- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02854826
Systems Addressing Frail Elders (SAFE) Care Implementation (SAFE)
August 28, 2018 updated by: Linda Burnes Bolton, Cedars-Sinai Medical Center
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
330
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion criteria:
Organizational Leadership Nursing Unit Leadership/staff Adults aged 65 years
Exclusion criteria:
65 years and older that are on hospice protocols or dying/comfort care protocols.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
SAFE Care Model Site Intervention:
|
|
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.
|
SAFE Care Model Site Intervention:
|
|
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.
|
SAFE Care Model Site Intervention:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 24 months
|
|
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.
|
Up to 24 months
|
|
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.
|
Up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Lianna Z Ansryan, MSN, Cedars Sinai
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
July 27, 2018
Study Completion (Actual)
July 27, 2018
Study Registration Dates
First Submitted
July 22, 2016
First Submitted That Met QC Criteria
July 31, 2016
First Posted (Estimate)
August 4, 2016
Study Record Updates
Last Update Posted (Actual)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 28, 2018
Last Verified
July 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 44067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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