Back to resultsA Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes (PEI)
Primary Purpose
Fecal Incontinence, Staffs' Attitudes
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Educational and counselling program
Educational program
Sponsored by
About this trial
This is an interventional health services research trial for Fecal Incontinence focused on measuring Fecal incontinence, attitudes, knowledge, quality of care
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%
Sites / Locations
- Sør-Trøndelag University College
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Educational and counselling program
Educational program
Control group
Arm Description
In addition to educational meeting and printed educational material the investigators will include the use of local opinion leaders and educational outreach
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.
The control group will not receive any educational program. It represents the present real life in nursing homes.
Outcomes
Primary Outcome Measures
The proportion patients assessed by the clinical guidelines
90% of the patients assessed by the clinical guideline
Secondary Outcome Measures
Proportion of completed patient health questionnaires
Response rate more than 80%
Acceptable performance of multiple choice test measuring change in staff knowledge.
80% claim that the test set understandable and relevant
The proportion of missing data in each completed questionnaire
Less than 10%
Full Information
NCT ID
NCT01939821
First Posted
July 4, 2013
Last Updated
January 25, 2017
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT01939821
Brief Title
A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes
Acronym
PEI
Official Title
A Pilot Study to Evaluate Feasibility of Educational Programs With Regard to Good Fecal Incontinence Care in Nursing Homes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence, Staffs' Attitudes
Keywords
Fecal incontinence, attitudes, knowledge, quality of care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational and counselling program
Arm Type
Experimental
Arm Description
In addition to educational meeting and printed educational material the investigators will include the use of local opinion leaders and educational outreach
Arm Title
Educational program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will not receive any educational program. It represents the present real life in nursing homes.
Intervention Type
Behavioral
Intervention Name(s)
Educational and counselling program
Intervention Description
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."
Intervention Type
Behavioral
Intervention Name(s)
Educational program
Intervention Description
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.
Primary Outcome Measure Information:
Title
The proportion patients assessed by the clinical guidelines
Description
90% of the patients assessed by the clinical guideline
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Proportion of completed patient health questionnaires
Description
Response rate more than 80%
Time Frame
3 months
Title
Acceptable performance of multiple choice test measuring change in staff knowledge.
Description
80% claim that the test set understandable and relevant
Time Frame
3 months
Title
The proportion of missing data in each completed questionnaire
Description
Less than 10%
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene Blekken, DrPH
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sør-Trøndelag University College
City
Trondheim
ZIP/Postal Code
7004
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
26002520
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.
Results Reference
result
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A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes
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