Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia

Not Applicable

Completed

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT04158726
• Lead Sponsor: Carevive Systems, Inc.

Brief Summary

Despite the suggestions that GA and frailty indices could be used to guide therapy selection, the ability to effectively incorporate the use of GA in older patients diagnosed with AML in a real-world clinic environment has not yet been established. Thus, in this study, the investigators seek to describe the feasibility of using this shorter GA tool, the mGA, administered via patient self-report on a touchscreen computer, as well as the real-time use and utility by clinicians and the correlation of mGA results on treatment decision-making.

Detailed Description

This outcomes study has a two-part intervention that includes 1) provider education and 2) patient and provider use of Carevive Treatment Care Planning technology. The provider education component of the intervention highlights evidenced guidelines and investigational agents in the treatment of AML in older adults. The Carevive CPS will be used for the second component of the intervention. The results of this study will provide important information about drivers of treatment decision-making and practice patterns, feasibility of a technology platform to incorporate important, but under-utilized components of value-based care into practice, and healthcare utilization data.

Study Timeline

• Study Start: 2019-04-26
• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-12
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• All participants must be adults ages 18 years of age or older.
• Patient participants must have a diagnosis of AML.
• Patients may be newly diagnosed, needing a new line of therapy and have not yet made a treatment decision, or on treatment and being assessed for potential new treatment
• All participants must be able to understand English.

Exclusion Criteria

• Any patient who cannot understand written or spoken English.
• Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The correlation of mGA for patients with AML on clinical outcomes at three months post treatment decision making.	3 months	Clinical outcomes include time on treatment, adherence to the prescribed treatment, quality of life (QoL), and patient side effects. Providers will review results of the mGA at a treatment decision visit and indicate if the mGA results influenced the treatment selection. Chart abstraction will be conducted at a 3-month post treatment planning visit time point to confirm treatment given. Baseline and 3-month QoL and symptom assessment measures will be collected and change over time will be analyzed. Comparisons of change in QoL and symptoms over 3 months, total time on treatment, and adherence among fit, intermediate, and frail groups will be made.

Secondary Outcome Measures

Name	Time	Method
Review of Real-world clinician practice patterns of hematologists managing older patients with AML (age>60),	3 months	Quantitative measures include data collected by the Carevive CPS platform to describe treatment practice patterns of hematologists caring for older patients with AML at three study sites. At baseline, and then again as part of participating clinicians' exit interview, each clinician will complete a survey that asks about his/her behaviors related to assessment and management of their older AML patients.

Trial Locations

Locations (1)

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States