Clinical trial NCT06296368: DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics
Official title: DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Malignancies
Lymphoma
Multiple Myeloma
Leukemia
Blood Cancers
Keywords: decision support tool
pragmatic study
best-worst scaling
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-03-06
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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).

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.

Primary outcomes:
measure: Difference in COLLABORATE scores between arms
timeFrame: Up to 24 months
Secondary outcomes:
measure: Difference in COLLABORATE scores between arms in a subgroup of patients
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comphrehensive Cancer Center at University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Daniel R Richardson, MD, MA, MSc
role: PRINCIPAL_INVESTIGATOR
References: