NCT02854826

Brief 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. 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2018

Completed
Last Updated

August 31, 2018

Status Verified

July 1, 2016

Enrollment Period

2.1 years

First QC Date

July 22, 2016

Last Update Submit

August 28, 2018

Conditions

Keywords

Frail Older Adults, Interprofessional Team

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Up to 24 months

Study Arms (3)

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.

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.

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.

Other: SAFE Care model of care

Interventions

SAFE 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.

Huntington HospitalTorrance Memorial HospitalUCLA Ronald Reagan Medical Center

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Organizational Leadership Nursing Unit Leadership/staff Adults aged 65 years

You may not qualify if:

  • years and older that are on hospice protocols or dying/comfort care protocols.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Lianna Z Ansryan, MSN

    Cedars Sinai

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DrPH, RN, FAAN, CNE, CNO, VP of Nursing

Study Record Dates

First Submitted

July 22, 2016

First Posted

August 4, 2016

Study Start

July 1, 2016

Primary Completion

July 27, 2018

Study Completion

July 27, 2018

Last Updated

August 31, 2018

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share