Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
modified Geriatric Assessment (mGA)
Sponsored by
About this trial
This is an interventional health services research trial for Acute Myeloid Leukemia
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).
Sites / Locations
- University of Alabama Birmingham
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04158726
First Posted
November 1, 2019
Last Updated
January 13, 2022
Sponsor
Carevive Systems, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04158726
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 26, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carevive Systems, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
modified Geriatric Assessment (mGA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The correlation of mGA for patients with AML on clinical outcomes at three months post treatment decision making.
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Review of Real-world clinician practice patterns of hematologists managing older patients with AML (age>60),
Description
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.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
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.
Description
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
Time Frame
3 months
Title
Change in the hematologists' knowledge, skills and attitudes from baseline following continuing education modules viewed by providers.
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debbie Wujcik, PhD,RN
Organizational Affiliation
Carevive Systems, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia
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