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Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare
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 case...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8012747/ https://www.ncbi.nlm.nih.gov/pubmed/33794789 http://dx.doi.org/10.1186/s12877-021-02114-z |
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author | Bablok, Isabella Binder, Harald Stelzer, Dominikus Kaier, Klaus Graf, Erika Wangler, Julian Jansky, Michael Löhr, Michael Schulz, Michael Kockläuner, Marie Geschke, Katharina Wuttke-Linnemann, Alexandra Fellgiebel, Andreas Farin, Erik |
author_facet | Bablok, Isabella Binder, Harald Stelzer, Dominikus Kaier, Klaus Graf, Erika Wangler, Julian Jansky, Michael Löhr, Michael Schulz, Michael Kockläuner, Marie Geschke, Katharina Wuttke-Linnemann, Alexandra Fellgiebel, Andreas Farin, Erik |
author_sort | Bablok, Isabella |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8012747 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-80127472021-04-01 Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare Bablok, Isabella Binder, Harald Stelzer, Dominikus Kaier, Klaus Graf, Erika Wangler, Julian Jansky, Michael Löhr, Michael Schulz, Michael Kockläuner, Marie Geschke, Katharina Wuttke-Linnemann, Alexandra Fellgiebel, Andreas Farin, Erik BMC Geriatr Study Protocol 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. BioMed Central 2021-04-01 /pmc/articles/PMC8012747/ /pubmed/33794789 http://dx.doi.org/10.1186/s12877-021-02114-z Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Bablok, Isabella Binder, Harald Stelzer, Dominikus Kaier, Klaus Graf, Erika Wangler, Julian Jansky, Michael Löhr, Michael Schulz, Michael Kockläuner, Marie Geschke, Katharina Wuttke-Linnemann, Alexandra Fellgiebel, Andreas Farin, Erik Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare |
title | Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare |
title_full | Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare |
title_fullStr | Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare |
title_full_unstemmed | Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare |
title_short | Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare |
title_sort | primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, demstepcare |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8012747/ https://www.ncbi.nlm.nih.gov/pubmed/33794789 http://dx.doi.org/10.1186/s12877-021-02114-z |
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