DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Preference Reporting to Improve Management and Experience (PRIME).
- Кому может быть актуально
- Состояния в реестре: Hematologic Malignancies, Lymphoma, Multiple Myeloma, Leukemia. Базовые параметры: от 60 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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).
Вмешательства
- Поведенческое Preference 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
Первичные конечные точки
- Difference in COLLABORATE scores between arms [Срок оценки: Up to 24 months]
Вторичные конечные точки (1)
- Difference in COLLABORATE scores between arms in a subgroup of patients [Срок оценки: Up to 24 months]
Критерии участия
Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- 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.
Критерии исключения
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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- Lineberger Comphrehensive Cancer Center at University of North Carolina — Chapel Hill
Идентификаторы
NCT: NCT06296368 · LCCC2305 · K08CA273684-01A1