A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes

Fecal Incontinence Clinical Trial

— PEI  

Official title:

A Pilot Study to Evaluate Feasibility of Educational Programs With Regard to Good Fecal Incontinence Care in Nursing Homes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939821
• Other study ID #: HIST
• Secondary ID: ES507368
• Status: Completed
• Phase: N/A
• First received: July 4, 2013
• Last updated: January 25, 2017
• Start date: September 2013
• Est. completion date: April 2014

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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%

Related Conditions & MeSH terms

• Fecal Incontinence
• Staffs' Attitudes

Intervention

Behavioral:
• Educational and counselling program
Educational and counselling program: In addition to educational meeting and printed educational material the investigators will include the use of local opinion leaders and educational outreach . Local opinion leaders are defined as "use of providers nominated by their colleges as educationally influential". Opinion leadership is the degree to which an individual is able to influence other individual's attitudes or overt behavior informally in a desired way with relative frequency. Educational outreach is defined as "use of a trained person who meets with providers in their practice setting to give information with the intent of changing the providers practice."
• Educational program
Educational program: Educational meeting and printed educational material Educational meeting is defined as "participation of healthcare providers in conference, lectures, workshops or traineeships". The investigators want to organize the educational meetings as an interactive workshop that target knowledge, attitudes, and skills at the individual healthcare professional/peer group level. Printed educational material is defined as "distribution of published or printed recommendations for clinical care, including clinical practice guidelines". In general, printed educational material target knowledge and potential skill gaps of individual healthcare professionals.

Locations

Country	Name	City	State
Norway	Sør-Trøndelag University College	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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 contr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion patients assessed by the clinical guidelines	90% of the patients assessed by the clinical guideline	3 months
Secondary	Proportion of completed patient health questionnaires	Response rate more than 80%	3 months
Secondary	Acceptable performance of multiple choice test measuring change in staff knowledge.	80% claim that the test set understandable and relevant	3 months
Secondary	The proportion of missing data in each completed questionnaire	Less than 10%	3 months