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

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Multifaceted educational program
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Education, Nurses, Nursing homes, Fecal incontinence, Cluster-randomized controlled trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sor Trondelag University College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multifaceted educational program

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Change in knowledge among registered nurses and authorized social educators
Measured my a multiple choice test
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
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
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

Full Information

First Posted
June 26, 2014
Last Updated
January 25, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Nurses Organisation
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1. Study Identification

Unique Protocol Identification Number
NCT02183740
Brief Title
Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence
Acronym
EPSPFI
Official Title
Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence: a Cluster-randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Nurses Organisation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
Education, Nurses, Nursing homes, Fecal incontinence, Cluster-randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifaceted educational program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multifaceted educational program
Primary Outcome Measure Information:
Title
Change in frequency of fecal incontinence among patients
Description
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.
Time Frame
Baseline, after 3 months and after 6 months
Secondary Outcome Measure Information:
Title
Remission of fecal incontinence among patients
Description
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
Time Frame
Baseline, after 3 months and after 6 months
Title
Change in knowledge among registered nurses and authorized social educators
Description
Measured my a multiple choice test
Time Frame
Baseline, after 3 months and after 6 months
Title
Change in FI-related concerns among patients
Description
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
Time Frame
Baseline, after 3 months and after 6 months
Title
Correlates of FI among patients
Description
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
Time Frame
Baseline, after 3 months and after 6 months
Title
Change in behavior among health personnel
Description
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
Time Frame
Baseline, after 3 months and after 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne G Vinsnes, Professor
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sor Trondelag University College
City
Trondheim
ZIP/Postal Code
7004
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25887238
Citation
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.
Results Reference
background
PubMed Identifier
26002520
Citation
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.
Results Reference
background

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

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