Sepsis Trial of Early Physical Therapy Outside the ICU

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sepsis Trial of Early Physical Therapy Outside the ICU: A Pilot Feasibility Study

Conditions
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Sepsis

Intervention / Treatment
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* Procedure: Additional physical therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Additional physical therapy<br> | Procedure: Additional physical therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At day 0 (baseline enrollment) and for the duration of the participants' hospitalization, a predicted average length of stay of 5 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At day 0 (baseline enrollment) and day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days) | 
| 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. | At day 5 (assessed at discharge; predicted average length of stay is 5 days) | 
| ICU Transfer Rate | The rate at which patients require transfer to the ICU will be assessed. | Participants will be followed for the duration of their hospitalization, an average length of stay of 5 days. | 
| Length of stay | The length of stay will be recorded for patients enrolled in the trial. | Participants will be followed for the duration of their hospitalization, a predicted average length of stay of 5 days. | 
| Employment status | For patients employed for pay prior to the index admission, employment status will be assessed by telephone survey 30 days post-discharge. | At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days). | 
| Post-hospitalization physical function | Patients' physical function will be assessed 30 days after discharge using the SF-10 instrument. | At day 35 (assessed at 30 days post discharge; predicted average length of stay is 5 days). |