Clinical trial NCT03196960: Effects of Mobility Dose in Surgical Intensive Care Unit Patients
Official title: Effects of Mobility Dose in Surgical Intensive Care Unit Patients on Adverse Discharge Disposition
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcopenia
Muscle Weakness
Critical Illness
Keywords: Mobilization Therapy
Critical Illness
Muscle Strength
Functional Mobility
Outcome
Intensive Care Unit
Quality of Life
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: Università degli Studi di Brescia
First posted: 2017-06-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients recovering in an intensive care unit following a trauma or a surgical procedure

Brief summary: The primary aim of this study is to assess if the mobility dose that patients receive in the surgical intensive care unit (SICU) predicts adverse discharge disposition (primary endpoint), and muscle wasting diagnosed by bedside ultrasound (secondary endpoint).

Detailed description: Our research group aims to better understand how patients on the SICU are mobilized and the impact it has on adverse discharge disposition and functional outcome after hospital discharge.

We have previously developed and validated the Surgical Intensive Care Unit Optimal Mobilization Score (SOMS), an algorithm to guide and facilitate early mobilization to advance mobility of SICU patients (NCT01363102). In addition, we have established the use of bedside ultrasound technology to quantify cross sectional area of the rectus femoris muscle, which allows an objective, user-independent quantification of muscle wasting (NCT02270502).

In this study we measure the dose of mobility, defined as a function of both the mobility provided by nursing and physical therapists (e.g., sitting at the edge of the bed, ambulating) as well as its duration. We will build on an existing mobility intensity quantification tool (NCT01674608) and add a domain that quantifies its duration in order to obtain a broad picture of the mobilization of patients on the SICU. The mobility dose is expressed by the mobility quantification score that has been developed by our team. We will then test the hypotheses that mobilization dose in the ICU predicts discharge disposition, defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility; or in-hospital mortality. Further we will evaluate the association between mobility dose and cross sectional area of the rectus femoris muscle measured by bedside ultrasound as a potential reflection of ICU-acquired muscle weakness (exploratory outcome).

Mobilization Quantification score: MQS (Detailed table linked in reference section)

This score integrates the highest rated activities within each mobility session - from physical therapy and nursing. By multiplying the scale it gets greater and allows a better interpretation of mobility intensity. It adds value of mobility dose across sessions considering the entire spectrum of active participation of the patient over the day.

Some specifics:

* If patient achieves a level in between predefined MQS levels we score the closest lower level
* We collect mobility data for the night time by interviewing the day nurses and asking them about the patients' mobilization also during night time
* We round up the duration of each mobility session: Passive range of motion (PRM) conducted 4 times during the day counts as: 1\*4=4 (corresponding to 4 units/hours)
* For each session, we calculate the highest mobility level for the duration of the mobility session: e.g. Patient is standing for 5 minutes before s/he walks with 2 assists for 10 minutes: 3\*7=21 (adding up the duration of various activities within a session and multiplying it by the highest achieved mobility level). Sitting passively in the chair is an exception (see below).

Sitting:

* Sitting in the chair counts as a separate session. Per sitting session a maximum of 2 hours are counted. For example: if a patient was sitting for a duration of either 2, 4 or 5 hours, we would always count: 2\*4=8
* For patients stepping/shuffling/walking to the chair we use level 5 every time the patient is doing it. E.g. patient is shuffling to the chair, sitting for 2 hours and then walking back: 5\*1+2\*4+5\*1 =28
* Distinct sitting sessions are defined by the patient being back in bed in between the sessions of sitting in the chair. E.g. the patient gets actively to chair by stand-step/shuffle, sits in chair for 6 hours, during sitting session patient gets up twice and afterwards gets back to bed by stand-step/shuffle:

5\*1(to chair)+2\*4(sitting)+5\*1(back to bed)+5\*2(standing up 2x in between)=28

Eligibility criteria: Inclusion Criteria:

* Adults (18 years of age or greater)
* Barthel score ≥70 from a proxy describing patient function 2 weeks before admission
* Expected stay on the ICU of \>=3 days

Exclusion Criteria:

