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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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 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

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.
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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cedars-Sinai Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Huntington Hospital
UniHealth Foundation
Ronald Reagan Medical Center
Torrance Memorial

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings