Medication Monitoring for Older Adults in Primary Care

Swansea University

Status: Completed

Conditions: Polypharmacy

Treatments: Other: Adverse Drug Reaction (ADRe) Profile

Study type: Interventional

Funder types: Other

Identifiers

NCT04663360

Swansea Nursing

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 64+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion criteria:

Patients:

• age > 64 years
• with a long-term condition
• prescribed > 5 medications daily. (Vitamin and nutritional supplements and moisturising skin preparations will not be counted as 'medicines'.)
• Willing and able to give informed, signed consent themselves, or where capacity is lacking in the opinion of their nurses, a consultee/representative accompanying the patient who is willing to give advice and assent to the service user participating and sign on their behalf.

Exclusion criteria

Patients:

• Age < 64 years
• Without any long-term conditions
• Prescribed < 5 medications daily
• Not willing to participate
• Unable to consent and no consultee/representative present
• Not fluent in English or Welsh (unless a family member can assist with translation)
• Receiving palliative care
• Expected to remain in the practice for the next 12 months

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Intervention

Experimental group

Description:

Intervention to be administered: Adverse Drug Reactions (ADRe) Profile. 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.

Treatment:

Other: Adverse Drug Reaction (ADRe) Profile

Control

No Intervention group

Description:

Usual clinical care.