Clinical trial NCT04741932: Interprofessional Dementia Care
Official title: Interprofessional Dementia Care: Redistribution of Tasks Between Physicians and Qualified Nurses in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Nurse's Role
Nurse Physician Relations
Keywords: Dementia
Dementia Care
Caregiver of people with dementia
Unmet needs
Medical management
Lead sponsor: German Center for Neurodegenerative Diseases (DZNE)
Sponsor class: OTHER
Collaborators: name: University Medicine Greifswald
name: University Medicine Rostock
name: GNEF Gesundheitsnetz Frankfurt am Main eG
name: Haffnet Management GmbH
name: Demenznetzwerk Uckermark e.V.
name: Techniker Krankenkasse
name: AOK Nordost
name: Federal Joint Committee
First posted: 2021-02-05
Enrollment: 471
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Special qualified nurses with an extended nursing role (Dementia Care Manager) record all nursing, medical, drug, psychosocial and social care needs using an IT-based care management system and then implement them over a period of six months.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Currently, around 1.7 million people with dementia live in Germany. The number of new cases per year is estimated to be around 244,000. At this time, no curative treatment for dementia exists. The progression of the disease results in high needs for care. Only a minority among People with Dementia (PwD) receive needs-based treatment and directive-compliant care. Previous studies found that more than 95% of PwD have an open need for care. The increase in chronically and multimorbid impaired patients leads to an increased number of patients in primary care. Particularly in rural regions, innovative care concepts based on a redistribution of tasks between specialized nurses and doctors could help to guarantee high-value care at all times. Nursing care can be expanded with regards to tasks and competencies, which is thought to increase the attractiveness of the nursing profession. Unfortunately, there are currently no scientific studies on the effectiveness and impact of such care concepts in Germany.

The Aim of this study is to implement a structured care concept for the reallocation of tasks between general practitioners (GPs) and nurses and to evaluate its effectiveness on the living and care situation of people with dementia living at home. "InDePendent" is a multicenter, cluster-randomized, controlled intervention study with a waiting-control group. Randomization is carried out at the level of the participating GPs in a ratio of 1:2 (intervention group : waiting-control group).

Detailed description: Previous studies found that PwD treated by primary care physicians on average have 8.8 (± 5.04; range = 0-31) unmet care needs, mainly related to nursing care (38%) and drug therapy (15%). PwD had additional needs for daily activities, social participation and showed a high level of psychological stress. The number of unmet care needs is more dependent on the physical limitations than on the cognitive impairments. The progression of dementia is therefore associated with an increase in open and unmet care needs and a reduced opportunity to recognize these needs in the primary care setting and to address them appropriately. At this time, no curative treatment for dementia exists. Thus, innovative models of high-value care have to be found in order to enable PwD to live an independent, self-determined life with a high quality of life for as long as possible. The increasing burden of disease associated with an increase in prevalence of dementia is associated with high health expenditures, which puts additional pressure on health care systems. From a health economical perspective the minimization of supply deficits and open needs of care are crucial aspects to avoid or delay a cost-intensive transfer to an inpatient facility. The overall goal of the InDePendent project is to improve the living and care situation of PwD and their relatives at home. Following this aim, an innovative redistribution of tasks between general practitioners and specialized nurses for dementia patients will be implemented and evaluated. In addition, the specialized nurses will be trained for cross-sector as well as cross-professional dementia care management (DCM), by acquisition of specific competencies to carry out medical tasks in delegation and substitution. Collaborating Dementia Networks and GP clinics will serve as the units of randomization and determine the patients' group status (control or intervention group). The GPs will systematically screen the patients for eligibility to participate in the study during routine care (eligibility criteria for screening: age ≥70 years, living at home). Patients will be screened using the validated DemTect questionnaire (eligibility for study participation: \<9 points). In case of a positive screening or an existing dementia diagnosis, potential participants will receive detailed information about the study including a study-information sheet from their GP, be invited to participate and asked to provide written informed consent.

