Objective: To assess the clinical effect of medication monitoring using the West Wales Adverse Drug Reaction (ADR) Profile for Respiratory Medicine.
Design: Single-site parallel-arm pragmatic trial using stratified randomisation.
Setting: Nurse-led respiratory outpatient clinic in general hospital in South Wales.
Participants: 54 patients with chronic respiratory disease receiving bronchodilators, corticosteroids or leukotriene receptor antagonists.
Intervention: Following initial observation of usual nursing care, we allocated participants at random to receive at follow up: either the West Wales ADR Profile for Respiratory Medicine in addition to usual care ('intervention arm' with 26 participants); or usual care alone ('control arm' with 28 participants).
Main outcome measures: Problems reported and actions taken.
Results: We followed up all randomised participants, and analysed data in accordance with treatment allocated. The increase in numbers of problems per participant identified at follow up was significantly higher in the intervention arm, where the median increase was 20.5 [inter-quartile range (IQR) 13-26], while that in the control arm was -1 [-3 to +2] [Mann-Whitney U test: z = 6.28, p<0.001]. The increase in numbers of actions per participant taken at follow up was also significantly higher in the intervention arm, where the median increase was 2.5 [1]-[4] while that in the control arm was 0 [-1.75 to +1] [Mann-Whitney U test: z = 4.40, p<0.001].
Conclusion: When added to usual nursing care, the West Wales ADR Profile identified more problems and prompted more nursing actions. Our ADR Profile warrants further investigation as a strategy to optimise medication management.
Trial registration: Controlled-trials.com ISRCTN10386209.