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Completed

NCT Number: NCT01939821

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

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.

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Key information

Conditions

Fecal Incontinence Behavior Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Staffs' Attitudes

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sør-Trøndelag University College

Trondheim, 7004, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Educational and counselling program

Behavioral

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

Behavioral

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 outcomes

  1. The proportion patients assessed by the clinical guidelines

    Time frame: 3 months

    90% of the patients assessed by the clinical guideline

Secondary outcomes

  1. Proportion of completed patient health questionnaires

    Time frame: 3 months

    Response rate more than 80%

  2. Acceptable performance of multiple choice test measuring change in staff knowledge.

    Time frame: 3 months

    80% claim that the test set understandable and relevant

  3. The proportion of missing data in each completed questionnaire

    Time frame: 3 months

    Less than 10%

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

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

Acronym: PEI

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2013
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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