Potentially Avoidable HospitalisationsRATHER-NHNCT07359521
Implementation and Evaluation of a Complex Intervention to Reduce Avoidable Transitions Between Nursing Home and Hospital
A study testing RATHER-NH Toolkit in people with Potentially Avoidable Hospitalisations, run by Vrije Universiteit Brussel at 6 sites in Belgium.
Trial summary
Hospital admissions can have a negative impact on the physical and emotional health of nursing home residents. Although evidence-based interventions have been developed to reduce hospitalisations, the evidence regarding their effectiveness is inconclusive and challenges have been reported in implementing these… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Potentially Avoidable Hospitalisations
- What is being tested?
- RATHER-NH Toolkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 6 sitesBelgium
- Study dates
- 1 Jun 2026to 1 Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A capacity of at least 60 beds
- Active engagement for the study from nursing home management, head nurses and the coordinating \& advisory physician, meaning:
- The nursing home manager, head nurses and the coordinating \& advisory physician agree that the implementation of the RATHER-NH intervention is a priority for their facility.
- The nursing home manager agrees to provide time for the nursing home staff members to participate in activities related to the implementation of RATHER-NH such as attending information sessions, training workshops, and feedback moments.
- The nursing home manager is willing to allocate time to at least two nursing home staff members (each approximately 0.1 FTE for the study duration) to act as local project champions and to at least four other staff members (type of staff to be decided with the nursing home manager) to form a local action team to support the implementation and evaluation of RATHER-NH.
Who cannot join
- Already participated in another project designed to reduce potentially avoidable hospitalisations.
- Already taking part in another major quality improvement initiative or study.
- A large reorganisation or change in staff is taking place or is planned during the study period.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites
WZC De Cocon
Dendermonde
WZC Sint-Elisabeth
Eeklo
WZC Domino
Ghent
WZC Annuntiaten
Heverlee
WZC Ter Moere
Lokeren
WZC Martinas
Merchtem
About this study
Official title: Implementation and Evaluation of a Complex Intervention to Reduce Avoidable Transitions Between Nursing Home and Hospital (RATHER-NH): Study Protocol for a Pilot Cluster Randomized Controlled Trial.
Hospital admissions can have a negative impact on the physical and emotional health of nursing home residents. Although evidence-based interventions have been developed to reduce hospitalisations, the evidence regarding their effectiveness is inconclusive and challenges have been reported in implementing these interventions within the nursing home context. Hence, this study aimed to implement and evaluate a complex intervention to reduce avoidable transitions between nursing home and hospital (RATHER-NH).
Read the detailed description
The researchers will conduct a pilot cluster randomized controlled trial (RCT) of the RATHER-NH intervention with an embedded process evaluation. This study has two specific objectives: 1) to evaluate the implementation of the RATHER-NH intervention, the perceived impact and underlying mechanisms of impact, and the contextual factors influencing implementation and impact; and 2) To assess the feasibility of the trial methods and procedures, and the potential primary and secondary outcome measures for a future full-scale RCT.
The study will be conducted in twelve nursing homes in Flanders, of which six will be randomly assigned to the intervention group and six to the control group.
The researchers will use the MRC guidance on complex intervention development and evaluation combined with the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to guide the implementation and evaluation of RATHER-NH.
Based on the results of the qualitative study with nursing home residents, family carers and professional stakeholders, and on existing scientific literature, a first version of a logic model was developed, which illustrates the different determinants and mechanisms that influence the anticipated outcomes and impact of the RATHER-NH intervention. The logic model was used to select relevant intervention tools from the INTERACT Quality Improvement Program and our own self-developed tool concerning a GP communication tool:
- Stop and Watch Early Warning Tool This is a checklist that marks the most relevant changes in the physical and behavioural condition of a nursing home resident that eventually may lead to a potentially avoidable hospitalisation.
- Decision trees Decision trees have been developed for several Ambulatory Care Sensitive Conditions (ACSCs), which are conditions that can lead to unplanned hospitalisation which may be avoided if the condition is promptly detected and managed correctly through access to medical care in the nursing home.
- General Practitioner communication tool This tool does tries to standardize the communication between the general practitioner and nursing home staff members.