Eligibility criteria: Inclusion Criteria:

* 70+ years
* PwD lives at home
* existing dementia diagnosis or screening result of DemTect \<9
* caregiver: main caregiver of a PwD (Hauptversorgungsperson)

Exclusion Criteria:

- not able to provide written consent

Primary outcomes:
measure: Number of unmet needs (CANE)
timeFrame: 6 months after baseline assessment
Secondary outcomes:
measure: Quality of life (Qol-AD)
timeFrame: 6 months after baseline assessment
measure: Health status (EQ-5D-5L)
timeFrame: 6 months after baseline assessment
measure: Costs of informal care (Resource Utilization in Dementia)
timeFrame: 6 months after baseline assessment
measure: Costs of formal care (Utilization of Medical and Nursing services)
timeFrame: 6 months after baseline assessment
measure: Caregiver Burden (Zarit)
timeFrame: 6 months after baseline assessment
Other outcomes:
Locations:
city: Elsterwerda
country: Germany
facility: MEDIS Ärztenetz medizinischer Versorgung Südbrandenburg
state: Brandenburg
city: Frankfurt
country: Germany
facility: GNEF Gesundheitsnetz Frankfurt am Main
state: Hessen
city: Prenzlau
country: Germany
facility: Demenz-Netzwerk Uckermark e.V.
state: Mecklenburg- Western Pommerania
city: Ueckermünde
country: Germany
facility: HaffNet Management GmbH
state: Mecklenburg- Western Pommerania
city: Greifswald
country: Germany
facility: DZNE
state: Mecklenburg-Western-Pomerania
Study officials:
affiliation: German Center for Neurodegenerative Diseases (DZNE)
name: Wolfgang Hoffmann, MD, MPH, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eichler T, Thyrian JR, Hertel J, Richter S, Wucherer D, Michalowsky B, Teipel S, Kilimann I, Dreier A, Hoffmann W. Unmet Needs of Community-Dwelling Primary Care Patients with Dementia in Germany: Prevalence and Correlates. J Alzheimers Dis. 2016;51(3):847-55. doi: 10.3233/JAD-150935.
citation: van der Roest HG, Meiland FJ, Comijs HC, Derksen E, Jansen AP, van Hout HP, Jonker C, Droes RM. What do community-dwelling people with dementia need? A survey of those who are known to care and welfare services. Int Psychogeriatr. 2009 Oct;21(5):949-65. doi: 10.1017/S1041610209990147. Epub 2009 Jul 15.
citation: Michalowsky B, Eichler T, Thyrian JR, Hertel J, Wucherer D, Laufs S, Flessa S, Hoffmann W. Medication cost of persons with dementia in primary care in Germany. J Alzheimers Dis. 2014;42(3):949-58. doi: 10.3233/JAD-140804.
citation: Reynolds T, Thornicroft G, Abas M, Woods B, Hoe J, Leese M, Orrell M. Camberwell Assessment of Need for the Elderly (CANE). Development, validity and reliability. Br J Psychiatry. 2000 May;176:444-52. doi: 10.1192/bjp.176.5.444.
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citation: Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
citation: Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
citation: Wimo A, Jonsson L, Zbrozek A. The Resource Utilization in Dementia (RUD) instrument is valid for assessing informal care time in community-living patients with dementia. J Nutr Health Aging. 2010 Oct;14(8):685-90. doi: 10.1007/s12603-010-0316-2.
citation: Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.
citation: Kleinke F, Michalowsky B, Radke A, Platen M, Muhlichen F, Scharf A, Mohr W, Penndorf P, Bahls T, van den Berg N, Hoffmann W. Advanced nursing practice and interprofessional dementia care (InDePendent): study protocol for a multi-center, cluster-randomized, controlled, interventional trial. Trials. 2022 Apr 11;23(1):290. doi: 10.1186/s13063-022-06249-1.