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Clinical Trials/NCT06473051
NCT06473051
Active, not recruiting
Not Applicable

Sustainable Improvement of INTERprofessional Care for Better Resident Outcomes: SCAling up an Evidence-based Care Model for Nursing Homes (INTERSCALE)

University of Basel1 site in 1 country40 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
Original set
Conditions
Unplanned Hospitalizations
Sponsor
University of Basel
Enrollment
40
Locations
1
Primary Endpoint
LTCF Leadership level: Degree of overall fidelity to the core elements of the INTERCARE model
Status
Active, not recruiting
Last Updated
2 months ago

Overview

Brief 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. 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)

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
October 31, 2027
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Franziska Zúñiga

Prof. Dr. Franziska Zúñiga

University of Basel

Eligibility Criteria

Inclusion Criteria

  • Study inclusion/

Exclusion Criteria

  • are based on level of participant:
  • Inclusion criteria:
  • \- 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)
  • Exclusion criteria:
  • \- 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

Arms & Interventions

Original Set (Set O)

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

Intervention: Original set

Adapted Set (Set A)

same as set O, except Coaching of INTERCARE nurse and meetings with facilities are at GROUP level

Intervention: Adapted set

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • 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(Two times: 1) in the middle of the implementation phase (month 6) and 2) at the end of intervention period (month 12))
  • LTCF level: Staff turnover(Quarterly exports, from baseline (month 0) through study completion period (month 24))
  • Other care staff level: Acceptability of the INTERCARE model(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(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(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))
  • Resident level: fidelity to core element Advanced Care Planning(Quarterly, from baseline (month 0) through study completion period (24 months))
  • LTCF level: Sustainability(Quarterly, from end of intervention phase (month 12) through end of sustainment phase (month 24))
  • INTERCARE Nurse level: Acceptability of the INTERCARE model(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))
  • Research group level: Costs of implementation strategies in Swiss Francs(Continuous tracking, from baseline (month 0) through study completion period (24 months))
  • INTERCARE Nurse level: Intention to leave(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(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))
  • Resident level: Unplanned transfers(Quarterly, from baseline (month 0) through study completion period (24 months))
  • LTCF level: Staff absenteeism(Quarterly exports, from baseline (month 0) through study completion period (month 24))
  • Other care staff level: Intention to leave(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(Monthly reporting, from baseline (month 0) through study completion period (month 24))
  • Other care staff level: Intention to stay(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))

Study Sites (1)

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