* Patients transferred from other hospitals, long-term rehabilitation facilities or nursing homes with a preceding stay of more than 48 hours
* Hospitalization 1 month prior to ICU admission \>7 days
* Discussion about changing the goals of care from cure to comfort
* High risk of persistent brain injury (GCS\<5 motor component and presence of TBI)
* Patients with neurodegenerative diseases
* Subjects with absence of a lower extremity
* Patients with paraplegia or tetraplegia
* Pregnancy

Primary outcomes:
measure: Adverse Hospital Discharge Disposition
timeFrame: Patient will be followed until hospital discharge, an expected 3 to 30 days
Secondary outcomes:
measure: Rectus Femoris Muscle Cross Sectional Area
timeFrame: Rectus femoris cross sectional area will be measured twice, at enrollment and day of ICU discharge, an expected 3 to 30 days.
measure: Mobility Dose as measured by the Mobilization Quantification Score (MQS)
timeFrame: Patients will be followed until SICU discharge, an expected 3 to 30 days.
measure: Abbreviated Functional independence measure (FIM) score at Surgical Intensive Care Unit (SICU) discharge and hospital discharge
timeFrame: Patients will be followed until hospital discharge an expected 3 to 40 days.
measure: SICU length of stay
timeFrame: Patients will be followed until SICU discharge, an expected 3 to 30 days.
measure: Hospital length of stay
timeFrame: Patients will be followed until hospital discharge an expected 3 to 40 days.
measure: SICU Ventilator-free days
timeFrame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
measure: SICU Vasopressor-free days
timeFrame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
measure: SICU Delirium-free days
timeFrame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
measure: SICU Neuromuscular Blocking drug-free days
timeFrame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
measure: Opioid Use
timeFrame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
measure: Corticosteroid Days
timeFrame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
measure: Physical Work Capacity
timeFrame: Measured three months after hospital discharge
measure: 3-Month Mortality
timeFrame: Evaluated three months after hospital discharge
measure: Falls
timeFrame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
measure: Side effects of mobilization therapy
timeFrame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Munich
country: Germany
facility: Klinikum Rechts der Isar
state: Bavaria
city: Brescia
country: Italy
facility: Università degli Studi di Brescia
state: Lombardy
Study officials:
affiliation: Massachusetts General Hospital
name: Matthias Eikermann, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mueller N, Murthy S, Tainter CR, Lee J, Riddell K, Fintelmann FJ, Grabitz SD, Timm FP, Levi B, Kurth T, Eikermann M. Can Sarcopenia Quantified by Ultrasound of the Rectus Femoris Muscle Predict Adverse Outcome of Surgical Intensive Care Unit Patients as well as Frailty? A Prospective, Observational Cohort Study. Ann Surg. 2016 Dec;264(6):1116-1124. doi: 10.1097/SLA.0000000000001546.
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citation: Kasotakis G, Schmidt U, Perry D, Grosse-Sundrup M, Benjamin J, Ryan C, Tully S, Hirschberg R, Waak K, Velmahos G, Bittner EA, Zafonte R, Cobb JP, Eikermann M. The surgical intensive care unit optimal mobility score predicts mortality and length of stay. Crit Care Med. 2012 Apr;40(4):1122-8. doi: 10.1097/CCM.0b013e3182376e6d.
citation: Tipping CJ, Bailey MJ, Bellomo R, Berney S, Buhr H, Denehy L, Harrold M, Holland A, Higgins AM, Iwashyna TJ, Needham D, Presneill J, Saxena M, Skinner EH, Webb S, Young P, Zanni J, Hodgson CL. The ICU Mobility Scale Has Construct and Predictive Validity and Is Responsive. A Multicenter Observational Study. Ann Am Thorac Soc. 2016 Jun;13(6):887-93. doi: 10.1513/AnnalsATS.201510-717OC.
citation: Scheffenbichler FT, Teja B, Wongtangman K, Mazwi N, Waak K, Schaller SJ, Xu X, Barbieri S, Fagoni N, Cassavaugh J, Blobner M, Hodgson CL, Latronico N, Eikermann M. Effects of the Level and Duration of Mobilization Therapy in the Surgical ICU on the Loss of the Ability to Live Independently: An International Prospective Cohort Study. Crit Care Med. 2021 Mar 1;49(3):e247-e257. doi: 10.1097/CCM.0000000000004808.