Current MICU research

ACTIVE CLINICAL TRIALS & STUDIES

COVID-focused trials

ACTIV-3 (PI: Christina Barkauskas) – Recruiting now!  A multicenter, international NIH-sponsored trial to determine the safety and efficacy of experimental monoclonal antibodies in hospitalized patients with COVID-19. Learn more here.

MSCs in COVID-19 ARDS (PI: Christina Barkauskas)- Recruiting now! A multicenter phase 3 clinical trial evaluating the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2.  Learn more here.

Pilot Study of Safety and Efficacy of Cord Tissue Derived Mesenchymal Stem Cells (hCT-MSC) in COVID-19 Related Acute Respiratory Distress Syndrome (ARDS) (PIs: Bryan Kraft, Nina Chen)- Recruiting now!  This multicenter phase 1 study is investigating whether cord tissue derived MSCs can improve ARDS due to COVID-19 pneumonia. Learn more here. 

COVID-19 Intensive Care Unit Biorepository (PIs: Bryan Kraft, Nina Chen)- Recruiting now! This single center observational study is collecting blood and body fluid samples and clinical data from critically ill patients with severe COVID-19 pneumonia to understand host-virus interactions, develop new diagnostic tests, discover new biomarkers, and develop potential therapies and vaccines for COVID-19.

LIFT COVID: mobile mindfulness-based training for patients who were hospitalized because of COVID-19. (PIs: Christopher Cox, Terri Hough, Marc Moss; Co-I Jack Iwashyna). Recruiting now! This is a NCCIH-funded RCT embedded within the NHLBI-funded PETAL Network’s BLUE CORAL observational study of COVID patient long-term outcomes.  It is designed to address the ‘long haul,’ persistent symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD) that COVID patients face.  In this study, 300 patients will be randomized to Lift or control.  The primary outcome is depression symptoms 2 months after randomization.  Control participants get access to Lift automatically at the conclusion of their trial period.  Learn more here.

Non-COVID-focused trials

Extracorporeal CO2 Removal for Mechanical Ventilation Avoidance During Acute Exacerbation of COPD (VENT-AVOID) (PI: Craig Rackley)- Recruiting now! This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Learn more here. 

A Phase II Study of Inhaled Carbon Monoxide for the Treatment of ARDS (PIs: Karen Welty-Wolf, Nina Chen)- Recruiting now! This multicenter phase 2 study is investigating whether low-dose inhaled carbon monoxide gas can accelerate resolution of acute respiratory distress syndrome (ARDS).  Learn more here. 

Blueprint: mobile coping skills training for ICU patients and their families (PI: Christopher Cox; Co-Is include Co-Is include Jason Katz, Daniel Gilstrap, Krista Haines, Raquel Bartz, Colleen Naglee, Mashael Al-Hegalan).  Recruiting now!   In this NHLBI-funded randomized trial, we will test a mobile app version of Blueprint, our coping skills training program, among ICU patients who have elevated psychological distress symptoms that persist even at arrival home.  Primary outcomes are feasibility, acceptability, and impact on psychological distress symptoms.  Learn more here.

PCplanner: an EHR-integratable app to assist in delivering needs-targeted ICU care (PIs: Christopher Cox and Sharron Docherty; Co-Is include Daniel Gilstrap, Krista Haines, Jason Katz, Raquel Bartz, Colleen Naglee, Mashael Al-Hegalan, Andy Mumm, David Casarett, Kimberly Johnson). Recruiting soon!  A NIA-funded RCT that will test PCplanner vs. usual care among at least 150 patient-family member dyads.  Primary outcomes are unmet palliative care needs, length of stay, use of aggressive care, and family member distress.  This is an extension of a past pilot funded by DIHI.  Learn more here.

LIFT2: mobile mindfulness-based training for ICU patients trial. (PIs: Christopher Cox, Terri Hough, Marc Moss). Recruiting now! This is a NCCIH-funded 3-center study (Duke, University of Washington, University of Colorado) is designed to address the persistent symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD) that ICU patients face.  In this study 240 ICU patients will be randomized to one of 8 different versions of the new Lift mobile app in a MOST design trial to see which version is optimal as measured across a variety of outcomes.  One key element will be to determine to what extent human contact (i.e., mindfulness interventionist) improves (or not) outcome.  Our specific aims will use quantitative and qualitative methods to: (1) evaluate Lift feasibility, acceptability, and usability as well as (2) estimate the effect of Lift on psychological distress symptoms.  Learn more here.

