| Literature DB >> 35887739 |
Dino Stefano Di Massimo1, Gianluca Catania2,3, Annachiara Crespi4, Andrea Fontanella5, Dario Manfellotto6, Micaela La Regina7, Stefano De Carli8, Laura Rasero9,10, Claudia Gatta1, Giovanna Pentella11, Gabriella Bordin12, Antonella Croso1, Annamaria Bagnasco2, Gualberto Gussoni4, Daiana Campani13, Erica Busca14, Danila Azzolina13, Alberto Dal Molin13,14.
Abstract
The aim of the study was to explore the effects of Intentional Rounding, a regular-based proactive patient monitoring, on falls and pressure ulcers in internal medicine units. This is a cluster-randomised controlled study, where units were assigned (1:1) to Intentional Rounding (intervention group) or Standard of Care (control group). The primary outcome was the cumulative incidence of falls and new pressure ulcers. These events were considered separately as secondary endpoints, together with the number of bell calls and the evaluation of patient satisfaction. Primary analyses were carried out on the modified intention-to-treat population (hospitalisation of at least 10 days). Recruitment occurred between October 2019 and March 2020, at which time the study was prematurely closed due to the COVID-19 pandemic. Enrolment totalled 1822 patients at 26 sites; 779 patients were included in the modified intention-to-treat analysis. The intervention group had a lower risk of falls (adjusted incidence rate ratio 0.14; 95% confidence interval, 0.02-0.78; p = 0.03). There were no statistical differences in new pressure ulcers or the cumulative incidence of both adverse events. Mean bell calls for each patient were 15.4 ± 24.1 in the intervention group and 13.7 ± 20.5 in the control group (p = 0.38). Additionally, patient satisfaction in the intervention group was almost at the maximum level. Our study supports the usefulness of Intentional Rounding in a complex and vulnerable population such as that hospitalised in internal medicine units.Entities:
Keywords: accidental falls; internal medicine; nursing care; pressure ulcers; randomised controlled trial; safety
Year: 2022 PMID: 35887739 PMCID: PMC9320400 DOI: 10.3390/jcm11143976
Source DB: PubMed Journal: J Clin Med ISSN: 2077-0383 Impact factor: 4.964
Figure 1Trial profile. The modified intention-to-treat population included the set of patients who had a duration of hospitalisation of at least 10 days.
Baseline characteristics of the modified intention-to-treat population.
| Intentional Rounding (n = 400) | Standard of Care (n = 379) | ||
|---|---|---|---|
| Age (years) | 81 (74–87) | 77 (69–84) | <0.0001 |
| Sex | 0.994 | ||
| Male | 187 (47%) | 178 (47%) | |
| Female | 213 (53%) | 201 (53%) | |
| Origin | 0.147 | ||
| Home | 311 (78%) | 316 (83%) | |
| Other | 89 (22%) | 63 (17%) | |
| Chronic/acute diseases | |||
| Cardiovascular | 228 (57%) | 216 (57%) | 0.966 |
| Endocrine/metabolic | 116 (29%) | 149 (39%) | 0.002 |
| Gastroenteropancreatic | 62 (16%) | 64 (17%) | 0.587 |
| Malignancy | 84 (21%) | 91 (23%) | 0.304 |
| Neuropsychiatric | 71 (18%) | 50 (13%) | 0.082 |
| Osteoarticular | 80 (20%) | 71 (18%) | 0.669 |
| Respiratory | 153 (38%) | 104 (27%) | 0.001 |
| Barthel Index | 45 (15–75) | 55 (25–95) | 0.001 |
| History of falls | 106 (27%) | 72 (19%) | 0.011 |
| Morse Scale | 35 (25–55) | 35 (15–50) | <0.0001 |
| Length of hospital stay (days) | 14 (12–17) | 14 (11–19) | 0.080 |
| 10–15 days | 266 (66%) | 222 (59%) | |
| 16–20 days | 74 (19%) | 79 (20%) | |
| More than 20 days | 60 (15%) | 78 (20%) |
Continuous data are reported as median (interquartile range) and categorical data as absolute frequencies (percentage). Wilcoxon-type tests were performed for continuous variables and the Pearson chi-square test, or Fisher’s exact test, whichever was appropriate, was performed for categorical variables.
Study outcomes in the modified intention-to-treat population.
| Outcomes | IR | CG | Observed IRR | NBM | |
|---|---|---|---|---|---|
| Composite outcome | 28 | 42 | 0.7 | 0.5 (0.15–1.67) | 0.26 |
| Falls | 4 | 19 | 0.22 | 0.14 (0.02–0.78) | 0.03 |
| Bedsores | 24 | 23 | 1.1 | 1 (0.26–3.60) | 0.98 |
Legend: CG—control group; IR—Intentional Rounding; IRR—incidence rate ratio; NBM—negative binomial model. The person-time in the modified intention-to-treat population was 6207 and 6537 days in the Intentional Rounding and Standard of Care group, respectively.
Figure 2Cumulative number of hospital stay events in the two patient populations. (a)—falls; (b)—new pressure ulcers; (c)—composite endpoint.