Nurse-led Medicines' Monitoring in Care Homes: a Process Evaluation

June 11, 2020 updated by: Professor Sue Jordon, Swansea University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Swansea, United Kingdom, SA3 2HQ
        • Three Cliffs Care Home
      • Swansea, United Kingdom, SA79EN
        • Glais Care Home
    • Cardiff, Wales
      • Cardiff., Cardiff, Wales, United Kingdom, CF33 4PN
        • Llys Gywn Residential Home
    • Wales
      • Cardiff, Wales, United Kingdom, CF36 3HU
        • Monkstone House
      • Cardiff, Wales, United Kingdom, CF36 5SR
        • Danygraig House
      • Swansea, Wales, United Kingdom, SA10 6NR
        • Neuadddrymmau care home
      • Swansea, Wales, United Kingdom, SA10 6YR
        • Cefnlodge Care Home
      • Swansea, Wales, United Kingdom, SA12 7PH
        • Swn-y-mor care home
      • Swansea, Wales, United Kingdom, SA18 1UF
        • Glangarnant care home
      • Swansea, Wales, United Kingdom, SA79LA
        • Fieldbay Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile
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
Behavioral: usual care
usual care
Fieldbay Care Homes
All groups are having identical intervention, so the above text applies to all.
Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile
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
Behavioral: usual care
usual care
Neuadd Drymmau Care Home
As above
Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile
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
Behavioral: usual care
usual care
Monkstone House,
As above
Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile
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
Behavioral: usual care
usual care
Danygraig House
As above
Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile
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
Behavioral: usual care
usual care
Ty Coch
As above
Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile
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
Behavioral: usual care
usual care
Swn y mor
As above
Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile
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
Behavioral: usual care
usual care
Hengoed court
As above
Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile
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
Behavioral: usual care
usual care
Hengoed park
As above
Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile
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
Behavioral: usual care
usual care
Cefn Lodge care home
As above
Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile
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
Behavioral: usual care
usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for ADRe Administration (Including Interruptions) in Minutes
Time Frame: up to 1 hour
Assessed by researchers observing resident/ care-giver interaction.
up to 1 hour
Number of Problems Identified Per Resident
Time Frame: up to 1 hour
Signs and symptoms of prescribed medicines as listed as undesirable effects in manufacturers' Summaries of Product Characteristics.
up to 1 hour
Number of Changes to Care by Nurses Identified Per Resident
Time Frame: up to 4 weeks
Measures taken to alleviate signs and symptoms of prescribed medicines as listed as undesirable effects in manufacturers' Summaries of Product Characteristics.
up to 4 weeks
Number of Pharmacist Recommendations for Prescription Review Per Resident
Time Frame: up to 4 weeks
Recommendations to optimise prescription regimens. These included specific points to review or change.
up to 4 weeks
Number of Drug Interactions Per Resident
Time Frame: up to 4 weeks
Regimen entered into the BNF drug interactions checker, and number of interactions flagged up were used for this outcome measure.
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swansea University

Collaborators

Abertawe Bro Morgannwg University Health Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SwanseaUCHHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data, will not be shared & participants not identified. The investigators aim to publish the outcomes in 2018. Swansea university website.

Study Data/Documents

  1. Publications
    Information comments: Prof Sue Jordan- publication list

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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