Improving Delivery of Aging-Related Supportive Care for Older Adults With Acute Myeloid Leukemia (ACTIVE DEFAULT)
19. August 2026 aktualisiert von: Aditi Sharma, University of Alabama at Birmingham
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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
40
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Aditi Sharma, MD
- Telefonnummer: 205-975-0412
- E-Mail: adshar@uabmc.edu
Studienorte
-
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35233
- University of Alabama at Birmingham
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Unterermittler:
- Nicole Henderson, PhD
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Kontakt:
- Aditi Sharma, MD
- Telefonnummer: 205-975-0412
- E-Mail: adshar@uabmc.edu
-
Hauptermittler:
- Aditi Sharma, MD
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Unterermittler:
- Gabrielle Rocque, MD, MSPH
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Unterermittler:
- Smita Bhatia, MD, MPH
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Unterermittler:
- Pankit Vachhani, MD
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Unterermittler:
- Andres Azuero, PhD, MBA
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Proportion of eligible triggered supportive care orders signed by the treating physician within 7 days (implementation fidelity)
Zeitfenster: 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.
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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)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Proportion of signed supportive care orders with at least one completed service visit (service engagement)
Zeitfenster: 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.
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90 days from Cycle 1 Day 1, the first day of venetoclax-based therapy (each cycle is 28 days)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Aditi Sharma, MD, University of Alabama at Birmingham
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Oktober 2026
Primärer Abschluss (Geschätzt)
31. Juli 2028
Studienabschluss (Geschätzt)
30. September 2028
Studienanmeldedaten
Zuerst eingereicht
17. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. August 2026
Zuerst gepostet (Tatsächlich)
20. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
21. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
19. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB-300016966
- UAB (Andere Kennung: UAB)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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