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NCT Number: NCT02183740

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

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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sor Trondelag University College

Trondheim, 7004, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multifaceted educational program

Behavioral

Primary outcomes

  1. Change in frequency of fecal incontinence among patients

    Time frame: 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.

Secondary outcomes

  1. Remission of fecal incontinence among patients

    Time frame: 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

  2. Change in knowledge among registered nurses and authorized social educators

    Time frame: Baseline, after 3 months and after 6 months

    Measured my a multiple choice test

  3. Change in FI-related concerns among patients

    Time frame: 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

  4. Correlates of FI among patients

    Time frame: 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

  5. Change in behavior among health personnel

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Norwegian Nurses Organisation

Registry information

Official study title

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

Acronym: EPSPFI

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 8, 2014
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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