Issue #2 | December 2024

Announcements

13,000

PCORI approved our increased sample size of 13,000 patients. We requested this update to allow for more conservative statistical methods to detect intraoperative awareness, a rare outcome. To maximize the statistical power for this safety outcome, we need to keep intervention adherence above 98% for each intervention. The Brice completion rate goal remains the same at 98%.

December/January Randomization Pause

Please do not consent patients for randomization between December 20th and January 1st.

Operational Update

Randomization counts as of Dec. 19

Institution	Total Randomized	Institution	Total Randomized
Brigham and Women’s Hospital	80	University of Michigan	398
Dartmouth-Hitchcock Medical Center	62	University of Pennsylvania	5
Duke University Hospital	187	University of Utah	313
Henry Ford Detroit	99	University of Virginia Health System	91
Massachusetts General Hospital	67	University of Washington	54
MD Anderson	150	Wake Forest School of Medicine	68
NYU Langone Medical Center	27	Washington University	489
Oregon Health Science University	33	Weill Cornell Medical College	300
University of Arkansas	36	Yale New Haven Hospital	291
University of California San Francisco	1,034	TOTAL:	3,784

95.0%

POD1 QoR15

98.0%

POD1 Brice

98.0%

TIVA Adherence

99.9%

INVA Adherence

Updates Coming Soon

Protocol & Consent Update - January

The increased sample size will require an update to the protocol and informed consent. The update will be entered at the center level and will flow down to sites automatically. Each site will see an update to the informed consent form (ICF) and the ICF Summary document which will need to be reviewed. Instructions for this portion of the modification will come via email once the modification is submitted at the project level.

Study Process Reminders

Staff Support for Delayed Cases

If a case is delayed on the day of surgery, it’s ok to withdraw the patient pre-randomization if the surgery will go after the team’s normally scheduled work hours.

Entering Patients in MQUARK

Patients must be entered into MQUARK, regardless of whether bidirectional communication occurs, if the study team attempts to contact them by any method. Enter patients into MQUARK if they meet inclusion criteria based on Epic search, and there are no obvious exclusion criteria in the EHR record.

Case Selection

Please avoid:

Medically complicated patients
Cases scheduled with clinicians who are uncomfortable with either anesthesia technique
Surgeries/clinicians/situations that led to previous crossovers if possible

New Educational Resources

3D-CAM Quiz

3D-CAM Tip Sheet

PK Modeling Tool: https://tiva-model.org/

New Reports in Tableau

We published a new Tableau report bundle called FOR SITES - Participant Level Survey Completions. The reports show whether surveys are missing or not (and whether survey attempts were completed), at a per participant level. This is the per participant level information used during site calls.

Please see the updated SOP for accessing Michigan's Windows Virtual Desktop and the Tableau Reports.

Please email thrive-dcc@med.umich.edu to request more team members be granted access.

Getting to Know the Team - Weill Cornell Medicine

Kane Pryor, M.D.

Weill Cornell Medicine

Dr. Kane Pryor is the THRIVE Site PI for Weill Cornell Medicine and also serves on the THRIVE Operations Committee. He is the Executive Vice Chair for Academic Affairs at Weill Cornell, where he runs a human subject research unit called the WCM Anesthesia Trials Group. Dr. Pryor and the Trials Group have been part of several large multi-center trials, including many in collaboration with Drs. Avidan, Kheterpal, and others at WashU and UMichigan. He saw THIRVE as a wonderful opportunity to work collaboratively with friends and colleagues while addressing an important clinical question of relevance to a large number of patients; he also appreciates that THRIVE provides an outstanding experience for the research team and colleagues at Weill Cornell that he hopes inspires them to develop their own research interests and careers. Outside of work, Dr. Pryor is an avid outdoors traveler and pursues mountaineering and trekking across the globe whenever possible. And loves the Knicks!

Michele Steinkamp

Weill Cornell Medicine

Michele Steinkamp is the THRIVE research nurse for Weill Cornell Medicine. Michele joined the WCM Anesthesiology Trials Group in 2008; prior to joining the research team, she worked as a critical care nurse. She is happy about the opportunity to work on THRIVE to contribute to an impactful study focused on improving patient-centered outcomes and enjoys the collaborative aspect of the project.

Outside work, Michele enjoys spending time with her family, friends and dog, exploring NYC, and, much to the dismay of her teenage son, nature photography.

Abha Kasubhai

Weill Cornell Medicine

Abha Kasubhai is the THRIVE Lead Research Assistant at Weill Cornell Medicine. She is grateful for the opportunity to foster long-term relationships with THRIVE participants and help make their perioperative experiences less daunting. Abha enjoys working with and learning from the variety of clinicians in the department. Outside of work, she enjoys exploring new restaurants, yoga, and baking!

Resources for Patients

A few helpful resources to send to patients who are considering enrolling in THRIVE or who might benefit from visual aides. If you have not already submitted this to the WUSTL IRB for site level approval please do so before using.

Please only use recruitment materials provided by THRIVE or those that have been approved for use by the CCC.

THRIVE Brochure - update the phone number and email address on the last page and submit to WUSTL IRB for approval

Overview Handout - update the phone number and email address in the Learn more section and submit to WUSTL IRB for approval

Visual Consent - update the contact info at the bottom of the page and submit to WUSTL IRB for approval

Study Timeline - update the phone number in the top right section and submit to WUSTL IRB for approval. Better for patients who have already consented

Suggestion Box

We would love to hear from you! Please let us know if there is a team member you would like to recognize or celebrate in the next newsletter, or if there are other updates you would like to know about.

Funded by

Contract 2020C3-21106