NCT03110471

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

Completed Results posted Last updated 24 June 2020

What this trial tests

trial testing West Wales Adverse Drug Reaction (WWADR) Profile in Dementia in 60 participants. Completed in 30 March 2018.

Timeline

1 March 2017

Primary endpoint
30 March 2018

30 March 2018

Quick facts

Lead sponsor	Swansea University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	60
Start date	1 March 2017
Primary completion	30 March 2018
Estimated completion	30 March 2018
Sites	10 locations across United Kingdom

Drugs / interventions tested

• West Wales Adverse Drug Reaction (WWADR) Profile
• usual care

Conditions studied

• Dementia — all drugs for Dementia →

Sponsor

Swansea University

Who can join

Adults 18 to 105, any sex, with Dementia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Drug Reactions (ADRs) Treated Primary · 6 months

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

Group	Value	95% CI
Whole Study - Observed Residents	30

Time for ADRe Administration (Including Interruptions) in Minutes Secondary · up to 1 hour

Assessed by researchers observing resident/ care-giver interaction.

Group	Value	95% CI
Whole Study - Observed Residents	27.7	± 12.0

Number of Problems Identified Per Resident Secondary · up to 1 hour

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

Group	Value	95% CI
Whole Study - Observed Residents	17.5	± 7.1

Number of Changes to Care by Nurses Identified Per Resident Secondary · 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.

Group	Value	95% CI
Whole Study - Observed Residents	2.3	± 1.6

Number of Pharmacist Recommendations for Prescription Review Per Resident Secondary · up to 4 weeks

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

Group	Value	95% CI
Whole Study - Observed Residents	3.8	± 2.1

Number of Drug Interactions Per Resident Secondary · up to 4 weeks

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

Group	Value	95% CI
Whole Study - Observed Residents	6.1	± 5.7

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Jordan S, Banner T, Gabe-Walters M, Mikhail JM, et al · · 2019 · cited 21× · PMID 31509537 · DOI 10.1371/journal.pone.0220885
2. 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.
   Jordan S, Banner T, Gabe-Walters M, Mikhail JM, et al · · 2018 · cited 9× · PMID 30269073 · DOI 10.1136/bmjopen-2018-023377