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

January 25, 2017 updated by: Norwegian University of Science and Technology

A Pilot Study to Evaluate Feasibility of Educational Programs With Regard to Good 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7004
        • Sør-Trøndelag University College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion patients assessed by the clinical guidelines
Time Frame: 3 months
90% of the patients assessed by the clinical guideline
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of completed patient health questionnaires
Time Frame: 3 months
Response rate more than 80%
3 months
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 months
The proportion of missing data in each completed questionnaire
Time Frame: 3 months
Less than 10%
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Lene Blekken, DrPH, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

September 6, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIST
  • ES507368 (Other Identifier: Sør-Trøndelag University College, Norway)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fecal Incontinence

Clinical Trials on Educational and counselling program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe