Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04158726
• Other study ID #: 422 AML GA
• Status: Completed
• Phase: N/A
• Start date: April 26, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2022
• Source: Carevive Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Behavioral:
• modified Geriatric Assessment (mGA)
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.

Locations

Country	Name	City	State
United States	University of Alabama Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Carevive Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Usability and acceptability of the electronic mGA is measured by both patients and providers using surveys after the visit. Feasibility of the mGA is assessed at the patient level and focuses on the patient's ability to complete the assessment via an electronic tablet prior to their visit without assistance. These measures will be collected using one comprehensive survey	3 months
Other	Change in the hematologists' knowledge, skills and attitudes from baseline following continuing education modules viewed by providers.	Clinicians will complete a pre-test and a post-test questionnaire, allowing for the determination of clinician competency to optimally manage older patients with AML based on GA screening. The comparisons will assess changes in knowledge, skills and attitudes as a direct result of the training. Surveys will be completed capturing the results and will be compared at the different timepoints.	3 months
Primary	The correlation of mGA for patients with AML on clinical outcomes at three months post treatment decision making.	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.	3 months
Secondary	Review of Real-world clinician practice patterns of hematologists managing older patients with AML (age>60),	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.	3 months