Unplanned HospitalizationsINTERSCALENCT06473051
Sustainable Improvement of INTERprofessional Care for Better Resident Outcomes
A study testing Original set and Adapted set in people with Unplanned Hospitalizations, run by University of Basel at 1 site in Switzerland.
Trial summary
INTERCARE is an interprofessional nurse-led care model developed specifically for long-term care facilities (LTCFs) in Switzerland that has been shown to successfully reduce unplanned transfers for residents. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Unplanned Hospitalizations
- What is being tested?
- Original set and Adapted set
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Located within German-speaking part of Switzerland
- ≥ 20 long-term care beds on the cantonal list of LTCFs (or a cooperation of smaller LTCFs with a total of at least 20 long-term care beds, working with the same INTERCARE nurse(s))
- Willingness to introduce the core components of INTERCARE (formal commitment)
- Willingness to provide routine resident assessment data (Resident Assessment Instrument-nursing home version (RAI-NH) or BESA system)
- Working contract or affiliation with the LTCF
- Educational background as an RN with ≥ 3 years' experience working with older persons
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- Assigned role of INTERCARE nurse
- All care staff who work directly with residents (e.g., care workers, physiotherapists and activity staff) of different educational backgrounds (e.g., RNs, LPNs, nurse aides) working in the LTCF at least 8h/week for ≥ 3 months
- Other therapeutic personnel involved in 8h/week or more in treatments/direct contact with residents
- All GP's who treat at least 5 residents in the LTCF at the time of data collection
- All residents present at the LTCF during the study duration with long-term care and billed according to the health insurance law
Who cannot join
- LTCFs located in the Italian- or French-speaking part of Switzerland.
- LTCFs who have previously worked with a nurse-led model similar to the INTERCARE/INTERSCALE research intervention
- INTERCARE nurse
- No contract with the LTCF
- Other care staff
- Non-health care professionals (e.g., administration)
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- General Practitioners (GPs)
- Temporary substitute GPs
- Residents
- Residents who opt out of participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sustainable Improvement of INTERprofessional Care for Better Resident Outcomes: SCAling up an Evidence-based Care Model for Nursing Homes (INTERSCALE)
INTERCARE is an interprofessional nurse-led care model developed specifically for long-term care facilities (LTCFs) in Switzerland that has been shown to successfully reduce unplanned transfers for residents. INTERCARE proved both effective in reducing unplanned transfers to the hospital but also more costly than the usual care. To sustainably implement evidence-base practices or programs such as INTERCARE on a large scale, implementation research studies are needed to assess fitting implementation strategies. Given that the INTERCARE study demonstrated replicability of the INTERCARE model in eleven LTCFs, showing clinical effectiveness, high acceptability, feasibility and LTCF' fidelity to the core components, the INTERSCALE study is the next step to reach scalability in a broader context of a cost-effective solution when supporting the implementation.
Read the detailed description
Background and rationale
Over the last two decades, a number of nurse-led care models have been developed and proven to be effective in reducing unplanned hospital transfers of residents in LTCFs with a range between 6.1% to 11.7% reduction in unplanned transfers and 30% reduction in overall transfers.
Particularly, nurse-led care models include nurses in expanded roles who take the lead in handling resident situations, coaching and empowering care teams and fostering interprofessional collaboration to support decision-making concerning transfers to the hospital. Most models have in common a multidisciplinary team including skilled medical providers such as geriatricians, specialist nurses, or registered nurses (RNs) with additional training, comprehensive geriatric assessment, root-cause analysis or benchmarking of hospitalizations, and individualized care planning (i.e., advance care planning).
In Switzerland, our research group recently developed and tested a nurse-led care model in Swiss nursing homes: improving INTERprofessional CARE for better resident outcomes (i.e. the INTERCARE study), which presented a pilot effort to develop evidenced-based knowledge regarding the effect of this model of care in Swiss LTCFs on avoidable hospitalizations. The INTERCARE model included six core components to be implemented by participating LTCFs: 1) strengthening interprofessional collaboration, 2) introducing an INTERCARE nurse, a registered nurse trained in geriatric knowledge and skills to take up an expanded role, 3) promoting comprehensive geriatric assessment, 4) introducing evidence-based tools to strengthen the communication within the care team (the STOP\&WATCH tool) and with general practitioners (the ISBAR tool), 5) introducing advance care planning, and 6) applying data-driven quality improvement. Introduction of the INTERCARE model within a facility is aimed to drive organizational change in LTCFs by skilling-up key staff like the INTERCARE nurse and introducing new processes and tools.
The INTERCARE study was evaluated using a hybrid-type II implementation effectiveness design, which simultaneously evaluated the effectiveness of the intervention by determining the clinical effectiveness of the model on unplanned transfers as well as to collect information about the effectiveness of implementation strategies. Overall findings demonstrated that the model was effective in reducing unplanned hospital transfers from LTCFs with high acceptability and sustainability amongst facilities but also with high-cost demands for both the LTCFs and the research team in view of the time invested to implement the model. More general information about the INTERCARE model can be found via the following website: https://intercare.nursing.unibas.ch.
The proposed INTERSCALE study is a next step to reach scalability of the INTERCARE model using a more cost-effective approach which can support the large-scale implementation of this intervention. In this study, the investigators focus on the organizational level to test the scalable unit (the INTERCARE model + the implementation strategies) and to further assess whether an adapted set of implementation strategies can be used by LTCFs to achieve similar implementation outcomes to the original study.
Specifically, implementation strategies can be understood as techniques that can help to enhance the adoption, implementation, and sustainability of evidence-based interventions such as the INTERCARE model. As part of the study, various strategies will be used at different study phases and will be tailored for the different levels of participants. Some examples of strategies to be used during the study preparation phase will include organising meetings with LTCF leadership and requesting interested facilities to sign a voluntary agreement regarding their participation in the study. During the implementation phase, the investigators will use blended learning modules to support INTERCARE nurses and LTCF leadership as well as provide periodical benchmarking and feedback for the facility. Some examples of strategies to be used during the sustainment phase will include helping facilities to organize quality monitoring systems and learning collaboratives for ensuring successful long-term implementation of the INTERCARE model within the facility.
Research Objectives:
Primary research objective: To compare the original and adapted set of implementation strategies in view of overall intervention fidelity to the INTERCARE model (aim 1).
Secondary research objectives:
- Further implementation outcomes: To compare the original and adapted set of implementation strategies in view of further implementation outcomes (e.g., fidelity to the six single core components of the INTERCARE model, acceptability, feasibility, sustainability, and costs of implementation strategies) (aim 2.1).
- Cost-effectiveness: to perform a cost-effectiveness analysis in view of unplanned transfers of LTCF residents, while comparing two sets of implementation strategies (aim 2.2).
- Clinical effectiveness:To assess the impact of the original and adapted set of implementation strategies on unplanned transfers of LTCF residents (aim 2.3a).
- Organizational outcomes: To assess the impact of the two sets of implementation strategies on several organizational outcomes (aim 2.3b).
Study design
An effectiveness-implementation hybrid type III design with a cluster-randomized controlled trial will be applied to test the scalable unit of the INTERCARE model in LTCFs in the Swiss-German speaking region. A sample of n=40 LTCFs will be randomized to either the original or the adapted set of implementation strategies (20 LTCFs per arm) offered by the research team, which will be implemented in up to 5 separate groups consisting of 6-10 LTCFs using a stepped start.
Study timeline
The study will start with a preparation phase of 2 months where LTCFs are introduced to the model and participate in preparatory workshops to prepare for the implementation of the intervention (i.e., the INTERCARE model). After the preparation phase, the following time points will ensue:
- 1 month get-in period (T0)
- 12 months of intervention phase (four data collection time-points, every three months after T0)
- 12 months of sustainment phase (four data collection time-points, every three months after the intervention phase)
- Conditions
- Unplanned Hospitalizations
- Being tested
- Original set, Adapted set
- Keywords
- Long-term care, Geriatric nursing, Implementation science, Organizational innovation, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Original setOther
The original set of implementation strategies will include the same strategies as applied in the INTERCARE study by the research group but will be updated to fit the current practice field.
Adapted setOther
The adapted set of implementation strategies will contain similar implementation strategies that are expected to achieve the same outcomes as the first set, but with less resources required (for instance, by providing group coaching sessions rather than single sessions).
| Study group | Role | What they receive |
|---|---|---|
| Original Set (Set O) | Experimental | Implementation strategies applied are:
* preparatory workshops
* implementation handbook
* Training and coaching of INTERCARE nurses (geriatric nurse experts)
* continuous support for participating facilities: meetings, ticket system
* benchmarking reports
Coaching of INTERCARE nurse and meetings with facilities are at INDIVIDUAL level Receives: Other: Original set |
| Adapted Set (Set A) | Experimental | same as set O, except
Coaching of INTERCARE nurse and meetings with facilities are at GROUP level Receives: Other: Adapted set |
What is being measured
The primary outcome is the main question the study is designed to answer.
LTCF Leadership level: Degree of overall fidelity to the core elements of the INTERCARE model
Overall fidelity score (percentage of minimal requirements of the INTERCARE model fulfilled) from the side of the LTCF Leadership will be measured using semi-structured interviews (degree of fulfillment: yes, partialy, no).
Measured: Quarterly, from baseline (month 0) through end of intervention phase (month 12)
Secondary outcomes (16)
Resident level: fidelity to core element Advanced Care Planning
Implementation of ACP with new residents: wishes concerning do-not-resuscitate orders, wishes concerning hospitalization, and antibiotic administration (yes/no) within three months of admission to the LTCF will be collected using structured data sheets.
Measured: Quarterly, from baseline (month 0) through study completion period (24 months)
General practitioner level: Degree of fidelity to the core elements "interprofessional collaboration" and "evidence-based instruments" (focus on use of ISBAR) of the INTERCARE model will be measured
Fidelity to the two core elements will be measured using questionnaire surveys.
Measured: Two times: 1) in the middle of the implementation phase (month 6) and 2) at the end of intervention period (month 12)
LTCF level: Sustainability
Sustainability of the INTERCARE model will be measured with an overall fidelity score (percentage of minimal requirements of the INTERCARE model fulfilled) from the side of the LTCF Leadership using semi-structured interviews (degree of fulfillment: yes, partialy, no). Sustainability is understood as the continued use of the INTERCARE model up to 12 months after the end of the intervention phase.
Measured: Quarterly, from end of intervention phase (month 12) through end of sustainment phase (month 24)
INTERCARE Nurse level: Acceptability of the INTERCARE model
Acceptability of core components of the INTERCARE model will be measured using Acceptability of Intervention Measure (AIM), a 4-item instrument measuring the acceptability of an intervention.
Measured: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
Other care staff level: Acceptability of the INTERCARE model
Acceptability of core components of the INTERCARE model will be measured using Acceptability of Intervention Measure (AIM), a 4-item instrument measuring the acceptability of an intervention.
Measured: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
INTERCARE Nurse level: Feasibility of the INTERCARE model
Feasibility of core components of the INTERCARE model will be measured using Feasibility of Intervention Measure (FIM), a 4-item instrument measuring the feasibility of an intervention.
Measured: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
Other care staff level: Feasibility of the INTERCARE model
Feasibility of core components of the INTERCARE model will be measured using Feasibility of Intervention Measure (FIM), a 4-item instrument measuring the feasibility of an intervention.
Measured: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
LTCF Leadership level: Facility costs and expenditures related to implementation strategies in Swiss Francs
Facility costs and expenditures related to implementation strategies from the side of the LTCF will be measured using structured data reporting forms. Recordings of time required for the implementation strategies and the salary estimate of employees involved will be done using a time-driven activity-based costing sheet.
Measured: Monthly reporting, from baseline (month 0) through study completion period (month 24)
Research group level: Costs of implementation strategies in Swiss Francs
A recording of activities as part of the implementation strategies, time required, and the salary estimate of employees involved in the application/participation of implementation strategies (e.g., coaching, training, information events) will be tracked by the involved members of the research team using a time-driven activity-based costing sheet.
Measured: Continuous tracking, from baseline (month 0) through study completion period (24 months)
Resident level: Unplanned transfers
Number of all unplanned transfers/1000 resident care days will be collected using structured data sheets.
Measured: Quarterly, from baseline (month 0) through study completion period (24 months)
LTCF level: Staff turnover
Percentage of employees with voluntary turnover per unit per month, calculated as number of employees leaving per month divided by average number of staff per month (number of staff at beginning of month + number of staff at end of month/2)
These routinely collected/administrative organizational data from the side of the LTCF on staff turnover will be tracked using structured data exports.
Measured: Quarterly exports, from baseline (month 0) through study completion period (month 24)
LTCF level: Staff absenteeism
- Percentage of staff who show short (up to 3 days), medium (3-10 days) or long-term absences (more than 10 days) per unit per quarter (due to illness or accident)
- Percentage of absence days per unit per quarter in relation to the total number of working days per unit per quarter
These routinely collected/administrative organizational data from the side of the LTCF on staff absenteeism will be tracked using structured data exports.
Measured: Quarterly exports, from baseline (month 0) through study completion period (month 24)
INTERCARE Nurse level: Intention to leave
Intention to leave will be measured using a 3-item instrument measuring Care Workers' Intention to Leave Employment in Nursing Homes.
Measured: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
Other care staff level: Intention to leave
Intention to leave will be measured using a 3-item instrument measuring Care Workers' Intention to Leave Employment in Nursing Homes.
Measured: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
INTERCARE Nurse level: Intention to stay
Intention to leave will be measured using a single item instrument assessing the likelihood of an individual to continue working in the current workplace for the next 12 months.
Measured: Three time points: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
Other care staff level: Intention to stay
Intention to leave will be measured using a single item instrument assessing the likelihood of an individual to continue working in the current workplace for the next 12 months.
Measured: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jul 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Unplanned HospitalizationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franziska Zúñiga, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473051
- Sponsor's protocol ID
- INTERSCALERCT
- Acronym
- INTERSCALE
- Status last verified
- Feb 2026
- First submitted
- 20 May 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hutchinson AF, Parikh S, Tacey M, Harvey PA, Lim WK. A longitudinal cohort study evaluating the impact of a geriatrician-led residential care outreach service on acute healthcare utilisation. Age Ageing. 2015 May;44(3):365-70. doi: 10.1093/ageing/afu196. Epub 2014 Dec 23.
PubMed 25536957Muench U, Simon M, Guerbaai RA, De Pietro C, Zeller A, Kressig RW, Zuniga F; INTERCARE Research Group. Preventable hospitalizations from ambulatory care sensitive conditions in nursing homes: evidence from Switzerland. Int J Public Health. 2019 Dec;64(9):1273-1281. doi: 10.1007/s00038-019-01294-1. Epub 2019 Sep 3.
PubMed 31482196Vogelsmeier A, Popejoy L, Canada K, Galambos C, Petroski G, Crecelius C, Alexander GL, Rantz M. Results of the Missouri Quality Initiative in Sustaining Changes in Nursing Home Care: Six-Year Trends of Reducing Hospitalizations of Nursing Home Residents. J Nutr Health Aging. 2021;25(1):5-12. doi: 10.1007/s12603-020-1552-8.
PubMed 33367456Schmudderich K, Kiwitt J, Palm R, Roes M, Holle B. Core elements and potential of nurse-led care models in residential long-term care: A scoping review. J Clin Nurs. 2023 May;32(9-10):1858-1884. doi: 10.1111/jocn.16231. Epub 2022 Feb 4.
