Blood Cancers, Hematologic Malignancies, Leukemia, Lymphoma, Multiple Myeloma
Conditions
Keywords
decision support tool, pragmatic study, best-worst scaling
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).
Interventions
BEHAVIORALPreference Reporting to Improve Management and Experience (PRIME)
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
Sponsors
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in COLLABORATE scores between arms | Up to 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in COLLABORATE scores between arms in a subgroup of patients | Up to 24 months | The secondary outcome will be the difference in CollaboRATE scores (percentage in each arm that report perfect scores 15/15) at the post-treatment decision assessment between control and intervention groups in a subgroup of participants: participants with newly-diagnosed Acute myeloid leukemia, Acute Lymphoblastic leukemia, Diffuse Large B-cell Lymphoma, and Multiple myeloma COLLABORATE scores is a Likert scale questionnaire that includes 3 questions rated from 1 to 5. Higher scores represent better patient engagement. |
Countries
United States
Contacts
CONTACTMadisyn L Parker
PRINCIPAL_INVESTIGATORDaniel R Richardson, MD, MA, MSc
UNC Lineberger Comprehensive Cancer Center
Outcome results
None listed