Improving Delivery of Aging-Related Supportive Care for Older Adults With Acute Myeloid Leukemia (ACTIVE DEFAULT)

Active Default Pilot: Implementation of Geriatric Assessment-Driven Supportive Care for Older Adults With Acute Myeloid Leukemia Receiving Venetoclax-Based Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Myeloid Leukemia (AML)
• Intervention / Treatment: Behavioral: Active Default

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aditi Sharma, MD; Phone Number: 205-975-0412; Email: adshar@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
      • Sub-Investigator: Nicole Henderson, PhD
      • Contact: Aditi Sharma, MD; Phone Number: 205-975-0412; Email: adshar@uabmc.edu
      • Principal Investigator: Aditi Sharma, MD
      • Sub-Investigator: Gabrielle Rocque, MD, MSPH
      • Sub-Investigator: Smita Bhatia, MD, MPH
      • Sub-Investigator: Pankit Vachhani, MD
      • Sub-Investigator: Andres Azuero, PhD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Patient participants:

• Age 60 years or older
• Newly diagnosed acute myeloid leukemia (AML), including de novo, secondary, or therapy-related AML, per current World Health Organization (WHO) or International Consensus Classification (ICC) classification
• Planned for first-line venetoclax-based lower-intensity therapy
• English-speaking
• Able to provide informed consent personally or through a Legally Authorized Representative (LAR)

Provider participants:

-Participating leukemia attending physicians and supportive care service leads involved in the care of enrolled participants

Exclusion Criteria:

Patient participants:

• Acute promyelocytic leukemia
• Planned intensive induction or non-venetoclax-based therapy
• Life expectancy under 14 days or hospice enrollment at screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of eligible triggered supportive care orders signed by the treating physician within 7 days (implementation fidelity)	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.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of signed supportive care orders with at least one completed service visit (service engagement)	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.	90 days from Cycle 1 Day 1, the first day of venetoclax-based therapy (each cycle is 28 days)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Aditi Sharma, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: August 17, 2026
• First Submitted That Met QC Criteria: August 17, 2026
• First Posted (Actual): August 20, 2026

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute
• Other Study ID Numbers: IRB-300016966; UAB (Other Identifier: UAB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No