PubMed 35122351Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Basinska 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 35279088Zuniga F, Guerbaai RA, de Geest S, Popejoy LL, Bartakova J, Denhaerynck K, Trutschel D, Basinska K, Nicca D, Kressig RW, Zeller A, Wellens NIH, de Pietro C, Desmedt M, Serdaly C, Simon M. Positive effect of the INTERCARE nurse-led model on reducing nursing home transfers: A nonrandomized stepped-wedge design. J Am Geriatr Soc. 2022 May;70(5):1546-1557. doi: 10.1111/jgs.17677. Epub 2022 Feb 5.
PubMed 35122238Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.
PubMed 25889199Gaudenz C, De Geest S, Schwendimann R, Zuniga F. Factors Associated With Care Workers' Intention to Leave Employment in Nursing Homes: A Secondary Data Analysis of the Swiss Nursing Homes Human Resources Project. J Appl Gerontol. 2019 Nov;38(11):1537-1563. doi: 10.1177/0733464817721111. Epub 2017 Jul 17.
PubMed 28715925McGilton KS, Tourangeau A, Kavcic C, Wodchis WP. Determinants of regulated nurses' intention to stay in long-term care homes. J Nurs Manag. 2013 Jul;21(5):771-81. doi: 10.1111/jonm.12130.
PubMed 23865929Zuniga F, Saringer-Hamiti L, Siqeca F, Holzer S, Guerbaai RA, Brunkert T, Islam F, Bartakova J, Orschulko A, Staudacher S, Kressig RW, Zeller A, Serdaly C, Wellens NIH, De Geest SM, Litschgi V, Zimmermann N, Simon M. Sustainable improvement of interprofessional care for better resident outcomes: protocol for the INTERSCALE hybrid type III effectiveness cluster-randomized trial comparing individualized and collaborative delivery of an evidence-based care model for long-term care. Implement Sci. 2026 Feb 20;21(1):24. doi: 10.1186/s13012-026-01489-0.
PubMed 41715176
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Improvement of INTERprofessional Care for Better Resident Outcomes: SCAling up an Evidence-based Care Model for Nursing Homes (INTERSCALE)
- ClinicalTrials.gov ID
- NCT06473051
- Acronym / sponsor ID
- INTERSCALE / INTERSCALERCT
- Conditions
- Unplanned Hospitalizations
- Keywords
- Long-term care, Geriatric nursing, Implementation science, Organizational innovation, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
INTERCARE is an interprofessional nurse-led care model developed specifically for long-term care facilities (LTCFs) in Switzerland that has been shown to successfully reduce unplanned transfers for residents. INTERCARE proved both effective in reducing unplanned transfers to the hospital but also more costly than the usual care. To sustainably implement evidence-base practices or programs such as INTERCARE on a large scale, implementation research studies are needed to assess fitting implementation strategies. Given that the INTERCARE study demonstrated replicability of the INTERCARE model in eleven LTCFs, showing clinical effectiveness, high acceptability, feasibility and LTCF' fidelity to the core components, the INTERSCALE study is the next step to reach scalability in a broader context of a cost-effective solution when supporting the implementation.
Detailed description
Background and rationale
Over the last two decades, a number of nurse-led care models have been developed and proven to be effective in reducing unplanned hospital transfers of residents in LTCFs with a range between 6.1% to 11.7% reduction in unplanned transfers and 30% reduction in overall transfers.
Particularly, nurse-led care models include nurses in expanded roles who take the lead in handling resident situations, coaching and empowering care teams and fostering interprofessional collaboration to support decision-making concerning transfers to the hospital. Most models have in common a multidisciplinary team including skilled medical providers such as geriatricians, specialist nurses, or registered nurses (RNs) with additional training, comprehensive geriatric assessment, root-cause analysis or benchmarking of hospitalizations, and individualized care planning (i.e., advance care planning).
