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)
Authors: Götze Kornelia , Bausewein Claudia , Feddersen Berend , Fuchs Angela , Hot Amra , Hummers Eva , Icks Andrea , Kirchner Änne , Kleinert Evelyn , Klosterhalfen Stephanie , Kolbe Henrike , Laag Sonja , Langner Henriette , Lezius Susanne , Meyer Gabriele , Montalbo Joseph , Nauck Friedemann , Reisinger Christine , Rieder Nicola , Schildmann Jan , Schunk Michaela , Stanze Henrikje , Vogel Christiane , Wegscheider Karl , Zapf Antonia , Marckmann Georg , in der Schmitten Jürgen ,   on behalf of the BEVOR study group, Albert Annika , Alheid Cornelia , Bausewein Claudia , Bruene Manuela , Calles Christian , Camci Havva , Daubmann Anne , Dahlke Sophie , Enger Stephanie , Feddersen Berend , Felder Gerd , Fluck Carsten , Freienstein Andreas , Freytag Theresa , Fuchs Angela , Icks Andrea , in der Schmitten Jürgen , Hensel Lena , Hummers Eva , Hot Amra , Kirchner Änne , Kleinert Evelyn , Klosterhalfen Stephanie , Kolbe Henrike , Laag Sonja , Langner Henriette , Lezius Susanne , Marckmann Georg , Meyer Gabriele , Montalbo Jospeh , Nauck Friedemann , Nguyen Thuy , Nowak Andre , Ossenberg Malte , Reisinger Christine , Reuter Sophia , Rieder Nicola , Riester Tanja , Rosu Irina , Rösgen Holger , Salanta Katharina , Sassi Zeinep , Schildmann Jan , Schulenberg Thomas , Schunk Michaela , Sommer Daniela , Stanze Henrikje , Stöhr Andreas , Theuerkauf Anke , Thilo Nancy , Tönjann Jessica , Partowinia-Peters Mahnaz , Prommersberger Sebastian , Przybylla Susanne , Vogel Christiane , Vomhof Markus , Wilken Janka , Zapf Antonia , Zimprich Jennifer 
Published: September 2022

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.