Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare.

Caregivers Dementia / diagnosis Germany Humans Primary Health Care Quality of Life Randomized Controlled Trials as Topic
Caregivers Case management Cluster randomized controlled trial Dementia Evaluation Multi-professional team Primary care Risk assessment

Journal

BMC geriatrics
ISSN: 1471-2318
Titre abrégé: BMC Geriatr
Pays: England
ID NLM: 100968548

Informations de publication

Date de publication:
01 04 2021
Historique:
received: 01 02 2021
accepted: 24 02 2021
entrez: 2 4 2021
pubmed: 3 4 2021
medline: 27 4 2021
Statut: epublish

Résumé

Most people with dementia (PwD) are cared for at home, with general practitioners (GPs) playing a key part in the treatment. However, primary dementia care suffers from a number of shortcomings: Often, diagnoses are made too late and therapies by GPs do not follow the guidelines. In cases of acute crises, PwD are too often admitted to hospital with adverse effects on the further course of the disease. The aim of this study is to implement and evaluate a new GP-based, complex dementia care model, DemStepCare. DemStepCare aims to ensure demand-oriented, stepped care for PwD and their caregivers. In a cluster randomized controlled trial, the care of PwD receiving a complex intervention, where the GP is supported by a multi-professional team, is compared to (slightly expanded) usual care. GPs are clustered by GP practice, with 120 GP practices participating in total. GP practices are randomized to an intervention or a control group. 800 PwD are to be included per group. Recruitment takes place in Rhineland-Palatinate, Germany. In addition, a second control group with at least 800 PwD will be formed using aggregated routine data from German health insurance companies. The intervention comprises the training of GPs, case management including repeated risk assessment of the patients' care situation, the demand-oriented service of an outpatient clinic, an electronic case record, external medication analyses and a link to regional support services. The primary aims of the intervention are to positively influence the quality of life for PwD, to reduce the caregivers' burden, and to reduce the days spent in hospital. Secondary endpoints address medication adequacy and GPs' attitudes and sensitivity towards dementia, among others. The GP-based dementia care model DemStepCare is intended to combine a number of promising interventions to provide a complex, stepped intervention that follows the individual needs of PwD and their caregivers. Its effectiveness and feasibility will be assessed in a formative and a summative evaluation. German Register of Clinical Trials (Deutsches Register Klinischer Studien, DRKS), DRKS00023560 . Registered 13 November 2020 - Retrospectively registered. HTML&TRIAL_ID=DRKS00023560.

Sections du résumé

BACKGROUND
Most people with dementia (PwD) are cared for at home, with general practitioners (GPs) playing a key part in the treatment. However, primary dementia care suffers from a number of shortcomings: Often, diagnoses are made too late and therapies by GPs do not follow the guidelines. In cases of acute crises, PwD are too often admitted to hospital with adverse effects on the further course of the disease. The aim of this study is to implement and evaluate a new GP-based, complex dementia care model, DemStepCare. DemStepCare aims to ensure demand-oriented, stepped care for PwD and their caregivers.
METHODS/DESIGN
In a cluster randomized controlled trial, the care of PwD receiving a complex intervention, where the GP is supported by a multi-professional team, is compared to (slightly expanded) usual care. GPs are clustered by GP practice, with 120 GP practices participating in total. GP practices are randomized to an intervention or a control group. 800 PwD are to be included per group. Recruitment takes place in Rhineland-Palatinate, Germany. In addition, a second control group with at least 800 PwD will be formed using aggregated routine data from German health insurance companies. The intervention comprises the training of GPs, case management including repeated risk assessment of the patients' care situation, the demand-oriented service of an outpatient clinic, an electronic case record, external medication analyses and a link to regional support services. The primary aims of the intervention are to positively influence the quality of life for PwD, to reduce the caregivers' burden, and to reduce the days spent in hospital. Secondary endpoints address medication adequacy and GPs' attitudes and sensitivity towards dementia, among others.
DISCUSSION
The GP-based dementia care model DemStepCare is intended to combine a number of promising interventions to provide a complex, stepped intervention that follows the individual needs of PwD and their caregivers. Its effectiveness and feasibility will be assessed in a formative and a summative evaluation.
TRIAL REGISTRATION
German Register of Clinical Trials (Deutsches Register Klinischer Studien, DRKS), DRKS00023560 . Registered 13 November 2020 - Retrospectively registered. HTML&TRIAL_ID=DRKS00023560.

Identifiants

DOI: 10.1186/s12877-021-02114-z PMID: 33794789 PMC: PMC8012747
pubmed: 33794789
doi: 10.1186/s12877-021-02114-z
pii: 10.1186/s12877-021-02114-z
pmc: PMC8012747
doi:

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

222

Subventions

Organisme : Innovation Committee of the Federal Joint Committee (G-BA), Innovation Fund
ID : 01NVF18027

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Auteurs

Isabella Bablok (I)

Institute of Medical Biometry and Statistics, Section of Health Care Research and Rehabilitation Research, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany. isabella.bablok@uniklinik-freiburg.de.

Harald Binder (H)

Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.

Dominikus Stelzer (D)

Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.

Klaus Kaier (K)

Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.

Erika Graf (E)

Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.

Julian Wangler (J)

Center for General and Geriatric Medicine, University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany.

Michael Jansky (M)

Center for General and Geriatric Medicine, University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany.

Michael Löhr (M)

Landschaftsverband Westfalen-Lippe, Hospital Gütersloh, Gütersloh, Germany.
Diakonie University of Applied Sciences, Bielefeld, Germany.

Michael Schulz (M)

Landschaftsverband Westfalen-Lippe, Hospital Gütersloh, Gütersloh, Germany.
Diakonie University of Applied Sciences, Bielefeld, Germany.

Marie Kockläuner (M)

Department of Pharmacy, University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany.

Katharina Geschke (K)

Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany.
Center for Mental Health in Old Age, Landeskrankenhaus (AöR), Mainz, Germany.

Alexandra Wuttke-Linnemann (A)

Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany.
Center for Mental Health in Old Age, Landeskrankenhaus (AöR), Mainz, Germany.

Andreas Fellgiebel (A)

Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany.
Center for Mental Health in Old Age, Landeskrankenhaus (AöR), Mainz, Germany.

Erik Farin (E)

Institute of Medical Biometry and Statistics, Section of Health Care Research and Rehabilitation Research, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.

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Classifications MeSH

questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Personnel de santé › Aidants › Primary dementia care based on the individual...
questionsmedicales.fr › Troubles mentaux › Troubles neurocognitifs › Démence › Primary dementia care based on the individual...
questionsmedicales.fr › Régions géographiques › Europe › Allemagne › Primary dementia care based on the individual...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Primary dementia care based on the individual...
questionsmedicales.fr › Administration des services de santé › Gestion des soins aux patients › Services de santé polyvalents › Soins de santé primaires › Primary dementia care based on the individual...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › Primary dementia care based on the individual...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Primary dementia care based on the individual...