In Switzerland, our research group recently developed and tested a nurse-led care model in Swiss nursing homes: improving INTERprofessional CARE for better resident outcomes (i.e. the INTERCARE study), which presented a pilot effort to develop evidenced-based knowledge regarding the effect of this model of care in Swiss LTCFs on avoidable hospitalizations. The INTERCARE model included six core components to be implemented by participating LTCFs: 1) strengthening interprofessional collaboration, 2) introducing an INTERCARE nurse, a registered nurse trained in geriatric knowledge and skills to take up an expanded role, 3) promoting comprehensive geriatric assessment, 4) introducing evidence-based tools to strengthen the communication within the care team (the STOP\&WATCH tool) and with general practitioners (the ISBAR tool), 5) introducing advance care planning, and 6) applying data-driven quality improvement. Introduction of the INTERCARE model within a facility is aimed to drive organizational change in LTCFs by skilling-up key staff like the INTERCARE nurse and introducing new processes and tools.
The INTERCARE study was evaluated using a hybrid-type II implementation effectiveness design, which simultaneously evaluated the effectiveness of the intervention by determining the clinical effectiveness of the model on unplanned transfers as well as to collect information about the effectiveness of implementation strategies. Overall findings demonstrated that the model was effective in reducing unplanned hospital transfers from LTCFs with high acceptability and sustainability amongst facilities but also with high-cost demands for both the LTCFs and the research team in view of the time invested to implement the model. More general information about the INTERCARE model can be found via the following website: https://intercare.nursing.unibas.ch.
The proposed INTERSCALE study is a next step to reach scalability of the INTERCARE model using a more cost-effective approach which can support the large-scale implementation of this intervention. In this study, the investigators focus on the organizational level to test the scalable unit (the INTERCARE model + the implementation strategies) and to further assess whether an adapted set of implementation strategies can be used by LTCFs to achieve similar implementation outcomes to the original study.
Specifically, implementation strategies can be understood as techniques that can help to enhance the adoption, implementation, and sustainability of evidence-based interventions such as the INTERCARE model. As part of the study, various strategies will be used at different study phases and will be tailored for the different levels of participants. Some examples of strategies to be used during the study preparation phase will include organising meetings with LTCF leadership and requesting interested facilities to sign a voluntary agreement regarding their participation in the study. During the implementation phase, the investigators will use blended learning modules to support INTERCARE nurses and LTCF leadership as well as provide periodical benchmarking and feedback for the facility. Some examples of strategies to be used during the sustainment phase will include helping facilities to organize quality monitoring systems and learning collaboratives for ensuring successful long-term implementation of the INTERCARE model within the facility.
Research Objectives:
Primary research objective: To compare the original and adapted set of implementation strategies in view of overall intervention fidelity to the INTERCARE model (aim 1).
Secondary research objectives:
- Further implementation outcomes: To compare the original and adapted set of implementation strategies in view of further implementation outcomes (e.g., fidelity to the six single core components of the INTERCARE model, acceptability, feasibility, sustainability, and costs of implementation strategies) (aim 2.1).
- Cost-effectiveness: to perform a cost-effectiveness analysis in view of unplanned transfers of LTCF residents, while comparing two sets of implementation strategies (aim 2.2).
- Clinical effectiveness:To assess the impact of the original and adapted set of implementation strategies on unplanned transfers of LTCF residents (aim 2.3a).
- Organizational outcomes: To assess the impact of the two sets of implementation strategies on several organizational outcomes (aim 2.3b).
Study design
An effectiveness-implementation hybrid type III design with a cluster-randomized controlled trial will be applied to test the scalable unit of the INTERCARE model in LTCFs in the Swiss-German speaking region. A sample of n=40 LTCFs will be randomized to either the original or the adapted set of implementation strategies (20 LTCFs per arm) offered by the research team, which will be implemented in up to 5 separate groups consisting of 6-10 LTCFs using a stepped start.
