Study Focuses on Bed Rest and Deconditioning in Hospital InpatientsPhase 3BRAVENCT04006990
The Bed Rest Avoidance Study
A Phase 3 study testing Provision of recliner chairs and encouragement to get out of bed in people with Study Focuses on Bed Rest and Deconditioning in Hospital Inpatients, run by University of Southern California at 1 site in United States.
Trial summary
Hospitalized patients spend the majority of their time lying in bed, even when they are capable of being out of bed. Up to 50% of inpatients suffer functional decline at least in part due to lying in bed after admission, and even those who are not placed on bed rest by their physicians spend an average of 20 out of 24… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Study Focuses on Bed Rest and Deconditioning in Hospital Inpatients
- What is being tested?
- Provision of recliner chairs and encouragement to get out of bed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,089 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to 19 Sep 2017
- Phase
- Phase 3
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospital Inpatient
- Admitted to the LAC+USC study wards during the study period
Who cannot join
- Age < 18
Trial locations and contacts
1 site in 1 country.
United States1 site
LAC USC Medical Center
Los Angeles, California, 90033
About this study
Hospitalized patients spend the majority of their time lying in bed, even when they are capable of being out of bed. Up to 50% of inpatients suffer functional decline at least in part due to lying in bed after admission, and even those who are not placed on bed rest by their physicians spend an average of 20 out of 24 hours lying in bed. The loss of functional ability and exercise tolerance happens remarkably fast, as early as hospital day 2 (24-48 hours). Functional decline often results in a prolonged hospital stay and the need for additional rehabilitation resources both during and after the hospitalization to return a patient to their baseline functional status. Functional decline has also been associated with excess mortality.
The investigators sought to flip the culture of hospital-based care such that the bed was viewed as a place for patients to sleep, and patients would be encouraged to get out of bed when they were not trying to sleep. The investigators hypothesized that patients were unaware of the risks of prolonged immobilization and that the lack of an alternative comfortable place for patients to sit other than their bed contributed to their immobility. Previous studies have demonstrated that mobility protocols improve patient-centered outcomes in narrow patient populations such as post-surgical patients or the elderly, but such interventions have not been studied in a heterogeneous patient population. Additionally, previously studied protocols have been labor-intensive from a nursing standpoint, requiring, for example, that staff provide one-on-one supervised ambulation 3-4 times per day. The investigators aimed to determine whether establishing a relatively low-intensity, pragmatic protocol to discourage patients from lying in bed would result in shorter length of stay by improving mobility. The investigators further aimed to assess the additional impact of providing a recliner chair, a safe and comfortable alternative to their bed on these outcomes.
Read more
This a prospective, controlled investigation of a novel intervention intended to reduce time subjects spent lying in bed. The intervention will be conducted at Los Angeles County + University of Southern California (LAC+USC) Medical Center from March 20, 2017 through September 19, 2017. The intervention and control wards are symmetrically laid out. All wards consist of medical/surgical beds without cardiac telemetry monitoring. Subjects will be admitted per clinical routine, with bed assignments made by the bed control department, which was not aware of the study. Handouts developed at a 3rd grade level will inform subjects and their families about the risks of bed rest and encouraged the subjects to only lie in bed when they were attempting to sleep. Handouts are translated into 5 languages (Spanish, Korean, Tagalog, Mandarin, Vietnamese). Nursing staff on the intervention wards will provide these handouts to subjects and their families as part of the standard admission process. In addition, laminated reminder signs identical to the handouts will be posted on the wall opposite the head of the bed. Posters were placed in the main entrance of the study units.
Half of the intervention rooms will also be provided with recliner chairs (Winco Vero Care Cliner) that were bariatrics rated to 500 pounds, vinyl-covered for facile disinfection, and had 180-degree swing arms and locking casters. The other intervention rooms and the control rooms had standard hospital chairs in addition to the hospital bed.
The primary outcome measure is the difference in the length of hospital stay for admissions to intervention rooms compared to control rooms. Subjects' age and gender will be collected in order to control for these factors in the primary analysis. The Medicare Severity Diagnosis Related Group (MS DRG) relative weight for each patient will be collected to control for illness severity.
As a secondary endpoint, functional status will be assessed using the "6-Clicks" objective functional scoring system. Scores will be measured at several points during the each hospitalization As a process measure, nurses will maintain a log of hours per shift that subjects spend in bed. Finally, as a safety measure, the rates of falls per 1000 patient-days will be collected.
Data will be abstracted using an automated query of the electronic health record's bed management database (Cerner, Kansas City, MO). All patients who are placed on one of the study wards during the intervention period-including those admitted from the emergency department, elective medical and surgical admissions, inter-hospital transfers and intra-hospital transfers-will be included.
