Care Consistency With Care Preferences in Nursing Homes

A Cluster-Randomized Study of the Effects of an Advance Care Planning Program (BEVOR)

Background: In this study (NCT04333303), we investigated whether a complex advance care planning (ACP) intervention improves care consistency with care preferences in nursing home residents.

Methods: 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.

Results: 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]).

Conclusion: 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.

Cite this as: Götze K, Bausewein C, Chernyak N, Feddersen B, Fuchs A, Hummers E, Icks A, Kirchner Ä, Klosterhalfen S, Kranefeld N, Laag S, Lezius S, Meyer G, Montalbo J, Nauck F, Pepić A, Przybylla S, Rosu I, Schildmann J, Schunk M, Stanze H, Stöhr A, Thilo N, Vogel C, Zapf A, Marckmann G, in der Schmitten J, on behalf of the BEVOR Study Consortium: Care consistency with care preferences in nursing homes: A cluster-randomized study of the effects of an advance care planning program (BEVOR). Dtsch Arztebl Int 2025; 122: 379–86. DOI: 10.3238/arztebl.m2025.0077

Conventional advance directives, i.e., those that are completed without facilitation and are confined to end-of-life scenarios, usually provide little guidance when the patient lacks decision-making capacity (1, 2, 3, 4, e1, e2, e3, e4). The concept of advance care planning (ACP) has been developed (5, 6, 7, 8, 9, e5) to increase the consistency of medical care with the care preferences of individual patients with incapacity to consent in life-threatening situations (e6). To promote care consistency with care preferences effectively, it has been suggested (10, 11, e7) that ACP should comprise behavioral and structural changes at three levels: individual (facilitated ACP conversations), institutional (organizational development), and regional (ACP networks) (7, 11, 12, 13).

However, only few trials—none of them in Germany—have yet evaluated the clinical impact of such complex ACP interventions on care consistency with care preferences in nursing homes (14, 15, 16, 17). While systematic reviews conclude that ACP may possibly decrease, among other unwanted outcomes, discordance between the care delivered and patients’ care preferences (in particular regarding hospital admissions and hospital deaths), the strain on relatives and nursing staff, net costs, study methods and the resulting evidence are inhomogeneous and often insufficient (13, 15, 18, 19, 20, 21).

In Germany, the costs of facilitated ACP conversations in nursing homes have been covered by statutory health insurance, as stipulated by § 132g of German Social Code V, since 2018 (22). In 2019, less than 10% of nursing homes had an ACP program in place (e8). Our study took advantage of this window of opportunity to investigate whether implementing a comprehensive ACP program, compared with care as usual, will result in nursing home residents’ care preferences being more often known and honored in life-threatening situations, i.e., in increasing the rate of care consistency with care preferences.

Methods

Design

This parallel-group, multicenter, cluster-randomized controlled trial (cRCT) was conducted in 44 German nursing homes over eight regions (Figure 1) between September 2019 and February 2023 with residents being the observation units clustered in nursing homes. The study received ethical approval and was registered prospectively (ClinicalTrials.gov ID: NCT04333303, 31 March 2020).

Figure 1

Consort flow diagram of study participants

The CONSORT statement for cRCT was applied (23, e9) (eTable 1). For further details of the methodology see (24).

Table 1

Baseline data for the intervention group (IG) and the control group (CG) at nursing home (cluster) and resident (observation unit) level

Study participants

The participating nursing homes had not yet implemented facilitated ACP. For the main analysis, all residents were included who lived in the nursing homes during the observation period (complete anonymous data collection [DC-1]). For secondary outcomes that required analysis of individual data (e.g., assessment of care consistency with care preferences), a subgroup of long-term care residents living in participating nursing homes at baseline were included in a separate data collection (DC-2) after giving their individual consent following written and oral information by trained staff. (For the sample size, see [24]).

Intervention

The complex ACP program, derived from Respecting Choices (25, e7) and earlier German and Swiss feasibility studies (14, 17) (Template for Intervention Description and Replication [26], see in [24]) encompassed interventions at the following levels (Figure 2):

Figure 2

Elements of the complex ACP program

• Individual level: facilitated ACP conversations and their documentation
• Institutional level: organizational development in the nursing homes to improve implementation of ACP
• Regional level: information, education and coordination of other relevant healthcare staff

The intervention elements were offered as planned. Due to the COVID-19 pandemic, the run-in phase of the intervention was extended from 9 to 18 months and the intervention was adapted to comply with pandemic control regulations.

Outcomes and measurements

The hospitalization rate was chosen as primary outcome (8) as a surrogate for care consistency delivered with care preferences, by reason of its availability in the aggregated data of the anonymous complete survey. Moreover, we assumed a substantial rate of unwanted hospital admissions which we expected to be reduced by the intervention (16, 27, e3). The secondary outcomes comprised the rate of care consistency with care preferences, selected life-sustaining treatments, place of death, and process parameters such as durable powers of attorney, advance directives, and advance directives by proxy [28] as well as written instructions for the event of an emergency (in the following: emergency plans) (e10). To measure the crucial (8) but methodologically challenging construct of the rate of care consistency with care preferences (29, 30, 31, e5, e11, e12, e13), we employed a specifically designed assessment tool (Box). A complete overview of outcomes and measurements can be found in eTable 2 and (24).

Box

Assessment tool for measuring care consistency with care preferences

Table 2

Hospitalization rate, advance directives, emergency plans, and proxy documents and care consistency with care preferences in the intentionto- treat analysis (2a–c) and the analysis of adherent populations (2d/2e)

Quality of life was measured as a safety parameter (WHOQOL-OLD [e14] or QUALIDEM [e15]). The psychological burden on bereaved family members was assessed using the Impact of Event Scale (revised) (33, e16) and the Hospital Anxiety and Depression Scale (German version) (34). For a complete overview see eTable 2 and (24).

Data collection

The data were collected between April 2020 and January 2023. DC-1 was based partly on routinely collected health data, partly on health data retrieved for this trial by trained nursing home staff and aggregated at nursing home level. For DC-2, trained study staff collected data by means of file analysis, interviews, and questionnaires. Blinding of study staff, peer review of the data, and external monitoring were accomplished in accordance with the study protocol (24).

Randomization

The nursing homes were randomly assigned to the intervention group (IG) or the control group (CG) on the basis of stratified (site and region) blockwise (with variable block length) 1:1 cluster randomization using a computer-generated list (24) .

Statistical analysis

The baseline characteristics were described by mean and standard deviation, median and interquartile range, or absolute and relative frequencies. All endpoints were analyzed with regression models according to their statistical distribution (independent variables: group and study site; covariate: the respective baseline measurement). For count variables and rate comparisons, Poisson regression considering the respective exposure was used and incidence rate ratios (IRR) were reported. Binary variables were assessed by means of logistic regression with reporting of odds ratios (OR), metric variables by means of linear regression models with reporting of mean differences. Effect estimators were reported with the corresponding 95% Wald confidence intervals and p-values. Mixed models with random intercepts (nursing home, resident, and life-threatening event) were used for variables relating to residents or treatment decisions.

The primary analysis followed the intention-to-treat (ITT) principle. The sensitivity analyses (primary outcome) comprised the per-protocol (PP) analysis and two adherence analyses (AA). In a predefined AA of DC-1, the IG was restricted to the adherent nursing homes. Adherence was judged by the rate of completed ACP processes plus achieved organizational and educational elements of institutional implementation, and was also used as a measure of intervention fidelity (eTable 3). For a post-hoc AA of DC-2, the IG was restricted to residents of the nursing homes with the most completed ACP processes (≥ median), regardless of institutional implementation. The impact of the COVID-19 pandemic on the hospitalization rate was assessed by investigating the time course in the CG (mixed Poisson regression; fixed factors: time point, random group, and their interaction, random intercept: nursing home; exposure: occupied bed days).

The secondary outcomes were evaluated exploratorily without multiplicity adjustment. The analyses were performed in accordance with the statistical analysis plan (SAP) published at clinicaltrials.gov (35). If the planned analyses were not possible for selected variables, the available data were evaluated descriptively.

Results

Study population

For DC-1, 44 nursing homes with all residents were included (5927 residents for the primary outcome). For DC-2, 892 residents were recruited (Figure 1). Selected baseline data are shown in Table 1 (for further details, see the eSupplement).

Hospitalization rate

During the observation period, 2015 hospitalizations were recorded in the IG, amounting to 798 876 occupied bed days, while in the CG there were 2023 hospitalizations (752 114 days). There was no significant difference in hospitalization rate between the two groups (Table 2a, eSupplement).

The PP population did not differ from the ITT population. Sensitivity analyses (35) revealed no relevant differences between the groups (eSupplement). In the COVID-19 pandemic analysis, hospitalizations decreased substantially in both groups (eSupplement).

ACP documentation

On the day of data collection, residents of the IG were more likely than those of the CG to have emergency plans in their charts (403/2,226 vs. 37/2,088); the difference was almost 12-fold (Table 2b, eSupplement).

Care consistency with care preferences

In the 662 (IG: 343, CG: 319) residents investigated in DC-2, consistency with preferences was evaluated for 656 (360 versus 296) critical treatment decisions in 550 (301 versus 249) potentially life-threatening events. No group difference was found with regard to care consistency with care preferences (Table 2c, eSupplement).

Further outcomes

Healthcare (e.g., resuscitation) and quality of life outcomes were comparable between the two groups (eSupplement).

Adherence analyses:

Effects of intervention fidelity

Only six of the 23 intervention nursing homes were adherent according to the predefined criteria (core elements of institutional implementation; see eTable 3), indicating overall poor permeation of the intervention. The six adherent nursing homes showed considerably higher rates of care consistency with care preferences than the control nursing homes, i.e., patients’ preferences were more often known and honored when it came to critical treatment decisions (Table 2d, eSupplement). At the same time, the intervention effect on the rate of emergency plans was almost three times higher in adherent nursing homes (IRR 30.1 [15.7; 57.6]) than in the ITT population (IRR 11.6 [8.2; 16.4]) (Table 2d, eSupplement). In contrast, ACP conversations alone, i.e., without institutional implementation, did not result in a group difference regarding care consistency with care preferences rates in a post-hoc analysis (Table 2e, eSupplement).

Discussion

The BEVOR trial is the first study in Germany and one of the few worldwide to have evaluated the clinical effects of a comprehensive ACP implementation focusing on nursing homes. Our complex intervention did not permeate as intended, and as a result the main analysis revealed no group differences in hospitalization rates (primary outcome) and other clinical outcomes that reflected the study’s objective, especially the rate of care consistency with care preferences. However, a predefined exploratory adherence analysis (AA) indicates that care consistency with care preferences did improve considerably in the adherent nursing homes.

Our results fit into a heterogeneous body of evidence. While ACP reliably increases the rate of advance directives in nursing homes (14, 15, 21), few trials have succeeded in achieving clinically relevant effects in this setting (20, 21, 36, 37). There is growing understanding that the necessary cultural change requires comprehensive interventions (11, 13, 18, 19), otherwise effects on clinical outcomes are unlikely (38).

While the BEVOR trial used such a comprehensive approach to ACP and a robust methodology, our ACP intervention was not taken up sufficiently to establish whether it has the potential to achieve the envisaged clinical outcomes or not. For example, only 19.4% of the residents in the IG had emergency plans in their chart (as a typical result of a completed ACP process). This is far below the envisaged 60% that we had deemed necessary for the intervention to show clinical effects.

The possible explanations for this insufficient permeation include intrinsic and extrinsic reasons. The most important extrinsic factor was the COVID-19 pandemic, which heavily impacted Germany from the onset of our study (March 2020) onwards: Numerous restrictions affecting nursing homes had far-reaching negative effects on multiple intervention elements, from individual ACP conversations all the way to institutional steering groups and educational events. Furthermore, our primary outcome, hospital admissions, dropped considerably in both groups due to the COVID-19 pandemic (e17). It is impossible to judge whether our intervention would have shown an effect without COVID-19.

Further possible extrinsic reasons include other system barriers (e.g., bureaucratic hurdles to refinancing of ACP facilitation from the statutory health insurance funds, staff shortages and turnover, insecurity on the part of staff in the face of life-threatening illnesses, insufficient palliative care) and lacking commitment on the part of nursing home managers in the face of competing priorities.

As for intrinsic reasons, our intervention may not have been sufficiently feasible or may have evoked resistance. However, since the extrinsic barriers plainly predominated and considerably hampered implementation at an early stage, this study gives hardly any insight into possible intrinsic flaws of the intervention. Assuming that the intervention was intrinsically sound—as demonstrated in the feasibility study (14)—we retrospectively believe it possible that even under more favorable extrinsic conditions, several years of robust implementation efforts would have been required to achieve permeation to a point where a possible effect on clinical outcomes could have been measured, as described in La Crosse county after 14 years of ACP implementation (39).

Although the intended effect of the intervention could not be demonstrated, the BEVOR trial nevertheless provides some noteworthy insights into the design and implementation of ACP:

First, at the end of the observation period, the rate of advance directives was considerably higher in the IG (incidence rates 58% [55; 61] versus 41% [39; 44]), confirming that still less than one in two nursing home residents have an advance directive (e3), and that offering facilitated ACP conversations can effectively increase this rate (14).

Second, even 2 years after the onset of the COVID-19 pandemic, emergency plans (40, e10) remained a rare exception in nursing homes in the CG. This may indicate how far current nursing home cultures are from patient-centered care in the face of life-threatening illness. However, our ACP intervention led to a large increase of such emergency documents. Of note, the exploratory analyses confirm that institutional implementation of ACP is crucial for this effect: The rate of emergency plans was higher in the nursing homes of the IG whose rate of ACP conversations was above the median, and higher still in the IG nursing homes with institutional implementation above the median (Table 2d/e). Possibly, the hospitalization rate would also have decreased in this latter intervention subgroup had it not fallen drastically in both groups as a result of the confounding COVID-19 pandemic.

Third, our finding that only in less than a third of cases treatment in potentially life-threatening events was clearly based on the individual resident’s (or his/her proxy’s) informed consent underlines the need for effective implementation of ACP in nursing homes. Notably, the exploratory adherence analysis showed that in nursing homes where ACP is implemented both at individual and institutional level, the proportion of residents whose treatment preferences were known and honored was substantially higher than in the control group. That adherent implementation of ACP at individual level (= rate of ACP facilitations ≥ median) alone, i.e., without corresponding adherence at institutional level, did not achieve this effect supports the hypothesis that ACP is most likely to be effective if it is implemented at both individual and systemic levels (Table 2d/e).

Limitations

Even though our sample was large and encompassed four culturally diverse regions of Germany, and despite the strength of a complete anonymous survey, this was not a random sample, which limits the generalizability of the results. Moreover, we studied one specific comprehensive ACP program, so our results may not be readily transferable to other ACP programs. With regard to the evaluation of care consistency with care preferences, this concept is known to be challenging to study (30, e5). While the instrument employed for this study to measure care consistency with care preferences has many strengths, it is still susceptible to biases, in particular recall bias.

Policy and research implications

Our findings have several implications for policy and research. First, the low rates of written emergency plans and of confirmed care consistency with care preferences in life-threatening situations underlines the moral and legal obligation to offer uncomplicated access to ACP for the vulnerable population of frail elderly persons. Second, our study’s exploratory analyses suggest that ACP will not be effective if limited to facilitated ACP conversations only. Rather, ACP must include organizational development and systemically implemented training for all institutions and personnel involved. It is the task of those responsible for healthcare policy to ensure the necessary resources and legal frameworks. Third, our results suggest that studying the clinical effects of a comprehensive ACP program may require a longer time horizon than the 3–4 years provided by typical funding schemes.

Acknowledgment
The study team wishes to thank Prof. Karl Wegscheider (Hamburg) for his seminal contributions to the conception and proposal of this study.

Ethics approval

HHU Düsseldorf (no. 2019–761, 14.02.2020), LMU Munich (no. 20–154, 20.03.2020), University Hospital Göttingen (no. 12/3/20Ü, 23.03.2020), MLU Halle-Wittenberg (no. 2020–048, 16.04.2020/27.4.2020).

Funding

The study was supported by the Innovation Fund of the German Federal Joint Committee (project no.: 01VSF18004).

Data sharing

The following data access policy is valid for up to 24 months after publication of the article: The data (the individual participant data on which the findings reported in this article are based, after anonymization) will be made available to all scientists who submit a methodologically and ethically sound proposal that conforms with the Data Protection Directive. The BEVOR Study steering group will decide whether the proposal can be approved in accordance with the Data Protection Directive.

Conflict of interest statement

KG has received honoraria, and in some cases reimbursement of travel and congress attendance costs, from the respective organizers for training courses/lectures at events on the topic of ACP and theory of change. She is an executive committee member of the professional societies ACP Germany and ACP International.

CB is president of the German Association for Palliative Medicine.

EH is vice-president of the German Association for General and Family Medicine (DEGAM) and honorary secretary of WONCA Europe.

JSc has received lecture honoraria from the Medical Association of the German federal state of Thuringia and the Christophorus Academy Munich.

NT has received reimbursement of travel and congress attendance costs as well as materials for data collection from the Department of General Practice and Family Medicine at University Medical Center Göttingen.

CV has received honoraria from the respective organizers for training courses/lectures at events on the topic of ACP. She is an executive committee member of ACP Germany.

GMa is an executive committee member of ACP Germany.

JidS has received honoraria from the respective organizers for training courses on the topic of ACP. He is an executive committee member of ACP Germany (www.acp-d.org).

The remaining authors declare that no conflict of interest exists.

Received on 27 September 2024, revised version received on 16 April 2025

Corresponding author
Dr. med. Kornelia Götze

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