Clinical trial NCT04158726: Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia
Official title: Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Lead sponsor: Carevive Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-12
Enrollment: 47
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The correlation of mGA for patients with AML on clinical outcomes at three months post treatment decision making.
timeFrame: 3 months
Secondary outcomes:
measure: Review of Real-world clinician practice patterns of hematologists managing older patients with AML (age>60),
timeFrame: 3 months
Other outcomes:
measure: Satisfaction (usability, acceptability, feasibility and utility) of incorporating electronic mGA into routine clinical care will be evaluated at baseline and each clinic visit.A comprehensive survey will be utilized to capture these outcomes.
timeFrame: 3 months
measure: Change in the hematologists' knowledge, skills and attitudes from baseline following continuing education modules viewed by providers.
timeFrame: 3 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
Study officials:
affiliation: Carevive Systems, Inc.
name: Debbie Wujcik, PhD,RN
role: PRINCIPAL_INVESTIGATOR
References: