Improving Delivery of Aging-Related Supportive Care for Older Adults With Acute Myeloid Leukemia

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07777471
Status
Not Yet Recruiting

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Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Active Default — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Active Default
    Patients aged 60 and older with newly diagnosed AML starting venetoclax-based therapy (n=25) receive the Active Default intervention: a geriatric assessment at the start of treatment, with results crossing pre-specified thresholds generating matched supportive care orders that are prepared in the electronic health record and sent to the treating physician to approve or decline. Patients are followed for 90 days, with phone check-ins and repeat physical function and cognition checks at about 60 days. Healthcare providers involved in enrolled patients' care (up to 15) complete a one-time survey and are invited to an optional interview about the approach.

Primary Outcome Measure

Proportion of eligible triggered supportive care orders signed by the treating physician within 7 days (implementation fidelity) [ 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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Aditi Sharma, MD
[email protected]
205-975-0412
Aditi Sharma, MD (PRINCIPAL_INVESTIGATOR)
Gabrielle Rocque, MD, MSPH (SUB_INVESTIGATOR)
Smita Bhatia, MD, MPH (SUB_INVESTIGATOR)
Pankit Vachhani, MD (SUB_INVESTIGATOR)
Andres Azuero, PhD, MBA (SUB_INVESTIGATOR)
Nicole Henderson, PhD (SUB_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, AL

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