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

Advanced nursing practice and interprofessional dementia care (InDePendent): study protocol for a multi-center, cluster-randomized, controlled, interventional trial

Authors: Fabian Kleinke, Bernhard Michalowsky, Anika Rädke, Moritz Platen, Franka Mühlichen, Annelie Scharf, Wiebke Mohr, Peter Penndorf, Thomas Bahls, Neeltje van den Berg, Wolfgang Hoffmann

Published in: Trials | Issue 1/2022

Abstract

Background

A redistribution of tasks between specialized nurses and primary care physicians, i.e., models of advanced nursing practice, has the potential to improve the treatment and care of the growing number of people with dementia (PwD). Especially in rural areas with limited access to primary care physicians and specialists, these models might improve PwD’s quality of life and well-being. However, such care models are not available in Germany in regular healthcare. This study examines the acceptance, safety, efficacy, and health economic efficiency of an advanced nursing practice model for PwD in the primary care setting in Germany.

Methods

InDePendent is a two-arm, multi-center, cluster-randomized controlled intervention study. Inclusion criteria are age ≥70 years, cognitively impaired (DemTect ≤8) or formally diagnosed with dementia, and living in the own home. Patients will be recruited by general practitioners or specialists. Randomization is carried out at the physicians’ level in a ratio of 1:2 (intervention vs. waiting-control group). After study inclusion, all participants will receive a baseline assessment and a follow-up assessment after 6 months. Patients of the intervention group will receive advanced dementia care management for 6 months, carried out by specialized nurses, who will conduct certain tasks, usually carried out by primary care physicians. This includes a standardized assessment of the patients’ unmet needs, the generation and implementation of an individualized care plan to address the patients’ needs in close coordination with the GP. PwD in the waiting-control group will receive routine care for 6 months and subsequently become part of the intervention group. The primary outcome is the number of unmet needs after 6 months measured by the Camberwell Assessment of Need for the Elderly (CANE). The primary analysis after 6 months is carried out using multilevel models and will be based on the intention-to-treat principle. Secondary outcomes are quality of life, caregiver burden, acceptance, and cost-effectiveness. In total, n=465 participants are needed to assess significant differences in the number of unmet needs between the intervention and control groups.

Discussion

The study will provide evidence about the acceptance, efficacy, and cost-effectiveness of an innovative interprofessional concept based on advanced nursing care. Results will contribute to the implementation of such models in the German healthcare system. The goal is to improve the current treatment and care situation for PwD and their caregivers and to expand nursing roles.

Trial registration

ClinicalTrials.gov NCT04741932. Registered on 2 February 2021.

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Title: Advanced nursing practice and interprofessional dementia care (InDePendent): study protocol for a multi-center, cluster-randomized, controlled, interventional trial
Authors: Fabian Kleinke
Bernhard Michalowsky
Anika Rädke
Moritz Platen
Franka Mühlichen
Annelie Scharf
Wiebke Mohr
Peter Penndorf
Thomas Bahls
Neeltje van den Berg
Wolfgang Hoffmann
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Care
Alzheimer's Disease
Dementia
Alzheimer's Disease
Dementia
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06249-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Advanced nursing practice and interprofessional dementia care (InDePendent): study protocol for a multi-center, cluster-randomized, controlled, interventional trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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