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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Care | Study protocol

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: Kornelia Götze, Claudia Bausewein, Berend Feddersen, Angela Fuchs, Amra Hot, Eva Hummers, Andrea Icks, Änne Kirchner, Evelyn Kleinert, Stephanie Klosterhalfen, Henrike Kolbe, Sonja Laag, Henriette Langner, Susanne Lezius, Gabriele Meyer, Joseph Montalbo, Friedemann Nauck, Christine Reisinger, Nicola Rieder, Jan Schildmann, Michaela Schunk, Henrikje Stanze, Christiane Vogel, Karl Wegscheider, Antonia Zapf, Georg Marckmann, Jürgen in der Schmitten, on behalf of the BEVOR study group

Published in: Trials | Issue 1/2022

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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.
Appendix
Available only for authorised users
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Metadata
Title
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
Kornelia Götze
Claudia Bausewein
Berend Feddersen
Angela Fuchs
Amra Hot
Eva Hummers
Andrea Icks
Änne Kirchner
Evelyn Kleinert
Stephanie Klosterhalfen
Henrike Kolbe
Sonja Laag
Henriette Langner
Susanne Lezius
Gabriele Meyer
Joseph Montalbo
Friedemann Nauck
Christine Reisinger
Nicola Rieder
Jan Schildmann
Michaela Schunk
Henrikje Stanze
Christiane Vogel
Karl Wegscheider
Antonia Zapf
Georg Marckmann
Jürgen in der Schmitten
on behalf of the BEVOR study group
Publication date
01-12-2022
Publisher
BioMed Central
Keywords
Care
Living Will
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06576-3

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