FRAME - Implementation of a PRO Measure to Inform Patient-Centered Survivorship Care in Oncology Outpatient Visits
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: FRAME model (questionnaire + dialogue + management plan).
- Кому может быть актуально
- Состояния в реестре: Cancer, Late Effects. Базовые параметры: Без ограничений · 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
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
FRAME (Focused Recognition, Assessment and Management of Late Effects): A Single-Center Implementation Study Using RE-AIM to Guide Evaluation in the Department of Oncology, Vejle Hospital
Обзор
FRAME is a patient-centered survivorship care model embedded in routine oncology visits. It consists of: (1) a pre-visit patient-reported questionnaire (FRAME-PRO), (2) a clinician-patient dialogue guided by the responses, and (3) a tailored management plan including stepped-care referrals (general practitioner and municipality; oncology department supportive services; specialized late-effects clinics). The implementation is evaluated with the RE-AIM framework supplemented by Proctor implementation outcomes. Data sources include the "Mit Sygehus" app, departmental registries, purpose-built questionnaires, fidelity checklists, and qualitative interviews with clinicians, patients, and informal caregivers.
Подробное описание
The project implements FRAME at the Department of Oncology, Vejle Hospital. The FRAME-PRO enables patients and informal caregivers to reflect on late effects and needs before the visit. During the visit, clinicians access FRAME-PRO electronically to prioritize what matters most, assess severity (triage), and co-create a management plan documented in the electronic health record using a purpose-developed standard phrase to support cross-sector information transfer. Implementation strategies are informed by the Expert Recommendations for Implementing Change (ERIC) and local logs (education, audit \& feedback, reminders, local champions, technical assistance). Evaluation follows RE-AIM: Reach (completion of FRAME-PRO), Effectiveness (referrals to supportive care, quality of life, time use), Adoption (clinician use), Implementation (fidelity to opening, discussing, and managing needs), and Maintenance (sustained use). Quantitative data are summarized descriptively; qualitative data are analyzed with content analysis. Ethics approval covers interviews with patients, caregivers, and clinicians.
Вмешательства
- Поведенческое FRAME model (questionnaire + dialogue + management plan)
Administration of the patient-developed FRAME-PRO prior to the visit; clinician-patient dialogue guided by responses; stepped-care management/referrals; documentation via standard EHR phrase. Implementation strategies include educational meetings/materials, ongoing training, audit \& feedback at weekly huddles, reminders/prompts, local champions, and local technical assistance.
Первичные конечные точки
- Proportion of oncologists who actively use FRAME in ≥50% of eligible outpatient visits. [Срок оценки: 3 months]
Вторичные конечные точки (11)
- Proportion of eligible outpatient visits with completed FRAME-PRO (via "Mit Sygehus"). [Срок оценки: Continuously during implementation (up to 6 months)]
- Change in proportion of visits/patients with referrals to supportive care units compared with pre-implementation baseline. [Срок оценки: Up to 6 months]
- Change in patient-reported global quality of life measured on a Likert-like scale from 1 (poor) to 5 (excellent). [Срок оценки: Up to 6 months]
- Degree to which clinicians and patients (a) open FRAME-PRO during the visit (yes/no), (b) discuss reported needs (yes/no), and (c) manage needs aligned with preferences (yes/no) [Срок оценки: Up to 6 months]
- Perceived feasibility of active FRAME use among clinicians on a likert-like scale from 1 (not feasible) to 5 (very feasible) [Срок оценки: 6 months]
- Clinician-perceived acceptability of FRAME-supported visits on a scale from 1 (not acceptable) to 5 (very acceptable) [Срок оценки: 6 months]
- Perceived fit of FRAME to the oncology outpatient setting and patient population on a scale from 1 (not appropriate) to 5 (very appropriate). [Срок оценки: 6 months]
- Time needed to include FRAME-PRO in the visit on a scale from 1 (definitely shorter time with FRAME) to 5 (definitely longer time with FRAME). [Срок оценки: 6 months]
- Integration of FRAME within the outpatient clinic (e.g., percent of clinicians using FRAME routinely) [Срок оценки: 6 months]
- Sustained active use of FRAME among clinicians in the last 3 months of the study window. [Срок оценки: Up to 12 months]
- Proportion of patients referred to supportive care units (actual numbers) [Срок оценки: 6 months]
Критерии участия
Критерии включения
\- All oncologists conducting outpatient visits at the Department of Oncology, Vejle Hospital during the study period.
Критерии исключения
\- None.
Participants for interviews:
- A purposive sample of patients, informal caregivers, and clinicians approached ≥6 months after launch
- written and verbally informed consent.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
Дания · 1 центр
- Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark — Vejle
Публикации
- Lyhne JD, Gade L, Hansen L, Johansen A, Smith A', Jensen LH, Ventzel L. Survivor-driven development of a PROM for use in routine colorectal cancer care. Acta Oncol. 2025 Mar 27;64:475-483. doi: 10.2340/1651-226X.2025.42032. PMID 40150842
Идентификаторы
NCT: NCT07281820 · FRAME-PRO · R392-A23403