A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes
PEI
A Pilot Study to Evaluate Feasibility of Educational Programs With Regard to Good Fecal Incontinence Care in Nursing Homes
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedJanuary 26, 2017
January 1, 2017
4 months
July 4, 2013
January 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion patients assessed by the clinical guidelines
90% of the patients assessed by the clinical guideline
3 months
Secondary Outcomes (3)
Proportion of completed patient health questionnaires
3 months
Acceptable performance of multiple choice test measuring change in staff knowledge.
3 months
The proportion of missing data in each completed questionnaire
3 months
Study Arms (3)
Educational and counselling program
EXPERIMENTALIn addition to educational meeting and printed educational material the investigators will include the use of local opinion leaders and educational outreach
Educational program
ACTIVE COMPARATORThe 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.
Control group
NO INTERVENTIONThe control group will not receive any educational program. It represents the present real life in nursing homes.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sør-Trøndelag University College
Trondheim, 7004, Norway
Related Publications (1)
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.
PMID: 26002520RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lene Blekken, DrPH
Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2013
First Posted
September 11, 2013
Study Start
September 1, 2013
Primary Completion
January 1, 2014
Study Completion
April 1, 2014
Last Updated
January 26, 2017
Record last verified: 2017-01