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

Sponsor
Swansea University (Other)
Overall Status
Completed
CT.gov ID
NCT03110471
Collaborator
Abertawe Bro Morgannwg University Health Board (Other)
60
Enrollment
10
Locations
12.9
Actual Duration (Months)
6
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile
  • Behavioral: usual care

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 Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Mar 30, 2018
Actual Study Completion Date :
Mar 30, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Adverse Drug Reactions (ADRs) Treated [6 months]

    ADRs (adverse drug reactions) (as listed in the British National Formulary and manufacturers' datasheets) where actions are taken to correct the problem.

Secondary Outcome Measures

  1. Time for ADRe Administration (Including Interruptions) in Minutes [up to 1 hour]

    Assessed by researchers observing resident/ care-giver interaction.

  2. Number of Problems Identified Per Resident [up to 1 hour]

    Signs and symptoms of prescribed medicines as listed as undesirable effects in manufacturers' Summaries of Product Characteristics.

  3. Number of Changes to Care by Nurses Identified Per Resident [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.

  4. Number of Pharmacist Recommendations for Prescription Review Per Resident [up to 4 weeks]

    Recommendations to optimise prescription regimens. These included specific points to review or change.

  5. Number of Drug Interactions Per Resident [up to 4 weeks]

    Regimen entered into the BNF drug interactions checker, and number of interactions flagged up were used for this outcome measure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 105 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Swansea University
  • Abertawe Bro Morgannwg University Health Board

Investigators

None specified.

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Professor Sue Jordon, Prof Susan Jordan, Swansea University
ClinicalTrials.gov Identifier:
NCT03110471
Other Study ID Numbers:
  • SwanseaUCHHS
First Posted:
Apr 12, 2017
Last Update Posted:
Jun 24, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Professor Sue Jordon, Prof Susan Jordan, Swansea University
Cognitive impairment
antipsychotics
antidepressants
Additional relevant MeSH terms:
Dementia

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Observed Residents Service Providers
Arm/Group Description The administration of ADRe by nurses with 30 residents was observed in ten volunteer care homes in South West Wales, U.K. Five care homes were recruited to the study from our earlier randomised controlled trial [24], and five were newly recruited. All observed residents were receiving prescribed mental health medicines. The wider policy context was explored in 30 interviews with service users, including family members, nurse managers and strategic health care leads in South Wales pharmacists nurses strategic leads
Period Title: Overall Study
STARTED 30 30
COMPLETED 30 30
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Observed Residents Service Providers and Users Total
Arm/Group Description Administration of ADRe by nurses to 30 residents in care homes observed Policy context explored in interviews with service users, nurse managers strategic leads Total of all reporting groups
Overall Participants 30 0 30
Age (Count of Participants)
<=18 years
0
0%
0
NaN
0
0%
Between 18 and 65 years
2
6.7%
0
NaN
2
6.7%
>=65 years
28
93.3%
0
NaN
28
93.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
77.7
(9.9)
77.7
(9.9)
Sex: Female, Male (Count of Participants)
Female
15
50%
15
Infinity
Male
15
50%
15
Infinity
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
United Kingdom
30
100%
30
Infinity

Outcome Measures

1. Primary Outcome
Title Number of Participants With Adverse Drug Reactions (ADRs) Treated
Description ADRs (adverse drug reactions) (as listed in the British National Formulary and manufacturers' datasheets) where actions are taken to correct the problem.
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
Observation of residents. Service providers and users were not observed: they gave interviews.
Arm/Group Title Whole Study - Observed Residents
Arm/Group Description Care home (long-stay) residents observed for adverse drug reactions.
Measure Participants 30
Count of Participants [Participants]
30
100%
2. Secondary Outcome
Title Time for ADRe Administration (Including Interruptions) in Minutes
Description Assessed by researchers observing resident/ care-giver interaction.
Time Frame up to 1 hour

Outcome Measure Data

Analysis Population Description
Observed resident/ care-giver interaction.
Arm/Group Title Whole Study - Observed Residents
Arm/Group Description Care home (long-stay) residents observed for adverse drug reactions.
Measure Participants 30
Mean (Standard Deviation) [minutes]
27.7
(12.0)
3. Secondary Outcome
Title Number of Problems Identified Per Resident
Description Signs and symptoms of prescribed medicines as listed as undesirable effects in manufacturers' Summaries of Product Characteristics.
Time Frame up to 1 hour

Outcome Measure Data

Analysis Population Description
Observed resident/ care-giver interaction.
Arm/Group Title Whole Study - Observed Residents
Arm/Group Description Care home (long-stay) residents observed for adverse drug reactions.
Measure Participants 30
Mean (Standard Deviation) [problems / resident]
17.5
(7.1)
4. Secondary Outcome
Title Number of Changes to Care by Nurses Identified Per Resident
Description Measures taken to alleviate signs and symptoms of prescribed medicines as listed as undesirable effects in manufacturers' Summaries of Product Characteristics.
Time Frame up to 4 weeks

Outcome Measure Data

Analysis Population Description
Observed resident/ care-giver interaction.
Arm/Group Title Whole Study - Observed Residents
Arm/Group Description Care home (long-stay) residents observed for adverse drug reactions.
Measure Participants 30
Mean (Standard Deviation) [care changes / resident]
2.3
(1.6)
5. Secondary Outcome
Title Number of Pharmacist Recommendations for Prescription Review Per Resident
Description Recommendations to optimise prescription regimens. These included specific points to review or change.
Time Frame up to 4 weeks

Outcome Measure Data

Analysis Population Description
Observed resident/ medicines charts reviewed in conjunction with the ADRe profile.
Arm/Group Title Whole Study - Observed Residents
Arm/Group Description Care home (long-stay) residents observed for adverse drug reactions.
Measure Participants 30
Mean (Standard Deviation) [recommended changes / resident]
3.8
(2.1)
6. Secondary Outcome
Title Number of Drug Interactions Per Resident
Description Regimen entered into the BNF drug interactions checker, and number of interactions flagged up were used for this outcome measure.
Time Frame up to 4 weeks

Outcome Measure Data

Analysis Population Description
Observed resident/ medicines charts reviewed.
Arm/Group Title Whole Study - Observed Residents
Arm/Group Description Care home (long-stay) residents observed for adverse drug reactions.
Measure Participants 30
Mean (Standard Deviation) [drug interactions / resident]
6.1
(5.7)

Adverse Events

Time Frame 7 months study period.No adverse events related to the intervention reported.
Adverse Event Reporting Description non drug trial. Adverse events from using the ADRe Profile were sought from care-givers at the end of the study. No adverse events were reported. Interviewees were not evaluated for adverse events associated with the study.
Arm/Group Title Observed Residents
Arm/Group Description This observation study had only one arm (intervention).
All Cause Mortality
Observed Residents
Affected / at Risk (%) # Events
Total 0/30 (0%)
Serious Adverse Events
Observed Residents
Affected / at Risk (%) # Events
Total 0/30 (0%)
Other (Not Including Serious) Adverse Events
Observed Residents
Affected / at Risk (%) # Events
Total 0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title sue jordan
Organization swansea university
Phone +44 (0) 1792 518541
Email s.e.jordan@swansea.ac.uk
Responsible Party:
Professor Sue Jordon, Prof Susan Jordan, Swansea University
ClinicalTrials.gov Identifier:
NCT03110471
Other Study ID Numbers:
  • SwanseaUCHHS
First Posted:
Apr 12, 2017
Last Update Posted:
Jun 24, 2020
Last Verified:
Jun 1, 2020