Transplant; Failure, HeartNCT04146727
Utilizing Technology for Optimization of Pain Management and Mobilization in High Risk Cardiac Surgical ICU Patients
An observational study of Transplant; Failure, Heart and Heart Failure, Congestive, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this project is to improve mobility in the perioperative period using activity trackers to augment current practice. Delirium and poor functional status following ICU stays are intractable problems for which clear solutions do not exist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant; Failure, Heart, Heart Failure, Congestive, Lung Transplant Failure
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2020to Jun 2021
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Investigators and co-investigators will approach eligible subjects about the study in person after identification of patients in the intensive care unit or prior to surgery if it is not an emergent surgery. Some of the patients will be patients of other surgeons and intensivists who are part of the team-based care of these cardiac surgical patients.
Who may be able to join
- Patients that are at high-risk patients for one of the following interventions, will be considered for this study:
- Axillary impella patients awaiting transplant, advanced MCS therapy or weaning
- MCS patients post procedure including TAH, LVADs
- Lung Transplant patients
- Subjects > 18 years of age.
- Ability to provide informed consent and follow-up with protocol procedures
Who cannot join
- Non-ambulatory patients
- Participation in an on-going protocol studying an experimental drug or device
- Use of a walker, cane or wheelchair at baseline
- Inability to wear the biosensor on the wrist
- Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Anahat Dhillion, MD, 310-423-3300, anahat.dhillion@cshs.org
Tracey S Early, BS, MA, 3104231231, tracey.early@cshs.org
About this study
The purpose of this project is to improve mobility in the perioperative period using activity trackers to augment current practice.
Delirium and poor functional status following ICU stays are intractable problems for which clear solutions do not exist. Digital health approaches have not been applied to these problems in the ICU setting and may represent a viable and unexplored intervention.
The program will involve the utilization of an activity tracker in ambulating patients. There will be two arms to the program. The first will involve the longitudinal study of ambulating lung transplant patients. Patients will be given an activity tracker at time of transplant which will continue throughout their care into their first month at home. The data will be collected to identify correlation between activity and clinical outcomes.
Read the detailed description
Early mobilization of patients, minimizing sedatives, maximizing pain control, optimizing sleep are strongly associated with decreased rates of delirium, decreased ICU length of stay, decreased hospital length of stay as well as improved functional status and quality of life at 1 year. Cardiac surgical patients that are at high risk of prolonged stay in the ICU due to the inherent nature of their disease (ie need for MCS (mechanical circulatory support) or lung transplantation) are most likely to benefit from a systematic aggressive approach to early mobilization. Technology such as activity trackers and virtual reality have been studied in general surgical populations but with limited data in the ICU and to date no studies in a cardiac surgical population. Activity trackers utilized in a multidisciplinary team to provide objective data to care teams and patients can be used to develop goal setting and patient motivation for teams, thereby improving mobility
Overall Goal: To evaluate whether quantitative information on post procedural ambulation in mechanical device patients, cardiac surgical patients and lung transplant patients can improve care teams ability to monitor and identify patients at high risk for complications and prolonged length of stay.
- The purpose of the research is to improve mobility in the perioperative period using Activity Trackers to augment current practice.
- Objective quantification and improvement in activity of post cardiac surgery patients might result in improved clinical outcomes, thereby making this tool a part of routine practice.
Patient Populations:
- Lung transplant patients
- Routine postoperative Cardiac surgical patients (elective cardiac surgical procedures including CABG and Valve replacement)
- Device Patients (axillary patients pre-open heart transplantation (OHT). Post MCS patients)
Specific Aim 1: Create standardized trajectories for ambulation of study subject populations from time of index procedure to 30 days postoperatively Specific Aim 2: To determine if deviation from the standardized trajectory of postoperative ambulation predicts disposition (home, rehabilitation facility or SNF), length of stay, 30 day readmissions, intensive care unit (ICU) readmission, DVT, respiratory insufficiency (aspiration) Specific Aim 3: To determine if decline in ambulation over 48 hours for a given patient predicts outcomes including length of stay, readmission to an icu, readmission to hospital, deep vein thrombosis (DVT), respiratory insufficiency.
