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

NCT04333303 | Completed DMC

• 1 other identifier: 01VSF18004
• Study Type: interventional
• Target: 5,927
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Cluster Randomised Controlled Trial (cRCT); ACP Intervention

Outcome Measures

Primary Outcomes (1)

• Change of hospital admissions

  Number of hospital admission per 100 residents

  21 months

Secondary Outcomes (8)

• Change of hospital days

  21 months

• Change in the number of residents whose preferences were (a) known and (b) followed in the face of potentially life-threatening events

  21 months

• Change in the number of pre-specified unwanted invasive treatments

  21 months

• Change in the rate of hospital as last place of care

  21 months

• Change in the perception of concordance

  21 months

Study Arms (2)

Advance Care Planning Program

EXPERIMENTAL

Implementation of a complex regional Advance Care Planning program.

Other: Implementation of a complex regional Advance Care Planning program

Care as usual

NO INTERVENTION

Interventions

Implementation of a complex regional Advance Care Planning program OTHER

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.

Advance Care Planning Program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all long-term care residents of the enrolled nursing homes

You may not qualify if:

• none

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• Federal Ministry of Health, Germany: collaborator
• University Hospital Goettingen: collaborator
• Martin-Luther-Universität Halle-Wittenberg: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• BARMER: collaborator
• University Hospital Munich: collaborator

Study Sites (4)

Heinrich-Heine-University

Düsseldorf, Germany

Location

University Medical Center

Göttingen, Germany

Location

Martin Luther University

Halle, Germany

Location

University Hospital Großhadern, LMU

Munich, Germany

Location

Related Publications (2)

• In der Schmitten J, Lex K, Mellert C, Rotharmel S, Wegscheider K, Marckmann G. Implementing an advance care planning program in German nursing homes: results of an inter-regionally controlled intervention trial. Dtsch Arztebl Int. 2014 Jan 24;111(4):50-7. doi: 10.3238/arztebl.2014.0050.

  PMID: 24612497 BACKGROUND

• Gotze K, Bausewein C, Feddersen B, Fuchs A, Hot A, Hummers E, Icks A, Kirchner A, Kleinert E, Klosterhalfen S, Kolbe H, Laag S, Langner H, Lezius S, Meyer G, Montalbo J, Nauck F, Reisinger C, Rieder N, Schildmann J, Schunk M, Stanze H, Vogel C, Wegscheider K, Zapf A, Marckmann G, In der Schmitten J; BEVOR study group. 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). Trials. 2022 Sep 12;23(1):770. doi: 10.1186/s13063-022-06576-3.

  PMID: 36096948 DERIVED

Study Officials

• Eva Hummers, Professor

  Department of General Practice, University Medical Center Göttingen

  PRINCIPAL INVESTIGATOR

• Friedemann Nauck, Professor

  Department of Palliative Medicine, University Medical Center Göttingen

  PRINCIPAL INVESTIGATOR

• Gabriele Meyer, Professor

  Institute of Health and Nursing Science, Martin Luther University Halle-Wittenberg

  PRINCIPAL INVESTIGATOR

• Jan Schildmann, Professor

  Institute of History and Ethics of Medicine, Martin Luther University Halle-Wittenberg

  PRINCIPAL INVESTIGATOR

• Claudia Bausewein, Professor

  Department of Palliative Medicine, University Hospital Großhadern, LMU Munich

  PRINCIPAL INVESTIGATOR

• Georg Marckmann, Professor

  Institute of Ethics, History and Theory of Medicine, LMU Munich

  PRINCIPAL INVESTIGATOR

• Antonia Zapf, Professor

  Department of Medical Biometry and Epidemiology, UKE Hamburg

  PRINCIPAL INVESTIGATOR

• Henrike Kolbe

  Coordination Center for Clinical Trials, Heinrich-Heine-University, Düsseldorf

  PRINCIPAL INVESTIGATOR

• Andrea Icks, Professor

  Department of Public Health, Heinrich-Heine-University, Düsseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 1. Investigators will be blinded towards group allocation. There is as risk of unblinding of investigators, therefore we will determine true blinding status at follow-up. 2. Outcomes Assessors will be consequently blinded with regard to group assignment until the statistical analysis plan is finalized.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Jürgen in der Schmitten, MD, PhD, MPH

Model Details: Of the anticipated 44 nursing homes entering randomisation, half (22) will be allocated to the ACP intervention, the others continue with usual care.

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 3, 2020
• Study Start: April 6, 2020
• Primary Completion: August 31, 2022
• Study Completion: January 31, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)