One-Day Prevalence Study on Pressure Injuries in Intensive Care Units

Pressure Injury Clinical Trial

— DecubICUs  

Official title:

Multicentre International One-Day Prevalence Study on Pressure Injuries in Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270345
• Other study ID #: DecubICUs
• Status: Completed
• Start date: May 15, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: European Society of Intensive Care Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to provide an up-to-date, global picture of the extent and patterns of pressure injuries in ICUs. Point prevalence studies are only of value when performed on a vast scale. To sample a representative cohort, it is the intention to recruit about 1200 ICUs with all continents covered and as many countries as possible within each continent.

Description:

The objective is to provide an up-to-date, international "global" picture of the extent and patterns of pressure injuries in ICUs. Thereto , the plan is to perform a 1-day, prospective, multicenter point-prevalence study. The large scale of the project should allow thorough epidemiological analyses. More precisely the study will enable to identify:

• major risk factors for pressure ulcer development;

• preventive measures used in distinct ICU populations and countries;

• shortages in the availability of evidence-based measures to prevent pressure sores;

• malpractice pressure sore prevention in particular regions or countries;

• occurrence rates of pressure ulcers with/without accurate adjustment for risk profile and preventive measures taken;

• benchmarking between regions/countries; clinical outcomes associated with pressure ulcers (major organ derangements and mortality);

• economic outcomes associated with pressure ulcers (length of ICU stay) and linking these outcomes with local practice regarding prevention measures applied/available.

• country and regional differences in prevalence of pressure ulcers and outcome.

Pressures ulcer stages will be graded following the classification system jointly developed by the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel.

Data to be recorded include patient demographics, data on severity of underlying disease and acute illness, organ failure, pressure ulcers, major risk factors for pressure ulcers, and measures taken to prevent pressure ulcers.

Statistical Plan

Power Calculation. For a risk factor with a prevalence in the study cohort of only 10% (for example patients with a BMI<20) and an outcome difference of only 5% to be statistically significant(15% vs. 20% in decubitus occurrence rate), a sample size of 5255 patients is required (478 patients with the index risk factor and 4777 without) (alpha=0.05; Beta>0.80).

Data cleaning &missing data. Exceptional values will be traced through distribution plotting. In case of uncertainties, the individual investigators will be contacted. Missing data will be handled by imputation (1, 2). Data quality checks will be performed, such as checks on completeness, consistency, correctness, and uniqueness.

Descriptives. A single final analysis is planned at the end of the study; no interim analyses are planned. Socio-demographic study cohort characteristics will be described as proportions for categorical variables and for continuous variables as mean and standard deviation if normally distributed or median and inter-quartile range if not normally distributed (according to the Kolmogorov-Smirnov test for normality).

The proportion of patients with decubitus (percentage, %, and their 95% confidence intervals) will be reported overall and according to geographic region (continent), country classification by income as defined by The World Bank (high-, upper-middle-, lower-middle-, and low-income countries), percentage of the gross domestic product spent on healthcare (obtained from the World Health Organization), and according to theEducation and Health Human Development Report of the United Nations Development Program. Subsequently, potentialdifferences in prevalence might offer the opportunity to evaluate variances in prevention measures on a large scale.

Modelling. Covariates that will be evaluated on their relationship with the presence of decubitus encompass various organizational aspects of the ICU (e.g. nurse-to-patient ratio), decubitus prevention measures (e.g. type of matrasses used), and patient-specific characteristics (e.g. age, underlying conditions, severity of acute illness, body morphology, BMI,length of ICU stay etc.). Covariates will be considered for adjusted analysis when they have an association with pressure injuries at a statistical level <0.25 in unadjusted (univariate) analysis or because of their clinical relevance. A stepwise approach willbe used to eliminate terms from the regression model; p<0.15 or p<0.10 will beset as the limit to keep covariates in the model.

Relationships with binary outcome variables (e.g. decubitus, mortality) will be assessed by means of unadjusted statistical tests and multivariate logistic regression. The value of additional propensity score correction in the regression model will be assessed. Multinomial logistic regression will be performed to assess independent relationships with decubitus stages. Likewise, linear mixed-effect modelling will be used to assess unadjusted and adjusted relationships with continuous outcome variables (e.g. length of ICU stay and length of hospitalization). Results of logistic regression will be reported as adjusted odds ratios with 95% confidence intervals.

To develop a decubitus prediction model for distinct ICU populations (e.g., trauma, surgical or medical patients) models will be build using machine learning techniques (e.g. Random Forest, Gradient Boosting Machine). In the process different techniques will be applied in order to receive the optimal accuracy. In order to gain insight in the correlation between predictors and variables, regression techniques will be applied, as state above.

For validation of our models the study cohort will be split into a training, test and validation set. As such this gives a fair interpretation of the results. Alternatively ten-fold cross-validation can be applied to prevent overfitting.

Benchmarking for individual centers based on decubitus will be performed by providing directly or indirectly standardized risks based on fixed center effects in a logistic regression model (3, 4). Besides the presence of the binary quality outcome (i.e. decubitus) and the center code, this model also includes patient-specific baseline co-variates to adjust for differential case-mix. The Firth correction will be applied to the logistic regression model to maintain convergence in the presence of very small centers (5).