Study timeline
The study will start with a preparation phase of 2 months where LTCFs are introduced to the model and participate in preparatory workshops to prepare for the implementation of the intervention (i.e., the INTERCARE model). After the preparation phase, the following time points will ensue:
- 1 month get-in period (T0)
- 12 months of intervention phase (four data collection time-points, every three months after T0)
- 12 months of sustainment phase (four data collection time-points, every three months after the intervention phase)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Original Set (Set O) | Experimental | Other: Original setImplementation strategies applied are: * preparatory workshops * implementation handbook * Training and coaching of INTERCARE nurses (geriatric nurse experts) * continuous support for participating facilities: meetings, ticket system * benchmarking reports Coaching of INTERCARE nurse and meetings with facilities are at INDIVIDUAL level |
| Adapted Set (Set A) | Experimental | Other: Adapted setsame as set O, except Coaching of INTERCARE nurse and meetings with facilities are at GROUP level |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- All residents present at the LTCF during the study duration with long-term care and billed according to the health insurance law
Key exclusion criteria (10 listed)
- INTERCARE nurse
- Other care staff
- General Practitioners (GPs)
- Residents
- Residents who opt out of participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Original setThe original set of implementation strategies will include the same strategies as applied in the INTERCARE study by the research group but will be updated to fit the current practice field. | Other | Original Set (Set O) |
| Adapted setThe adapted set of implementation strategies will contain similar implementation strategies that are expected to achieve the same outcomes as the first set, but with less resources required (for instance, by providing group coaching sessions rather than single sessions). | Other | Adapted Set (Set A) |
Primary outcome
LTCF Leadership level: Degree of overall fidelity to the core elements of the INTERCARE model
Time frame: Quarterly, from baseline (month 0) through end of intervention phase (month 12)
Overall fidelity score (percentage of minimal requirements of the INTERCARE model fulfilled) from the side of the LTCF Leadership will be measured using semi-structured interviews (degree of fulfillment: yes, partialy, no).
16 secondary outcomes
Resident level: fidelity to core element Advanced Care Planning
Time frame: Quarterly, from baseline (month 0) through study completion period (24 months)
General practitioner level: Degree of fidelity to the core elements "interprofessional collaboration" and "evidence-based instruments" (focus on use of ISBAR) of the INTERCARE model will be measured
Time frame: Two times: 1) in the middle of the implementation phase (month 6) and 2) at the end of intervention period (month 12)
LTCF level: Sustainability
Time frame: Quarterly, from end of intervention phase (month 12) through end of sustainment phase (month 24)
INTERCARE Nurse level: Acceptability of the INTERCARE model
Time frame: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
Other care staff level: Acceptability of the INTERCARE model
Time frame: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
INTERCARE Nurse level: Feasibility of the INTERCARE model
Time frame: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
Other care staff level: Feasibility of the INTERCARE model
Time frame: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
LTCF Leadership level: Facility costs and expenditures related to implementation strategies in Swiss Francs
Time frame: Monthly reporting, from baseline (month 0) through study completion period (month 24)
Research group level: Costs of implementation strategies in Swiss Francs
Time frame: Continuous tracking, from baseline (month 0) through study completion period (24 months)
Resident level: Unplanned transfers
Time frame: Quarterly, from baseline (month 0) through study completion period (24 months)
LTCF level: Staff turnover
Time frame: Quarterly exports, from baseline (month 0) through study completion period (month 24)
LTCF level: Staff absenteeism
Time frame: Quarterly exports, from baseline (month 0) through study completion period (month 24)
INTERCARE Nurse level: Intention to leave
Time frame: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
Other care staff level: Intention to leave
Time frame: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
INTERCARE Nurse level: Intention to stay
Time frame: Three time points: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
Other care staff level: Intention to stay
Time frame: Three times: 1) at the get-in period (month 0); 2) in the middle of the implementation phase (month 6) and 3) at the end of intervention period (month 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 25536957Hutchinson AF, Parikh S, Tacey M, Harvey PA, Lim WK. A longitudinal cohort study evaluating the impact of a geriatrician-led residential care outreach service on acute healthcare utilisation. Age Ageing. 2015 May;44(3):365-70. doi: 10.1093/ageing/afu196. Epub 2014 Dec 23.
