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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Trondheim、ノルウェー、7004
- Sor Trondelag University College
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Multifaceted educational program
A multifaceted educational program for nursing home staff consisting of:
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介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in frequency of fecal incontinence among patients
時間枠：Baseline, after 3 months and after 6 months
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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.
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Baseline, after 3 months and after 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Remission of fecal incontinence among patients
時間枠：Baseline, after 3 months and after 6 months
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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
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Baseline, after 3 months and after 6 months
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Change in knowledge among registered nurses and authorized social educators
時間枠：Baseline, after 3 months and after 6 months
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Measured my a multiple choice test
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Baseline, after 3 months and after 6 months
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Change in FI-related concerns among patients
時間枠：Baseline, after 3 months and after 6 months
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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
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Baseline, after 3 months and after 6 months
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Correlates of FI among patients
時間枠：Baseline, after 3 months and after 6 months
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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
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Baseline, after 3 months and after 6 months
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Change in behavior among health personnel
時間枠：Baseline, after 3 months and after 6 months
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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
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Baseline, after 3 months and after 6 months
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協力者と研究者
捜査官
- 主任研究者：Anne G Vinsnes, Professor、Norwegian University of Science and Technology
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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