Effect of Advance Care Planning to Improve Patient-centered Care of Nursing Home Residents

Summary

Advance Care Planning (ACP) is an approach to support individuals in understanding and sharing their values, treatment goals, and preferences regarding future medical care. This study aims to evaluate the clinical effectiveness of implementing a complex regional ACP program focussing on nursing homes and their related health care providers.

For this purpose, a cluster-randomised controlled trial (cRCT) is being conducted in four study centres in Germany: Düsseldorf, Göttingen, Halle (Saale), and Munich. 44 nursing homes with 3,520 residents will be randomised into either an intervention group, receiving the ACP-intervention described below, or into a control group that will receive usual care.

The complex ACP intervention comprises training of professional ACP facilitators (micro level), supporting organisational development in nursing homes and other relevant institutions (meso level), and moderating regional change management among a network of all related health care institutions and actors (macro level).

Clinical outcomes will be measured in order to describe whether the intervention improved care consistency with care preferences.

Data will be collected by two independent approaches:

Firstly, participating nursing homes will provide anonymous data on all their long-term care residents of a defined time period, including the hospitalisation rate (primary outcome). The primary hypothesis will test whether the complex intervention reduces the rate of hospital admissions. A group comparison of all hospitalisations in the past 12 months is made 21 months after randomisation.

Secondly, all residents who have given informed consent in the first three months of the study will be repeatedly surveyed until month 21 (or until they die earlier). Treatment decisions in the face of life-threatening illness that affect any of a list of pre-defined outcomes will be evaluated as to whether they were consistent with the residents' care preferences.

If residents decease, patient-centered care in the last weeks of life will be evaluated by additional interviews with the next bereaved relative, and an involved nurse. Besides, bereaved relatives will be assessed for trauma, depression and anxiety.

In addition, a process evaluation and a health economic evaluation are carried out according to Medical Research Council (MRC) recommendations.

Conditions

• Advance Care Planning
• Nursing Homes

Interventions

OTHER

Implementation of a complex regional Advance Care Planning program

Sustainable implementation of ACP at micro- (qualification of professional ACP facilitators to lead conversations in cooperation with family physicians), meso- (qualification of relevant co-actors, organisational development of participating institutions) and macro-level (regional ACP steering group and network), ensuring that valid ACP is encouraged, facilitated, documented, known and honored. Core of the intervention is a modular 9-day-training for ACP facilitators. These will be preferably located in regional pools, serving more than one nursing home, and reimbursed, if certified, by German sickness funds based on recent legislation (§ 132g Social Code Book \[SGB\] V: 1 full-time facilitator for 400 residents). ACP conversations will be offered to all residents. Regional intervention at meso- and macro-level comprises various formats of specific ACP training and information for leadership and staff, and aims to support professional change management.

Sponsors & Collaborators

• Federal Ministry of Health, Germany

  collaborator OTHER_GOV

• University Hospital Goettingen

  collaborator OTHER

• Martin-Luther-Universität Halle-Wittenberg

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• BARMER

  collaborator OTHER

• University Hospital Munich

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  lead OTHER

Principal Investigators

• Eva Hummers, Professor · Department of General Practice, University Medical Center Göttingen

• Friedemann Nauck, Professor · Department of Palliative Medicine, University Medical Center Göttingen

• Gabriele Meyer, Professor · Institute of Health and Nursing Science, Martin Luther University Halle-Wittenberg

• Jan Schildmann, Professor · Institute of History and Ethics of Medicine, Martin Luther University Halle-Wittenberg

• Claudia Bausewein, Professor · Department of Palliative Medicine, University Hospital Großhadern, LMU Munich

• Georg Marckmann, Professor · Institute of Ethics, History and Theory of Medicine, LMU Munich

• Antonia Zapf, Professor · Department of Medical Biometry and Epidemiology, UKE Hamburg

• Henrike Kolbe · Coordination Center for Clinical Trials, Heinrich-Heine-University, Düsseldorf

• Andrea Icks, Professor · Department of Public Health, Heinrich-Heine-University, Düsseldorf

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-04-06

Primary Completion

2022-08-31

Completion

2023-01-31

Countries

• Germany

Study Locations