Design and methods of the Hospital Elder Life Program (HELP), a multicomponent targeted intervention to prevent delirium in hospitalized older patients: efficacy and cost-effectiveness in Dutch health care.

Background: The Hospital Elder Life Program (HELP) has been shown to be highly efficient and (cost-)effective in reducing delirium incidence in the USA. HELP provides multicomponent protocols targeted at specific risk factors for delirium and introduces a different view on care organization, with trained volunteers playing a pivotal role. The primary aim of this study is the quantification of the (cost-)effectiveness of HELP in the Dutch health care system. The second aim is to investigate the experiences of patients, families, professionals and trained volunteers participating in HELP.

Methods/design: A multiple baseline approach (also known as a stepped-wedge design) will be used to evaluate the (cost-) effectiveness of HELP in a cluster randomized controlled study. All patients aged 70 years and older who are at risk for delirium and are admitted to cardiology, internal medicine, geriatrics, orthopedics and surgery at two participating community hospitals will be included. These eight units are implementing the intervention in a successive order that will be determined at random. The incidence of delirium, the primary outcome, will be measured with the Confusion Assessment Method (CAM). Secondary outcomes include the duration and severity of delirium, quality of life, length of stay and the use of care services up to three months after hospital discharge. The experiences of patients, families, professionals and volunteers will be investigated using a qualitative design based on the grounded theory approach. Professionals and volunteers will be invited to participate in focus group interviews. Additionally, a random sample of ten patients and their families from each hospital unit will be interviewed at home after discharge.

Discussion: We hypothesize that HELP will reduce delirium incidence during hospital admission and decrease the duration and severity of delirium and length of hospital stays among these older patients, which will lead to reduced health care costs. The results of this study may fundamentally change our views on care organization for older patients at risk for delirium. The stepped-wedge design was chosen for ethical, practical and statistical reasons. The study results will be generalizable to the Dutch hospital care system, and the proven cost-effectiveness of HELP will encourage the spread and implementation of this program.

Trial Registration: Netherlands Trial register: NTR3842.