ICUconnect: addressing Palliative Care Needs Among Intensive Care Unit Family Members (PIs: Christopher Cox; and Sharron Docherty; Co-Is Mashael Al-Hegalan, Krista Haines, Yasmin O’Keefe). Recruiting now! See information at ClinicalTrials.gov. The quality of palliative care is highly variable in an intensive care unit (ICU) setting.  To address these challenges, the investigators developed a mobile app that allows families to both give and receive information relevant to palliative care and for ICU clinicians to visualize patient/family data and therefore better support them.  To determine the effect of this intervention, the investigators propose to conduct a randomized clinical trial (RCT) comparing the intervention to usual care to address four specific aims: (1) Using a cluster randomized clinical trial, determine the effect of the intervention vs usual care on unmet needs [as measured by the NEST scale] and patient-centered care [as measured by the IPC scale], (2) Determine the impact of the intervention on unmet needs and patient-centered care based across different racial groups, and (3) Explore family member and clinician experiences with intervention using mixed methods to understand mechanisms within unique case contexts [exploratory aim]. The investigators hypothesize that compared to usual care, PCneeds will reduce family members’ unmet needs, increase the patient-centeredness care, and reduce hospital length of stay overall–though the magnitude of effect will be greater among Blacks compared to Whites.  This is funded by NIMHD and DIHI.  Learn more by clicking here.

Physical therapy interventions for the critically ill (PI: Amy Pastva) Recruiting now!This is a great study that aims to use physical therapy in innovative ways to improve recovery (and the speed with which it occurs).

Understanding patient / family needs in an ICU setting (PI: Christopher Cox). Recruiting now!  This NINR-funded study aims to understand what patients and families need for support during the ICU stay–and how a new survey can help to quickly summarize this information. 

Prediction of Functional Outcomes from Chronic Critical Illness (ProFOCCI; PIs: Shannon Carson, Christopher Cox, Ivor Douglas, Aluko Hope, Terri Hough, Dough White).  Done recruiting.  This is a NINR-funded 5-year multi-center prospective cohort study designed to build a prediction model for 1-year survival, cognitive functioning, physical functioning, and mental health functioning for patients who receive life support longer than average.  The overarching aim is to use these data to assist patients, families, and clinicians with decision making in an ICU environment.

S-NO for severe ARDS (PI: Harvey Marshall). Not yet recruiting.

COMPLETED CLINICAL TRIALS & STUDIES

Improving decision making for families of ICU patients (PI: Christopher Cox).  Finished.  Also, see more detailed information at ClinicalTrials.gov  Deciding about prolonged life support for critically ill patients can be very difficult.  This NHLBI-funded randomized, multi-center study aims to determine if an internet-based decision aid can improve the quality of decision making for substitute decision makers of patients who are in the intensive care unit (ICU).  Click here to learn more.  Click here for manuscript.

Mindfulness program for ICU patients / LIFT1 (PI: Christopher Cox; ClinicalTrials.gov link).  Finished.  This 2-center study (Duke, University of Washington) is designed to address the persistent symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD) that ICU patients face.  In this NCCIH-funded study 90 ICU patients will be randomized to an education program, 4 weekly telephone sessions of mindfulness training, or a 4-week course of self-directed mindfulness that uses an app.  Our specific aims will use quantitative and qualitative methods to: (1) evaluate mMBT and self-directed mMBT feasibility, acceptability, and usability as well as (2) better estimate the effect of both mMBT or self-directed mMBT on psychological distress symptoms.  Click here to learn more.  Click here for manuscript.

Coping skills training for ICU patients and their families / CSTEP (PI: Christopher Cox).  Finished.  Also, see more detailed information at ClinicalTrials.gov  Patients who receive life support in intensive care units commonly suffer from persistent depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms after discharge.  In this PCORI-funded multi-center randomized trial, we are trying to learn which is a better way to manage this distress: a telephone/internet-based adaptive coping skills training program or an ICU-specific educational program.  Click here to learn more.  Click here for manuscript.

Understanding palliative care triggers from the perspective of patients, families, and providers (PIs: Nick Wysham, Haley Goucher, Jessica McFarlin, Nancy Knudsen, Tony Galanos, Christopher Cox).  Finished.  Click here for manuscript.

PCplanner: an EHR-integratable app to assist in better triaging ICU patients to palliative care services. (PI: Christopher Cox; co-Is Jessica McFarlin, Tony Galanos, Nancy Knudsen).  Finished.  Generously supported by the Duke Institute for Healthcare Innovation (DIHI).  This study aims to use the electronic health record plus tablet computers to help find patients and families at need–and then provide palliative care to them.  Click here to learn more.  Click here for manuscript.

Chaplain-based care and attitudes about it in an ICU setting (PI: Philip Choi).  Finished.

Informing decisions in chronic critical illness (PIs: Judith & Shannon Carson; site PI: Christopher Cox).  Publication here.  

ICU-FOCUSED RESEARCH PROGRAMS AT DUKE

The Duke Program for Supporting People and Enhancing Recovery (ProSPER) – ProSPER is a patient- and family-centered research team headquartered at Duke University in Durham, North Carolina and led by Christopher Cox.  Duke ProSPER includes intensive care unit and palliative care doctors, psychologists, research coordinators, biostatisticians, behavioral economists, app developers, videographers, animators, musicians, graphic designers, and others.  We partner with other researchers, colleagues, and friends across the world to do our work.  All of our ideas, mobile apps, and resources include the help and feedback of actual patients, family members, and clinicians. To learn more about ProSPER, its work, and its studies click here.

For more information on any study (or to add one), please contact christopher.cox@duke.edu