Clinical trial NCT01939821: A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes
Official title: A Pilot Study to Evaluate Feasibility of Educational Programs With Regard to Good Fecal Incontinence Care in Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Staffs' Attitudes
Keywords: Fecal incontinence
attitudes
knowledge
quality of care
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators are planning to do a cluster randomized trial to test the effect of different educational programs for staff according to nursing home patients FI (fecal incontinence). Since there are very few published trials of treatment of FI in older people, and no rigorously evaluated studies on interventions for FI in nursing homes, or rigorously evaluated continence education program for staff concerning continence care, a pilot study is necessary. The aim for the pilot study is to evaluate feasibility, acceptability and adherence according to the educational intervention, methods used and outcome measures. This is designed to be an external pilot study. External pilot studies are small scale versions of the main study which are not intended to be part of the main study. The pilot intervention period is 3 month.


Eligibility criteria: Inclusion Criteria:

* Nursing homes Wards with 24 hour long term care residency, similar nurse/patient ratio and General Practitioner consultancy, comparable patient groups according to frailty, comparable ward size according to number of patients and staff.
* Patients All patients on long term residency (1 month or more) are eligible for measurements.
* Registered nurses (RN) and authorized social educators (ASE) RN's and ASE's with position above 50% are eligible according to participation in the educational meeting and to be recruited as a local opinion leader in intervention 2. All staff is invited to the educational outreach meetings throughout the intervention period.

Exclusion Criteria:

* Nursing homes with diverse staff and patient composition
* Patients on short term residency
* Registered nurses (RN) and authorized social educators (ASE) RN's and ASE's with position less than 50%

Primary outcomes:
measure: The proportion patients assessed by the clinical guidelines
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of completed patient health questionnaires
timeFrame: 3 months
measure: Acceptable performance of multiple choice test measuring change in staff knowledge.
timeFrame: 3 months
measure: The proportion of missing data in each completed questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Sør-Trøndelag University College
Study officials:
affiliation: Norwegian University of Science and Technology
name: Lene Blekken, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
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.