Critical IllnessSTANDNCT03863470
Study of Therapeutic Exercise in Acute Respiratory Failure to Improve Neuromuscular Disability Trial
A study testing Early mobilization intervention in people with Critical Illness and Acute Respiratory Failure, run by University of Pennsylvania at 4 sites in United States.
Trial summary
This is a stepped-wedge, cluster randomized, trial evaluating the effect of an early goal-directed mobilization intervention for ICU patients with acute respiratory failure within 12 medical and surgical ICUs across 4 hospitals in the University of Pennsylvania Health System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Acute Respiratory Failure
- What is being tested?
- Early mobilization intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,917 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Mar 2019to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old; AND
- Admission to 1 of 12 participating ICUs; AND
- Continuous mechanical ventilation for ≥ 48 hours (without interruption); AND
- Baseline independent ambulatory status
Who cannot join
- Admitting diagnosis of any of the following conditions:
- Cardiopulmonary arrest
- Raised intracranial pressure
- Acute neurological admission diagnosis
- Subarachnoid hemorrhage
- Ischemic stroke
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Chester County Hospital
West Chester, Pennsylvania, 19380
About this study
This is a stepped-wedge, cluster randomized, trial evaluating the effect of an early goal-directed mobilization intervention for ICU patients with acute respiratory failure within 12 medical and surgical ICUs across 4 hospitals in the University of Pennsylvania Health System. The investigators will conduct a 54-week trial to measure the effect of the intervention on multiple patient-centered outcomes of patient physical function and cognition, in addition to ICU and hospital length of stay and duration of mechanical ventilation compared to usual care.
Read the detailed description
The STAND trial aims to measure the effect of an early goal-directed mobilization algorithm versus usual care for ICU patients with acute respiratory failure in the medical and surgical ICUs across University of Pennsylvania Health System (UPHS) with respect to patient-centered outcomes of patient physical function and cognition as well as multiple secondary clinical outcomes. To achieve this goal, the investigators will conduct a 54-week stepped-wedge, cluster randomized, trial to test the intervention during the course of providing usual care among a large and diverse population of patients admitted to 12 ICUs across 4 hospitals within UPHS. The intervention is an early mobilization protocol implemented during a patient's stay in the ICU. It involves three steps: 1) the clinical team will set a standardized mobility goal for each patient during morning rounds and display the goal on the patient's door; 2) a facilitator will be established in the ICU to communicate mobility goals and activities across clinical personnel shifts; 3) patient mobility scores will be displayed to clinical and administrative staff in the ICU via the ICU board. Approximately 1,500 adult patients with continuous mechanical ventilation for ≥48 hours (without interruption) and baseline independent ambulatory status will be enrolled. Participating ICUs will be randomized into 6 clusters of 2 ICUs each. Each ICU contributes a minimum of 12 weeks of data under the usual care control condition prior to implementing the early mobilization intervention. Then, using the stepped-wedge design, all ICUs will implement the intervention in 6-week intervals with the order and timing of implementation determined by random assignment. By the end of the trial, all ICUs will have utilized the intervention for at least 12 weeks. The primary outcome is peak patient activity level as measure by the ICU mobility score (IMS) at ICU discharge. Secondary outcomes include an array of clinical outcomes.
- Conditions
- Critical Illness, Acute Respiratory Failure
- Being tested
- Early mobilization intervention
- Keywords
- Early ICU mobility
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilization interventionBehavioural
The intervention consists of 3 components: 1) A simplified mobilization goal (using the Surgical Optimal Mobility Score) will be defined during daily morning ward rounds and displayed on the doors of patients' rooms; 2) a facilitator will communicate to the care team regarding mobility goals; 3) clinicians will receive feedback on patient's mobility as mobility scores will be made available electronically on the ICU board - a dashboard for monitoring patient care in the ICU
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention (Control) | No intervention | There is no trial-driven approach to care. All hospitals contribute a minimum of 12 weeks of outcomes data prior to adopting the intervention. Pre-specified outcomes data will be electronically extracted for patients meeting eligibility criteria but there will be no attempt to influence delivery of usual care within the ICU. The length of the control phase will differ for each ICU cluster, depending on the sequence in which ICU-clusters are assigned to switch to the intervention phase. |
| Early mobilization intervention | Active comparator | The clinical team will set a standardized mobility goal for each patient during morning rounds and display the goal on the patient's door. A facilitator will be established in the ICU to communicate mobility goals and activities across clinical personnel shifts. Patient mobility scores will be displayed to clinical and administrative staff in the ICU via the ICU board. Receives: Behavioral: Early mobilization intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak hour patient activity level
Peak hour patient activity level as measured by the ICU mobility score (IMS) at ICU discharge. IMS score ranges from 0 to 10.
