Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence (EPSPFI)
Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence: a Cluster-randomized Controlled Trial
Fecal incontinence (FI) has an increasing prevalence in the geriatric population which cannot be explained by co-morbidity or anatomical and psychological changes of aging alone. In the nursing home population previous studies suggest a prevalence between 10 and 69%, but is most often reported to be between 40 and 55%. FI leads to a high direct and indirect economic burden to the health-care system, and is an important cause og institutionalization of the elderly patients. In addition, FI is associated with shame, social isolation and reduced quality of life.
The importance of identifying treatable causes of FI in the frail elderly, rather than just managing passively, is strongly emphasized. It is indicated that the level of awareness among health personnel regarding appropriate assessment and treatment options is limited, and that FI is considered a normal part of aging.
This study is based on the assumption that FI among nursing home patients can be prevented, cured or ameliorated by offering nursing home staff knowledge of best practise. The primary objective of the study is to test the hypothesis that a multifaceted educational program for staff on assessment and treatment of FI, is associated with a reduction in patients' frequency of FI.
The design of the study is a two armed cluster randomized trail (C-RCT) with a repeated cross-sectional approach.The results will be analysed according to multilevel and longitudinal modelling, and the study will use mixed effect models with the cluster treated as a random effect.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Trondheim, Норвегия, 7004
- Sor Trondelag University College
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Nursing homes with similar:
- patients characteristcs
- care staff/patients ratio
- general practitioner consultancy
Patients:
- All patients on long term care residency (residency >month)
Registered Nurses/authorized social educators:
- All working half time or more
Exclusion Criteria:
Nursing homes:
- With some kind of speciality (eks rehabilitation, dementia)
Patients:
- Short term care residency
Registered nurses/authorized social educator:
- Working less than half time
- Working only night shifts
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Multifaceted educational program
A multifaceted educational program for nursing home staff consisting of:
|
|
|
Без вмешательства: Control
The control arm will not receive any educational program and will continue with usual care.
Data with information about ordinary care will be gathered as part of the data collection procedure in the study.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in frequency of fecal incontinence among patients
Временное ограничение: Baseline, after 3 months and after 6 months
|
As measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012), section H: Continence.
Because of relatively high risk of death and movement out of clusters, a repeated cross-sectional opproach to analyses will be used.
Frequency of FI will thereby be analysed on a across-sectional group level.
|
Baseline, after 3 months and after 6 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Remission of fecal incontinence among patients
Временное ограничение: Baseline, after 3 months and after 6 months
|
For remission of FI a cohort approach to data analyses with only those identified with FI at baseline and still present at 3 and 6 month follow-up, will be included in the analyses
|
Baseline, after 3 months and after 6 months
|
|
Change in knowledge among registered nurses and authorized social educators
Временное ограничение: Baseline, after 3 months and after 6 months
|
Measured my a multiple choice test
|
Baseline, after 3 months and after 6 months
|
|
Change in FI-related concerns among patients
Временное ограничение: Baseline, after 3 months and after 6 months
|
Relevant concerns as measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012) are: Mood and behavior, psycho-social wellbeing, urinary continence, constipation, diarrhea, skin condition, participation in activities
|
Baseline, after 3 months and after 6 months
|
|
Correlates of FI among patients
Временное ограничение: Baseline, after 3 months and after 6 months
|
Relevant correlates as measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012) are: cognitive functioning, communication and vision, functionality and mobility, medical diagnosis, mouth and nutrition status, medications, treatment, examination/procedures
|
Baseline, after 3 months and after 6 months
|
|
Change in behavior among health personnel
Временное ограничение: Baseline, after 3 months and after 6 months
|
Measured by analyses of patient assessments and interventions as documented by health personnel in the electronic patient record and by the Fecal Incontinence in Nursing Home Patients questionnaire
|
Baseline, after 3 months and after 6 months
|
Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Anne G Vinsnes, Professor, Norwegian University of Science and Technology
Публикации и полезные ссылки
Общие публикации
- Blekken LE, Vinsnes AG, Gjeilo KH, Morkved S, Salvesen O, Norton C, Nakrem S. Effect of a multifaceted educational program for care staff concerning fecal incontinence in nursing home patients: study protocol of a cluster randomized controlled trial. Trials. 2015 Mar 1;16:69. doi: 10.1186/s13063-015-0595-3.
- Blekken LE, Nakrem S, Gjeilo KH, Norton C, Morkved S, Vinsnes AG. Feasibility, acceptability, and adherence of two educational programs for care staff concerning nursing home patients' fecal incontinence: a pilot study preceding a cluster-randomized controlled trial. Implement Sci. 2015 May 23;10:72. doi: 10.1186/s13012-015-0263-8.
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
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
- HiST05
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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. .