Effectiveness of a complex regional advance care planning intervention to improve care consistency with care preferences: study protocol for a multi-center, cluster-randomized controlled trial focusing on nursing home residents (BEVOR trial)

Abstract

Background: According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents.

Methods: This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications.

Discussion: This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly.

Trial registration: ClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020.

Keywords: ACP facilitation; Advance care planning; Cluster-randomized controlled trial; Complex intervention; Nursing homes; Patient-centered care; Study protocol.

Fig. 1

Flow chart of data collections and interventions throughout the trial. Caption: ACP advance care planning, EMS emergency medical service. t0: baseline, t1: end of run-in phase of the intervention / begin of 12-months observation period, t2: end of observation period

Fig. 2

Overview of the elements of the regional ACP program. The intervention elements at the individual level support the residents to plan for future medical care. On the institutional and regional level, a systems redesign and networking is to ensure that the residents’ wishes will be known and honored in case of critical illness accompanied by a lack of decisional capacity. Caption: ACP advance care planning, AD advance directive, QA quality assurance. For further information, see additional file 1 (selected intervention details) and 2 (TIDeR Checklist).

Fig. 3

Schedule of enrolment, interventions and assessments after pandemic-related extension of project duration (update 05/2021). Caption: IG intervention group, CG control group, f/u follow-up. “Cal” denotes a trial data collection circle for calibration purposes, referring to 3 months before t1. T0 is reference point for the retrospective parts of the baseline data collection 1 (DC-1) and data collection 2a (DC-2a); t1 highlights the end of the run-in period of the intervention and the beginning of the observation period; t2 marks the end of the observation period. DC-1 consists of two parts: (a) a retrospective NH records survey referring to the 12 months prior to t0, t1, and t2, respectively, and (b) a cross-sectional NH records survey at the day of data collection. DC-2 consists of three parts: DC-2a (framework survey) is a cross-sectional NH records-based survey at the day of collection combined with a retrospective NH records survey up to 12 months prior to t0 and t2, respectively; DC-2b (care consistency with care preferences (3CP)) is a retrospective, NH records- and interview-based evaluation of critical treatment decisions 3 months prior to data collection; DC-2c (after death survey) is an interview survey of the bereaved person and responsible nurse