Measured: Within 48 hours of ICU discharge
Secondary outcomes (7)
ICU mortality
ICU Mortality
Measured: From ICU admission to ICU discharge, approximately 3 days
ICU length of stay
ICU length of stay (days)
Measured: From ICU admission to ICU discharge, approximately 3 days
Hospital length of stay
Hospital length of stay (days)
Measured: From hospital admission to hospital discharge, approximately 5 days
Duration of mechanical ventilation
Duration of time spent on continuous mechanical ventilation (hours)
Measured: From hospital admission to hospital discharge, approximately 5 days
Duration of time spent in deep sedation
Duration of time spent in deep sedation (hours)
Measured: From hospital admission to hospital discharge, approximately 5 days
Neurological function
Composite measure of delirium and coma free days
Measured: From hospital admission to hospital discharge, approximately 5 days
Richmond Agitation-Sedation Scale (RASS)
RASS score at time of first spontaneous breathing trial. RASS score ranges from -5 (unarousable) to +4 (combative); A score of 0 = alert and calm.
Measured: From hospital admission to hospital discharge, approximately 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start4 Mar 2019
- Primary completion15 Mar 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,917 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Halpern, University of Pennsylvania
- Investigators
- William Schweickert, MD, Principal investigator, University of Pennsylvania School of Medicine - Pulmonary, Allergy, and Critical CareScott D Halpern, MD PhD, Principal investigator, University of Pennsylvania School of Medicine - PAIR CenterJuliane Jablonski, DNP RN, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863470
- Sponsor's protocol ID
- 831966
- Acronym
- STAND
- Status last verified
- Oct 2022
- First submitted
- 27 Feb 2019
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schweickert WD, Jablonski J, Bayes B, Chowdhury M, Whitman C, Tian J, Blette B, Tran T, Halpern SD. Structured Mobilization for Critically Ill Patients: A Pragmatic Cluster-randomized Trial. Am J Respir Crit Care Med. 2023 Jul 1;208(1):49-58. doi: 10.1164/rccm.202209-1763OC.
PubMed 36996413
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Therapeutic Exercise in Acute Respiratory Failure to Improve Neuromuscular Disability Trial
- ClinicalTrials.gov ID
- NCT03863470
- Acronym / sponsor ID
- STAND / 831966
- Conditions
- Critical Illness, Acute Respiratory Failure
- Keywords
- Early ICU mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,917 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a stepped-wedge, cluster randomized, trial evaluating the effect of an early goal-directed mobilization intervention for ICU patients with acute respiratory failure within 12 medical and surgical ICUs across 4 hospitals in the University of Pennsylvania Health System. The investigators will conduct a 54-week trial to measure the effect of the intervention on multiple patient-centered outcomes of patient physical function and cognition, in addition to ICU and hospital length of stay and duration of mechanical ventilation compared to usual care.