The tools from the RATHER-NH intervention toolkit have fixed and flexible elements. To adapt elements of the tools to the local context, each participating nursing home will engage in a facilitated group discussion to assess the context and their specific needs, facilitated by the researcher and guided by the i-PARIHS framework. While the fixed elements of each tool need to be maintained to preserve the intervention fidelity, the flexible and hence adaptable elements can be tailored to fit the specific needs, routines, and structures of each nursing home. This ensures that the intervention is both evidence-informed and context-sensitive, increasing the likelihood of successful implementation.
Based on evidence from our qualitative study with key stakeholders and findings from other relevant studies, several implementation barriers are anticipated when implementing complex nursing home interventions such as the RATHER-NH intervention. These barriers were linked to the implementation strategies as described in the Expert Recommendations for Implementing Change (ERIC) Matching Tool. These strategies combined will form the implementation strategy for RATHER-NH (e.g. conduct educational meetings, ongoing training and identify and prepare champions). To ensure the implementation strategy is responsive to the specific needs of each nursing home, this will also be discussed during the facilitated group discussion to tailor and operationalise the implementation strategies by adapting the flexible elements of the implementation strategies to the local context. Next to the researcher, an external trainer will be recruited to support the implementation of the intervention within the nursing homes.
- Conditions
- Potentially Avoidable Hospitalisations
- Being tested
- RATHER-NH Toolkit
- Keywords
- Nursing homes, Potentially avoidable hospitalisations, Quality improvement program, Implementation, Pilot cluster RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RATHER-NH ToolkitOther
- Stop and Watch Early Warning Tool B) Decision trees C) General Practitioner communication tool
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Nursing homes in the intervention group will implement tools from the RATHER-NH intervention toolkit using a tailored implementation strategy over a period of approximately 9 months. Receives: Other: RATHER-NH Toolkit |
| Control group | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes on healthcare use per 100 person-months
Rate of hospitalisations per 100 person-months, rate of out-of-hours GP contacts per 100 person-months, rate of emergency department visits (without hospitalisation) per 100 person-months.
Measured: Retrospective baseline measurement of 3 months, during the intervention (period of 9 months) untill 3 months post-intervention for the post-interventions measurement.
Outcomes on healthcare use per hospitalisation
Length of hospital stay, cause of hospitalisation, hospitalisation in the last month of life (in case of death) and place of death
Measured: Retrospective baseline measurement of 3 months, during the intervention (period of 9 months) untill 3 months post-intervention for the post-interventions measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jun 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potentially Avoidable HospitalisationsStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- Model description
- Pilot Cluster RCT with an embedded process evaluation
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tinne Smets, Prof., Principal investigator, End-of-Life Care Research Group - Vrije Universiteit Brussel en Universiteit Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359521
- Sponsor's protocol ID
- 25441_RATHER-NH RCT
- Other IDs
- G069022N
- Acronym
- RATHER-NH
- Status last verified
- Aug 2026
- First submitted
- 15 Dec 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be collected during the trial. The collected data will be on facility level.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Complex Intervention to Reduce Avoidable Transitions Between Nursing Home and Hospital (RATHER-NH): Study Protocol for a Pilot Cluster Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07359521
- Acronym / sponsor ID
- RATHER-NH / 25441_RATHER-NH RCT
- Conditions
- Potentially Avoidable Hospitalisations
- Keywords
- Nursing homes, Potentially avoidable hospitalisations, Quality improvement program, Implementation, Pilot cluster RCT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 22 Jan 2026 (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.
Hospital admissions can have a negative impact on the physical and emotional health of nursing home residents. Although evidence-based interventions have been developed to reduce hospitalisations, the evidence regarding their effectiveness is inconclusive and challenges have been reported in implementing these interventions within the nursing home context. Hence, this study aimed to implement and evaluate a complex intervention to reduce avoidable transitions between nursing home and hospital (RATHER-NH).
Detailed description
The researchers will conduct a pilot cluster randomized controlled trial (RCT) of the RATHER-NH intervention with an embedded process evaluation. This study has two specific objectives: 1) to evaluate the implementation of the RATHER-NH intervention, the perceived impact and underlying mechanisms of impact, and the contextual factors influencing implementation and impact; and 2) To assess the feasibility of the trial methods and procedures, and the potential primary and secondary outcome measures for a future full-scale RCT.
The study will be conducted in twelve nursing homes in Flanders, of which six will be randomly assigned to the intervention group and six to the control group.
The researchers will use the MRC guidance on complex intervention development and evaluation combined with the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to guide the implementation and evaluation of RATHER-NH.
