DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics
DISCOVERY
2 other identifiers
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2024
CompletedFirst Posted
Study publicly available on registry
March 6, 2024
CompletedStudy Start
First participant enrolled
June 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
January 28, 2026
January 1, 2026
4.2 years
February 28, 2024
January 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in COLLABORATE scores between arms
The effectiveness of PRIME to improve the value-concordance of treatment decisions in older subjects presenting to hematologic malignancy clinics will be determined by differences in CollaboRATE scores (Percentage in each arm that report perfect scores 15/15) at the post-treatment decision assessment between control and intervention groups. COLLABORATE scores is a Likert scale questionnaire that includes 3 questions rated from 1 to 5. Higher scores represent better patient engagement.
Up to 24 months
Secondary Outcomes (1)
Difference in COLLABORATE scores between arms in a subgroup of patients
Up to 24 months
Study Arms (2)
Usual Care
NO INTERVENTIONReceive usual care.
PRIME intervention
EXPERIMENTALReceive the PRIME intervention.
Interventions
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
Eligibility Criteria
You may qualify if:
- Written or verbal informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.
- Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 60 years at the time of consent.
- New patient to either the hematologic malignancies clinic or the bone marrow transplant/cellular therapy clinic.
You may not qualify if:
- \. Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent or participation in the intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lineberger Comphrehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina, 27516, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel R Richardson, MD, MA, MSc
UNC Lineberger Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2024
First Posted
March 6, 2024
Study Start
June 21, 2024
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
January 28, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share