Clinical trial NCT02183740: Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence
Official title: Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence: a Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Keywords: Education
Nurses
Nursing homes
Fecal incontinence
Cluster-randomized controlled trial
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Norwegian Nurses Organisation
First posted: 2014-07-08
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in frequency of fecal incontinence among patients
timeFrame: Baseline, after 3 months and after 6 months
Secondary outcomes:
measure: Remission of fecal incontinence among patients
timeFrame: Baseline, after 3 months and after 6 months
measure: Change in knowledge among registered nurses and authorized social educators
timeFrame: Baseline, after 3 months and after 6 months
measure: Change in FI-related concerns among patients
timeFrame: Baseline, after 3 months and after 6 months
measure: Correlates of FI among patients
timeFrame: Baseline, after 3 months and after 6 months
measure: Change in behavior among health personnel
timeFrame: Baseline, after 3 months and after 6 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Sor Trondelag University College
Study officials:
affiliation: Norwegian University of Science and Technology
name: Anne G Vinsnes, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.