Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-02-28
Brief Title:
DISCOVERY Evaluating a Decision Support Tool for Adults Seen in HematologyOncology Clinics
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
DISCOVERY Evaluating a Decision Support Tool for Adults Seen in HematologyOncology Clinics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISCOVERY
Brief Summary:
The purpose of this study is to evaluate whether a novel decision support tool called PRIME Preference Reporting to Improve Management and Experience which combines values-elicitation with tailored feedback to patients and providers improves patient-reported values-concordance of initial treatment decisions compared to usual care
Detailed Description:
In the last decade remarkable advances in drug development have led to the approval of 52 new therapies for patients with hematologic malignancies These new approvals are increasingly enabling clinicians to personalize chemotherapy decisions to achieve what matters most to patients Therefore accurately assessing patient preferences is critical to personalizing treatment decisions particularly among older adults who face high treatment-related morbidity andor shorter anticipated survival
Patient preferences have traditionally been inferred from face-to-face conversations However numerous studies including several systematic reviews have demonstrated that this process alone is inadequate to reliably capture patient preferences To support standard shared decision making multiple stakeholders strongly advocate the development of validated patient-reported measures that accurately capture patients preferences In recent guidance about the care of older adults with leukemia the American Society of Hematology explicitly recommends the development of novel decision support tools to address this growing challenge in patient-centered care Improved shared decision making has been associated with increased patient-reported quality of care and satisfaction and a reduction in healthcare utilization
This study will determine the effectiveness of a novel decision support tool called PRIME Preference Reporting to Improve Management and Experience to improve the values-concordance of initial treatment decisions Using best-worst scaling a validated values-elicitation method PRIME provides a personalized report to providers and patients of their most important treatment priorities
In this pragmatic trial participants will be randomized to receive decision support with PRIME or usual care prior to their first visit with their oncologist The primary outcome will be clinically significant improvement in values-concordance of the initial treatment decision on CollaboRATE a validated 12-point measure
Patient preferences have traditionally been inferred from face-to-face conversations However numerous studies including several systematic reviews have demonstrated that this process alone is inadequate to reliably capture patient preferences To support standard shared decision making multiple stakeholders strongly advocate the development of validated patient-reported measures that accurately capture patients preferences In recent guidance about the care of older adults with leukemia the American Society of Hematology explicitly recommends the development of novel decision support tools to address this growing challenge in patient-centered care Improved shared decision making has been associated with increased patient-reported quality of care and satisfaction and a reduction in healthcare utilization
This study will determine the effectiveness of a novel decision support tool called PRIME Preference Reporting to Improve Management and Experience to improve the values-concordance of initial treatment decisions Using best-worst scaling a validated values-elicitation method PRIME provides a personalized report to providers and patients of their most important treatment priorities
In this pragmatic trial participants will be randomized to receive decision support with PRIME or usual care prior to their first visit with their oncologist The primary outcome will be clinically significant improvement in values-concordance of the initial treatment decision on CollaboRATE a validated 12-point measure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None