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HospitalisationsINTERCARENCT03590470

Nurse-led Care Models in Swiss Nursing Homes: Improving Interprofessional Care for Better Resident Outcomes (INTERCARE)

A study testing Implementation of a nurse-led model of care in people with Hospitalisations, run by University of Basel at 7 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Hospitalisations
What is being tested?
Implementation of a nurse-led model of care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
944 participants
Where
7 sitesSwitzerland
Study dates
20 Jun 2018to 1 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • Nursing homes
  • Italian-speaking
  • French-speaking
  • Residents
  • Short term or day care residents, other residents with a discharge planned within two months after admittance

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Switzerland7 sites
  • Obesunne

    Arlesheim, 4144

  • St Christophorus

    Basel, 4057

  • Marienhaus

    Basel

  • Domicil schwabgut

    Bern, 3018

  • Zentrum Schlossmat

    Burgdorf, 3400

  • Viva Luzern

    Lucerne, 6003

  • Reusspark

    Niederwil, 5524

Other trials in Switzerland

About this study

Official title: Nurse-led Care Model in Swiss Nursing Homes: Improving INTERprofessional CARE for Better Resident Outcomes (INTERCARE)

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.
Read the 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.

Being tested
Implementation of a nurse-led model of care
Keywords
avoidable hospitalisations, quality of care, nursing homes, implementation science, quality improvement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implementation of a nurse-led model of careOther

    A nurse-model of care consisting of a specifically trained geriatric nurse expert, communication and quality improvement tools will be implemented in 11 nursing homes in the German speaking part of Switzerland

Study groups in NCT03590470
Study groupRoleWhat they receive
Experimental_INTERCARE interventionExperimentalImplementation of a nurse-led model of care adapted to the Swiss context, comprising a geriatric nurse expert with specific training in multidimensional clinical assessment and quality improvement tools.
Receives: Other: Implementation of a nurse-led model of care
ControlNo interventionThe design used for the INTERCARE intervention is a non-randomized stepped wedge design, therefore all nursing homes will receive the intervention but at different time points. All nursing homes will be in a control phase before receiving the intervention, and switch to the intervention phase, once the intervention is implemented.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of all unplanned hospitalizations /1000 resident care days

    Due to the complexity involved in the measurement of avoidable hospitalizations, we will follow experts' recommendation [24], tracking all unplanned hospital admissions as a primary endpoint. The primary endpoint will be calculated as number of unplanned hospitalisations per 1000 resident care days.

    Measured: 21 months

Secondary outcomes (6)
  1. Avoidable hospitalizations

    Number of hospitalizations for ambulatory care sensitive conditions (ACSC). ACSCs will be assessed via the residents' hospital discharge report.

    Measured: 21 months

  2. Avoidable emergency department (ED) visits

    Number of avoidable ED visits per 1000 care days

    Measured: 21 months

  3. Resident quality indicators: Pain

    National quality indicators such as pain are collected by means of the Resident assessment Instrument for nursing homes in routine practice, and are collected independently of the study. The quality indicator "pain" will be measured by:

    • % of residents with self-reported pain
    • % of residents with observed pain (i.e. daily pain of moderate intensity or non-daily pain of severe intensity)

    Measured: 21 months

  4. Resident quality indicators: physical restraints

    National quality indicators such as physical restraints are collected by means of the Resident assessment Instrument for nursing homes in routine practice, and are collected independently of the study. The quality indicator "physical restraint" will be measured by:

    % of residents with daily fixation of the trunk or seating that does not allow standing during the preceding 7 days, or with daily use of bedrails over the preceding 7 days

    Measured: 21 months

  5. Resident quality indicators: Polypharmacy

    National quality indicators such as polypharmacy are collected by means of the Resident assessment Instrument for nursing homes in routine practice, and are collected independently of the study. The quality indicator "polypharmacy" will be measured by:

    % of residents receiving 9 or more medications (active components) over the preceding 7 days

    Measured: 21 months

  6. Resident quality indicators: weight loss

    National quality indicators such as weight loss are collected by means of the Resident assessment Instrument for nursing homes in routine practice, and are collected independently of the study. The quality indicator "weight loss" will be measured by:

    % of residents with weight loss of 5% or more during the preceding 30 days, or of 10% or more in the preceding 180 days.

    Measured: 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2018
  2. Study start20 Jun 2018
  3. Primary completion28 Feb 2020
  4. Study completion1 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Sequential
Model description
Non-randomized stepped-wedge design
Masking
None (open label)
Enrolment
944 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03590470
Sponsor's protocol ID
EKNZ2018-00501
Acronym
INTERCARE
Status last verified
Nov 2020
First submitted
10 Jun 2018
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zuniga F, Kotkowski K, Guerbaai RA, Simon M, Serdaly C, De Geest S, Zeller A, Kressig RW, Wellens NIH, Brunkert T. Understanding a Complex Intervention to Reduce Unplanned Hospitalizations From Nursing Homes: Process Evaluation of INTERCARE. Health Sci Rep. 2026 Jan 11;9(1):e71748. doi: 10.1002/hsr2.71748. eCollection 2026 Jan.

    PubMed 41527584
  • Guerbaai RA, DeGeest S, Popejoy LL, Simon M, Wellens NIH, Denhaerynck K, Zuniga F. Evaluating the implementation fidelity to a successful nurse-led model (INTERCARE) which reduced nursing home unplanned hospitalisations. BMC Health Serv Res. 2023 Feb 9;23(1):138. doi: 10.1186/s12913-023-09146-8.

    PubMed 36759902
  • 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.

    PubMed 35681157
  • 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.

    PubMed 35279088

Questions about this trial

What is this clinical trial studying?

A study testing Implementation of a nurse-led model of care in people with Hospitalisations, run by University of Basel at 7 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of all unplanned hospitalizations /1000 resident care days (time frame: 21 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03590470, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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