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

Fecal Incontinence Clinical Trial

— EPSPFI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183740
• Other study ID #: HiST05
• Status: Completed
• Phase: N/A
• First received: June 26, 2014
• Last updated: January 25, 2017
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: January 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Behavioral:
• Multifaceted educational program

Locations

Country	Name	City	State
Norway	Sor Trondelag University College	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Norwegian Nurses Organisation

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Blekken LE, Nakrem S, Gjeilo KH, Norton C, Mørkved 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. — View Citation

Blekken LE, Vinsnes AG, Gjeilo KH, Mørkved S, Salvesen Ø, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in knowledge among registered nurses and authorized social educators	Measured my a multiple choice test	Baseline, after 3 months and after 6 months
Secondary	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
Secondary	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
Secondary	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