Statistical analysis will be performed using SPSS and R. The head investigator (SB) is responsible for all statistical analysis. Advanced statistical methods will be executed byMiekeDeschepper (Strategic Policy Cell at Ghent University Hospital).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13340
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients (>18 years of age) present on the date of data collection

Exclusion Criteria:

• There are no exclusion criteria. All patients should be included. Patients with severe clinical conditions not allowing safe pressure ulcer identification should not be evaluated for the respective risk zones. If it is known that the patient has a pressure ulcer at the body sites that cannot be safely evaluated, the stage of the pressure ulcer should be recorded as previously known. If it is unknown whether the patient has a pressure ulcer at these body sites, this should be indicated with a '?' in the Case Report Form

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Belgium	All Centers From All Over the World Willing to Contribute Are Welcome	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
European Society of Intensive Care Medicine

Country where clinical trial is conducted

Belgium, 

References & Publications (15)

Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age Ageing. 2004 May;33(3):230-5. — View Citation

Blot S, Cankurtaran M, Petrovic M, Vandijck D, Lizy C, Decruyenaere J, Danneels C, Vandewoude K, Piette A, Vershraegen G, Van Den Noortgate N, Peleman R, Vogelaers D. Epidemiology and outcome of nosocomial bloodstream infection in elderly critically ill patients: a comparison between middle-aged, old, and very old patients. Crit Care Med. 2009 May;37(5):1634-41. doi: 10.1097/CCM.0b013e31819da98e. — View Citation

European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel (2009) Prevention and treatment of pressure ulcers: quick reference guide. National Pressure Ulcer Advisory Panel, Washington DC

Firth D: Bias Reduction of Maximum Likelihood Estimates.Biometrika Vol. 80, No. 1 (Mar., 1993), pp. 27-38

Harvey SE, Parrott F, Harrison DA, Bear DE, Segaran E, Beale R, Bellingan G, Leonard R, Mythen MG, Rowan KM; CALORIES Trial Investigators. Trial of the route of early nutritional support in critically ill adults. N Engl J Med. 2014 Oct 30;371(18):1673-84. doi: 10.1056/NEJMoa1409860. Epub 2014 Oct 1. — View Citation

Iranmanesh S, Rafiei H, Sabzevari S. Relationship between Braden scale score and pressure ulcer development in patients admitted in trauma intensive care unit. Int Wound J. 2012 Jun;9(3):248-52. doi: 10.1111/j.1742-481X.2011.00852.x. Epub 2011 Sep 13. — View Citation

Keller BP, Wille J, van Ramshorst B, van der Werken C. Pressure ulcers in intensive care patients: a review of risks and prevention. Intensive Care Med. 2002 Oct;28(10):1379-88. Epub 2002 Sep 7. Review. — View Citation

Manzano F, Navarro MJ, Roldán D, Moral MA, Leyva I, Guerrero C, Sanchez MA, Colmenero M, Fernández-Mondejar E; Granada UPP Group. Pressure ulcer incidence and risk factors in ventilated intensive care patients. J Crit Care. 2010 Sep;25(3):469-76. doi: 10.1016/j.jcrc.2009.09.002. Epub 2009 Oct 30. — View Citation

Matos LS, Duarte NLV, Minetto RdCs, (2010) Incidence and prevalence of ulcer for pressure in CTI of a Public Hospital of DF. Revista Eletronica de Enfermagem 12: 719-726

Nijs N, Toppets A, Defloor T, Bernaerts K, Milisen K, Van Den Berghe G. Incidence and risk factors for pressure ulcers in the intensive care unit. J Clin Nurs. 2009 May;18(9):1258-66. doi: 10.1111/j.1365-2702.2008.02554.x. Epub 2008 Dec 11. — View Citation

Schafer JL, Olsen MK. Multiple Imputation for Multivariate Missing-Data Problems: A Data Analyst's Perspective. Multivariate Behav Res. 1998 Oct 1;33(4):545-71. doi: 10.1207/s15327906mbr3304_5. — View Citation

Schafer JL. Multiple imputation: a primer. Stat Methods Med Res. 1999 Mar;8(1):3-15. Review. — View Citation

Terekeci H, Kucukardali Y, Top C, Onem Y, Celik S, Oktenli C. Risk assessment study of the pressure ulcers in intensive care unit patients. Eur J Intern Med. 2009 Jul;20(4):394-7. doi: 10.1016/j.ejim.2008.11.001. Epub 2008 Dec 6. — View Citation

Van Messem M, Varewyck M: Evaluating hospital peformance Risk Standard package. Ghent: Ghent University; 2015

Varewyck M, Vansteelandt S, Eriksson M, Goetghebeur E. On the practice of ignoring center-patient interactions in evaluating hospital performance. Stat Med. 2016 Jan 30;35(2):227-38. doi: 10.1002/sim.6634. Epub 2015 Aug 24. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major risk factors for pressure injury development.	Pressures injury stages will be graded following the classification system jointly developed by the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, and Pan Pacific Pressure Injury Alliance. Data to be recorded include patient demographics, data on severity of underlying disease and acute illness, organ failure, pressure ulcers, major risk factors for pressure ulcers, and measures taken to prevent pressure injuries.	on the data collection day of 18 May 2018 (84 days follow-up)