NCT Number: NCT07777471
The goal of this clinical trial is to test a way of delivering supportive care to adults 60 years and older who are starting venetoclax-based treatment for newly diagnosed acute myeloid leukemia (AML). Older adults with AML often have aging-related needs, such as problems with mobility, nutrition, mood, memory, or medications, that are not always addressed in a consistent way. In this study, a health questionnaire and short in-person checks (a geriatric assessment) are used to find these needs early, and matching supportive care orders are prepared in the electronic health record and sent to the treating doctor, who decides whether to place each one. This approach is called Active Default. The main questions the study aims to answer are:
* How often are the prepared supportive care orders signed by treating doctors (implementation fidelity)? * Can each step of the process, from completing the assessment to receiving supportive care services, be carried out as planned?
Participants will:
* Complete questionnaires and short in-person checks of walking, balance, strength, memory, mood, and medications at the start of treatment * Receive supportive care services (for example physical therapy, nutrition, or social work) if their doctor approves the prepared orders * Answer phone check-ins over 90 days and repeat two short checks at about two months * Be invited to one optional interview about their experience
Healthcare providers involved in participants' care will be invited to complete a one-time survey and an optional interview about the approach.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35233, United States
Aditi Sharma, MD
CONTACT
Aditi Sharma, MD
PRINCIPAL_INVESTIGATOR
Andres Azuero, PhD, MBA
SUB_INVESTIGATOR
Gabrielle Rocque, MD, MSPH
SUB_INVESTIGATOR
Nicole Henderson, PhD
SUB_INVESTIGATOR
Pankit Vachhani, MD
SUB_INVESTIGATOR
Smita Bhatia, MD, MPH
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient participants:
Provider participants:
-Participating leukemia attending physicians and supportive care service leads involved in the care of enrolled participants
Exclusion criteria
Patient participants:
An electronic health record-based order-queuing mechanism that delivers geriatric assessment-driven supportive care. A structured geriatric assessment is completed at the start of venetoclax-based therapy. Results crossing pre-specified thresholds trigger matched supportive care orders (for example physical therapy, nutrition, social work, pharmacy medication review, geriatrics, mental health, chaplaincy), which the study team prepares as proposed orders for the treating physician to approve or decline. The supportive care services themselves are standard of care; the intervention modifies only the order-entry workflow.
Time frame: Within 7 days of each supportive care order placement; orders are placed after the baseline geriatric assessment and within 7 days before or after Cycle 1 Day 1 of venetoclax-based therapy (each cycle is 28 days)
Measured as the number of eligible geriatric assessment-triggered supportive care orders signed by the treating physician within 7 days of order placement, divided by the total number of eligible triggered orders, using electronic health record order data. Eligible triggers are those not already engaged in the corresponding service or pre-declined by the patient at the pre-referral screen. Reported as a point estimate with 95% Clopper-Pearson confidence interval.
Time frame: 90 days from Cycle 1 Day 1, the first day of venetoclax-based therapy (each cycle is 28 days)
Measured as the number of signed supportive care orders with at least one completed visit in the corresponding service within 90 days of Cycle 1 Day 1, divided by the total number of signed orders, using electronic health record data. Reported as a point estimate with 95% Clopper-Pearson confidence interval.
Contact information is provided by the study sponsor or research team.
University of Alabama at Birmingham
Other
Active Default Pilot: Implementation of Geriatric Assessment-Driven Supportive Care for Older Adults With Acute Myeloid Leukemia Receiving Venetoclax-Based Therapy
Acronym: ACTIVE DEFAULT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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