Based on the results of the qualitative study with nursing home residents, family carers and professional stakeholders, and on existing scientific literature, a first version of a logic model was developed, which illustrates the different determinants and mechanisms that influence the anticipated outcomes and impact of the RATHER-NH intervention. The logic model was used to select relevant intervention tools from the INTERACT Quality Improvement Program and our own self-developed tool concerning a GP communication tool:
- Stop and Watch Early Warning Tool This is a checklist that marks the most relevant changes in the physical and behavioural condition of a nursing home resident that eventually may lead to a potentially avoidable hospitalisation.
- Decision trees Decision trees have been developed for several Ambulatory Care Sensitive Conditions (ACSCs), which are conditions that can lead to unplanned hospitalisation which may be avoided if the condition is promptly detected and managed correctly through access to medical care in the nursing home.
- General Practitioner communication tool This tool does tries to standardize the communication between the general practitioner and nursing home staff members.
The tools from the RATHER-NH intervention toolkit have fixed and flexible elements. To adapt elements of the tools to the local context, each participating nursing home will engage in a facilitated group discussion to assess the context and their specific needs, facilitated by the researcher and guided by the i-PARIHS framework. While the fixed elements of each tool need to be maintained to preserve the intervention fidelity, the flexible and hence adaptable elements can be tailored to fit the specific needs, routines, and structures of each nursing home. This ensures that the intervention is both evidence-informed and context-sensitive, increasing the likelihood of successful implementation.
Based on evidence from our qualitative study with key stakeholders and findings from other relevant studies, several implementation barriers are anticipated when implementing complex nursing home interventions such as the RATHER-NH intervention. These barriers were linked to the implementation strategies as described in the Expert Recommendations for Implementing Change (ERIC) Matching Tool. These strategies combined will form the implementation strategy for RATHER-NH (e.g. conduct educational meetings, ongoing training and identify and prepare champions). To ensure the implementation strategy is responsive to the specific needs of each nursing home, this will also be discussed during the facilitated group discussion to tailor and operationalise the implementation strategies by adapting the flexible elements of the implementation strategies to the local context. Next to the researcher, an external trainer will be recruited to support the implementation of the intervention within the nursing homes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot Cluster RCT with an embedded process evaluation
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: RATHER-NH ToolkitNursing homes in the intervention group will implement tools from the RATHER-NH intervention toolkit using a tailored implementation strategy over a period of approximately 9 months. |
| Control group | No intervention | –Care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A capacity of at least 60 beds
- Active engagement for the study from nursing home management, head nurses and the coordinating \& advisory physician, meaning:
Key exclusion criteria (3 listed)
- Already participated in another project designed to reduce potentially avoidable hospitalisations.
- Already taking part in another major quality improvement initiative or study.
- A large reorganisation or change in staff is taking place or is planned during the study period.
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 |
|---|---|---|
| RATHER-NH ToolkitA) Stop and Watch Early Warning Tool B) Decision trees C) General Practitioner communication tool | Other | Intervention group |
Primary outcome
Outcomes on healthcare use per 100 person-months
Time frame: Retrospective baseline measurement of 3 months, during the intervention (period of 9 months) untill 3 months post-intervention for the post-interventions measurement.
Rate of hospitalisations per 100 person-months, rate of out-of-hours GP contacts per 100 person-months, rate of emergency department visits (without hospitalisation) per 100 person-months.
Outcomes on healthcare use per hospitalisation
Time frame: Retrospective baseline measurement of 3 months, during the intervention (period of 9 months) untill 3 months post-intervention for the post-interventions measurement.
Length of hospital stay, cause of hospitalisation, hospitalisation in the last month of life (in case of death) and place of death
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 10 Aug 2026.
- Individual participant dataSharing planned: No. IPD will not be collected during the trial. The collected data will be on facility level.
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.
Tinne Smets, Prof. principal investigator
End-of-Life Care Research Group - Vrije Universiteit Brussel en Universiteit Gent
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RATHER-NH Toolkit in people with Potentially Avoidable Hospitalisations, run by Vrije Universiteit Brussel at 6 sites in Belgium.
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 5 inclusion and 3 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. 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?
Outcomes on healthcare use per 100 person-months (time frame: Retrospective baseline measurement of 3 months, during the intervention (period of 9 months) untill 3 months post-intervention for the post-interventions measurement.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.