Aneurin Bevan Health Board
Newport, Gwent, NP18 3XQ, United Kingdom
NCT Number: NCT04663360
Polypharmacy has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations. Many adverse drug reactions could be prevented with closer monitoring. This project will establish the effectiveness of the nurse-led intervention - the ADRe Profile - for medicines commonly prescribed in primary care and evaluate intervention implementation in general practices.
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Notify Me64 year and older
All sexes
Interventional
Not applicable
Newport, Gwent, NP18 3XQ, United Kingdom
The number of medicines people take is increasing. Older adults are particularly at risk of adverse drug reactions due to polypharmacy. Adverse drug reactions cause avoidable patient harm, and around 5-8% of unplanned hospital admissions in the UK, costing the NHS £1.5-2.5bn pa. Many adverse drug reactions could be prevented with closer monitoring. The nurse-led Adverse Drug Reactions Profile (ADRe Profile) represents a unique instrument that records patients' observations and self-reported information on signs and symptoms that is likely to relate to an adverse reaction to medications. This project will establish the effectiveness of ADRe Profile in identifying patient problems possibly resulting from medicines in general practices and will be implemented in 3 phases.
Phase 1 (4 months) Validity and reliability testing of the ADRe Profile will be performed with key stakeholders (patients, nurses, care assistants, GP's and pharmacists), before introducing the tool to general practices. Feasibility testing will also be undertaken.
Phase 2 (12 months) The aim of this phase is to test whether the ADRe Profile identifies and ameliorates health problems. The practice nurse (or the researcher) will perform an ADRe consultation with a group of eligible service users and compare the number and nature of health and well-being problems identified with a similar group of service users who receive normal care.
Phase 3 (6 months) Finally, to further explore the impact of the ADRe Profile, the researchers will conduct semi-structured interviews with health professionals (nurses, care assistants, GPs and pharmacists) and service users.
The investigators hope that this study will help patients gain maximum benefits from their medicines and support nurses, pharmacists and GP's to reduce any bothersome side effects and problems that, if not addressed promptly, can lead to hospital admissions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
Patients:
Exclusion criteria
Patients:
ADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts.
Time frame: 4 months from the start of the study
Comparison of completeness of the ADRe Profile completed through a video call with ADRe Profiles previously completed in person
Time frame: 4 months from the start of the study
To determine how much of the potential variability of the records is due to errors in measurement, to estimate a degree to which service users accurately evaluate their symptoms when compared with a nurse researcher. Cohen's Kappa will be calculated.
Time frame: 16 months from the start of the study
Establishing the overlap of information - the number and nature of the ADRe items that have previously been collected and recorded in the patients' nursing and medical notes.
Time frame: 16 months from the start of the study
Number of patients with a change in signs and symptoms related to adverse effects of prescribed medicines. Care quality/ clinical gain/ benefit to patients as recorded in notes and on the Profile by the number and nature of all health problems addressed, particularly serious adverse events.
Time frame: 16 months from the start of the study
Number of patients with changes in prescription regimens: drug or dose. Number and nature of changes.
Time frame: 22 months from the start of the study
A brief survey will be distributed to the main stakeholders (patients, nurses, GP's and pharmacists) following completion of Randomised Controlled Trial.
Time frame: 22 months from the start of the study
Semi-structured interview with the main stakeholders (patients, nurses, GP's and pharmacists) to explore their views on feasibility of ADRe Profile integration in GP practices.
Time frame: 16 months from the start of the study
Average length of the health professionals' time involvement with one ADRe Profile
Time frame: 16 months from the start of the study
Estimated costs of ADRe implementation in GP practices
Time frame: 22 months from the start of the study
Semi-structured interview with the main stakeholders (patients, nurses, GP's and pharmacists) to explore their views on whether and how ADRe Profile contributed to multidisciplinary collaboration between nurses, doctors and pharmacists
Time frame: 22 months from the start of the study
Semi-structured interview with the patients to seek their views on whether and how ADRe Profile contributes to patient-centered care
Swansea University
Other
Medication Monitoring in General Practice: Clinical Impact of Implementing a Nurse-led Adverse Drug Reaction (ADRe) Profile in Older Adults With 5 or More Prescribed Medicines
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