is aware of the Mental Capacity Act 2005. For those without capacity to consent, as this is not a CTIMP, their consultees will be approached for advice regarding involvement. For many participants the consultee is a relative in regular contact; however, some service users have no regular visitors, and rely on professional support. Information sheets (in English and Welsh) and verbal information will be offered and potential participants will be given at least a week to decide whether to be observed or interviewed. Residents (or their family or consultees) to be observed will be asked to sign consent to non-participant observation and review of case notes.
Service users' and carers' views will be obtained as part of this project.
Anticipated outcome: The enhanced Profiles will offer a measure of care quality that matters to service users for example, pain, sedation, food and fluid intake and a sustainable strategy to improve care quality by: a) regular systematic review and transfer of information to pharmacists and prescribers (Francis 2013, Andrews and Butler 2014, Older People's Commissioner 2014, Flynn 2015); b) integration with NHS services e.g. contacts with prescribers, GPs, dentists and opticians; c) pharmacist reviews to optimise medication regimens for participants.
Outcomes to be reported:
Number and nature of problems addressed (including prescription changes)and understanding of any changes needed to optimise clinical gain and sustain implementation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Glangarnant Care Home | – | Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile, Behavioral: usual careThis 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 | – | Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile, Behavioral: usual careAll groups are having identical intervention, so the above text applies to all. |
| Neuadd Drymmau Care Home | – | Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile, Behavioral: usual careAs above |
| Monkstone House, | – | Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile, Behavioral: usual careAs above |
| Danygraig House | – | Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile, Behavioral: usual careAs above |
| Ty Coch | – | Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile, Behavioral: usual careAs above |
| Swn y mor | – | Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile, Behavioral: usual careAs above |
| Hengoed court | – | Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile, Behavioral: usual careAs above |
| Hengoed park | – | Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile, Behavioral: usual careAs above |
| Cefn Lodge care home | – | Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile, Behavioral: usual careAs above |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- Providing residential or nursing care or both to >4 service users meeting inclusion criteria below.
- Willing to use the WWADR monitoring Profile in routine practice
- Involved in the provision of care for service users described above
- Willing to participate in the study
Key exclusion criteria (7 listed)
- <5 residents meet the inclusion criteria Unwilling or unable to volunteer to undertake nurse-led medicines' monitoring
- • Not well enough to participate, as screened by their nurses;
- Professionals
- Not involved with service users in care homes
- Unwilling to consent to participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| West Wales Adverse Drug Reaction (WWADR) ProfileNurse-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 | Behavioural | Cefn Lodge care home, Danygraig House, Fieldbay Care Homes, Glangarnant Care Home, Hengoed court, Hengoed park, Monkstone House,, Neuadd Drymmau Care Home, Swn y mor, Ty Coch |
| usual careusual care | Behavioural | Cefn Lodge care home, Danygraig House, Fieldbay Care Homes, Glangarnant Care Home, Hengoed court, Hengoed park, Monkstone House,, Neuadd Drymmau Care Home, Swn y mor, Ty Coch |
Primary outcome
Number of Participants With Adverse Drug Reactions (ADRs) Treated
Time frame: 6 months
ADRs (adverse drug reactions) (as listed in the British National Formulary and manufacturers' datasheets) where actions are taken to correct the problem.
5 secondary outcomes
Time for ADRe Administration (Including Interruptions) in Minutes
Time frame: up to 1 hour
Number of Problems Identified Per Resident
Time frame: up to 1 hour
Number of Changes to Care by Nurses Identified Per Resident
Time frame: up to 4 weeks
Number of Pharmacist Recommendations for Prescription Review Per Resident
Time frame: up to 4 weeks
Number of Drug Interactions Per Resident
Time frame: up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25925459Schork NJ. Personalized medicine: Time for one-person trials. Nature. 2015 Apr 30;520(7549):609-11. doi: 10.1038/520609a. No abstract available.
- Background: PubMed 24023828Hakkarainen 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.
- Background: PubMed 26180890NICE 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/
- BackgroundAitken M. & Valkova S. (2013). Avoidable costs in US Healthcare. IMS Institute for Healthcare Informatics, Parsippany, NJ, USA
- Background: PubMed 12028277Jordan 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.
- Background: PubMed 11851783Jordan 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.
- Background: PubMed 24798210Gabe 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.
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- BackgroundFrancis, R. (2013) Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. London: The Stationery office. http://www.midstaffspublicinquiry.com/report.
- How the west wales adr profiles workLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data, will not be shared \& participants not identified. The investigators aim to publish the outcomes in 2018. Swansea university website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Swansea University at 10 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Drug Reactions (ADRs) Treated (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03110471, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.