Clinical trial NCT06473051: Sustainable Improvement of INTERprofessional Care for Better Resident Outcomes
Official title: Sustainable Improvement of INTERprofessional Care for Better Resident Outcomes: SCAling up an Evidence-based Care Model for Nursing Homes (INTERSCALE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unplanned Hospitalizations
Keywords: Long-term care
Geriatric nursing
Implementation science
Organizational innovation
Randomized Controlled Trial
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

Eligibility criteria: Study inclusion/exclusion criteria are based on level of participant:

1. LTCF

   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
2. INTERCARE nurse

   Inclusion criteria:

   - Working contract or affiliation with the LTCF

   - Educational background as an RN with ≥ 3 years' experience working with older persons

   - Assigned role of INTERCARE nurse

   Exclusion criteria:

   - No contract with the LTCF
3. Other care staff

   Inclusion criteria:
   * 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

   Exclusion criteria:

   - Non-health care professionals (e.g., administration)
4. General Practitioners (GPs)

   Inclusion criteria:
   * All GP's who treat at least 5 residents in the LTCF at the time of data collection

   Exclusion criteria:

   - Temporary substitute GPs
5. Residents

Inclusion criteria:

- All residents present at the LTCF during the study duration with long-term care and billed according to the health insurance law

Exclusion criteria:

- Residents who opt out of participating in the study

Primary outcomes:
measure: LTCF Leadership level: Degree of overall fidelity to the core elements of the INTERCARE model
timeFrame: Quarterly, from baseline (month 0) through end of intervention phase (month 12)
Secondary outcomes:
measure: Resident level: fidelity to core element Advanced Care Planning
timeFrame: Quarterly, from baseline (month 0) through study completion period (24 months)
measure: 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
timeFrame: Two times: 1) in the middle of the implementation phase (month 6) and 2) at the end of intervention period (month 12)
measure: LTCF level: Sustainability
timeFrame: Quarterly, from end of intervention phase (month 12) through end of sustainment phase (month 24)
measure: INTERCARE Nurse level: Acceptability of the INTERCARE model
timeFrame: 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)
measure: Other care staff level: Acceptability of the INTERCARE model
timeFrame: 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)
measure: INTERCARE Nurse level: Feasibility of the INTERCARE model
timeFrame: 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)
measure: Other care staff level: Feasibility of the INTERCARE model
timeFrame: 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)
measure: LTCF Leadership level: Facility costs and expenditures related to implementation strategies in Swiss Francs
timeFrame: Monthly reporting, from baseline (month 0) through study completion period (month 24)
measure: Research group level: Costs of implementation strategies in Swiss Francs
timeFrame: Continuous tracking, from baseline (month 0) through study completion period (24 months)
measure: Resident level: Unplanned transfers
timeFrame: Quarterly, from baseline (month 0) through study completion period (24 months)
measure: LTCF level: Staff turnover
timeFrame: Quarterly exports, from baseline (month 0) through study completion period (month 24)
measure: LTCF level: Staff absenteeism
timeFrame: Quarterly exports, from baseline (month 0) through study completion period (month 24)
measure: INTERCARE Nurse level: Intention to leave
timeFrame: 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)
measure: Other care staff level: Intention to leave
timeFrame: 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)
measure: INTERCARE Nurse level: Intention to stay
timeFrame: 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)
measure: Other care staff level: Intention to stay
timeFrame: 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 outcomes:
Locations:
city: Basel
country: Switzerland
facility: Institute of Nursing Science
Study officials:
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