HospitalisationsINTERCARENCT03590470
Nurse-led Care Models in Swiss Nursing Homes: Improving Interprofessional Care for Better Resident Outcomes (INTERCARE)
A study testing Implementation of a nurse-led model of care in people with Hospitalisations, run by University of Basel at 7 sites in Switzerland.
Trial summary
This implementation science project aims to implement a nurse-led model of care in 11 nursing homes in the German speaking part of Switzerland, to reduce avoidable hospitalisations. The model will be introduced using a non-randomized stepped-wedge design. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospitalisations
- What is being tested?
- Implementation of a nurse-led model of care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 944 participants
- Where
- 7 sitesSwitzerland
- Study dates
- 20 Jun 2018to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Nursing homes
- German-speaking
- Size: ≥80 long-term care beds (NHs with >60 beds will be considered if they have a high hospitalisation rate)
- Hospitalisation rates: ≥0.8/1000 resident days
- Residents
- All long-term care residents
Show all 13Show fewer
- Geriatric nurse experts:
- Registered nurse
- At least three years' experience in long-term care
- Nursing home staff
- Care workers of all educational levels, including students
- Other health professionals employed by the NH (such as therapists, dieticians) with direct resident contact
- Employed by the NH and working in the NH for a minimum of 3 months
Who cannot join
- Nursing homes
- Italian-speaking
- French-speaking
- Residents
- Short term or day care residents, other residents with a discharge planned within two months after admittance
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Switzerland7 sites
Obesunne
Arlesheim, 4144
St Christophorus
Basel, 4057
Marienhaus
Basel
Domicil schwabgut
Bern, 3018
Zentrum Schlossmat
Burgdorf, 3400
Viva Luzern
Lucerne, 6003
Reusspark
Niederwil, 5524
About this study
Official title: Nurse-led Care Model in Swiss Nursing Homes: Improving INTERprofessional CARE for Better Resident Outcomes (INTERCARE)
This implementation science project aims to implement a nurse-led model of care in 11 nursing homes in the German speaking part of Switzerland, to reduce avoidable hospitalisations. The model will be introduced using a non-randomized stepped-wedge design. First, training will be delivered to leadership teams and to geriatric nurse experts, secondly after a baseline measurement period, including distribution of questionnaires and collection of resident data mainly national quality indicators and data regarding hospitalisations, the nurse led model will be implemented and thereafter 2 measurement periods will follow (6 months after the beginning of the intervention and at the end). Quantitative resident data will be retrieved from the RAI-NH three-monthly, and hospitalization data with the help of a data platform, reflection tools and hospital discharge reports continuously from the baseline period until the end of the data collection in 02.2020. The hypotheses of the project are:
- To assess the effectiveness of the nurse-led care model on unplanned hospitalizations (primary outcome) and additional resident and staff outcomes, hypothesizing that nursing homes with a nurse-led care model have lower rates of unplanned hospitalizations and show improvements in additional resident and staff outcomes
- To assess the effect of the degree of adoption on client outcomes, hypothesizing that a higher degree of adoption is related to better client outcomes
- To describe the implementation costs the Swiss nurse-led interprofessional NH care model on the NH level and to assess the economic impact of INTERCARE with a cost-effectiveness analysis adopting a health care system perspective (comparing the increase in staff costs with the decrease of days of avoidable hospitalizations)
- To explore resident/family and staff perceptions of service outcomes (e.g., timeliness) and the acceptability of the nurse-led care model;
- To describe the degree to which the model was adopted, its feasibility, the fidelity with which it was applied, and the barriers and facilitators met by NH leadership and nurse experts.
Read the detailed description
This multicentre study uses a mixed-methods approach to evaluate testing of a nurse-led care model intervention. Each of the 11 NHs participating in this study will recruit at least one registered nurse with at least three years' long-term care experience, which will undergo training to become a geriatric nurse expert. Training of the geriatric nurse experts will be delivered as a blended-learning approach, combining face to face (F2F) teaching and E-learning modules. The 8 modules will cover the following topics: 1. leadership, 2. communication, 3. comprehensive geriatric assessment, 4. geriatric syndromes, 5. chronic conditions, 6. acute conditions, 7. pharmacology in geriatrics and 8. quality improvement. Modules 1-3 and 8 will be delivered as 5 days of F2F teaching before the implementation start, followed by E-learnings, and 8 expert meetings to be continued throughout the intervention. The last meeting takes place in November 2019. Additionally, the practical training will be enhanced by individual supervision with an experienced nurse expert and/or geriatrician. Modules 4-7 will be delivered via E-learning modules. All modules will cover approximately 66h of F2F learning and 60 hours of E-learning, depending on the level of education and experience of each nurse. In total the geriatric nurse expert training should account for approximately 125 hours.
The registered nurse which will take on the role of geriatric nurse expert will either be recruited within the pool of nurses in each respective NH or recruited from the outside. The nurse-led care model will be built with core components, such as interprofessional collaboration, presence of a geriatric nurse expert, comprehensive geriatric assessment, advance care planning, guidance and coaching, data driven quality and evidence-based tools. Each NH will have to implement these core components along with implementing the role of geriatric nurse expert.
The intervention will be implemented and evaluated by means of a non-randomized quasi experimental stepped-wedge design, over a period of 21 months. The stepped wedge design allows inclusion of all NHs, thus does not exclude NHs from receiving the INTERCARE | Research plan Version 1.1/09.05. 2018 20/53 intervention. The "stepped" or "graded" unidirectional allocation to the intervention enables each NH to act as its own control. After a 3-month baseline phase, NHs will sequentially begin implementation of the nurse-led care model, which they will continue to use post-implementation. A get-in period of 1 month will be planned to address possible timing problems at the intervention start. Another advantage of the design is the graded start in the NHs facilitating delivery of the intervention, as each NH will discuss with the research team when they will receive the intervention. The first two NHs will start their baseline data collection in June 2018 and implement the intervention in September 2018, and every month thereafter, two other NHs will start with the intervention.
A non-randomized design was chosen to enable NHs to choose when they will start with the intervention, to allow for each NH to prepare accordingly for the implementation. Limitations of this study design might arise from its novelty. So far, no gold standard for data analysis has been established. In addition to this, non-randomization of the starting point of the intervention may imply that NHs were prepared for the intervention and this may be reflected in the results.
- Conditions
- Hospitalisations
- Being tested
- Implementation of a nurse-led model of care
- Keywords
- avoidable hospitalisations, quality of care, nursing homes, implementation science, quality improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of a nurse-led model of careOther
A nurse-model of care consisting of a specifically trained geriatric nurse expert, communication and quality improvement tools will be implemented in 11 nursing homes in the German speaking part of Switzerland
| Study group | Role | What they receive |
|---|---|---|
| Experimental_INTERCARE intervention | Experimental | Implementation of a nurse-led model of care adapted to the Swiss context, comprising a geriatric nurse expert with specific training in multidimensional clinical assessment and quality improvement tools. Receives: Other: Implementation of a nurse-led model of care |
| Control | No intervention | The design used for the INTERCARE intervention is a non-randomized stepped wedge design, therefore all nursing homes will receive the intervention but at different time points. All nursing homes will be in a control phase before receiving the intervention, and switch to the intervention phase, once the intervention is implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of all unplanned hospitalizations /1000 resident care days
Due to the complexity involved in the measurement of avoidable hospitalizations, we will follow experts' recommendation [24], tracking all unplanned hospital admissions as a primary endpoint. The primary endpoint will be calculated as number of unplanned hospitalisations per 1000 resident care days.
Measured: 21 months
Secondary outcomes (6)
Avoidable hospitalizations
Number of hospitalizations for ambulatory care sensitive conditions (ACSC). ACSCs will be assessed via the residents' hospital discharge report.
Measured: 21 months
Avoidable emergency department (ED) visits
Number of avoidable ED visits per 1000 care days
Measured: 21 months
Resident quality indicators: Pain
National quality indicators such as pain are collected by means of the Resident assessment Instrument for nursing homes in routine practice, and are collected independently of the study. The quality indicator "pain" will be measured by:
- % of residents with self-reported pain
- % of residents with observed pain (i.e. daily pain of moderate intensity or non-daily pain of severe intensity)
Measured: 21 months
Resident quality indicators: physical restraints
National quality indicators such as physical restraints are collected by means of the Resident assessment Instrument for nursing homes in routine practice, and are collected independently of the study. The quality indicator "physical restraint" will be measured by:
% of residents with daily fixation of the trunk or seating that does not allow standing during the preceding 7 days, or with daily use of bedrails over the preceding 7 days
Measured: 21 months
Resident quality indicators: Polypharmacy
National quality indicators such as polypharmacy are collected by means of the Resident assessment Instrument for nursing homes in routine practice, and are collected independently of the study. The quality indicator "polypharmacy" will be measured by:
% of residents receiving 9 or more medications (active components) over the preceding 7 days
Measured: 21 months
Resident quality indicators: weight loss
National quality indicators such as weight loss are collected by means of the Resident assessment Instrument for nursing homes in routine practice, and are collected independently of the study. The quality indicator "weight loss" will be measured by:
% of residents with weight loss of 5% or more during the preceding 30 days, or of 10% or more in the preceding 180 days.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start20 Jun 2018
- Primary completion28 Feb 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HospitalisationsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Non-randomized stepped-wedge design
- Masking
- None (open label)
- Enrolment
- 944 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, University Department of Geriatric Medicine FELIX PLATTER, University of Applied Sciences and Arts of Southern Switzerland, Insel Gruppe AG, University Hospital Bern, Hôpital ophtalmique Jules-Gonin (HOJG), Serdaly & Ankers, Switzerland, Vaud state public health department, stiftung pflegewissenchaft, KU Leuven
- Responsible party
- Principal investigator, Michael Simon, University of Basel
- Investigators
- Michael Simon, PhD, Principal investigator, Institut für Pflegewissenschaft Fakultät für Medizin, Universität Basel Bernoullistrasse 28, Raum 107 CH-4056 Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590470
- Sponsor's protocol ID
- EKNZ2018-00501
- Acronym
- INTERCARE
- Status last verified
- Nov 2020
- First submitted
- 10 Jun 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zuniga F, Kotkowski K, Guerbaai RA, Simon M, Serdaly C, De Geest S, Zeller A, Kressig RW, Wellens NIH, Brunkert T. Understanding a Complex Intervention to Reduce Unplanned Hospitalizations From Nursing Homes: Process Evaluation of INTERCARE. Health Sci Rep. 2026 Jan 11;9(1):e71748. doi: 10.1002/hsr2.71748. eCollection 2026 Jan.
PubMed 41527584Guerbaai RA, DeGeest S, Popejoy LL, Simon M, Wellens NIH, Denhaerynck K, Zuniga F. Evaluating the implementation fidelity to a successful nurse-led model (INTERCARE) which reduced nursing home unplanned hospitalisations. BMC Health Serv Res. 2023 Feb 9;23(1):138. doi: 10.1186/s12913-023-09146-8.
PubMed 36759902Bartakova J, Zuniga F, Guerbaai RA, Basinska K, Brunkert T, Simon M, Denhaerynck K, De Geest S, Wellens NIH, Serdaly C, Kressig RW, Zeller A, Popejoy LL, Nicca D, Desmedt M, De Pietro C. Health economic evaluation of a nurse-led care model from the nursing home perspective focusing on residents' hospitalisations. BMC Geriatr. 2022 Jun 9;22(1):496. doi: 10.1186/s12877-022-03182-5.
PubMed 35681157Basinska 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 35279088
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led Care Model in Swiss Nursing Homes: Improving INTERprofessional CARE for Better Resident Outcomes (INTERCARE)
- ClinicalTrials.gov ID
- NCT03590470
- Acronym / sponsor ID
- INTERCARE / EKNZ2018-00501
- Conditions
- Hospitalisations
- Keywords
- avoidable hospitalisations, quality of care, nursing homes, implementation science, quality improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 944 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, University Department of Geriatric Medicine FELIX PLATTER, University of Applied Sciences and Arts of Southern Switzerland, Insel Gruppe AG, University Hospital Bern, Hôpital ophtalmique Jules-Gonin (HOJG), Serdaly & Ankers, Switzerland, Vaud state public health department, stiftung pflegewissenchaft, KU Leuven
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 18 Jul 2018 (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.
