Reducing 30-Day Sepsis Readmissions: Impact of a Post Discharge Education Program

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sepsis education

About this trial

This is an interventional prevention trial for Sepsis focused on measuring sepsis, education, cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Oncology patients discharged to home following a diagnosis of sepsis, severe sepsis or septic shock Patient must have a mobile phone/device English speakers Age range 18 - 85 years Exclusion Criteria: Less than 18 years of age and older than 85 years of age No mobile phone/device Non-English speaking No diagnosis of sepsis, severe sepsis, or septic shock Non-Oncology patient

Sites / Locations

Barnes-Jewish Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sepsis Education

Arm Description

The patient will receive a daily notification via their mobile phone and conduct the daily activity for 30 days. The program is interactive and aimed at measures that prevent exposure to infection sources in the environment, as well as recognition of early signs of infection and possible sepsis. Each session takes approximately 2 minutes or less. Each scenario or session has the user identify where germs may be present and then asks the user to perform a simple action to remove the germs (e.g. with an antiseptic wipe). The range of activities include cleaning of surfaces, proper mask use, and hand sanitizing. This includes areas of their home such as the kitchen, bathroom, living room/family room. The program also addresses common community areas such as public transit, grocery stores, and restaurants

Outcomes

Primary Outcome Measures

Readmission rates

Secondary Outcome Measures

Full Information

NCT ID

NCT05602896

First Posted

October 27, 2022

Last Updated

October 2, 2023

Sponsor

Washington University School of Medicine

Collaborators

BJC HealthCare, Viven Health

1. Study Identification

Unique Protocol Identification Number

NCT05602896

Brief Title

Reducing 30-Day Sepsis Readmissions: Impact of a Post Discharge Education Program

Official Title

Reducing 30-Day Sepsis Readmissions: Impact of a Post Discharge Education Program

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 31, 2024 (Anticipated)

Primary Completion Date

July 31, 2025 (Anticipated)

Study Completion Date

July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

BJC HealthCare, Viven Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

This study will advance the knowledge in the field by determining the effectiveness of discharge education regarding prevention of a new infection which is the highest cause of readmission for sepsis patient. In evaluating the impact care teams will develop a clearer link between specific home-based education interventions and infection prevention. This study is an exploratory study designed to identify whether patient education through an innovative teaching method can have an impact on readmissions. This study may the first of several based on findings from this initial, exploratory study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

Keywords

sepsis, education, cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sepsis Education

Arm Type

Experimental

Arm Description

The patient will receive a daily notification via their mobile phone and conduct the daily activity for 30 days. The program is interactive and aimed at measures that prevent exposure to infection sources in the environment, as well as recognition of early signs of infection and possible sepsis. Each session takes approximately 2 minutes or less. Each scenario or session has the user identify where germs may be present and then asks the user to perform a simple action to remove the germs (e.g. with an antiseptic wipe). The range of activities include cleaning of surfaces, proper mask use, and hand sanitizing. This includes areas of their home such as the kitchen, bathroom, living room/family room. The program also addresses common community areas such as public transit, grocery stores, and restaurants

Intervention Type

Other

Intervention Name(s)

Sepsis education

Intervention Description

The education program has been reviewed and approved by BJH Center for Practice Excellence

Primary Outcome Measure Information:

Title

Readmission rates

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Oncology patients discharged to home following a diagnosis of sepsis, severe sepsis or septic shock Patient must have a mobile phone/device English speakers Age range 18 - 85 years Exclusion Criteria: Less than 18 years of age and older than 85 years of age No mobile phone/device Non-English speaking No diagnosis of sepsis, severe sepsis, or septic shock Non-Oncology patient

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nancy Bickel, MSN, APRN, ANCP-BC, ACNS-BC

Phone

314-747-3000

Email

nancy.bickel@bjc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nancy Bickel, MSN, APRN, ANCP-BC, ACNS-BC

Organizational Affiliation

BJC HealthCare

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barnes-Jewish Hospital

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nancy Bickel, MSN, APRN, ANCP-BC, ACNS-BC

Phone

314-747-3000

Email

nancy.bickel@bjc.org

First Name & Middle Initial & Last Name & Degree

Nancy Bickel, MSN, APRN, ANCP-BC, ACNS-BC

First Name & Middle Initial & Last Name & Degree

Marin Kolleff, M.D., FACP, FCCP

First Name & Middle Initial & Last Name & Degree

Cassandra Arroyo, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

No

Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Sepsis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial