Clinical trial NCT03110471: Nurse-led Medicines' Monitoring in Care Homes: a Process Evaluation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Keywords: Cognitive impairment
antipsychotics
antidepressants
Lead sponsor: Swansea University
Sponsor class: OTHER
Collaborators: name: Abertawe Bro Morgannwg University Health Board
First posted: 2017-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

1. What is needed to sustain implementation of the WWADR Profile in routine practice
2. 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.

Eligibility criteria: Care Homes.

Inclusion criteria:

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

Exclusion criteria:

\<5 residents meet the inclusion criteria Unwilling or unable to volunteer to undertake nurse-led medicines' monitoring

Inclusion Criteria service users:

* Inclusion criteria:

  * 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

Exclusion Criteria:

* • Not well enough to participate, as screened by their nurses;

  * Aged \<18;
  * Receiving active palliative care.

Professionals

Inclusion criteria

* Involved in the provision of care for service users described above
* Willing to participate in the study

Exclusion criteria

* Not involved with service users in care homes
* Unwilling to consent to participation

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions (ADRs) Treated
timeFrame: 6 months
Secondary outcomes:
measure: Time for ADRe Administration (Including Interruptions) in Minutes
timeFrame: up to 1 hour
measure: Number of Problems Identified Per Resident
timeFrame: up to 1 hour
measure: Number of Changes to Care by Nurses Identified Per Resident
timeFrame: up to 4 weeks
measure: Number of Pharmacist Recommendations for Prescription Review Per Resident
timeFrame: up to 4 weeks
measure: Number of Drug Interactions Per Resident
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Cardiff.
country: United Kingdom
facility: Llys Gywn Residential Home
state: Cardiff, Wales
city: Cardiff
country: United Kingdom
facility: Monkstone House
state: Wales
city: Cardiff
country: United Kingdom
facility: Danygraig House
state: Wales
city: Swansea
country: United Kingdom
facility: Neuadddrymmau care home
state: Wales
city: Swansea
country: United Kingdom
facility: Cefnlodge Care Home
state: Wales
city: Swansea
country: United Kingdom
facility: Swn-y-mor care home
state: Wales
city: Swansea
country: United Kingdom
facility: Glangarnant care home
state: Wales
city: Swansea
country: United Kingdom
facility: Fieldbay Ltd
state: Wales
city: Swansea
country: United Kingdom
facility: Three Cliffs Care Home
city: Swansea
country: United Kingdom
facility: Glais Care Home
Study officials:
References:
citation: Schork NJ. Personalized medicine: Time for one-person trials. Nature. 2015 Apr 30;520(7549):609-11. doi: 10.1038/520609a. No abstract available.
citation: Hakkarainen 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.
citation: NICE 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/
citation: Aitken M. & Valkova S. (2013). Avoidable costs in US Healthcare. IMS Institute for Healthcare Informatics, Parsippany, NJ, USA
citation: 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.
citation: Jordan 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.
citation: Gabe 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.
citation: Jones 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.
citation: Jordan 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.
citation: Jordan 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.
citation: Yang 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.
citation: Francis, R. (2013) Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. London: The Stationery office. http://www.midstaffspublicinquiry.com/report.
citation: 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
citation: Flynn M. 2015 In Search of Accountability. Welsh Government, Cardiff, OGL Crown copyright 2015 WG25658 ISBN 978 1 4734 4027 2
citation: 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
citation: Jordan 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.
citation: Jordan 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.
citation: Jordan 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.