In this study (NCT04333303), we investigated whether a complex advance care planning (ACP) intervention improves care consistency with care preferences in nursing home residents. Forty-four German nursing homes were randomly assigned to an ACP intervention addressing the individual, institutional, and regional levels or to a control group (no intervention). The hospitalization rate over an observation period of 12 months (primary outcome) was analyzed as a surrogate for care consistency with care preferences at the nursing home level. Secondary outcomes comprised process-related and clinical parameters, including care consistency with care preferences (analysis level: residents/nursing homes). Outcomes were evaluated by means of Poisson and logistic regression models with incidence rate ratios (IRR) and odds ratios (OR) as effect estimators in an intention-to-treat analysis. Of 44 nursing homes, 23 received the intervention. The hospitalization rate did not differ between the two groups (IRR 1.0; 95% CI: [0.97; 1.1]) but declined to a similar extent in both during the COVID-19 pandemic. The consistency of care with care preferences was similar in both groups as well (OR 0.9 [0.4; 1.9]). The predefined exploratory analysis suggests that care consistency with care preferences was more likely in the 6 out of 23 nursing homes that met predefined adherence criteria (OR 1.9 [0.7; 5.3]). Written emergency plans were significantly more common in the intervention group (IRR 11.6 [8.2; 16.4]), and even more so in adherent nursing homes (IRR 30.1 [15.7; 57.6]). The intervention did not permeate sufficiently, especially due to the COVID-19 pandemic that may, in addition, have masked intrinsic shortcomings of the intervention. Thus, this trial does not allow a conclusive assessment of whether or not the intervention can promote care consistency with care preferences. However, exploratory analyses indicate that successful institutional implementation in conjunction with individual ACP conversations may increase care consistency with care preferences.
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