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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01939821
First Posted: September 11, 2013
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
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.

Condition Intervention
Fecal Incontinence Staffs' Attitudes Behavioral: Educational and counselling program Behavioral: Educational program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: A Pilot Study to Evaluate Feasibility of Educational Programs With Regard to Good Fecal Incontinence Care in Nursing Homes

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • The proportion patients assessed by the clinical guidelines [ Time Frame: 3 months ]
    90% of the patients assessed by the clinical guideline


Secondary Outcome Measures:
  • Proportion of completed patient health questionnaires [ Time Frame: 3 months ]
    Response rate more than 80%

  • Acceptable performance of multiple choice test measuring change in staff knowledge. [ Time Frame: 3 months ]
    80% claim that the test set understandable and relevant

  • The proportion of missing data in each completed questionnaire [ Time Frame: 3 months ]
    Less than 10%


Enrollment: 60
Study Start Date: September 2013
Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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."
Active Comparator: Educational program
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.
Behavioral: 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.
No Intervention: Control group
The control group will not receive any educational program. It represents the present real life in nursing homes.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939821


Locations
Norway
Sør-Trøndelag University College
Trondheim, Norway, 7004
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Lene Blekken, DrPH Norwegian University of Science and Technology
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01939821     History of Changes
Other Study ID Numbers: HIST
ES507368 ( Other Identifier: Sør-Trøndelag University College, Norway )
First Submitted: July 4, 2013
First Posted: September 11, 2013
Last Update Posted: January 26, 2017
Last Verified: January 2017

Keywords provided by Norwegian University of Science and Technology:
Fecal incontinence
attitudes
knowledge
quality of care

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases