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Trial Title:
DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics
NCT ID:
NCT06296368
Condition:
Hematologic Malignancies
Lymphoma
Multiple Myeloma
Leukemia
Blood Cancers
Conditions: Official terms:
Multiple Myeloma
Hematologic Neoplasms
Conditions: Keywords:
decision support tool
pragmatic study
best-worst scaling
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Preference Reporting to Improve Management and Experience (PRIME)
Description:
PRIME is a decision support tool that uses best-worst scaling to provide a personalized
report to providers and patients of their most important treatment priorities
Arm group label:
PRIME intervention
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 and/or 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).
Criteria for eligibility:
Criteria:
Inclusion Criteria In order to participate in this study a subject must meet all of the
eligibility criteria outlined below.
1. Written or verbal informed consent obtained to participate in the study and HIPAA
authorization for the release of personal health information.
2. Subjects are willing and able to comply with study procedures based on the judgment
of the investigator.
3. Age ≥ 60 years at the time of consent.
4. New patient to either the hematologic malignancies clinic or the bone marrow
transplant/cellular therapy clinic.
Exclusion Criteria
All subjects meeting any of the exclusion criteria listed below at baseline will be
excluded from study participation:
1. Dementia, altered mental status, or psychiatric condition that would prohibit the
understanding or rendering of informed consent or participation in the intervention.
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lineberger Comphrehensive Cancer Center at University of North Carolina
Address:
City:
Chapel Hill
Zip:
27516
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mireille L Leone
Phone:
919-445-0768
Email:
mireille_leone@med.unc.edu
Investigator:
Last name:
Daniel R Richardson,, MD, MA, MSc
Email:
Principal Investigator
Start date:
June 21, 2024
Completion date:
September 1, 2028
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06296368
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
