Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence

Study Overview
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Brief Summary
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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.

Official Title
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Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence: a Cluster-randomized Controlled Trial

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Behavioral: Multifaceted educational program


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifaceted educational program<br>A multifaceted educational program for nursing home staff consisting of: One seven hours educational meeting (interactive workshop) conducted in the nursing home. Theoretical input and case-base discussions considering guidelines for nurse led assessment og interventions of patients fecal incontinence.The content will be made available as educational material. Recruitment of one local opinion leader per nursing home unit. Seven educational outreach meetings (1 hour 30 minutes per meeting) during the three months intervention period. | Behavioral: Multifaceted educational program<br> <br> |
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency of fecal incontinence among patients | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission of fecal incontinence among patients | 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 | Measured my a multiple choice test | Baseline, after 3 months and after 6 months | 
| Change in FI-related concerns among patients | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Education, Nurses, Nursing homes, Fecal incontinence, Cluster-randomized controlled trial