- Being tested
- Provision of recliner chairs and encouragement to get out of bed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of recliner chairs and encouragement to get out of bedBehavioural
Provision of recliner chairs and encouragement to get out of bed
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects are given recliner chairs and education on the dangers of bedrest Receives: Behavioral: Provision of recliner chairs and encouragement to get out of bed |
| Control | No intervention | Subjects are treated with standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Measured: 1 year
Secondary outcomes (1)
Six Clicks Functional Score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start20 Mar 2017
- Primary completion19 Sep 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study Focuses on Bed Rest and Deconditioning in Hospital InpatientsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,089 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Brad Spellberg, University of Southern California
- Investigators
- Brad Spellberg, MD, Principal investigator, LAC+USC Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006990
- Sponsor's protocol ID
- HS-16-00804
- Acronym
- BRAVE
- Status last verified
- Nov 2023
- First submitted
- 1 Jul 2019
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bed Rest Avoidance Study
- ClinicalTrials.gov ID
- NCT04006990
- Acronym / sponsor ID
- BRAVE / HS-16-00804
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,089 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 5 Jul 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.
Hospitalized patients spend the majority of their time lying in bed, even when they are capable of being out of bed. Up to 50% of inpatients suffer functional decline at least in part due to lying in bed after admission, and even those who are not placed on bed rest by their physicians spend an average of 20 out of 24 hours lying in bed. The loss of functional ability and exercise tolerance happens remarkably fast, as early as hospital day 2 (24-48 hours). Functional decline often results in a prolonged hospital stay and the need for additional rehabilitation resources both during and after the hospitalization to return a patient to their baseline functional status. Functional decline has also been associated with excess mortality.
The investigators sought to flip the culture of hospital-based care such that the bed was viewed as a place for patients to sleep, and patients would be encouraged to get out of bed when they were not trying to sleep. The investigators hypothesized that patients were unaware of the risks of prolonged immobilization and that the lack of an alternative comfortable place for patients to sit other than their bed contributed to their immobility. Previous studies have demonstrated that mobility protocols improve patient-centered outcomes in narrow patient populations such as post-surgical patients or the elderly, but such interventions have not been studied in a heterogeneous patient population. Additionally, previously studied protocols have been labor-intensive from a nursing standpoint, requiring, for example, that staff provide one-on-one supervised ambulation 3-4 times per day. The investigators aimed to determine whether establishing a relatively low-intensity, pragmatic protocol to discourage patients from lying in bed would result in shorter length of stay by improving mobility. The investigators further aimed to assess the additional impact of providing a recliner chair, a safe and comfortable alternative to their bed on these outcomes.
This a prospective, controlled investigation of a novel intervention intended to reduce time subjects spent lying in bed. The intervention will be conducted at Los Angeles County + University of Southern California (LAC+USC) Medical Center from March 20, 2017 through September 19, 2017. The intervention and control wards are symmetrically laid out. All wards consist of medical/surgical beds without cardiac telemetry monitoring. Subjects will be admitted per clinical routine, with bed assignments made by the bed control department, which was not aware of the study. Handouts developed at a 3rd grade level will inform subjects and their families about the risks of bed rest and encouraged the subjects to only lie in bed when they were attempting to sleep. Handouts are translated into 5 languages (Spanish, Korean, Tagalog, Mandarin, Vietnamese). Nursing staff on the intervention wards will provide these handouts to subjects and their families as part of the standard admission process. In addition, laminated reminder signs identical to the handouts will be posted on the wall opposite the head of the bed. Posters were placed in the main entrance of the study units.
Half of the intervention rooms will also be provided with recliner chairs (Winco Vero Care Cliner) that were bariatrics rated to 500 pounds, vinyl-covered for facile disinfection, and had 180-degree swing arms and locking casters. The other intervention rooms and the control rooms had standard hospital chairs in addition to the hospital bed.
The primary outcome measure is the difference in the length of hospital stay for admissions to intervention rooms compared to control rooms. Subjects' age and gender will be collected in order to control for these factors in the primary analysis. The Medicare Severity Diagnosis Related Group (MS DRG) relative weight for each patient will be collected to control for illness severity.
As a secondary endpoint, functional status will be assessed using the "6-Clicks" objective functional scoring system. Scores will be measured at several points during the each hospitalization As a process measure, nurses will maintain a log of hours per shift that subjects spend in bed. Finally, as a safety measure, the rates of falls per 1000 patient-days will be collected.
Data will be abstracted using an automated query of the electronic health record's bed management database (Cerner, Kansas City, MO). All patients who are placed on one of the study wards during the intervention period-including those admitted from the emergency department, elective medical and surgical admissions, inter-hospital transfers and intra-hospital transfers-will be included.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Provision of recliner chairs and encouragement to get out of bedSubjects are given recliner chairs and education on the dangers of bedrest |
| Control | No intervention | –Subjects are treated with standard care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospital Inpatient
- Admitted to the LAC+USC study wards during the study period
Key exclusion criteria (1 listed)
- Age < 18
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 |
|---|---|---|
| Provision of recliner chairs and encouragement to get out of bedProvision of recliner chairs and encouragement to get out of bed | Behavioural | Intervention |
Primary outcome
Hospital Length of Stay
Time frame: 1 year
1 secondary outcome
Six Clicks Functional Score
Time frame: 6 months
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 8 Nov 2023.
- Individual participant dataSharing planned: No
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.
Brad Spellberg, MD principal investigator
LAC+USC Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Provision of recliner chairs and encouragement to get out of bed in people with Study Focuses on Bed Rest and Deconditioning in Hospital Inpatients, run by University of Southern California at 1 site 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 2 inclusion and 1 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 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hospital Length of Stay (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2023; AzTrials last refreshed its copy on 27 Oct 2026.