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

OBJECTIVES

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.

DESIGN

A preliminary study to test the feasibility of an RCT.

SETTING

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

PARTICIPANTS

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

INTERVENTIONS: 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.

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

RESULTS

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.

CONCLUSIONS

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.

TRIAL REGISTRATION NUMBER: NCT04663360; Pre-Results.