Frail Older AdutlsSAFENCT02854826
Systems Addressing Frail Elders (SAFE) Care Implementation
An observational study of Frail Older Adutls, run by Cedars-Sinai Medical Center.
Trial summary
Systems Addressing Frail Elders (SAFE) Care is a nurse-led interprofessional team model to rapidly identify and provide safe and effective inpatient care to high risk older adults and help support their successful transition back to the community. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Frail Older Adutls
- What is being tested?
- SAFE Care model of care
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 27 Jul 2018
- Phase
- Observational
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This project does not have a set recruitment/enrollment goal. Process evaluation information will be collected by interview and observation of leadership and staff at three implementation sites. Quality Improvement (QI) outcome data will be collected involving elderly patients (> 65 years) admitted to two med-surg units at each of the three collaborating sites over designated time periods: One month prior to implementation and six month after intervention. QI data from each hospital will be de-identified and submitted to core research team for analysis of patient outcomes.
Who may be able to join
- Organizational Leadership Nursing Unit Leadership/staff Adults aged 65 years
Who cannot join
- 65 years and older that are on hospice protocols or dying/comfort care protocols.
About this study
Systems Addressing Frail Elders (SAFE) Care is a nurse-led interprofessional team model to rapidly identify and provide safe and effective inpatient care to high risk older adults and help support their successful transition back to the community. Developed and demonstrated to be effective in one hospital - the model is now being disseminated and studied in three additional hospitals (multiple organizational case study).
Read the detailed description
Three Magnet hospitals in Los Angeles County (Huntington Hospital, Torrance Memorial Medical Center and Ronald Reagan UCLA Health System) are collaborating on this demonstration and evaluation project (Multiple Case-Study Design). The project will engage interprofessional hospital leadership; provide training and coaching in implementation processes of the SAFE Care model; and track outcome of the SAFE Care model as implemented in the three collaborating site hospitals (three case studies). The investigators hope to contribute to the existing state of the science in dissemination and implementation of evidenced-based innovations. The collective data from the three sites (collected through interviews with hospital leadership and staff and with de-identified patient data on program implementation outcomes) will provide information about the effectiveness of the implementation process and support further dissemination.
- Conditions
- Frail Older Adutls
- Being tested
- SAFE Care model of care
- Keywords
- Frail Older Adults, Interprofessional Team
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFE Care model of careOther
SAFE Care Model Site Intervention:
- Endorse best practices for frail patients;
- Identify frail patients promptly using multi-dimensional screening and assessments;
- Employ interprofessional unit-based care team approach to frailty risk reduction during inpatient stay and create post-acute care transitions (PACT) plan recommendations;
- Develop electronic health record templates for patient-centered interprofessional frailty notes;
- Communicate PACT plans to primary care providers to promote safe transitions to the ambulatory setting and across the continuum of care.
- Increase awareness, improve management of frailty, and improve overall health and well-being for adults who are frail or at risk of becoming frail.
| Study group | Role | What they receive |
|---|---|---|
| UCLA Ronald Reagan Medical Center | Site 1 (UCLA Regan Medical Center): Leaders from nursing, pharmacy, social work/case management, physician, administration, performance improvement, information systems and the Nursing Research/Evidence Based Practice Council will implement, monitor and evaluate the SAFE Care model of care. Two nursing units will be identified for staff training in screening at-risk older adults. One units will be randomly selected to initiate the SAFE Care program. The "comparison" unit staff will screen for at-risk patients and continue usual high standard of care assessments and care planning. Both units will be closely followed with formative and summative evaluation data presented for local and all-site findings. Receives: Other: SAFE Care model of care | |
| Huntington Hospital | Site 2 (Huntington Hospital): Leaders from nursing, pharmacy, social work/case management, physician, administration, performance improvement, information systems and the Nursing Research Council/ Evidence Based Practice will implement, monitor and evaluate the SAFE Care model of care. Two nursing units will be identified for staff training in screening at-risk older adults. One units will be randomly selected to initiate the SAFE Care program. The "comparison" unit staff will screen for at-risk patients and continue usual high standard of care assessments and care planning. Both units will be closely followed with formative and summative evaluation data presented for local and all-site findings. Receives: Other: SAFE Care model of care | |
| Torrance Memorial Hospital | Site 3 (Torrance Memorial Hospital): Leaders from nursing, pharmacy, social work/case management, physician, administration, performance improvement, information systems and the Nursing Research/ Evidence Based Practice Council will implement, monitor and evaluate the SAFE Care model of care. Two nursing units will be identified for staff training in screening at-risk older adults. One units will be randomly selected to initiate the SAFE Care program. The "comparison" unit staff will screen for at-risk patients and continue usual high standard of care assessments and care planning. Both units will be closely followed with formative and summative evaluation data presented for local and all-site findings. Receives: Other: SAFE Care model of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of SAFE Care model. Decreased Length of Stay
The purpose of this project is to spread a successful model for rapidly identifying high risk vulnerable adults during an acute inpatient episode and intervening as an interprofessional team. An added purpose is to engage and promote involvement of participating hospitals' nursing research and evidence-based practice nurse experts in evaluating, adapting, and disseminating the SAFE Care model principles. We will evaluate if there is replication of the findings of the previous research (a cluster randomized controlled trial) conducted at Cedars-Sinai; that is, reduced LOS, reduced hospital complications (increased patient safety) and reduced use of ICU days. The evaluation plan for this project strongly supports collection and sharing of data on the process and outcomes of implementation of SAFE Care.
