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CompletedNCT03955133

The Adverse Drug Reaction (ADRe) Profile for Polypharmacy

Polypharmacy and Adverse Drug Reactions: Nurse-led Intervention to Minimise Adverse Drug Reactions for Older Adults in Care Homes: a Quality Improvement Process Intervention

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Swansea University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Polypharmacy, the use of multiple or inappropriate medications, has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations. The nurse-led intervention (The ADRe Profile) to review mental health medicines has demonstrated improved care quality by: identifying serious adverse drug reactions (ADRs); reducing prescription of mental health medicines; reducing the prevalence of pain and nausea; and, increasing non-urgent national health service (NHS) contacts. The investigators will develop ADRe to encompass medicines commonly prescribed in primary care and evaluate intervention implementation in care homes in Aneurin Bevan University Health Board.

Detailed description

The investigators will introduce medicines' monitoring using the PADRe Profile into up to 7 care homes, each with up to 26 residents prescribed \>4 medicines (estimated \~90% residents). Each home will identify a nurse lead and a deputy. Nurses will be asked to administer the PADRe Profile with all patients prescribed \>4 medicines. Barriers, facilitators, and feasibility of the Profile will be explored. This will identify how, in which contexts medicines' monitoring can be integrated into routine care, relate the Profile to improved processes and outcomes of care, and inform implementation strategies (see logic model in cited papers). Data collection: * Record review before and after each of 3 administrations of the intervention to identify clinical and prescription changes. Narrative accounts of problems causing moderate or severe harm will be prepared. * Serial interviews and debriefs with nurses: three per nurse. * Stakeholder interviews with patients, participating pharmacists and prescribers for an overview of implementation.

Conditions

Interventions

TypeNameDescription
OTHERAdverse Drug Reaction ADRe Profile for PolypharmacyPADRe 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 British National Formulary (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. A full description is published (references below).

Timeline

Start date
2018-12-18
Primary completion
2019-05-31
Completion
2020-12-31
First posted
2019-05-17
Last updated
2021-08-17
Results posted
2021-08-09

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03955133. Inclusion in this directory is not an endorsement.

The Adverse Drug Reaction (ADRe) Profile for Polypharmacy (NCT03955133) · Clinical Trials Directory