HELP! Problems in executing a pragmatic, randomized, stepped wedge trial on the Hospital Elder Life Program to prevent delirium in older patients

Trials
Noor HeimMarieke J Schuurmans

Abstract

A pragmatic, stepped wedge trial design can be an appealing design to evaluate complex interventions in real-life settings. However, there are certain pitfalls that need to be considered. This paper reports on the experiences and lessons learned from the conduct of a cluster randomized, stepped wedge trial evaluating the effect of the Hospital Elder Life Program (HELP) in a Dutch hospital setting to prevent older patients from developing delirium. We evaluated our trial which was conducted in eight departments in two hospitals in hospitalized patients aged 70 years or older who were at risk for delirium by reflecting on the assumptions that we had and on what we intended to accomplish when we started, as compared to what we actually realized in the different phases of our study. Lessons learned on the design, the timeline, the enrollment of eligible patients and the use of routinely collected data are provided accompanied by recommendations to address challenges. The start of the trial was delayed which caused subsequent time schedule problems. The requirement for individual informed consent for a quality improvement project made the inclusion more prone to selection bias. Most units experienced major difficulties in including ...Continue Reading

References

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Citations

Sep 27, 2018·Upsala Journal of Medical Sciences·Rolf GedeborgTomas Salmonson
May 10, 2020·International Journal of Epidemiology·Karla Hemming, Monica Taljaard
Feb 23, 2021·Clinical Trials : Journal of the Society for Clinical Trials·William J CraggSally P Stenning
Jul 20, 2021·The Cochrane Database of Systematic Reviews·Jennifer K BurtonTerry J Quinn
Jun 26, 2021·American Journal of Respiratory and Critical Care Medicine·Paul J T RoodUNKNOWN UNDERPIN-ICU Study Investigators
Nov 27, 2021·The Cochrane Database of Systematic Reviews·Jennifer K BurtonTerry J Quinn
Mar 19, 2021·Revista colombiana de psiquiatría·José G FrancoJuan David Velasquez Tirado

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Software Mentioned

HELP
R
Excel
lme4

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