A complex intervention to promote prevention of delirium in older adults by targeting caregiver's participation during and after hospital discharge - study protocol of the TRAnsport and DElirium in older people (TRADE) project

Abstract

Background: Among potentially modifiable risk factors for delirium, transfers between wards, hospitals and other facilities have been mentioned with low evidence. TRADE (TRAnsport and DElirium in older people) was set up to investigate i) the impact of transfer and/or discharge on the onset of delirium in older adults and ii) feasibility and acceptance of a developed complex intervention targeting caregiver's participation during and after hospital discharge or transfer on cognition and the onset of delirium in older adults.

Methods: The study is designed according to the guidelines of the UK Medical Research Council (MRC) for development and evaluation of complex interventions and comprises two steps: development and feasibility/piloting. The development phase includes i) a multicenter observational prospective cohort study to assess delirium incidence and cognitive decline associated with transfer and discharge, ii) a systematic review of the literature, iii) stakeholder focus group interviews and iv) an expert workshop followed by a Delphi survey. Based on this information, a complex intervention to better and systematically involve family caregivers in discharge and transport was developed. The intervention will be tested in a pilot study using a stepped wedge design with a detailed process and health economic evaluation. The study is conducted at four acute care hospitals in southwest Germany. Primary endpoints are the delirium incidence and cognitive function. Secondary endpoints include prevalence of caregiver companionship, functional decline, cost and cost effectiveness, quality of discharge management and quality of admission management in admitting hospitals or nursing homes. Data will be collected prior to discharge as well as after 3, 7 and 90 days.

Discussion: TRADE will help to evaluate transfer and discharge as a possible risk factor for delirium. In addition, TRADE evaluates the impact and modifiability of caregiver's participation during patient's transfer or discharge on delirium incidence and cognitive decline providing the foundation for a confirmatory implementation study.

Trial registration: DRKS (Deutsches Register für klinische Studien) DRKS00017828 . Registered on 17th September 2019. Retrospectively registered.

Keywords: Caregiver; Complex intervention; Delirium; Dementia; Discharge; Family; Geriatrics; Older adults; Transfer; Transport.

Fig. 1

Project overview. TRADE consists of three parts

Fig. 2

Delirium prevention and intervention strategies with eight major items (8-item-program)

Fig. 3

Elements of intervention in the timeline of discharge management. Legend: Green boxes: timeline of discharge planning; white boxes: involvement of caregivers, number in brackets: aspect of 8-item-program; blue boxes: involvement of nurses/ ward secretaries; orange boxes: involvement of health care professional depending on the procedures of hospital (responsibility of nurses/physician/discharge manager/social services/etc.); grey circle: Intervention elements

Fig. 4

Study timelines. Legend: White boxes: Assessment time point in observation and intervention trial T0, T1, T2 and T3 with approximated assessment time per assessed group (patient/primary caregiver/nurse); grey boxes: intervention, process evaluation and additional data collection

Fig. 5

Framework of process evaluation, adapted from Moore et al. [57]. Legend: Grey boxes: Focus of process evaluation and key questions; white boxes: Type of data collection