Dialysis Geriatric Care Model
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: Geriatric Care Model, Usual Care.
- Кому может быть актуально
- Состояния в реестре: Chronic Kidney Diseases, Dialysis, Geriatric. Базовые параметры: от 55 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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Официальное название
Integration of Geriatric Care Into Dialysis Clinics
Обзор
The objectives of this study are to refine the dialysis care model with key stakeholder input and conduct a pilot randomized controlled trial (RCT) to obtain evidence critical to inform a definitive RCT.
Подробное описание
The investigators designed a new dialysis care model that includes a centralized geriatric team that uses information from the Geriatric screen for OLder Dialysis patients (GOLD) to develop individualized recommendations for geriatric syndrome management based on the patient's priorities. The study population is older adults receiving hemodialysis and dialysis staff. The investigators will have patient participants complete the care model and undergo geriatric evaluation. This phase will be referred to as refinement aim 1. The investigators will then assess agreement of each GOLD instrument with its corresponding geriatric evaluation. The investigators will assess acceptability and feasibility of the care model through surveys and interviews with patients and dialysis staff to complete refinement aim 2. Once the new dialysis care model is redefined, the investigators will conduct the third phase, pilot RCT (geriatric care model vs. usual care) and assess geriatric problem management at 4 months, as well as, patient reported outcomes, physical function, and health care utilization at intervals up to 12 months. The analyses will include 1) measure of agreement using Cohen's kappa, 2) qualitative rapid analyses, 3) descriptive statistics from acceptability and feasibility surveys, 4) descriptive statistics from pilot RCT data, and 5) tests for difference in geriatric problem management between treatment and control groups. The study does not involve activity from participants that would exceed normal or routine care so there are negligible physical, financial, or legal risks.
Вмешательства
- Поведенческое Geriatric Care Model
First, older adults complete the Geriatric screen for OLder adults receiving Dialysis (GOLD), a battery of validated, self-administered geriatric screening instruments, used to identify Geriatric 5M-related problems. Then, a research team with geriatrics expertise leads patient prioritization of GOLD-identified problems in a telehealth visit and provides the dialysis team with guideline-directed, individualized recommendations for geriatric problem management. - Поведенческое Usual Care
Participants will continue to receive standard of care. Then after 12 months, they will follow the Geriatric Care Model. They will complete the Geriatric screen for OLder adults receiving Dialysis (GOLD), a battery of validated, self-administered geriatric screening instruments, used to identify Geriatric 5M-related problems. Then, a research team with geriatrics expertise leads patient prioritization of GOLD-identified problems in a telehealth visit and provides the dialysis team with guideline
Первичные конечные точки
- Change in geriatric problem management as measured by survey [Срок оценки: Baseline, 4 months]
Вторичные конечные точки (5)
- Practicality as measured by amount of time utilized by study personnel to conduct RCT (randomized controlled trial) [Срок оценки: up to 12 months]
- Practicality as measured by number of participants who needed study personnel assistance to complete the GOLD electronically [Срок оценки: up to 12 months]
- Fidelity as measured by the Care model recommendation checklist [Срок оценки: Baseline, 4 months]
- Retention as measured by number of participants who complete the study [Срок оценки: up to 12 months]
- Recruitment as measured by number of participants enrolled [Срок оценки: up to 12 months]
Критерии участия
Patient Inclusion Criteria:
- community-dwelling dialysis patients 55 and older
- may have cognitive impairment
Patient Exclusion Criteria:
- advanced dementia
- non-English or Spanish speaking
- nursing home residents
- hospice enrollees
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- Duke University — Durham
Идентификаторы
NCT: NCT05793138 · Pro00112850