Measured: Up to 24 months
Implementation of SAFE Care model. Reduced use of ICU days
he purpose of this project is to spread a successful model for rapidly identifying high risk vulnerable adults during an acute inpatient episode and intervening as an interprofessional team. An added purpose is to engage and promote involvement of participating hospitals' nursing research and evidence-based practice nurse experts in evaluating, adapting, and disseminating the SAFE Care model principles. We will evaluate if there is replication of the findings of the previous research (a cluster randomized controlled trial) conducted at Cedars-Sinai; that is, reduced LOS, reduced hospital complications (increased patient safety) and reduced use of ICU days. The evaluation plan for this project strongly supports collection and sharing of data on the process and outcomes of implementation of SAFE Care.
Measured: Up to 24 months
Implementation of SAFE Care model. Reduced hospital complications
he purpose of this project is to spread a successful model for rapidly identifying high risk vulnerable adults during an acute inpatient episode and intervening as an interprofessional team. An added purpose is to engage and promote involvement of participating hospitals' nursing research and evidence-based practice nurse experts in evaluating, adapting, and disseminating the SAFE Care model principles. We will evaluate if there is replication of the findings of the previous research (a cluster randomized controlled trial) conducted at Cedars-Sinai; that is, reduced LOS, reduced hospital complications (increased patient safety) and reduced use of ICU days. The evaluation plan for this project strongly supports collection and sharing of data on the process and outcomes of implementation of SAFE Care.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start1 Jul 2016
- Primary completion27 Jul 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Older AdutlsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UniHealth Foundation, Ronald Reagan Medical Center, Huntington Hospital, Torrance Memorial
- Responsible party
- Principal investigator, Linda Burnes Bolton, Cedars-Sinai Medical Center
- Investigators
- Lianna Z Ansryan, MSN, Study director, Cedars Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854826
- Sponsor's protocol ID
- 44067
- Acronym
- SAFE
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2016
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Addressing Frail Elders (SAFE) Care Implementation
- ClinicalTrials.gov ID
- NCT02854826
- Acronym / sponsor ID
- SAFE / 44067
- Conditions
- Frail Older Adutls
- Keywords
- Frail Older Adults, Interprofessional Team
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- UniHealth Foundation, Ronald Reagan Medical Center, Huntington Hospital, Torrance Memorial
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 4 Aug 2016 (estimated)
- 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.
Systems Addressing Frail Elders (SAFE) Care is a nurse-led interprofessional team model to rapidly identify and provide safe and effective inpatient care to high risk older adults and help support their successful transition back to the community. Developed and demonstrated to be effective in one hospital - the model is now being disseminated and studied in three additional hospitals (multiple organizational case study).
Detailed description
Three Magnet hospitals in Los Angeles County (Huntington Hospital, Torrance Memorial Medical Center and Ronald Reagan UCLA Health System) are collaborating on this demonstration and evaluation project (Multiple Case-Study Design). The project will engage interprofessional hospital leadership; provide training and coaching in implementation processes of the SAFE Care model; and track outcome of the SAFE Care model as implemented in the three collaborating site hospitals (three case studies). The investigators hope to contribute to the existing state of the science in dissemination and implementation of evidenced-based innovations. The collective data from the three sites (collected through interviews with hospital leadership and staff and with de-identified patient data on program implementation outcomes) will provide information about the effectiveness of the implementation process and support further dissemination.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UCLA Ronald Reagan Medical Center | – | Other: SAFE Care model of careSite 1 (UCLA Regan Medical Center): Leaders from nursing, pharmacy, social work/case management, physician, administration, performance improvement, information systems and the Nursing Research/Evidence Based Practice Council will implement, monitor and evaluate the SAFE Care model of care. Two nursing units will be identified for staff training in screening at-risk older adults. One units will be randomly selected to initiate the SAFE Care program. The "comparison" unit staff will screen for at-risk patients and continue usual high standard of care assessments and care planning. Both units will be closely followed with formative and summative evaluation data presented for local and all-site findings. |
| Huntington Hospital | – | Other: SAFE Care model of careSite 2 (Huntington Hospital): Leaders from nursing, pharmacy, social work/case management, physician, administration, performance improvement, information systems and the Nursing Research Council/ Evidence Based Practice will implement, monitor and evaluate the SAFE Care model of care. Two nursing units will be identified for staff training in screening at-risk older adults. One units will be randomly selected to initiate the SAFE Care program. The "comparison" unit staff will screen for at-risk patients and continue usual high standard of care assessments and care planning. Both units will be closely followed with formative and summative evaluation data presented for local and all-site findings. |
| Torrance Memorial Hospital | – | Other: SAFE Care model of careSite 3 (Torrance Memorial Hospital): Leaders from nursing, pharmacy, social work/case management, physician, administration, performance improvement, information systems and the Nursing Research/ Evidence Based Practice Council will implement, monitor and evaluate the SAFE Care model of care. Two nursing units will be identified for staff training in screening at-risk older adults. One units will be randomly selected to initiate the SAFE Care program. The "comparison" unit staff will screen for at-risk patients and continue usual high standard of care assessments and care planning. Both units will be closely followed with formative and summative evaluation data presented for local and all-site findings. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This project does not have a set recruitment/enrollment goal. Process evaluation information will be collected by interview and observation of leadership and staff at three implementation sites. Quality Improvement (QI) outcome data will be collected involving elderly patients (> 65 years) admitted to two med-surg units at each of the three collaborating sites over designated time periods: One month prior to implementation and six month after intervention. QI data from each hospital will be de-identified and submitted to core research team for analysis of patient outcomes.