Detailed description
The STAND trial aims to measure the effect of an early goal-directed mobilization algorithm versus usual care for ICU patients with acute respiratory failure in the medical and surgical ICUs across University of Pennsylvania Health System (UPHS) with respect to patient-centered outcomes of patient physical function and cognition as well as multiple secondary clinical outcomes. To achieve this goal, the investigators will conduct a 54-week stepped-wedge, cluster randomized, trial to test the intervention during the course of providing usual care among a large and diverse population of patients admitted to 12 ICUs across 4 hospitals within UPHS. The intervention is an early mobilization protocol implemented during a patient's stay in the ICU. It involves three steps: 1) the clinical team will set a standardized mobility goal for each patient during morning rounds and display the goal on the patient's door; 2) a facilitator will be established in the ICU to communicate mobility goals and activities across clinical personnel shifts; 3) patient mobility scores will be displayed to clinical and administrative staff in the ICU via the ICU board. Approximately 1,500 adult patients with continuous mechanical ventilation for ≥48 hours (without interruption) and baseline independent ambulatory status will be enrolled. Participating ICUs will be randomized into 6 clusters of 2 ICUs each. Each ICU contributes a minimum of 12 weeks of data under the usual care control condition prior to implementing the early mobilization intervention. Then, using the stepped-wedge design, all ICUs will implement the intervention in 6-week intervals with the order and timing of implementation determined by random assignment. By the end of the trial, all ICUs will have utilized the intervention for at least 12 weeks. The primary outcome is peak patient activity level as measure by the ICU mobility score (IMS) at ICU discharge. Secondary outcomes include an array of clinical outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention (Control) | No intervention | –There is no trial-driven approach to care. All hospitals contribute a minimum of 12 weeks of outcomes data prior to adopting the intervention. Pre-specified outcomes data will be electronically extracted for patients meeting eligibility criteria but there will be no attempt to influence delivery of usual care within the ICU. The length of the control phase will differ for each ICU cluster, depending on the sequence in which ICU-clusters are assigned to switch to the intervention phase. |
| Early mobilization intervention | Active comparator | Behavioral: Early mobilization interventionThe clinical team will set a standardized mobility goal for each patient during morning rounds and display the goal on the patient's door. A facilitator will be established in the ICU to communicate mobility goals and activities across clinical personnel shifts. Patient mobility scores will be displayed to clinical and administrative staff in the ICU via the ICU board. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old; AND
- Admission to 1 of 12 participating ICUs; AND
- Continuous mechanical ventilation for ≥ 48 hours (without interruption); AND
- Baseline independent ambulatory status
Key exclusion criteria (6 listed)
- Admitting diagnosis of any of the following conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early mobilization interventionThe intervention consists of 3 components: 1) A simplified mobilization goal (using the Surgical Optimal Mobility Score) will be defined during daily morning ward rounds and displayed on the doors of patients' rooms; 2) a facilitator will communicate to the care team regarding mobility goals; 3) clinicians will receive feedback on patient's mobility as mobility scores will be made available electronically on the ICU board - a dashboard for monitoring patient care in the ICU | Behavioural | Early mobilization intervention |
Primary outcome
Peak hour patient activity level
Time frame: Within 48 hours of ICU discharge
Peak hour patient activity level as measured by the ICU mobility score (IMS) at ICU discharge. IMS score ranges from 0 to 10.
7 secondary outcomes
ICU mortality
Time frame: From ICU admission to ICU discharge, approximately 3 days
ICU length of stay
Time frame: From ICU admission to ICU discharge, approximately 3 days
Hospital length of stay
Time frame: From hospital admission to hospital discharge, approximately 5 days
Duration of mechanical ventilation
Time frame: From hospital admission to hospital discharge, approximately 5 days
Duration of time spent in deep sedation
Time frame: From hospital admission to hospital discharge, approximately 5 days
Neurological function
Time frame: From hospital admission to hospital discharge, approximately 5 days
Richmond Agitation-Sedation Scale (RASS)
Time frame: From hospital admission to hospital discharge, approximately 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Derived from this study: PubMed 36996413Schweickert WD, Jablonski J, Bayes B, Chowdhury M, Whitman C, Tian J, Blette B, Tran T, Halpern SD. Structured Mobilization for Critically Ill Patients: A Pragmatic Cluster-randomized Trial. Am J Respir Crit Care Med. 2023 Jul 1;208(1):49-58. doi: 10.1164/rccm.202209-1763OC.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Schweickert, MD principal investigator
University of Pennsylvania School of Medicine - Pulmonary, Allergy, and Critical Care
Scott D Halpern, MD PhD principal investigator
University of Pennsylvania School of Medicine - PAIR Center
Juliane Jablonski, DNP RN principal investigator
University of Pennsylvania
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early mobilization intervention in people with Critical Illness and Acute Respiratory Failure, run by University of Pennsylvania at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak hour patient activity level (time frame: Within 48 hours of ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03863470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.