Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions

TL;DR

This study tested the feasibility of a trial using the ADRe Profile to identify and address adverse drug reactions in older patients in UK primary care.

Contribution

The study demonstrates the feasibility of using the ADRe Profile in a cluster randomized trial despite low clinician engagement.

Findings

Recruitment of GP practices was very low (0.94%), but patient recruitment and retention were successful.

The ADRe Profile identified numerous clinical issues not previously recorded in patient records.

Despite limited clinician engagement, the ADRe Profile showed potential for clinical impact and was cost-effective.

Abstract

We aimed to investigate the feasibility of a cluster randomised controlled trial (RCT) of the ADRe Profile in UK primary care. The ADRe Profile is a patient monitoring system to identify and address adverse drug reactions (ADR) and ADR-related issues to pre-empt clinical deterioration.

A preliminary study to test the feasibility of an RCT.

General practices (GPs) in South-West Wales, UK.

20 patients aged >64 and prescribed >4 long-term medicines.

Participants reported their health-related problems using the ADRe-Profile. Participants completed the profile independently initially, then with researcher support, capturing vital signs, clinical observations and patient-reported symptoms.

Feasibility was assessed based on recruitment, retention, adherence to protocols, potential for clinical impact and staff costs.

We recruited two GP practices (0.94% of 213 contacted), and 20 patients aged >64 (51.3% of those approached). Retention was 100%. ADRe Profiles had a 98.29% completion rate, identifying 289 clinical problems, including pain (16 of 20 patients), dyspnoea (10/20), dizziness (8/20), bleeding/bruising (7/20) and falls (4/20). Most problems (90%) and vital signs (78%) recorded on ADRe Profiles were absent from existing patient records. Researchers recommended further investigations (164 instances) and interventions (126 suggestions). Despite the potential for clinical benefits, engagement from clinicians was limited. Cost estimates for ADRe administration ranged from £40 to £73, within the funding available from Health and Care Research Wales.

An RCT of the ADRe Profile was feasible, despite gatekeeping by clinicians. Recruitment of GP practices was challenging, with <1% of eligible practices participating. In contrast, patient recruitment and retention were successful. ADRe aligns with WHO patient safety goals and could improve healthcare by addressing ADR-related problems proactively in this vulnerable population.

NCT04663360; Pre-Results.

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