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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sør-Trøndelag University College
ClinicalTrials.gov Identifier:
NCT01939821
First received: July 4, 2013
Last updated: May 2, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Sør-Trøndelag University College:

Primary Outcome Measures:
  • The proportion patients assessed by the clinical guidelines [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    90% of the patients assessed by the clinical guideline


Secondary Outcome Measures:
  • Proportion of completed patient health questionnaires [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Response rate more than 80%

  • Acceptable performance of multiple choice test measuring change in staff knowledge. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    80% claim that the test set understandable and relevant

  • The proportion of missing data in each completed questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01939821

Locations
Norway
Sør-Trøndelag University College
Trondheim, Norway, 7004
Sponsors and Collaborators
Sør-Trøndelag University College
Investigators
Principal Investigator: Vinsnes G Vinsnes, DrPH Sør-Trøndelag University College
  More Information

No publications provided

Responsible Party: Sør-Trøndelag University College
ClinicalTrials.gov Identifier: NCT01939821     History of Changes
Other Study ID Numbers: HIST, ES507368
Study First Received: July 4, 2013
Last Updated: May 2, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Sør-Trøndelag University College:
Fecal incontinence
attitudes
knowledge
quality of care

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

ClinicalTrials.gov processed this record on August 20, 2014