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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03110471
Recruitment Status : Completed
First Posted : April 12, 2017
Results First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
Abertawe Bro Morgannwg University Health Board
Information provided by (Responsible Party):
Professor Sue Jordon, Swansea University

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
Dementia Behavioral: West Wales Adverse Drug Reaction (WWADR) Profile Behavioral: usual care

Show Show detailed description

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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 : March 1, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time for ADRe Administration (Including Interruptions) in Minutes [ Time Frame: up to 1 hour ]
    Assessed by researchers observing resident/ care-giver interaction.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110471


Locations
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United Kingdom
Llys Gywn Residential Home
Cardiff., Cardiff, Wales, United Kingdom, CF33 4PN
Monkstone House
Cardiff, Wales, United Kingdom, CF36 3HU
Danygraig House
Cardiff, Wales, United Kingdom, CF36 5SR
Neuadddrymmau care home
Swansea, Wales, United Kingdom, SA10 6NR
Cefnlodge Care Home
Swansea, Wales, United Kingdom, SA10 6YR
Swn-y-mor care home
Swansea, Wales, United Kingdom, SA12 7PH
Glangarnant care home
Swansea, Wales, United Kingdom, SA18 1UF
Fieldbay Ltd
Swansea, Wales, United Kingdom, SA79LA
Three Cliffs Care Home
Swansea, United Kingdom, SA3 2HQ
Glais Care Home
Swansea, United Kingdom, SA79EN
Sponsors and Collaborators
Swansea University
Abertawe Bro Morgannwg University Health Board
  Study Documents (Full-Text)

Documents provided by Professor Sue Jordon, Swansea University:
Study Protocol  [PDF] November 1, 2016
No Statistical Analysis Plan (SAP) exists for this study.

Additional Information:
Study Data/Documents: Publications  This link exits the ClinicalTrials.gov site
Prof Sue Jordan- publication list

Publications of Results:
Other Publications:
Aitken M. & Valkova S. (2013). Avoidable costs in US Healthcare. IMS Institute for Healthcare Informatics, Parsippany, NJ, USA
Francis, 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

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Responsible Party: Professor Sue Jordon, Prof Susan Jordan, Swansea University
ClinicalTrials.gov Identifier: NCT03110471    
Other Study ID Numbers: SwanseaUCHHS
First Posted: April 12, 2017    Key Record Dates
Results First Posted: June 24, 2020
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Sue Jordon, Swansea University:
Cognitive impairment
antipsychotics
antidepressants
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders