Идёт набор NCT06272552

Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact

Без фазы С лечением PROMs PREMs Implementation Research Impact Evaluation

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: PROMs and PREMs, PREMs, Control, Healthcare professionals.
Кому может быть актуально: Состояния в реестре: PROMs, PREMs, Implementation Research, Impact Evaluation. Базовые параметры: от 18 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: Испания
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

Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact.

Обзор

There has been increasing interest in the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such implementation. Objective: To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management. Design: Randomized control trial. Setting: In and outpatient departments of a public hospital in Spain. Participants: 1,440 adult patients managed for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery. Intervention: Patients will monthly complete, through an App from their smartphones, PROMs and PREMs (arm A, n=480), or only PREMs (arm B, n=480). Responses to PROMs will be transformed into a graphic summary, accessible for physicians and patients at the follow-up visits of the project (9 and 18 months after recruitment). Main outcome measures: Comparison of change among arms on the assessment variables - such as health-related quality of life (EQ-5D-5L), satisfaction with care, or patient-professionals communication. These constructs will be measured at recruitment and at follow up visits for all patients, regardless of their arm allocation (arm C would only be administered these questionnaires, without intervention, n=480). Expected results: Incorporating PROMs and PREMs in routine clinical care may improve patients\' and health professionals\' experiences on health care, as well as improve patients\' health.

Вмешательства

Другое PROMs and PREMs
Participants are administered PROMs and PREMs at a given timeline adequate to each participant conditions for a duration of 2 years. The administration of PROMs is done by email using the REDCap platform. The research team and health care professionals have access to their patient\&amp;#39;s results to aid in the patients clinical care. Participants are administered a PREM once a year for two years. Only health care administrators, department heads and researchers will have access to the PR
Другое PREMs
Participants are administered a PREM once a year for two years. Only health care administrators, department heads and researchers will have access to the PREMs data, and this data will always be aggregated data to avoid identification of the patients. The administration of the PREM is done by email using the REDCap platform. At recruitment and once a year, participants answer an evaluation questionnaire to measure the impact of completing PROMs and PREMs. This questionnaire is completed during
Другое Control
At recruitment and once a year, participants answer an evaluation questionnaire to measure the impact of completing PROMs and PREMs. This questionnaire is completed during a clinic visit.
Другое Healthcare professionals
Healthcare professionals participating in the study answer an evaluation questionnaire before the implementation starts at their service and two years later to measure their perceptions about the implementation.

Первичные конечные точки

Evaluation quesionnaire (PRMIAT) of the implementation to be completed by all patients and healthcare professionals [Срок оценки: At recruitment and at 1 year intervals]
Health-related quality of life [Срок оценки: At recruitment and at 1 year intervals]

Критерии участия

Критерии включения

Being an active patient of the nephrology service, prostate cancer service, breast cancer service, or bariatric surgery service
In possession of an email account and having basic knowledge of how to manage emails
In possession of a smartphone, computer, or tablet with access to the Internet
Fluent and able to read in Spanish