Key inclusion criteria (1 listed)
- Organizational Leadership Nursing Unit Leadership/staff Adults aged 65 years
Key exclusion criteria (1 listed)
- 65 years and older that are on hospice protocols or dying/comfort care protocols.
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 |
|---|---|---|
| SAFE Care model of careSAFE Care Model Site Intervention: 1. Endorse best practices for frail patients; 2. Identify frail patients promptly using multi-dimensional screening and assessments; 3. Employ interprofessional unit-based care team approach to frailty risk reduction during inpatient stay and create post-acute care transitions (PACT) plan recommendations; 4. Develop electronic health record templates for patient-centered interprofessional frailty notes; 5. Communicate PACT plans to primary care providers to promote safe transitions to the ambulatory setting and across the continuum of care. 6. Increase awareness, improve management of frailty, and improve overall health and well-being for adults who are frail or at risk of becoming frail. | Other | Huntington Hospital, Torrance Memorial Hospital, UCLA Ronald Reagan Medical Center |
Primary outcome
Implementation of SAFE Care model. Decreased Length of Stay
Time frame: Up to 24 months
The purpose of this project is to spread a successful model for rapidly identifying high risk vulnerable adults during an acute inpatient episode and intervening as an interprofessional team. An added purpose is to engage and promote involvement of participating hospitals' nursing research and evidence-based practice nurse experts in evaluating, adapting, and disseminating the SAFE Care model principles. We will evaluate if there is replication of the findings of the previous research (a cluster randomized controlled trial) conducted at Cedars-Sinai; that is, reduced LOS, reduced hospital complications (increased patient safety) and reduced use of ICU days. The evaluation plan for this project strongly supports collection and sharing of data on the process and outcomes of implementation of SAFE Care.
Implementation of SAFE Care model. Reduced use of ICU days
Time frame: Up to 24 months
he purpose of this project is to spread a successful model for rapidly identifying high risk vulnerable adults during an acute inpatient episode and intervening as an interprofessional team. An added purpose is to engage and promote involvement of participating hospitals' nursing research and evidence-based practice nurse experts in evaluating, adapting, and disseminating the SAFE Care model principles. We will evaluate if there is replication of the findings of the previous research (a cluster randomized controlled trial) conducted at Cedars-Sinai; that is, reduced LOS, reduced hospital complications (increased patient safety) and reduced use of ICU days. The evaluation plan for this project strongly supports collection and sharing of data on the process and outcomes of implementation of SAFE Care.
Implementation of SAFE Care model. Reduced hospital complications
Time frame: Up to 24 months
he purpose of this project is to spread a successful model for rapidly identifying high risk vulnerable adults during an acute inpatient episode and intervening as an interprofessional team. An added purpose is to engage and promote involvement of participating hospitals' nursing research and evidence-based practice nurse experts in evaluating, adapting, and disseminating the SAFE Care model principles. We will evaluate if there is replication of the findings of the previous research (a cluster randomized controlled trial) conducted at Cedars-Sinai; that is, reduced LOS, reduced hospital complications (increased patient safety) and reduced use of ICU days. The evaluation plan for this project strongly supports collection and sharing of data on the process and outcomes of implementation of SAFE Care.
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 31 Aug 2018.
- Individual participant dataSharing planned: No
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.
Lianna Z Ansryan, MSN study director
Cedars Sinai
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Older Adutls, run by Cedars-Sinai Medical Center.
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 1 inclusion and 1 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Implementation of SAFE Care model. Decreased Length of Stay (time frame: Up to 24 months). The study lists 3 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 31 Aug 2018; AzTrials last refreshed its copy on 29 Oct 2026.