The Adverse Drug Reaction (ADRe) Profile for Polypharmacy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Medication Monitoring for Older Adults in Primary Care

NCT04663360

Polypharmacy

COMPLETED NA

Adverse Drug Event Prevention Using Structured Pharmacist Review

NCT01467128

Adverse Drug Reactions

COMPLETED PHASE4

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

NCT03110471

Dementia

COMPLETED

Iatrogenic Drug Risk in People Over 75, With or Without Cognitive Disorders, From an Inventory of Their Family Pharmacy

NCT03686943

Elderly Iatrogenic Drug Risk

WITHDRAWN

Impact of Multidisciplinary Review of Drug Prescriptions on Patient Safety in a Residence for Dependent Elderly

NCT02118259

Geriatrics Residence for Dependent Elderly Health Services for the Aged

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Polypharmacy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participating care homes will receive the intervention at the same time. Residents' records and medicines charts will be reviewed sequentially.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Use of the intervention could not be blinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention

This is a single arm before and after study with data collection at 4 time points.

Group Type EXPERIMENTAL

Adverse Drug Reaction ADRe Profile for Polypharmacy

Intervention Type OTHER

PADRe 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adverse Drug Reaction ADRe Profile for Polypharmacy

PADRe 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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* • Resident at the care home and expected to continue to live there for 1 year

* Currently taking \>3 prescribed medicines daily
* Willing and able to give informed, signed consent themselves, or where capacity is lacking, a consultee is willing to give advice and assent to the resident participating.