The purpose of this project is to improve mobility in the perioperative period using activity trackers to augment current practice.
Delirium and poor functional status following ICU stays are intractable problems for which clear solutions do not exist. Digital health approaches have not been applied to these problems in the ICU setting and may represent a viable and unexplored intervention.
The program will involve the utilization of an activity tracker in ambulating patients. There will be two arms to the program. The first will involve the longitudinal study of ambulating lung transplant patients. Patients will be given an activity tracker at time of transplant which will continue throughout their care into their first month at home. The data will be collected to identify correlation between activity and clinical outcomes.
The second part of the program will be within the intensive care unit. The daily step count will be recorded for all ambulatory patients that fall into one of the defined subject populations and have signed informed consent. Step counts will be displayed for the care teams as well as the patient. This will be utilized by team to continuously evaluate and modify physical mobility goals for the patient with earlier recognition of decreasing mobility which is associated with worse outcomes. The goals and progress for the patient will be displayed to the nursing staff and the patient which we hypothesize will increase motivation.
Our hypothesis is that these interventions will increase mobility, decrease ICU length of stay, optimize the ICU experience, and potentially increase in 6-month functional status.
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU Duration | The total study duration is determined by their length of stay in the ICU. | |
| Transplant through 1 month at Home | Time from surgery through 1 month at home. Maximum duration is length of stay in the ICU plus 1 month at home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily ambulation
Steps taken
Measured: From date of inclusion until discharge from hospital assessed up to 30 days post enrollment
Length of Stay
Days until Discharge to a transitional care facility vs. home
Measured: From date of inclusion until discharge from hospital assessed up to 30 days post enrollment
Admit again to ICU
Readmissions to an ICU or hospital
Measured: From date of inclusion until event or 30 days post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study startJan 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant; Failure, HeartStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 168 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anahat Dhillon, Cedars-Sinai Medical Center
- Investigators
- Anahat Dhillon, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146727
- Sponsor's protocol ID
- pro000578722
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Technology for Optimization of Pain Management and Mobilization in High Risk Cardiac Surgical ICU Patients
- ClinicalTrials.gov ID
- NCT04146727
- Acronym / sponsor ID
- pro000578722
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 31 Oct 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.
The purpose of this project is to improve mobility in the perioperative period using activity trackers to augment current practice.
Delirium and poor functional status following ICU stays are intractable problems for which clear solutions do not exist. Digital health approaches have not been applied to these problems in the ICU setting and may represent a viable and unexplored intervention.
The program will involve the utilization of an activity tracker in ambulating patients. There will be two arms to the program. The first will involve the longitudinal study of ambulating lung transplant patients. Patients will be given an activity tracker at time of transplant which will continue throughout their care into their first month at home. The data will be collected to identify correlation between activity and clinical outcomes.
Detailed description
Early mobilization of patients, minimizing sedatives, maximizing pain control, optimizing sleep are strongly associated with decreased rates of delirium, decreased ICU length of stay, decreased hospital length of stay as well as improved functional status and quality of life at 1 year. Cardiac surgical patients that are at high risk of prolonged stay in the ICU due to the inherent nature of their disease (ie need for MCS (mechanical circulatory support) or lung transplantation) are most likely to benefit from a systematic aggressive approach to early mobilization. Technology such as activity trackers and virtual reality have been studied in general surgical populations but with limited data in the ICU and to date no studies in a cardiac surgical population. Activity trackers utilized in a multidisciplinary team to provide objective data to care teams and patients can be used to develop goal setting and patient motivation for teams, thereby improving mobility
Overall Goal: To evaluate whether quantitative information on post procedural ambulation in mechanical device patients, cardiac surgical patients and lung transplant patients can improve care teams ability to monitor and identify patients at high risk for complications and prolonged length of stay.
- The purpose of the research is to improve mobility in the perioperative period using Activity Trackers to augment current practice.
