Medication monitoring in a nurse-led respiratory outpatient clinic: pragmatic randomised trial of the West Wales Adverse Drug Reaction Profile.

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 21 [23 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 [2 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

Flow of participants through the trial.

<p>Flow of participants through the trial.</p

Trial design.

<p>Trial design.</p

Numbers of actions taken per participant: Outcome 2.2.

<p>Numbers of actions taken per participant: Outcome 2.2.</p

Additional file 2: Table S1. of Body mass index and type 2 diabetes in Thai adults: defining risk thresholds and population impacts

Baseline characteristics for participants versus non-participants. (DOCX 14 kb

Patient monitoring: number of participants with documentation of each problem.

<p>* Guidelines appended to the Profile offered definitions of acceptable ranges of measurement and standards. Guidelines are available on request.</p><p>2 participants joined late and 2 were lost to the study.</p

Recruitment, Retention, Demographics and Prescription medicines at study entry.

<p>* Categorisation follows a needs assessment. Service users are assessed by NHS nurses and designated as needing nursing care or residential care. Assessments are usually based on the Royal College of Nursing’s (2004) ‘Nursing assessment and Older People An RCN Toolkit’. London, RCN: <a href="http://www.rcn.org.uk/__data/assets/pdf_file/0010/78616/002310.pdf" target="_blank">http://www.rcn.org.uk/__data/assets/pdf_file/0010/78616/002310.pdf</a></p><p><b>**</b> Any combination preparations were counted as a single item. Enumerating the active ingredients of each product would have been impractical, particularly for antacids and multivitamins.</p><p>Recruitment, Retention, Demographics and Prescription medicines at study entry.</p

The medication chain.

<p>The medication chain.</p

Number of prescribed medicines in each step for each site.

<p>Bold text indicates roll-out of medicines’ monitoring and Profile administration 1 month before these data collection points (occasions when researchers extracted data from participants’ records). n = number of service users in the site. One participant from site 4 passed away between steps 3 & 4. One participant from site 5 was hospitalised between steps 3 & 4. Participants joined site 5 at steps 2 and 3. Problems explored are listed in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.t005" target="_blank">Table 5</a> and on the Profile, <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.s001" target="_blank">S1 Appendix</a>. Fuller versions of these tables, including medians and 25^th = 75^th centiles are in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.s007" target="_blank">S3 table</a>.</p

Problems addressed with and without the Profile: total numbers and examples.

<p>Visits to dentists and opticians were compared ‘before and after’ (see analysis and <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.t006" target="_blank">Table 6</a>). ADLs—activities of daily living.</p