Improving Delivery of Aging-Related Supportive Care for Older Adults With Acute Myeloid Leukemia
NCT07777471 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-08-21
Summary
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.
Conditions
- Acute Myeloid Leukemia (AML)
Interventions
- BEHAVIORAL
-
Active Default
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.
Sponsors & Collaborators
-
University of Alabama at Birmingham
lead OTHER
Principal Investigators
-
Aditi Sharma, MD · University of Alabama at Birmingham
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-10-01
- Primary Completion
- 2028-07-31
- Completion
- 2028-09-30
Countries
- United States
Study Locations
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