- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04158726
Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia
January 13, 2022 updated by: Carevive Systems, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- University of Alabama Birmingham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The correlation of mGA for patients with AML on clinical outcomes at three months post treatment decision making.
Time Frame: 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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Review of Real-world clinician practice patterns of hematologists managing older patients with AML (age>60),
Time Frame: 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.
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 3 months
|
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
|
Change in the hematologists' knowledge, skills and attitudes from baseline following continuing education modules viewed by providers.
Time Frame: 3 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Debbie Wujcik, PhD,RN, Carevive Systems, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 26, 2019
Primary Completion (Actual)
November 30, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
November 1, 2019
First Submitted That Met QC Criteria
November 6, 2019
First Posted (Actual)
November 12, 2019
Study Record Updates
Last Update Posted (Actual)
January 18, 2022
Last Update Submitted That Met QC Criteria
January 13, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 422 AML GA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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