Clinical trial NCT03590470: Nurse-led Care Models in Swiss Nursing Homes: Improving Interprofessional Care for Better Resident Outcomes (INTERCARE)
Official title: Nurse-led Care Model in Swiss Nursing Homes: Improving INTERprofessional CARE for Better Resident Outcomes (INTERCARE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalisations
Keywords: avoidable hospitalisations
quality of care
nursing homes
implementation science
quality improvement
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: University Department of Geriatric Medicine FELIX PLATTER
name: University of Applied Sciences and Arts of Southern Switzerland
name: Insel Gruppe AG, University Hospital Bern
name: Hôpital ophtalmique Jules-Gonin (HOJG)
name: Serdaly & Ankers, Switzerland
name: Vaud state public health department
name: stiftung pflegewissenchaft
name: KU Leuven
First posted: 2018-07-18
Enrollment: 944
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Non-randomized stepped-wedge design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This implementation science project aims to implement a nurse-led model of care in 11 nursing homes in the German speaking part of Switzerland, to reduce avoidable hospitalisations. The model will be introduced using a non-randomized stepped-wedge design. First, training will be delivered to leadership teams and to geriatric nurse experts, secondly after a baseline measurement period, including distribution of questionnaires and collection of resident data mainly national quality indicators and data regarding hospitalisations, the nurse led model will be implemented and thereafter 2 measurement periods will follow (6 months after the beginning of the intervention and at the end). Quantitative resident data will be retrieved from the RAI-NH three-monthly, and hospitalization data with the help of a data platform, reflection tools and hospital discharge reports continuously from the baseline period until the end of the data collection in 02.2020. The hypotheses of the project are:

* To assess the effectiveness of the nurse-led care model on unplanned hospitalizations (primary outcome) and additional resident and staff outcomes, hypothesizing that nursing homes with a nurse-led care model have lower rates of unplanned hospitalizations and show improvements in additional resident and staff outcomes
* To assess the effect of the degree of adoption on client outcomes, hypothesizing that a higher degree of adoption is related to better client outcomes
* To describe the implementation costs the Swiss nurse-led interprofessional NH care model on the NH level and to assess the economic impact of INTERCARE with a cost-effectiveness analysis adopting a health care system perspective (comparing the increase in staff costs with the decrease of days of avoidable hospitalizations)
* To explore resident/family and staff perceptions of service outcomes (e.g., timeliness) and the acceptability of the nurse-led care model;
* To describe the degree to which the model was adopted, its feasibility, the fidelity with which it was applied, and the barriers and facilitators met by NH leadership and nurse experts.

Detailed description: This multicentre study uses a mixed-methods approach to evaluate testing of a nurse-led care model intervention. Each of the 11 NHs participating in this study will recruit at least one registered nurse with at least three years' long-term care experience, which will undergo training to become a geriatric nurse expert. Training of the geriatric nurse experts will be delivered as a blended-learning approach, combining face to face (F2F) teaching and E-learning modules. The 8 modules will cover the following topics: 1. leadership, 2. communication, 3. comprehensive geriatric assessment, 4. geriatric syndromes, 5. chronic conditions, 6. acute conditions, 7. pharmacology in geriatrics and 8. quality improvement. Modules 1-3 and 8 will be delivered as 5 days of F2F teaching before the implementation start, followed by E-learnings, and 8 expert meetings to be continued throughout the intervention. The last meeting takes place in November 2019. Additionally, the practical training will be enhanced by individual supervision with an experienced nurse expert and/or geriatrician. Modules 4-7 will be delivered via E-learning modules. All modules will cover approximately 66h of F2F learning and 60 hours of E-learning, depending on the level of education and experience of each nurse. In total the geriatric nurse expert training should account for approximately 125 hours.

The registered nurse which will take on the role of geriatric nurse expert will either be recruited within the pool of nurses in each respective NH or recruited from the outside. The nurse-led care model will be built with core components, such as interprofessional collaboration, presence of a geriatric nurse expert, comprehensive geriatric assessment, advance care planning, guidance and coaching, data driven quality and evidence-based tools. Each NH will have to implement these core components along with implementing the role of geriatric nurse expert.

The intervention will be implemented and evaluated by means of a non-randomized quasi experimental stepped-wedge design, over a period of 21 months. The stepped wedge design allows inclusion of all NHs, thus does not exclude NHs from receiving the INTERCARE \| Research plan Version 1.1/09.05. 2018 20/53 intervention. The "stepped" or "graded" unidirectional allocation to the intervention enables each NH to act as its own control. After a 3-month baseline phase, NHs will sequentially begin implementation of the nurse-led care model, which they will continue to use post-implementation. A get-in period of 1 month will be planned to address possible timing problems at the intervention start. Another advantage of the design is the graded start in the NHs facilitating delivery of the intervention, as each NH will discuss with the research team when they will receive the intervention. The first two NHs will start their baseline data collection in June 2018 and implement the intervention in September 2018, and every month thereafter, two other NHs will start with the intervention.

A non-randomized design was chosen to enable NHs to choose when they will start with the intervention, to allow for each NH to prepare accordingly for the implementation. Limitations of this study design might arise from its novelty. So far, no gold standard for data analysis has been established. In addition to this, non-randomization of the starting point of the intervention may imply that NHs were prepared for the intervention and this may be reflected in the results.

Eligibility criteria: Inclusion Criteria:

Nursing homes

* German-speaking
* Size: ≥80 long-term care beds (NHs with \>60 beds will be considered if they have a high hospitalisation rate)
* Hospitalisation rates: ≥0.8/1000 resident days

Residents

- All long-term care residents

Geriatric nurse experts:

* Registered nurse
* At least three years' experience in long-term care

Nursing home staff

* Care workers of all educational levels, including students
* Other health professionals employed by the NH (such as therapists, dieticians) with direct resident contact
* Employed by the NH and working in the NH for a minimum of 3 months

Exclusion Criteria:

Nursing homes

* Italian-speaking
* French-speaking

Residents

- Short term or day care residents, other residents with a discharge planned within two months after admittance

Primary outcomes:
measure: Number of all unplanned hospitalizations /1000 resident care days
timeFrame: 21 months
Secondary outcomes:
measure: Avoidable hospitalizations
timeFrame: 21 months
measure: Avoidable emergency department (ED) visits
timeFrame: 21 months
measure: Resident quality indicators: Pain
timeFrame: 21 months
measure: Resident quality indicators: physical restraints
timeFrame: 21 months
measure: Resident quality indicators: Polypharmacy
timeFrame: 21 months
measure: Resident quality indicators: weight loss
timeFrame: 21 months
Other outcomes:
Locations:
city: Arlesheim
country: Switzerland
facility: Obesunne
city: Basel
country: Switzerland
facility: St Christophorus
city: Basel
country: Switzerland
facility: Marienhaus
city: Bern
country: Switzerland
facility: Domicil schwabgut
city: Burgdorf
country: Switzerland
facility: Zentrum Schlossmat
city: Luzern
country: Switzerland
facility: Viva Luzern
city: Niederwil
country: Switzerland
facility: Reusspark
Study officials:
affiliation: Institut für Pflegewissenschaft Fakultät für Medizin, Universität Basel Bernoullistrasse 28, Raum 107 CH-4056 Basel
name: Michael Simon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bartakova J, Zuniga F, Guerbaai RA, Basinska K, Brunkert T, Simon M, Denhaerynck K, De Geest S, Wellens NIH, Serdaly C, Kressig RW, Zeller A, Popejoy LL, Nicca D, Desmedt M, De Pietro C. Health economic evaluation of a nurse-led care model from the nursing home perspective focusing on residents' hospitalisations. BMC Geriatr. 2022 Jun 9;22(1):496. doi: 10.1186/s12877-022-03182-5.
citation: Basinska K, Zuniga F, Simon M, De Geest S, Guerbaai RA, Wellens NIH, Nicca D, Brunkert T. Implementation of a complex intervention to reduce hospitalizations from nursing homes: a mixed-method evaluation of implementation processes and outcomes. BMC Geriatr. 2022 Mar 12;22(1):196. doi: 10.1186/s12877-022-02878-y.