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Sepsis Trial of Early Physical Therapy Outside the ICU (STEP TO IT)

Primary Purpose

Sepsis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Additional physical therapy
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

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

Inclusion Criteria:

  • Any English-speaking patient over the age of 18 who is currently admitted to a general care floor under the care of the Medicine Faculty Hospitalist Service at the University of Michigan Health System and has severe sepsis is eligible to take part in this study.

Exclusion Criteria:

  • Subjects must be deemed by the study team to give informed consent by being able to state the basic purpose of the study. Consent by a legally authorized representative (LAR) will not be sought.

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Additional physical therapy

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline ambulation
Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days. This outcome will be assessed at baseline and at each study protocol physical therapy session during the index hospitalization.

Secondary Outcome Measures

Change in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (iADLs)
Baseline ADLs will be assessed using chart review. 30 day follow-up ADL and iADL function will be assessed using a telephone survey
Discharge location
The location of discharge (home, subacute rehabilitation facility, skilled nursing facility) will be assessed at discharge for all patients enrolled in the study.
ICU Transfer Rate
The rate at which patients require transfer to the ICU will be assessed.
Length of stay
The length of stay will be recorded for patients enrolled in the trial.
Employment status
For patients employed for pay prior to the index admission, employment status will be assessed by telephone survey 30 days post-discharge.
Post-hospitalization physical function
Patients' physical function will be assessed 30 days after discharge using the SF-10 instrument.

Full Information

First Posted
May 22, 2014
Last Updated
October 14, 2019
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02159222
Brief Title
Sepsis Trial of Early Physical Therapy Outside the ICU
Acronym
STEP TO IT
Official Title
Sepsis Trial of Early Physical Therapy Outside the ICU: A Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether an additional physical therapy program can improve the mobility and functional outcomes of patients diagnosed with severe sepsis (an illness in which the body has a severe response to bacteria or other germs and develops worsened function of a major organ such as the kidneys, heart, or lungs).
Detailed Description
Patients who are admitted to the hospitalist service at the University of Michigan Hospital will be screened for the presence of severe sepsis. Those who are deemed eligible and provide consent will be enrolled. Study patients will receive additional physical therapy according to a protocol developed for this study in addition to the usual care recommended by their regular treating physician. Additional treatments will be individualized based on enrolled patients' baseline physical function and progress and may include standing, stretching, transferring, and walking - either with assistance or independently. Treating therapists have been trained in the use of the protocol and individualization to maintain the highest standard of patient safety. Patients will be contacted 30 days after discharge to answer questions about their health and ability to perform routine tasks at home.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Additional physical therapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Additional physical therapy
Primary Outcome Measure Information:
Title
Change from baseline ambulation
Description
Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days. This outcome will be assessed at baseline and at each study protocol physical therapy session during the index hospitalization.
Time Frame
At day 0 (baseline enrollment) and for the duration of the participants' hospitalization, a predicted average length of stay of 5 days.
Secondary Outcome Measure Information:
Title
Change in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (iADLs)
Description
Baseline ADLs will be assessed using chart review. 30 day follow-up ADL and iADL function will be assessed using a telephone survey
Time Frame
At day 0 (baseline enrollment) and day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days)
Title
Discharge location
Description
The location of discharge (home, subacute rehabilitation facility, skilled nursing facility) will be assessed at discharge for all patients enrolled in the study.
Time Frame
At day 5 (assessed at discharge; predicted average length of stay is 5 days)
Title
ICU Transfer Rate
Description
The rate at which patients require transfer to the ICU will be assessed.
Time Frame
Participants will be followed for the duration of their hospitalization, an average length of stay of 5 days.
Title
Length of stay
Description
The length of stay will be recorded for patients enrolled in the trial.
Time Frame
Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days.
Title
Employment status
Description
For patients employed for pay prior to the index admission, employment status will be assessed by telephone survey 30 days post-discharge.
Time Frame
At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
Title
Post-hospitalization physical function
Description
Patients' physical function will be assessed 30 days after discharge using the SF-10 instrument.
Time Frame
At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
Other Pre-specified Outcome Measures:
Title
Readmission
Time Frame
At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
Title
In-Hospital Mortality
Time Frame
Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days
Title
Falls
Time Frame
Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days.
Title
Arrhythmia
Description
Clinically significant arrhythmias occurring during therapy sessions will be documented and recorded as a safety outcome.
Time Frame
During each study protocol physical therapy session while hospitalized
Title
Pressure ulcers
Description
The presence and severity of pressure ulcers will be recorded.
Time Frame
Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days.
Title
Cognitive function
Description
Enrolled patients' cognitive function will be assessed using the TICS-m instrument
Time Frame
At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
Title
Depression
Description
Patients will be screened for depression using the PHQ-2 instrument as part of the follow-up telephone survey.
Time Frame
At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).
Title
30-Day Post-Hospitalization Mortality
Time Frame
At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any English-speaking patient over the age of 18 who is currently admitted to a general care floor under the care of the Medicine Faculty Hospitalist Service at the University of Michigan Health System and has severe sepsis is eligible to take part in this study. Exclusion Criteria: Subjects must be deemed by the study team to give informed consent by being able to state the basic purpose of the study. Consent by a legally authorized representative (LAR) will not be sought.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Odden, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

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Sepsis Trial of Early Physical Therapy Outside the ICU

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