This implementation science project aims to implement a nurse-led model of care in 11 nursing homes in the German speaking part of Switzerland, to reduce avoidable hospitalisations. The model will be introduced using a non-randomized stepped-wedge design. First, training will be delivered to leadership teams and to geriatric nurse experts, secondly after a baseline measurement period, including distribution of questionnaires and collection of resident data mainly national quality indicators and data regarding hospitalisations, the nurse led model will be implemented and thereafter 2 measurement periods will follow (6 months after the beginning of the intervention and at the end). Quantitative resident data will be retrieved from the RAI-NH three-monthly, and hospitalization data with the help of a data platform, reflection tools and hospital discharge reports continuously from the baseline period until the end of the data collection in 02.2020. The hypotheses of the project are:
- To assess the effectiveness of the nurse-led care model on unplanned hospitalizations (primary outcome) and additional resident and staff outcomes, hypothesizing that nursing homes with a nurse-led care model have lower rates of unplanned hospitalizations and show improvements in additional resident and staff outcomes
- To assess the effect of the degree of adoption on client outcomes, hypothesizing that a higher degree of adoption is related to better client outcomes
- To describe the implementation costs the Swiss nurse-led interprofessional NH care model on the NH level and to assess the economic impact of INTERCARE with a cost-effectiveness analysis adopting a health care system perspective (comparing the increase in staff costs with the decrease of days of avoidable hospitalizations)
- To explore resident/family and staff perceptions of service outcomes (e.g., timeliness) and the acceptability of the nurse-led care model;
- To describe the degree to which the model was adopted, its feasibility, the fidelity with which it was applied, and the barriers and facilitators met by NH leadership and nurse experts.
Detailed description
This multicentre study uses a mixed-methods approach to evaluate testing of a nurse-led care model intervention. Each of the 11 NHs participating in this study will recruit at least one registered nurse with at least three years' long-term care experience, which will undergo training to become a geriatric nurse expert. Training of the geriatric nurse experts will be delivered as a blended-learning approach, combining face to face (F2F) teaching and E-learning modules. The 8 modules will cover the following topics: 1. leadership, 2. communication, 3. comprehensive geriatric assessment, 4. geriatric syndromes, 5. chronic conditions, 6. acute conditions, 7. pharmacology in geriatrics and 8. quality improvement. Modules 1-3 and 8 will be delivered as 5 days of F2F teaching before the implementation start, followed by E-learnings, and 8 expert meetings to be continued throughout the intervention. The last meeting takes place in November 2019. Additionally, the practical training will be enhanced by individual supervision with an experienced nurse expert and/or geriatrician. Modules 4-7 will be delivered via E-learning modules. All modules will cover approximately 66h of F2F learning and 60 hours of E-learning, depending on the level of education and experience of each nurse. In total the geriatric nurse expert training should account for approximately 125 hours.
The registered nurse which will take on the role of geriatric nurse expert will either be recruited within the pool of nurses in each respective NH or recruited from the outside. The nurse-led care model will be built with core components, such as interprofessional collaboration, presence of a geriatric nurse expert, comprehensive geriatric assessment, advance care planning, guidance and coaching, data driven quality and evidence-based tools. Each NH will have to implement these core components along with implementing the role of geriatric nurse expert.
The intervention will be implemented and evaluated by means of a non-randomized quasi experimental stepped-wedge design, over a period of 21 months. The stepped wedge design allows inclusion of all NHs, thus does not exclude NHs from receiving the INTERCARE | Research plan Version 1.1/09.05. 2018 20/53 intervention. The "stepped" or "graded" unidirectional allocation to the intervention enables each NH to act as its own control. After a 3-month baseline phase, NHs will sequentially begin implementation of the nurse-led care model, which they will continue to use post-implementation. A get-in period of 1 month will be planned to address possible timing problems at the intervention start. Another advantage of the design is the graded start in the NHs facilitating delivery of the intervention, as each NH will discuss with the research team when they will receive the intervention. The first two NHs will start their baseline data collection in June 2018 and implement the intervention in September 2018, and every month thereafter, two other NHs will start with the intervention.
A non-randomized design was chosen to enable NHs to choose when they will start with the intervention, to allow for each NH to prepare accordingly for the implementation. Limitations of this study design might arise from its novelty. So far, no gold standard for data analysis has been established. In addition to this, non-randomization of the starting point of the intervention may imply that NHs were prepared for the intervention and this may be reflected in the results.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized stepped-wedge design
| Arm | Type | Receives |
|---|---|---|
| Experimental_INTERCARE intervention | Experimental | Other: Implementation of a nurse-led model of careImplementation of a nurse-led model of care adapted to the Swiss context, comprising a geriatric nurse expert with specific training in multidimensional clinical assessment and quality improvement tools. |
| Control | No intervention | –The design used for the INTERCARE intervention is a non-randomized stepped wedge design, therefore all nursing homes will receive the intervention but at different time points. All nursing homes will be in a control phase before receiving the intervention, and switch to the intervention phase, once the intervention is implemented. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Nursing homes
- German-speaking
- Size: ≥80 long-term care beds (NHs with >60 beds will be considered if they have a high hospitalisation rate)
- Hospitalisation rates: ≥0.8/1000 resident days
- Residents
Key exclusion criteria (5 listed)
- Nursing homes
- Italian-speaking
- French-speaking
- Residents
- Short term or day care residents, other residents with a discharge planned within two months after admittance
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 |
|---|---|---|
| Implementation of a nurse-led model of careA nurse-model of care consisting of a specifically trained geriatric nurse expert, communication and quality improvement tools will be implemented in 11 nursing homes in the German speaking part of Switzerland | Other | Experimental_INTERCARE intervention |
Primary outcome
Number of all unplanned hospitalizations /1000 resident care days
Time frame: 21 months
Due to the complexity involved in the measurement of avoidable hospitalizations, we will follow experts' recommendation [24], tracking all unplanned hospital admissions as a primary endpoint. The primary endpoint will be calculated as number of unplanned hospitalisations per 1000 resident care days.
6 secondary outcomes
Avoidable hospitalizations
Time frame: 21 months
Avoidable emergency department (ED) visits
Time frame: 21 months
Resident quality indicators: Pain
Time frame: 21 months
Resident quality indicators: physical restraints
Time frame: 21 months
Resident quality indicators: Polypharmacy
Time frame: 21 months
Resident quality indicators: weight loss
Time frame: 21 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 41527584Zuniga F, Kotkowski K, Guerbaai RA, Simon M, Serdaly C, De Geest S, Zeller A, Kressig RW, Wellens NIH, Brunkert T. Understanding a Complex Intervention to Reduce Unplanned Hospitalizations From Nursing Homes: Process Evaluation of INTERCARE. Health Sci Rep. 2026 Jan 11;9(1):e71748. doi: 10.1002/hsr2.71748. eCollection 2026 Jan.
- Derived from this study: PubMed 36759902Guerbaai RA, DeGeest S, Popejoy LL, Simon M, Wellens NIH, Denhaerynck K, Zuniga F. Evaluating the implementation fidelity to a successful nurse-led model (INTERCARE) which reduced nursing home unplanned hospitalisations. BMC Health Serv Res. 2023 Feb 9;23(1):138. doi: 10.1186/s12913-023-09146-8.
- Derived from this study: PubMed 35681157Bartakova J, Zuniga F, Guerbaai RA, Basinska K, Brunkert T, Simon M, Denhaerynck K, De Geest S, Wellens NIH, Serdaly C, Kressig RW, Zeller A, Popejoy LL, Nicca D, Desmedt M, De Pietro C. Health economic evaluation of a nurse-led care model from the nursing home perspective focusing on residents' hospitalisations. BMC Geriatr. 2022 Jun 9;22(1):496. doi: 10.1186/s12877-022-03182-5.
- Derived from this study: 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.
- 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.
Michael Simon, PhD principal investigator
Institut für Pflegewissenschaft Fakultät für Medizin, Universität Basel Bernoullistrasse 28, Raum 107 CH-4056 Basel
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of a nurse-led model of care in people with Hospitalisations, run by University of Basel at 7 sites 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 13 inclusion and 5 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: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of all unplanned hospitalizations /1000 resident care days (time frame: 21 months). 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 NCT03590470, which also lists 4 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 13 Nov 2020.