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

NCT ID: NCT02183740

Last Updated: 2017-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-08-31

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.

Detailed Description

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Conditions

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Fecal Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Multifaceted educational program

A multifaceted educational program for nursing home staff consisting of:

1. 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.
2. Recruitment of one local opinion leader per nursing home unit.
3. Seven educational outreach meetings (1 hour 30 minutes per meeting) during the three months intervention period.

Group Type EXPERIMENTAL

Multifaceted educational program

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multifaceted educational program

Intervention Type BEHAVIORAL

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Norwegian Nurses Organisation

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne G Vinsnes, Professor

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Sor Trondelag University College

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 25887238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26002520 (View on PubMed)

Other Identifiers

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HiST05

Identifier Type: -

Identifier Source: org_study_id

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