Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473051
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-20
Brief Title:
Sustainable Improvement of INTERprofessional Care for Better Resident Outcomes
Sponsor:
University of Basel
Organization:
University of Basel
Study Overview
Official Title:
Sustainable Improvement of INTERprofessional Care for Better Resident Outcomes SCAling up an Evidence-based Care Model for Nursing Homes INTERSCALE
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTERSCALE
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 61 to 117 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 ie 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 ie 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 STOPWATCH 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 httpsintercarenursingunibasch
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 eg fidelity to the six single core components of the INTERCARE model acceptability feasibility sustainability and costs of implementation strategies aim 21
Cost-effectiveness to perform a cost-effectiveness analysis in view of unplanned transfers of LTCF residents while comparing two sets of implementation strategies aim 22
Clinical effectivenessTo assess the impact of the original and adapted set of implementation strategies on unplanned transfers of LTCF residents aim 23a
Organizational outcomes To assess the impact of the two sets of implementation strategies on several organizational outcomes aim 23b
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 n40 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 ie 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
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 61 to 117 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 ie 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 ie 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 STOPWATCH 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 httpsintercarenursingunibasch
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 eg fidelity to the six single core components of the INTERCARE model acceptability feasibility sustainability and costs of implementation strategies aim 21
Cost-effectiveness to perform a cost-effectiveness analysis in view of unplanned transfers of LTCF residents while comparing two sets of implementation strategies aim 22
Clinical effectivenessTo assess the impact of the original and adapted set of implementation strategies on unplanned transfers of LTCF residents aim 23a
Organizational outcomes To assess the impact of the two sets of implementation strategies on several organizational outcomes aim 23b
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 n40 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None