- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03360305
GAPcare: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department (GAPcare)
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Falls are the leading cause of fatal and non-fatal injury among older adults. EDs frequently evaluate older adults after their falls, but the typical evaluation consists of an injury assessment alone. There is a critical need for an ED-based intervention that addresses reasons for the fall and provides on-the-spot assessment and guidance to prevent subsequent falls. Failure to prevent subsequent falls will result in increased morbidity, mortality, healthcare utilization, loss of independence, and rising health care costs as the population of older adults increases.
Participants in GAPcare will be older adults (≥65 years-old) who present to the ED for a fall. We will pursue the following specific aims to test and further refine the GAPcare intervention: (1) Examine the feasibility of recruitment and retention of eligible patients into the GAPcare intervention, (2) determine the initial efficacy of the GAPcare intervention in reducing subsequent falls and healthcare utilization at 6 months. Our long-term goal is to prevent the early morbidity and mortality of older adults who present to the ED after a fall. The overall objective of this survey is to gather preliminary data on the feasibility of an ED based fall prevention project.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Rhode Island
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Providence, Rhode Island, Соединенные Штаты, 02906
- The Miriam Hospital
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Providence, Rhode Island, Соединенные Штаты, 02903
- Rhode Island Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Community-dwelling adult (non-institutionalized) 65 years-old or older presenting to ED after a fall
- Able to communicate in English
- Fall not due to syncope or external force (i.e., struck by car or assault)
- Fall not due to serious illness (i.e. stroke, acute myocardial infarction)
- Will be discharged to home, assisted living, or rehabilitation at completion of ED visit (i.e., not admitted)
- Legally authorized representative present to give informed consent if patient has cognitive impairment on Six Item Screener (score of less than four)
Exclusion Criteria:
- Unable to give informed consent due to intoxication or altered mental status
- Presence of injuries that prevent mobilization (i.e., pelvic or lower extremity fractures)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Без вмешательства: Usual care
The ED clinician will perform a standard medical evaluation.
This evaluation includes a focused history and exam to identify injuries.
Laboratory tests and radiologic imaging may be ordered.
If necessary, the patient will receive consultation with specialty services (e.g., orthopedics).
The research assistant (RA) will read the CDC STEADI brochure to the patient and provide them with a printed copy at the conclusion of their visit.
The RA will solicit feedback from the clinician and the patient at the conclusion of the visit using the post-visit survey.
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Экспериментальный: Intervention
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Subjects will receive PT and pharmacist evaluation.
PT will help determine whether subject may benefit from doing exercises to improve strength or balance.
PT may also supply subject with an assist device.
A pharmacist will ask patient about any medication they are taking and will make recommendations on how their medication could be changed to prevent falls.
Pharmacists will communicate this information to subject's doctors.
Subjects will receive a fall calendar for home, where they will record any falls they have after their discharge from the ED.
They will receive a phone call at home asking about any recent falls and health care interactions.
Study personnel will call subjects every 2 weeks for 6 months.
Subjects may receive a referral for outpatient or home-based physical and occupational therapy at the end of the visit.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Feasibility of Implementing Intervention in Emergency Department
Временное ограничение: 12 Months
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Assess the feasibility of implementing this intervention in an ED setting.
We will report enrollment, reasons for accepting or declining enrollment, and drop-out from the study using the CONSORT approach.
We will compare the demographic characteristics of the GAPcare participants in both arms using Chi-square or Fisher's exact test for categorical variables and Student's t-test or Wilcoxon's test for continuous variables, as appropriate.
We will use Wilcoxon's test to compare the median ED length of stay between participants of both study arms.
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12 Months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Initial efficacy
Временное ограничение: 12 Months
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Determine if the GAPcare intervention versus usual care reduces subsequent falls and all-cause and fall-related ED visits and hospital admissions in the six-month follow-up.
We will compare the proportion and number of falls, ED visits, and hospital admissions in each group using chi-square (proportions) and Wilcoxon's and Student's t-tests (occurrence).
If sample size permits, we will conduct survival analysis to do a time-to-event analysis.
Survival time will be defined as the time from randomization to the time of the first recurrent fall, next ED visit, and hospital admission.
First, we will use the Kaplan-Meier method to estimate the cumulative probability of fall-free and visit-free survival time.
Next, we will use the log-rank test to test differences between survival curves for the intervention vs. usual care arm.
Finally, hazard ratios and 95% confidence intervals will be calculated using the Cox Proportional Hazards model.
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12 Months
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Feedback
Временное ограничение: 21-24 Months
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We will gather feedback from clinicians and patients on the utility and barriers of the GAPcare intervention versus usual care.
We will assess 1) patient satisfaction with the care delivered, 2) barriers and facilitators of the intervention, 3) suggestions for improvement, and 4) specific feedback from clinicians on the suitability of the intervention to an ED setting.
Researchers will review and code each transcript independently.
A consensus process will follow, in which the researchers will categorize data into common themes within each of the 4 domains.
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21-24 Months
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Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- Goldberg EM, Resnik L, Marks SJ, Merchant RC. GAPcare: the Geriatric Acute and Post-acute Fall Prevention Intervention-a pilot investigation of an emergency department-based fall prevention program for community-dwelling older adults. Pilot Feasibility Stud. 2019 Aug 27;5:106. doi: 10.1186/s40814-019-0491-9. eCollection 2019.
- Goldberg EM, Marks SJ, Ilegbusi A, Resnik L, Strauss DH, Merchant RC. GAPcare: The Geriatric Acute and Post-Acute Fall Prevention Intervention in the Emergency Department: Preliminary Data. J Am Geriatr Soc. 2020 Jan;68(1):198-206. doi: 10.1111/jgs.16210. Epub 2019 Oct 17.
- Goldberg EM, Marks SJ, Resnik LJ, Long S, Mellott H, Merchant RC. Can an Emergency Department-Initiated Intervention Prevent Subsequent Falls and Health Care Use in Older Adults? A Randomized Controlled Trial. Ann Emerg Med. 2020 Dec;76(6):739-750. doi: 10.1016/j.annemergmed.2020.07.025. Epub 2020 Aug 25.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- GAPcare
- R03AG056349 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования GAPcare intervention
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Meghan MarsacChildren's Hospital of PhiladelphiaЗавершенный
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Seton Healthcare FamilyUniversity of Texas at AustinЗавершенныйКачество жизни | Хроническое заболевание | Хроническое заболеваниеСоединенные Штаты
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University Medical Center GroningenGGZ Drenthe Mental Health InstitutionРекрутингСердечно-сосудистый риск | Депрессия, униполярная | Депрессия, биполярное расстройствоНидерланды
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Kessler FoundationUniversity of Southern California; VA Office of Research and Development; Kessler Institute... и другие соавторыНеизвестныйТравматическое повреждение мозгаСоединенные Штаты
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University of North Carolina, Chapel HillNational Institute of Allergy and Infectious Diseases (NIAID)РекрутингДоконтактная профилактика ВИЧСоединенные Штаты
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Duke UniversityNational Institutes of Health (NIH)Еще не набираютПродвинутый рак | Рак желудочно-кишечного тракта
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University of Illinois at ChicagoЗавершенный
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Hospital Clinic of BarcelonaInstitut d'Investigacions Biomèdiques August Pi i Sunyer; University of BarcelonaЗавершенныйЗаболевания печени | Неалкогольная жировая болезнь печени | Образ жизни, ЗдоровыйИспания
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Munich Municipal HospitalTechnical University of Munich; University of RegensburgНеизвестныйИнфаркт головного мозгаГермания