- Objective quantification and improvement in activity of post cardiac surgery patients might result in improved clinical outcomes, thereby making this tool a part of routine practice.
Patient Populations:
- Lung transplant patients
- Routine postoperative Cardiac surgical patients (elective cardiac surgical procedures including CABG and Valve replacement)
- Device Patients (axillary patients pre-open heart transplantation (OHT). Post MCS patients)
Specific Aim 1: Create standardized trajectories for ambulation of study subject populations from time of index procedure to 30 days postoperatively Specific Aim 2: To determine if deviation from the standardized trajectory of postoperative ambulation predicts disposition (home, rehabilitation facility or SNF), length of stay, 30 day readmissions, intensive care unit (ICU) readmission, DVT, respiratory insufficiency (aspiration) Specific Aim 3: To determine if decline in ambulation over 48 hours for a given patient predicts outcomes including length of stay, readmission to an icu, readmission to hospital, deep vein thrombosis (DVT), respiratory insufficiency.
The purpose of this project is to improve mobility in the perioperative period using activity trackers to augment current practice.
Delirium and poor functional status following ICU stays are intractable problems for which clear solutions do not exist. Digital health approaches have not been applied to these problems in the ICU setting and may represent a viable and unexplored intervention.
The program will involve the utilization of an activity tracker in ambulating patients. There will be two arms to the program. The first will involve the longitudinal study of ambulating lung transplant patients. Patients will be given an activity tracker at time of transplant which will continue throughout their care into their first month at home. The data will be collected to identify correlation between activity and clinical outcomes.
The second part of the program will be within the intensive care unit. The daily step count will be recorded for all ambulatory patients that fall into one of the defined subject populations and have signed informed consent. Step counts will be displayed for the care teams as well as the patient. This will be utilized by team to continuously evaluate and modify physical mobility goals for the patient with earlier recognition of decreasing mobility which is associated with worse outcomes. The goals and progress for the patient will be displayed to the nursing staff and the patient which we hypothesize will increase motivation.
Our hypothesis is that these interventions will increase mobility, decrease ICU length of stay, optimize the ICU experience, and potentially increase in 6-month functional status.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU Duration | – | –The total study duration is determined by their length of stay in the ICU. |
| Transplant through 1 month at Home | – | –Time from surgery through 1 month at home. Maximum duration is length of stay in the ICU plus 1 month at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Investigators and co-investigators will approach eligible subjects about the study in person after identification of patients in the intensive care unit or prior to surgery if it is not an emergent surgery. Some of the patients will be patients of other surgeons and intensivists who are part of the team-based care of these cardiac surgical patients.
Key inclusion criteria (6 listed)
- Patients that are at high-risk patients for one of the following interventions, will be considered for this study:
- Axillary impella patients awaiting transplant, advanced MCS therapy or weaning
- MCS patients post procedure including TAH, LVADs
- Lung Transplant patients
- Subjects > 18 years of age.
Key exclusion criteria (5 listed)
- Non-ambulatory patients
- Participation in an on-going protocol studying an experimental drug or device
- Use of a walker, cane or wheelchair at baseline
- Inability to wear the biosensor on the wrist
- Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Daily ambulation
Time frame: From date of inclusion until discharge from hospital assessed up to 30 days post enrollment
Steps taken
Length of Stay
Time frame: From date of inclusion until discharge from hospital assessed up to 30 days post enrollment
Days until Discharge to a transitional care facility vs. home
Admit again to ICU
Time frame: From date of inclusion until event or 30 days post enrollment
Readmissions to an ICU or hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
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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.
Anahat Dhillon, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant; Failure, Heart and Heart Failure, Congestive, run by Cedars-Sinai Medical Center 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Oct 2019. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anahat Dhillion, MD (3104233300, Anahat.Dhillon@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily ambulation (time frame: From date of inclusion until discharge from hospital assessed up to 30 days post enrollment). The study lists 3 primary outcomes in all. 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 31 Oct 2019.