Issue #3 | January 2025

Announcements

Pause Consenting Tuesday-Wednesday, January 21-22

The CCC will submit the protocol and ICF modification next Tuesday. All sites must PAUSE CONSENTING next Tuesday and Wednesday, January 21-22. Screening, approaching, randomizing, and survey follow up can all continue normally. Please refer to Laura's email with detailed instructions. Consenting may resume once your sites receive an email from the CCC/DCC saying the new consent is ready.

Protocol & ICF Modifications

Once the CCC submits the protocol and ICF for modification to the WUSTL sIRB, we expect it will be approved the same day. The WUSTL sIRB will then update all sites’ individual consents on a rolling basis over the course of two days. Each site will receive an email from the WUSTL IRB once their consent is approved. However, your MDH consent needs to be updated as well and the DCC can not start that until we know the IRB approval date. Since we don’t know exactly when each site will receive approval, everyone will need to pause consenting while we update all the consents in MyDataHelps.

We think it will take two days to update all the consents at the IRB and in MDH, but if there’s a hiccup we might need three days. We anticipate reactivation Thursday morning, but we will send an email confirming all the consents have been updated. Please do not start consenting until you receive an email saying it’s ok to do so.

Sites CAN CONTINUE screening, approaching (schedule consent calls for interested patients for later in the week), randomizing, and collecting surveys from patients.

One of the changes in this modification is to the assessment of understanding question about compensation that is part of the consent survey in MDH.

Current version:

New version:

Operational Update

Randomization counts as of Jan. 15

Institution	Total Randomized	Institution	Total Randomized
Brigham and Women’s Hospital	85	University of Michigan	414
Dartmouth-Hitchcock Medical Center	63	University of Pennsylvania	6
Duke University Hospital	198	University of Utah	316
Henry Ford Detroit	104	University of Virginia Health System	96
Massachusetts General Hospital	68	University of Washington	60
MD Anderson	178	Wake Forest School of Medicine	69
NYU Langone Medical Center	30	Washington University	508
Oregon Health Science University	37	Weill Cornell Medical College	311
University of Arkansas	39	Yale New Haven Hospital	325
University of California San Francisco	1,053	TOTAL:	3,960

95.1%

POD1 QoR15

97.6%

POD1 Brice

97.8%

TIVA Adherence

99.9%

INVA Adherence

New Tableau Report - Consented to Phone Screen

There is a new Tableau Report in the “FOR SITES - Trial Operational Metrics” bundle called “Consented to Phone Screen”. The WUSTL sIRB requires that we report the number of patients who consent to the phone screening as part of annual review reporting. This is determined by patients who have a Yes marked to the first question on the Approach Screening tab in MQUARK.

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.

Fire Drill! Where is Your Downtime Packet?

Do you know where your downtime packet is? What about newer members of your team?

Every site was mailed a packet of paper documents and envelopes for use in the event that randomization or other time-sensitive activities could not be completed in MQUARK or MyDataHelps.

Each packet includes:

10 sealed envelopes for manual randomization
MQUARK DOS form
SAE forms
UB-CAM survey
3D-CAM survey
EQ-5D-5L survey
WHODAS 2.0 survey
Quality of Recovery (QoR) Survey
Modified Brice Survey

Emerging Literature

Perspectives of Older Patients on Speaking With an Anesthesia Provider Before the Day of Surgery: A Cross-Sectional Study

“The most common topics patients wanted to discuss were to address what possible side effects from anesthesia could occur, the type of anesthesia they would receive, and if other anesthesia options were available.” Read the paper here.

Getting to Know the Team - Washington University in St. Louis

Stephen Gregory, M.D.

Washington University in St. Louis

Dr. Stephen Gregory is the THRIVE site PI at Washington University School of Medicine. He is currently the Division Chief of Perioperative Medicine, and his clinical practice is split between the cardiothoracic operating rooms and the Center for Preoperative Assessment and Planning. He was excited to be a part of the THRIVE trial because it is focused on a practical and very relevant clinical question that affects almost all of our patients. He has really enjoyed working with the great clinical research team at Washington University and collaborating with so many excellent researchers at other institutions in the trial. In his spare time, he spends time with his wife and two children and is an avid cyclist, weightlifter, and video gamer.

Shayna Rosen

Washington University in St. Louis

Shayna Rosen is the lead coordinator at Washington University in St. Louis. As part of the Clinical Coordinating Center, she has enjoyed helping to onboard and welcome new sites to the THRIVE team. Shayna values the relationships she builds with THRIVE participants and appreciates the opportunity to provide kindness and consistency during what can often be a challenging time. She is excited to contribute to research that has the potential to significantly benefit future patients. In her free time, Shayna enjoys traveling, reading, and walking dogs at her local animal shelter.

Jen Percich

Washington University in St. Louis

Jennifer Percich is a Senior Clinical Research Coordinator for the THRIVE Study at Wash U. Jen joined the THRIVE study in the feasibility stage. Before that she spent 5 years working in Neurology on a Dominantly Inherited Alzheimer's Disease Study. Jen loves people and feels like she can really learn about the world through other people's stories. This makes THRIVE the perfect fit. Getting to speak with, recruit and then be there for a patient on the day of surgery is so fulfilling. Outside of work she likes to run and spend time with her husband, 4 children, and her granddaughter (most favorite person but don’t tell).

Suggestion Box

Thank you for the suggestion about improving the TIVA Model for mobile devices! We passed on the request to the project team.

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