- Background: PubMed 31482196Muench U, Simon M, Guerbaai RA, De Pietro C, Zeller A, Kressig RW, Zuniga F; INTERCARE Research Group. Preventable hospitalizations from ambulatory care sensitive conditions in nursing homes: evidence from Switzerland. Int J Public Health. 2019 Dec;64(9):1273-1281. doi: 10.1007/s00038-019-01294-1. Epub 2019 Sep 3.
- Background: PubMed 33367456Vogelsmeier A, Popejoy L, Canada K, Galambos C, Petroski G, Crecelius C, Alexander GL, Rantz M. Results of the Missouri Quality Initiative in Sustaining Changes in Nursing Home Care: Six-Year Trends of Reducing Hospitalizations of Nursing Home Residents. J Nutr Health Aging. 2021;25(1):5-12. doi: 10.1007/s12603-020-1552-8.
- Background: PubMed 35122351Schmudderich K, Kiwitt J, Palm R, Roes M, Holle B. Core elements and potential of nurse-led care models in residential long-term care: A scoping review. J Clin Nurs. 2023 May;32(9-10):1858-1884. doi: 10.1111/jocn.16231. Epub 2022 Feb 4.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Background: PubMed 35279088Basinska 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.
- Background: PubMed 35122238Zuniga F, Guerbaai RA, de Geest S, Popejoy LL, Bartakova J, Denhaerynck K, Trutschel D, Basinska K, Nicca D, Kressig RW, Zeller A, Wellens NIH, de Pietro C, Desmedt M, Serdaly C, Simon M. Positive effect of the INTERCARE nurse-led model on reducing nursing home transfers: A nonrandomized stepped-wedge design. J Am Geriatr Soc. 2022 May;70(5):1546-1557. doi: 10.1111/jgs.17677. Epub 2022 Feb 5.
- Background: PubMed 25889199Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.
- Background: PubMed 28715925Gaudenz C, De Geest S, Schwendimann R, Zuniga F. Factors Associated With Care Workers' Intention to Leave Employment in Nursing Homes: A Secondary Data Analysis of the Swiss Nursing Homes Human Resources Project. J Appl Gerontol. 2019 Nov;38(11):1537-1563. doi: 10.1177/0733464817721111. Epub 2017 Jul 17.
- Background: PubMed 23865929McGilton KS, Tourangeau A, Kavcic C, Wodchis WP. Determinants of regulated nurses' intention to stay in long-term care homes. J Nurs Manag. 2013 Jul;21(5):771-81. doi: 10.1111/jonm.12130.
- Derived from this study: PubMed 41715176Zuniga F, Saringer-Hamiti L, Siqeca F, Holzer S, Guerbaai RA, Brunkert T, Islam F, Bartakova J, Orschulko A, Staudacher S, Kressig RW, Zeller A, Serdaly C, Wellens NIH, De Geest SM, Litschgi V, Zimmermann N, Simon M. Sustainable improvement of interprofessional care for better resident outcomes: protocol for the INTERSCALE hybrid type III effectiveness cluster-randomized trial comparing individualized and collaborative delivery of an evidence-based care model for long-term care. Implement Sci. 2026 Feb 20;21(1):24. doi: 10.1186/s13012-026-01489-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Original set and Adapted set in people with Unplanned Hospitalizations, run by University of Basel at 1 site 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 11 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
LTCF Leadership level: Degree of overall fidelity to the core elements of the INTERCARE model (time frame: Quarterly, from baseline (month 0) through end of intervention phase (month 12)). 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 NCT06473051, which also lists 11 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 25 Feb 2026.